HAI115879: Dose Ranging of GSK2336805 in Combination Therapy

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01648140
• Collaborator: PPD (Industry)
• Enrollment: 286
• Locations: 34
• Arms: 4
• Duration (Months): 23.5
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection.

In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: GSK2336805 40 mg; Drug: GSK2336805 60 mg; Drug: Pegylated interferon alpha-2a; Drug: Ribavirin; Drug: Telaprevir	Phase 2

Detailed Description

Subjects with chronic genotype 1 hepatitis C virus (HCV) infection will be randomly assigned on a 2:2:1 basis to 1 of 3 treatment arms: T40 (GSK2336805 40 mg and PEG + RIBA) or T60 (GSK2336805 60 mg and PEG + RIBA) or PEG + RIBA and telaprevir (PRT). Randomization will be stratified by interleukin 28B (IL28B) rs12979860 status (C/C versus carriage of the T allele), HCV genotype (1a vs. 1b), and plasma HCV Ribonucleic Acid (RNA) (<800,000 IU/mL versus ≥800,000 IU/mL).

An additional nonrandomized single-arm cohort of subjects with chronic genotype 4 HCV infection will be enrolled in parallel. A maximum of 15 genotype 4 subjects will receive GSK2336805 60 mg and PEG + RIBA. The purpose of this cohort is to further characterize the antiviral activity of GSK2336805 in subjects with chronic genotype 4 HCV infection. The schedule of assessments for the genotype 4 subjects will be the same as for the genotype 1 subjects. Recruitment of the genotype 4 subjects may be terminated when the target sample of genotype 1 subjects have been randomized.

Subjects in a GSK2336805 treatment arm who achieve extended rapid virologic response (eRVR) will receive a total of 24 weeks of therapy (12 weeks GSK2336805 in combination with PEG + RIBA followed by 12 weeks PEG + RIBA). Subjects who are HCV detectable at Week 4 and then undetectable at Week 12 will receive a total of 48 weeks of therapy (12 weeks GSK2336805 in combination with PEG + RIBA followed by 36 weeks PEG + RIBA). Subjects in the telaprevir treatment control arm will be managed according to the current product label for treatment-naïve subjects.

Subjects who complete treatment will undergo follow-up monitoring for 24 weeks after completion of therapy. At the end of the 24-week follow-up visit, subjects will have completed their participation in the study. The total duration of the study will be 48 weeks for subjects who achieve eRVR at Week 12 and up to 72 weeks for subjects who do not achieve eRVR at Week 12.

Study Design

• Study Type: Interventional
• Actual Enrollment: 286 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 16, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T40 Hepatitis C virus (HCV) genotype 1 GSK2336805 40 mg, pegylated interferon alpha-2a, and ribavirin arm	Drug: GSK2336805 40 mg; 20 mg tablet, round, 10-mm diameter, white to off-white, no markings; Drug: Pegylated interferon alpha-2a; 180 microgram per 0.5 mL prefilled syringe for single use; Other Names: Pegasys ; Drug: Ribavirin; 200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with "200" on 1 side and the logo "3RP" on the other side; Other Names: Ribasphere
Experimental: T60 Hepatitis C virus (HCV) genotype 1 GSK2336805 60 mg, pegylated interferon alpha-2a, and ribavirin arm	Drug: GSK2336805 60 mg; 30 mg tablet, round, 10-mm diameter, white to off-white, no markings; Drug: Pegylated interferon alpha-2a; 180 microgram per 0.5 mL prefilled syringe for single use; Other Names: Pegasys ; Drug: Ribavirin; 200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with "200" on 1 side and the logo "3RP" on the other side; Other Names: Ribasphere
Active Comparator: PRT Hepatitis C virus (HCV) genotype 1 Telaprevir, pegylated interferon alpha-2a, and ribavirin arm	Drug: Pegylated interferon alpha-2a; 180 microgram per 0.5 mL prefilled syringe for single use; Other Names: Pegasys ; Drug: Ribavirin; 200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with "200" on 1 side and the logo "3RP" on the other side; Other Names: Ribasphere ; Drug: Telaprevir; 375 mg film-coated tablet; Other Names: Incivek (United States) Incivo (European Union)
Experimental: G4 Hepatitis C virus (HCV) genotype 4 GSK2336805 60 mg, pegylated interferon alpha-2a, and ribavirin arm	Drug: GSK2336805 60 mg; 30 mg tablet, round, 10-mm diameter, white to off-white, no markings; Drug: Pegylated interferon alpha-2a; 180 microgram per 0.5 mL prefilled syringe for single use; Other Names: Pegasys ; Drug: Ribavirin; 200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with "200" on 1 side and the logo "3RP" on the other side; Other Names: Ribasphere

Outcome Measures

Primary Outcome Measures

1. Number of Participants Achieving eRVR [Week 4 and Week 12]

   eRVR is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.

2. Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 [From the start of study treatment up to Week 12]

   An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

3. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 [Baseline (Week 0) up to 12-week treatment period]

   Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

4. Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12]

   Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

5. Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

   Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

6. Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

   Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

7. Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

   Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

8. Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

   Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

9. Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

   Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

10. Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

    Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

11. Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

    Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

12. Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

    Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

13. Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

    Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

14. Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12]

    Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

15. Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 [Baseline (Week 0), Weeks 2 and 12]

    Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.

16. Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1 and 12]

    The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

17. Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 [Baseline (Week 0) and Weeks 1 and 12]

    The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Secondary Outcome Measures

1. Number of Participants With Any AEs and Any SAEs After Week 12 [From Week 12 up to PT Week 24 FU]

   An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

2. Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) [From the start of the treatment up to PT FU Week 24]

   Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.

3. Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 [Day 1, Day 2, Week 4, and Week 12]

   Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.

4. Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4 [Week 4 (24 h post dose)]

   Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.

5. Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4 [Week 4 (24 h post dose)]

   Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.

6. Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4 [Week 4 (24 h post dose)]

   Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.

7. Apparent Clearance (CL/F) at Week 4 [Week 4 (24 h post dose)]

   Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).

8. Apparent Volume of Distribution (Vz/F) at Week 4 [Week 4 (24 h post dose)]

   Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.

9. Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

   Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

10. Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

11. Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

12. Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

13. Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

14. Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

15. Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

16. Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

17. Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.

18. Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.

19. Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

20. Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

21. Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.

22. Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 [Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4]

    Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

23. Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status [Week 4 and Week 12]

    Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

24. Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status [Week 4 and Week 12]

    Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

25. Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status [Week 4]

    Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

26. Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status [Week 4]

    Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

27. Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status [Week 4 and Week 12]

    Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

28. Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2 [Day 2]

    Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

• Male or female aged 18 to 70 years of age, inclusive, at Screening.

• Genotype 1 or genotype 4 hepatitis C virus (HCV) infection as assessed by Versant HCV Genotype assay 2.0 (LiPA).

• Chronic HCV infection documented by at least 1 measurement of serum HCV RNA greater than or equal to 100,000 IU/mL measured during Screening by the COBAS High Pure/COBAS

TaqMan HCV Test v2.0 and at least one of the following:

• A positive anti-HCV antibody, HCV RNA, or HCV genotype test at least 6 months prior to Baseline (Day 1) together with positive HCV RNA and anti-HCV antibody tests at the time of Screening; or

• A positive HCV RNA test and anti-HCV antibody test at the time of Screening together with either a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis).

• Naïve to all HCV antiviral treatment(s), including, but not limited to, immunomodulatory and nucleoside/nucleotide treatments for chronic HCV infection.

• Agree to interleukin 28B (IL28B) genotyping.

• A subject, who, in the opinion of the investigator, is an appropriate candidate for pegylated interferon alpha-2a (PEG)/ribavirin (RIBA)/protease inhibitor combination therapy for genotype 1 subjects and PEG/RIBA combination therapy for genotype 4 subjects.

• Body mass index >18 kg/m2 but not exceeding 36 kg/m2.

• A liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of noncirrhotic as judged by a local pathologist (defined as Knodell less than or equal to 3, Metavir less than or equal to 2, Ishak less than or equal to 4, or Batts and Ludwig less than or equal to 2). Both incomplete and transition to cirrhosis (e.g., Metavir score 3) are considered as cirrhosis. If no recent (<36 months) liver biopsy is available, a study-qualifying biopsy must be performed prior to Baseline (Day 1).

• All fertile males and females must use 2 forms of effective contraception between them during treatment and during the 24 weeks after treatment ends.

• Females, is eligible to enter and participate in the study if of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) and includes any female who has had a hysterectomy or has had a bilateral oophorectomy (ovariectomy) or has had a bilateral tubal ligation or is postmenopausal (demonstrate total cessation of menses for greater than 1 year).

• Females, is eligible to enter and participate in the study if of childbearing potential and has a negative urine or serum pregnancy test at Screening and within the 24-hour period prior to the first dose of study medication and completely abstains from intercourse for 2 weeks before exposure to the study medication, throughout the clinical study, and for 24 weeks after completion or premature discontinuation from this study or uses 2 of the following acceptable methods of contraception throughout the clinical study and for 24 weeks after completion or premature discontinuation from this study:

• Any intrauterine device with a documented failure rate of <1% per year

• Double-barrier contraception (condom, diaphragm, or cervical cap used with spermicidal jelly)

• Male partner who is sterile prior to the female subject's study entry and is the sole sexual partner for that female

• Any other contraceptive method with a documented failure rate of <1% per year

• Otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening.

Exclusion Criteria:

• Positive test at Screening visit for hepatitis B surface antigen (HBsAg) or antihuman immunodeficiency virus antibody

• History of any other clinically significant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson's disease, 1-antitrypsin deficiency, alcoholic liver disease, >Grade 1 nonalcoholic steatohepatitis, and toxin exposures). Subjects with Gilbert's syndrome who otherwise meet all inclusion/exclusion criteria are eligible.

• History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease

• Positive results on urine screen for drugs of abuse test at Screening (unless used as medical treatment, e.g., with a prescription)

• History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation program)

• Screening visit electrocardiogram corrected QT (QTc) interval value >450 ms and/or clinically significant electrocardiogram findings

• Personal or family history of Torsade de Pointes findings

• Pregnant or nursing

• Male with a female partner who is pregnant

• Abnormal hematological and biochemical parameters, including:

• Neutrophil count <1500 cells/mm3 (or <1250 cells/mm3 for African American/Black subjects)

• Hemoglobin <11 g/dL in females or <12 g/dL in males

• Creatinine greater than or equal to 1.5 × the upper limit of normal (ULN)

• Estimated creatinine clearance less than or equal to 50 mL/min (as calculated using the Cockcroft-Gault formula)

• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase greater than or equal to 5 × ULN

• Total bilirubin greater than or equal to 2.0 × ULN (except subjects with Gilbert's syndrome)

• Albumin less than or equal to 3.0 g/dL

• Platelet count less than or equal to 90,000/mm3

• History of major organ transplantation with an existing functional graft

• Thyroid dysfunction not adequately controlled

• History of suicide attempt or hospitalization for depression in the past 5 years

• History of any current (within 6 months) severe or poorly controlled psychiatric disorder

• Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago are eligible for study participation but must be assessed and followed (if recommended) by a mental health professional.

• History or current evidence of immunologic disorder; cardiac or pulmonary disease; seizure disorder; or cancer or history of malignancy that in the opinion of the investigator makes the subject unsuitable for the study.

• Treated with herbal or natural remedies with antiviral activity within 30 days of the baseline visit or has a history of having received any systemic antineoplastic or immunomodulatory treatment (including mycophenolate mofetil, thymosin alpha, supraphysiologic doses of steroids >10 mg/day and radiation) within 6 months of the baseline visit or expects that such treatment will be needed at any time during the study.

• Participated in a clinical study with an investigational drug, biologic, or device within 3 months prior to the first dose administration.

• History of a known allergy to antiviral medications, including telaprevir, pegylated interferon alpha-2a (PEG), ribavirin (RIBA), or any excipient in the investigational product or history of drug or other allergy that, in the opinion of the investigator, contradicts participation.

• Requires prohibited medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Dothan	Alabama	United States	36305
2	GSK Investigational Site	Anaheim	California	United States	92801
3	GSK Investigational Site	Los Angeles	California	United States	90017
4	GSK Investigational Site	DeLand	Florida	United States	32720
5	GSK Investigational Site	Orlando	Florida	United States	32806
6	GSK Investigational Site	Columbus	Georgia	United States	31904
7	GSK Investigational Site	Savannah	Georgia	United States	31405
8	GSK Investigational Site	Baltimore	Maryland	United States	21229
9	GSK Investigational Site	Brockton	Massachusetts	United States	02302
10	GSK Investigational Site	Springfield	Massachusetts	United States	01105
11	GSK Investigational Site	Las Vegas	Nevada	United States	89109
12	GSK Investigational Site	New York	New York	United States	10016
13	GSK Investigational Site	Asheville	North Carolina	United States	28801
14	GSK Investigational Site	Fayetteville	North Carolina	United States	28304
15	GSK Investigational Site	Jenkintown	Pennsylvania	United States	19046
16	GSK Investigational Site	Houston	Texas	United States	77074
17	GSK Investigational Site	Annandale	Virginia	United States	22003
18	GSK Investigational Site	Norfolk	Virginia	United States	23502
19	GSK Investigational Site	Brussels		Belgium	1070
20	GSK Investigational Site	Liege		Belgium	4000
21	GSK Investigational Site	Sofia		Bulgaria	1407
22	GSK Investigational Site	Sofia		Bulgaria	1431
23	GSK Investigational Site	Sofia		Bulgaria	1606
24	GSK Investigational Site	Varna		Bulgaria	9010
25	GSK Investigational Site	Lyon Cedex 04		France	69317
26	GSK Investigational Site	Paris Cedex 13		France	75651
27	GSK Investigational Site	Pessac Cedex		France	33604
28	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
29	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69120
30	GSK Investigational Site	Wuerzburg	Bayern	Germany	97080
31	GSK Investigational Site	Berlin		Germany	13353
32	GSK Investigational Site	Hamburg		Germany	20099
33	GSK Investigational Site	Ponce		Puerto Rico	00716
34	GSK Investigational Site	San Juan		Puerto Rico	00927

Sponsors and Collaborators

• GlaxoSmithKline
• PPD

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Protocol contains no citations

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01648140
• Other Study ID Numbers: 115879
• First Posted: Jul 24, 2012
• Last Update Posted: Jun 2, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Genotype 4; GSK2336805; pegylated interferon; telaprevir; Genotype 1; chronic hepatitis C; ribavirin; NS5A inhibitor; hepatitis C virus (HCV) infection
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a

Study Results

Participant Flow

Recruitment Details	This study was conducted across 29 centers in 6 countries (United States, Puerto Rico, Germany, Belgium, France, and Bulgaria) from 15 August 2012 to 16 July 2014.
Pre-assignment Detail	Participants with treatment-naïve(TN) chronic genotype1(G1) hepatitis C virus (HCV) infection were randomly allocated on 2:2:1 basis to 2 dose levels of GSK2336805 or telaprevir. In a nonrandomized single-arm cohort, participants with TN genotype4(G4) chronic HCV infection were enrolled in parallel at dose level of 60 milligrams (mg) of GSK2336805.

Arm/Group Title	GSK2336805 40 mg, G1 HCV	GSK2336805 60 mg, G1 HCV	Telaprevir, G1 HCV	GSK2336805 60 mg, G4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Period Title: Overall Study
STARTED	41	40	17	13
COMPLETED	29	28	9	11
NOT COMPLETED	12	12	8	2

Baseline Characteristics

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV	Total
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Total of all reporting groups
Overall Participants	41	40	17	13	111
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.7 (13.23)	40.8 (9.87)	39.4 (12.02)	45.3 (11.46)	42.2 (11.73)
Sex: Female, Male (Count of Participants)
Female	13 31.7%	16 40%	6 35.3%	3 23.1%	38 34.2%
Male	28 68.3%	24 60%	11 64.7%	10 76.9%	73 65.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	1 7.7%	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	6 14.6%	6 15%	2 11.8%	3 23.1%	17 15.3%
White	34 82.9%	33 82.5%	15 88.2%	9 69.2%	91 82%
More than one race	1 2.4%	1 2.5%	0 0%	0 0%	2 1.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Achieving eRVR
Description	eRVR is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.
Time Frame	Week 4 and Week 12

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Number [Participants]	23 56.1%	21 52.5%	9 52.9%	9 69.2%

2. Primary Outcome

Title	Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12
Description	An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time Frame	From the start of study treatment up to Week 12

Outcome Measure Data

Analysis Population Description

Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Any AE	39 95.1%	37 92.5%	17 100%	13 100%
Any SAE	0 0%	2 5%	3 17.6%	1 7.7%

3. Primary Outcome

Title	Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
Description	Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) up to 12-week treatment period

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
DBP; Day2; n=41, 40, 17, 13	-1.2 (6.63)	-1 (7.03)	-3 (9.03)	-1.5 (10.45)
DBP; Week1; n=41, 39, 15, 13	-0.4 (7.98)	-2.2 (9.13)	1 (10.54)	-1 (7.99)
DBP; Week2; n=41, 39, 14, 13	-0.4 (10.41)	-1.7 (9.52)	-0.3 (8.8)	-2.8 (11.09)
DBP; Week4; n=41, 39, 14, 13	-1.2 (7.73)	-4.4 (9.78)	-3.9 (9.74)	0.8 (9.92)
DBP; Week6; n=41, 39, 13, 13	-1.2 (7.65)	-4.8 (9.86)	-5.9 (7.82)	-1.6 (10.1)
DBP; Week8; n=41, 39, 13, 13	-2.1 (10)	-2.9 (9.11)	-4.4 (7.63)	-2.4 (9.02)
DBP; Week12; n=38, 35, 12, 13	0.3 (8.48)	-4.4 (10.24)	-3.5 (9.2)	-1 (9.11)
SBP; Day2; n=41, 40, 17, 13	-1.4 (10.1)	-0.8 (12.85)	-3.3 (10.46)	-1.3 (13.95)
SBP; Week1; n=41, 39, 15, 13	0.9 (12.99)	-3 (11.24)	-4.5 (12.67)	-2.6 (11.84)
SBP; Week2; n=41, 39, 14, 13	-2 (10.57)	-0.7 (11.67)	-4.1 (12.67)	-4.2 (17.35)
SBP; Week4; n=41, 39, 14, 13	-3.6 (11.56)	-4.2 (16.2)	-3.8 (9.73)	-5.2 (15.3)
SBP; Week6; n=41, 39, 13, 13	-0.4 (14.47)	-3.8 (13.28)	-5.9 (11.39)	0.2 (14.47)
SBP; Week8; n=41, 39, 13, 13	-3.7 (12.15)	-1.5 (12.64)	-2.9 (10.36)	-4.2 (12.95)
SBP; Week12; n=38, 35, 12, 13	-1.9 (13.65)	-1.4 (11.72)	-5.2 (5.81)	-2.6 (19.16)

4. Primary Outcome

Title	Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Description	Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Heart Rate; Day2; n=41, 40, 17, 13	6.5 (8.65)	5.4 (9.96)	9.3 (11.74)	3.8 (5.79)
Heart Rate; Week1; n=41, 39, 15, 13	1.5 (8.33)	3.1 (8.75)	8.1 (6.32)	7.7 (10.11)
Heart Rate; Week2; n=41, 39, 14, 13	3.8 (9.02)	4.2 (12.14)	8.7 (8.17)	7.8 (8.6)
Heart Rate; Week4; n=41, 39, 14, 13	6.8 (9.42)	4.2 (11.78)	10.7 (11.39)	5.5 (8.35)
Heart Rate; Week6; n=41, 39, 13, 13	8 (10.15)	5 (10.98)	13.8 (9.75)	10.2 (8.2)
Heart Rate; Week8; n=41, 39, 13, 13	4.7 (9.91)	6.8 (12.42)	14.2 (10.36)	12.8 (12.27)
Heart Rate; Week12; n=38, 35, 12, 13	7 (9.2)	5.3 (12.1)	11 (8.02)	8.4 (9.47)

5. Primary Outcome

Title	Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Basophils; Week1; n=38, 38, 14, 11	-0.011 (0.0191)	-0.011 (0.0193)	-0.012 (0.0105)	-0.013 (0.0119)
Basophils; Week2; n=40, 38, 14, 10	-0.014 (0.0175)	-0.01 (0.0192)	-0.009 (0.0107)	-0.009 (0.0179)
Basophils; Week4; n=41, 38, 14, 13	-0.017 (0.0184)	-0.012 (0.0187)	-0.01 (0.0118)	-0.015 (0.0113)
Basophils; Week6; n=41, 37, 12, 12	-0.015 (0.021)	-0.013 (0.0205)	-0.013 (0.0114)	-0.013 (0.0106)
Basophils; Week8; n=38, 39, 13, 13	-0.019 (0.0155)	-0.016 (0.018)	-0.009 (0.0132)	-0.012 (0.0142)
Basophils; Week12; n=37, 36, 12, 12	-0.018 (0.0184)	-0.013 (0.0187)	-0.011 (0.0124)	-0.012 (0.0153)
Eosinophils; Week1; n=38, 38, 14, 11	-0.051 (0.0874)	-0.075 (0.106)	-0.059 (0.0578)	-0.085 (0.1052)
Eosinophils; Week2; n=40, 38, 14, 10	-0.08 (0.1004)	-0.111 (0.0912)	-0.059 (0.104)	-0.114 (0.1247)
Eosinophils; Week4; n=41, 38, 14, 13	-0.105 (0.0872)	-0.132 (0.1057)	-0.079 (0.1089)	-0.108 (0.0923)
Eosinophils; Week6; n=41, 37, 12, 12	-0.117 (0.0929)	-0.134 (0.1182)	-0.113 (0.0607)	-0.109 (0.1208)
Eosinophils; Week8; n=38, 39, 13, 13	-0.121 (0.0897)	-0.134 (0.1061)	-0.13 (0.0965)	-0.104 (0.0916)
Eosinophils; Week12; n=37, 36, 12, 12	-0.118 (0.0916)	-0.112 (0.1594)	-0.106 (0.1152)	-0.102 (0.1428)
Lymphocytes; Week1; n=38, 38, 14, 11	-0.319 (0.5006)	-0.282 (0.5698)	-0.608 (0.5466)	-0.371 (0.4332)
Lymphocytes; Week2; n=40, 38, 14, 10	-0.448 (0.5385)	-0.603 (0.5921)	-0.675 (0.5639)	-0.553 (0.4346)
Lymphocytes; Week4; n=41, 38, 14, 13	-0.787 (0.5055)	-0.854 (0.5114)	-0.989 (0.5293)	-0.773 (0.4104)
Lymphocytes; Week6; n=41, 37, 12, 12	-0.963 (0.5313)	-1.043 (0.5928)	-1.334 (0.4906)	-0.93 (0.4955)
Lymphocytes; Week8; n=38, 39, 13, 13	-0.953 (0.4624)	-1.061 (0.6021)	-1.256 (0.3509)	-0.964 (0.5098)
Lymphocytes; Week12; n=37, 36, 12, 12	-1.118 (0.5139)	-1.074 (0.5883)	-1.438 (0.4773)	-1.048 (0.6612)
Monocytes; Week1; n=38, 38, 14, 11	-0.103 (0.1418)	-0.056 (0.145)	0.034 (0.1502)	-0.025 (0.0808)
Monocytes; Week2; n=40, 38, 14, 10	-0.122 (0.227)	-0.061 (0.1785)	-0.091 (0.1562)	-0.034 (0.1687)
Monocytes; Week4; n=41, 38, 14, 13	-0.151 (0.1771)	-0.129 (0.158)	-0.126 (0.1471)	-0.055 (0.2103)
Monocytes; Week6; n=41, 37, 12, 12	-0.182 (0.1664)	-0.171 (0.1326)	-0.245 (0.1786)	-0.135 (0.1088)
Monocytes; Week8; n=38, 39, 13, 13	-0.229 (0.167)	-0.165 (0.1779)	-0.185 (0.1344)	-0.124 (0.2164)
Monocytes; Week12; n=37, 36, 12, 12	-0.185 (0.1715)	-0.183 (0.1438)	-0.219 (0.1493)	-0.133 (0.2048)
Total Neutrophils; Week1; n=38, 38, 14, 11	-2.338 (1.4959)	-1.871 (1.5089)	-1.158 (1.2688)	-1.378 (0.598)
Total Neutrophils; Week 2; n=40, 38, 14, 10	-2.114 (1.9189)	-2.121 (1.6445)	-1.186 (1.3343)	-1.468 (0.584)
Total Neutrophils; Week4; n=41, 38, 14, 13	-2.487 (1.9145)	-2.333 (1.5497)	-1.412 (1.5704)	-1.603 (0.5953)
Total Neutrophils; Week6; n=41, 37, 12, 12	-2.51 (1.8144)	-2.247 (1.5132)	-1.413 (1.4303)	-1.683 (0.661)
Total Neutrophils; Week8; n=38, 39, 13, 13	-2.706 (1.7553)	-2.168 (1.6902)	-1.222 (1.3481)	-1.613 (0.6882)
Total Neutrophils; Week12; n=37, 36, 12, 12	-2.894 (1.8124)	-2.188 (1.7297)	-1.649 (0.8749)	-1.483 (0.5873)
Platelet Count; Week1; n=38, 39, 14, 11	-58.5 (36.23)	-51.4 (36.42)	-59.5 (36.29)	-33.1 (33.32)
Platelet Count; Week2; n=41, 38, 14, 11	-58 (43.92)	-57.8 (44.02)	-41.4 (37.44)	-34.4 (41.74)
Platelet Count; Week4; n=41, 38, 14, 13	-54.4 (49.18)	-55.9 (47.19)	-56.2 (50.99)	-33.8 (61.79)
Platelet Count; Week6; n=41, 38, 12, 13	-66.8 (50.43)	-71.9 (38.6)	-71.3 (47.07)	-46 (46.05)
Platelet Count; Week8; n=39, 39, 13, 13	-74.9 (42.31)	-75.7 (45.82)	-60.1 (43.26)	-52.6 (43.54)
Platelet Count; Week12; n=38, 34, 12, 12	-73.4 (45.3)	-85.3 (40.42)	-58.8 (58.77)	-53 (39.49)
White Blood Cell count; Week1; n=38, 38, 14, 11	-2.83 (1.705)	-2.3 (1.872)	-1.81 (1.516)	-1.87 (0.508)
White Blood Cell count; Week2; n=40, 38, 14, 10	-2.77 (2.178)	-2.92 (1.81)	-2.01 (1.869)	-2.17 (0.886)
White Blood Cell count; Week4; n=41, 38, 14, 13	-3.55 (2.183)	-3.47 (1.712)	-2.61 (2.055)	-2.55 (0.919)
White Blood Cell count; Week6; n=41, 37, 12, 12	-3.78 (2.051)	-3.62 (1.682)	-3.09 (1.69)	-2.85 (0.923)
White Blood Cell count; Week8; n=38, 39, 13, 13	-4.03 (2.028)	-3.55 (1.896)	-2.8 (1.477)	-2.8 (1.04)
White Blood Cell count; Week12; n=37, 36, 12, 12	-4.33 (2.149)	-3.58 (1.934)	-3.42 (1.104)	-2.77 (0.963)

6. Primary Outcome

Title	Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Red Blood Cell count; Week1; n=38, 39, 14, 12	-0.15 (0.226)	-0.04 (0.279)	-0.18 (0.212)	-0.13 (0.303)
Red Blood Cell count; Week2; n=41, 38, 14, 12	-0.48 (0.376)	-0.44 (0.508)	-0.57 (0.312)	-0.28 (0.361)
Red Blood Cell count; Week4; n=41, 38, 14, 13	-0.88 (0.507)	-0.64 (0.623)	-1.03 (0.441)	-0.72 (0.559)
Red Blood Cell count; Week6; n=41, 38, 12, 13	-0.97 (0.504)	-0.78 (0.563)	-1.28 (0.49)	-0.86 (0.52)
Red Blood Cell count; Week8; n=39, 39, 13, 13	-1.01 (0.506)	-0.82 (0.534)	-1.45 (0.357)	-0.85 (0.412)
Red Blood Cell count; Week12; n=38, 36, 12, 12	-1.08 (0.48)	-0.79 (0.56)	-1.61 (0.464)	-0.92 (0.459)

7. Primary Outcome

Title	Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Hemoglobin; Week1; n=38, 39, 14, 12	-5.2 (6.98)	-2.3 (9.38)	-6.6 (5.83)	-5.3 (8.85)
Hemoglobin; Week2; n=41, 38, 14, 12	-16.7 (12.54)	-14.9 (16.21)	-20.5 (10.66)	-9.9 (11.5)
Hemoglobin; Week4; n=41, 38, 14, 13	-28.6 (15.38)	-22.1 (18.98)	-34.4 (13.55)	-22.5 (14.89)
Hemoglobin; Week6; n=41, 38, 12, 13	-30.1 (14.54)	-24.7 (16)	-40.8 (14.11)	-25.2 (12.28)
Hemoglobin; Week8; n=39, 39, 13, 13	-30.5 (13.29)	-25.5 (14.22)	-44.9 (11.73)	-25.2 (8.66)
Hemoglobin; Week12; n=38, 36, 12, 12	-33 (12.88)	-24.1 (13.41)	-47.4 (14.12)	-27.6 (12.05)

8. Primary Outcome

Title	Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Hematocrit; Week1; n=38, 39, 14, 12	-0.0196 (0.02345)	-0.0069 (0.02751)	-0.0201 (0.01921)	-0.0166 (0.0298)
Hematocrit; Week2; n=41, 38, 14, 12	-0.0539 (0.03653)	-0.0465 (0.04738)	-0.0609 (0.03007)	-0.0335 (0.03625)
Hematocrit; Week4; n=41, 38, 14, 13	-0.0848 (0.04576)	-0.0621 (0.05468)	-0.0999 (0.03967)	-0.0668 (0.04445)
Hematocrit; Week6; n=41, 38, 12, 13	-0.0859 (0.0411)	-0.0685 (0.04487)	-0.1203 (0.04463)	-0.074 (0.03316)
Hematocrit; Week8; n=39, 39, 13, 13	-0.0838 (0.03955)	-0.0663 (0.04144)	-0.1235 (0.03288)	-0.07 (0.02758)
Hematocrit; Week12; n=38, 36, 12, 12	-0.0843 (0.04038)	-0.0589 (0.03648)	-0.1318 (0.03847)	-0.0688 (0.03298)

9. Primary Outcome

Title	Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Mean corpuscle volume; Week1; n=38, 39, 14, 12	-1.1 (1.21)	-0.8 (1.37)	-0.4 (1.15)	-0.7 (1.37)
Mean corpuscle volume; Week2; n=41, 38, 14, 12	-2 (1.84)	-1.4 (1.59)	-1.4 (1.09)	-1.5 (1.45)
Mean corpuscle volume; Week4; n=41, 38, 14, 13	0.3 (3.33)	0.2 (3.4)	-0.8 (1.58)	-0.2 (2.94)
Mean corpuscle volume; Week6; n=41, 38, 12, 13	2.3 (4.76)	1.8 (4.67)	-0.2 (2.37)	1.4 (4.63)
Mean corpuscle volume; Week8; n=39, 39, 13, 13	3.8 (5.39)	3 (5.2)	3.1 (2.78)	2.2 (3.75)
Mean corpuscle volume; Week12; n=38, 34, 12, 12	5.7 (6)	4.2 (6.3)	5.3 (4.14)	3.8 (4.28)

10. Primary Outcome

Title	Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Albumin; Week1; n=40, 39, 15, 13	-0.6 (2.67)	-0.3 (2.46)	-1.1 (1.6)	-1 (1.87)
Albumin; Week2; n=41, 38, 14, 13	-1.3 (2.98)	-1.5 (2.68)	-2 (2.6)	-0.2 (2.39)
Albumin; Week4; n=41, 39, 14, 13	-1.9 (2.48)	-1.5 (2.52)	-3 (3.21)	-1.2 (1.46)
Albumin; Week6; n=41, 38, 13, 13	-2.2 (2.65)	-1.5 (2.27)	-3.5 (3.36)	-2.1 (2.22)
Albumin; Week8; n=40, 39, 13, 13	-2.6 (2.99)	-1.7 (2)	-3.7 (4.71)	-1.5 (1.94)
Albumin; Week12; n=37, 35, 12, 13	-2.1 (3.03)	-1.3 (2.84)	-3.3 (3.02)	-1.6 (2.1)

11. Primary Outcome

Title	Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
ALP; Week1; n=40, 39, 15, 13	0 (7.73)	1.5 (10.21)	3.9 (19.36)	-0.2 (17.45)
ALP; Week2; n=41, 38, 14, 13	4.6 (9.26)	3.8 (16.22)	9.4 (21.15)	3.8 (12.43)
ALP; Week4; n=41, 39, 14, 13	8.6 (11.12)	7.1 (13.76)	11.7 (26.61)	7.2 (15.3)
ALP; Week6; n=41, 38, 13, 13	9.1 (13.73)	7.2 (17.1)	16.6 (31.03)	6.6 (16.38)
ALP; Week8; n=40, 39, 13, 13	6.9 (15.59)	6.5 (15.91)	15.5 (25.83)	5.6 (14.72)
ALP; Week12; n=37, 35, 12, 13	6.7 (15.56)	6.4 (20.78)	11.7 (25.09)	7.3 (18.33)
ALT; Week1; n=40, 39, 15, 13	-26.8 (31.64)	-24.4 (32.39)	-30.7 (30.1)	-25.6 (20.74)
ALT; Week2; n=41, 38, 14, 13	-28.2 (40.33)	-24.9 (47.49)	-35.4 (36.38)	-26.8 (24.25)
ALT; Week4; n=41, 39, 14, 13	-32.5 (44.5)	-25.3 (50.87)	-40.4 (38.73)	-33 (28.79)
ALT; Week6; n=41, 38, 13, 13	-36 (49.77)	-30.3 (50.74)	-40.8 (41.51)	-38.4 (29.11)
ALT; Week8; n=40, 39, 13, 13	-36.8 (55.75)	-25.4 (55.92)	-39.9 (40.27)	-39.5 (29.92)
ALT; Week12; n=37, 35, 12, 13	-38.9 (59.7)	-23.5 (59.69)	-43.7 (40.45)	-36.8 (24.75)
AST; Week1; n=40, 39, 15, 13	-12.3 (16.28)	-15.2 (21.55)	-18.1 (21.77)	-13.9 (10.52)
AST; Week2; n=41, 38, 14, 13	-10 (20.84)	-11.6 (26.3)	-18.4 (23.52)	-10.2 (12.56)
AST; Week4; n=41, 39, 14, 13	-12.8 (21.45)	-10.6 (27.4)	-20.9 (25.86)	-15.8 (11.92)
AST; Week6; n=41, 38, 13, 13	-13.8 (21.56)	-13.8 (25.01)	-21.6 (28.43)	-19.5 (12.99)
AST; Week8; n=40, 39, 13, 13	-13.1 (26.01)	-7.6 (38.38)	-21.8 (26.38)	-18.6 (12.38)
AST; Week12; n=37, 35, 12, 13	-14.4 (25.58)	-6.5 (36.17)	-25.7 (27.32)	-17.3 (12.68)
CK; Week1; n=40, 39, 15, 13	18.2 (82.13)	-10.9 (103.31)	-3.3 (32.1)	-43.5 (82.73)
CK; Week2; n=41, 38, 14, 13	-0.7 (53.87)	-22.6 (77.26)	-9.6 (36.26)	-28.5 (54.43)
CK; Week4; n=41, 39, 14, 13	4.5 (141.46)	-32.1 (59.61)	-14.4 (22.06)	-47.7 (59.52)
CK; Week6; n=41, 38, 13, 13	-26 (63.11)	56.1 (566.79)	-21.5 (48.49)	-64.5 (110.82)
CK; Week8; n=40, 39, 13, 13	-21.3 (95.03)	-33.2 (65.96)	-30.3 (51.17)	-66.8 (107.3)
CK; Week12; n=37, 35, 12, 13	-36.3 (75.56)	-33.9 (47.72)	-20.9 (59.82)	-48.5 (61.63)
GGT; Week1; n=40, 39, 15, 13	-3.7 (20.79)	-2 (16.83)	-10.3 (19.38)	-6.4 (23.77)
GGT; Week2; n=41, 38, 14, 13	-11.7 (33.78)	-17.1 (45.23)	-19.9 (29.59)	-7.2 (29.11)
GGT; Week4; n=41, 39, 14, 13	-24.5 (52.93)	-25.5 (59.64)	-27.7 (36.64)	-16.2 (36.59)
GGT; Week6; n=41, 38, 13, 13	-28.1 (67.33)	-30.5 (72.27)	-30.5 (44.3)	-23.8 (39.91)
GGT; Week8; n=40, 39, 13, 13	-32.1 (70.41)	-27.2 (80.33)	-30.5 (45.05)	-28.5 (45.5)
GGT; Week12; n=37, 35, 12, 13	-29.7 (80.2)	-20.7 (73.43)	-33.6 (49.61)	-30 (53.44)

12. Primary Outcome

Title	Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Total Bilirubin; Week1; n=40, 39, 15, 13	6.9 (8.74)	6.7 (8.93)	8.1 (11.81)	4.2 (8.36)
Total Bilirubin; Week2; n=41, 38, 14, 13	5.8 (6.62)	5.5 (6.84)	5.6 (9.8)	6.5 (9.34)
Total Bilirubin; Week4; n=41, 39, 14, 13	2.2 (5.03)	2.9 (3.52)	0.7 (8.94)	2.5 (5.97)
Total Bilirubin; Week6; n=41, 38, 13, 13	1.5 (4.14)	2.7 (3.97)	-0.5 (9.09)	2.1 (6.87)
Total Bilirubin; Week8; n=40, 39, 13, 13	1.4 (4.63)	2.3 (4.93)	-0.3 (9.83)	1.8 (6.39)
Total Bilirubin; Week12; n=37, 35, 12, 13	0.4 (4.46)	1.4 (5.61)	-2.8 (10.04)	1.2 (5.31)
Direct Bilirubin; Week1; n=1, 1, 1, 1	0 (NA)	2 (NA)	-8 (NA)	-1 (NA)
Direct Bilirubin; Week2; n=1, 1, 1, 1	0 (NA)	0 (NA)	-14 (NA)	1 (NA)
Direct Bilirubin; Week4; n=1, 1, 0, 0	0 (NA)	2 (NA)	NA (NA)	NA (NA)
Direct Bilirubin; Week6; n=1, 1, 0, 0	0 (NA)	0 (NA)	NA (NA)	NA (NA)
Creatinine; Week1; n=40, 39, 15, 13	-1.41 (5.983)	0.23 (5.446)	5.12 (7.883)	-3.85 (5.868)
Creatinine; Week2; n=41, 38, 14, 13	-2.47 (7.966)	-2.78 (5.725)	4.13 (6.518)	-1.17 (7.692)
Creatinine; Week4; n=41, 39, 14, 13	-3.4 (5.894)	-1.33 (6.403)	5.35 (10.16)	-3.57 (9.599)
Creatinine; Week6; n=41, 38, 13, 13	-2.15 (6.18)	-0.34 (7.667)	7.1 (7.905)	-2.05 (9.365)
Creatinine; Week8; n=40, 39, 13, 13	-1.88 (5.724)	-0.51 (5.425)	9.43 (10.839)	-0.08 (10.23)
Creatinine; Week12; n=38, 35, 12, 13	-1.49 (8.411)	-1.99 (8.704)	6.85 (10.363)	-2.41 (12.239)

13. Primary Outcome

Title	Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Chloride; Week1; n=40, 39, 15, 13	0.5 (2.1)	-0.4 (2.03)	0.6 (2.61)	-0.2 (1.95)
Chloride; Week2; n=41, 38, 14, 13	0.7 (2.37)	0.1 (1.9)	0.5 (1.61)	-0.7 (2.21)
Chloride; Week4; n=41, 39, 14, 13	1.7 (2.31)	1 (2.46)	1.6 (2.21)	0.1 (2.5)
Chloride; Week6; n=41, 38, 13, 13	1.6 (2.62)	0.8 (2.57)	0.8 (2.73)	-0.1 (1.38)
Chloride; Week8; n=40, 39, 13, 13	2 (3.49)	0.7 (2.36)	2.2 (3)	-0.8 (2.77)
Chloride; Week12; n=37, 35, 12, 13	1.5 (2.36)	0.1 (3.35)	1.9 (2.61)	1.2 (2.95)
Bicarbonate; Week1; n=40, 39, 15, 13	0 (3.05)	-0.9 (2.57)	-1.2 (2.54)	-0.7 (2.56)
Bicarbonate; Week2; n=41, 38, 14, 13	-0.3 (2.2)	-0.8 (3.1)	-1.5 (2.98)	-0.2 (3.65)
Bicarbonate; Week4; n=41, 39, 14, 13	-0.9 (1.91)	-0.8 (2.55)	-1.4 (1.86)	-0.5 (2.67)
Bicarbonate; Week6; n=41, 38, 13, 13	-0.4 (2)	-0.7 (2.23)	-1.5 (2.18)	0.6 (2.6)
Bicarbonate; Week8; n=40, 39, 13, 13	-0.7 (2.41)	-0.8 (2.35)	-1.2 (2.19)	0 (2.2)
Bicarbonate; Week12; n=37, 35, 12, 13	-0.6 (2.42)	-0.9 (2.37)	-1.1 (2.23)	-0.5 (2.76)
Glucose; Week1; n=40, 39, 15, 13	-0.37 (1.485)	-0.34 (0.761)	-0.03 (0.616)	0.36 (1.619)
Glucose; Week2; n=41, 38, 14, 13	-0.22 (1.467)	-0.17 (0.791)	0.11 (0.52)	0.13 (1.765)
Glucose; Week4; n=41, 39, 14, 13	-0.03 (1.162)	0.02 (1.054)	-0.11 (0.601)	-0.48 (0.832)
Glucose; Week6; n=41, 38, 13, 13	-0.15 (1.315)	-0.18 (1.154)	0.18 (0.772)	-0.55 (0.755)
Glucose; Week8; n=40, 39, 13, 13	-0.05 (1.165)	-0.06 (0.835)	0.04 (0.675)	-0.36 (1.191)
Glucose; Week12; n=38, 35, 12, 13	-0.3 (1.877)	-0.39 (1.047)	-0.23 (0.757)	-0.45 (1.063)
Potassium; Week1; n=40, 39, 15, 13	-0.02 (0.392)	-0.06 (0.339)	-0.11 (0.376)	-0.02 (0.313)
Potassium; Week2; n=41, 38, 14, 13	-0.1 (0.428)	-0.12 (0.453)	-0.39 (0.417)	-0.02 (0.316)
Potassium; Week4; n=41, 39, 14, 13	-0.16 (0.411)	-0.11 (0.455)	-0.34 (0.497)	-0.05 (0.499)
Potassium; Week6; n=41, 38, 13, 13	-0.15 (0.483)	-0.16 (0.387)	-0.45 (0.355)	-0.21 (0.38)
Potassium; Week8; n=40, 39, 13, 13	-0.11 (0.49)	-0.19 (0.42)	-0.51 (0.348)	-0.14 (0.348)
Potassium; Week12; n=37, 35, 12, 13	-0.15 (0.394)	-0.21 (0.362)	-0.38 (0.447)	-0.1 (0.428)
Sodium; Week1; n=40, 39, 15, 13	-0.4 (1.85)	-0.8 (1.76)	-0.2 (2.46)	-0.8 (2.08)
Sodium; Week2; n=41, 38, 14, 13	-0.1 (2.15)	-0.6 (1.81)	0 (1.8)	-1.3 (2.25)
Sodium; Week4; n=41, 39, 14, 13	0.1 (2.16)	-0.1 (2.2)	0.4 (1.78)	-0.8 (1.95)
Sodium; Week6; n=41, 38, 13, 13	0.2 (2.39)	-0.3 (2.39)	0.2 (2.91)	0 (2)
Sodium; Week8; n=40, 39, 13, 13	0.3 (3.28)	-0.6 (2.24)	1.1 (2.18)	-0.6 (2.22)
Sodium; Week12; n=37, 35, 12, 13	0.1 (1.91)	-0.3 (2.36)	0.8 (2.66)	0.5 (2.18)
Inorganic Phosphorus; Week1; n=40, 39, 15, 13	-0.13 (0.1599)	-0.086 (0.1415)	-0.122 (0.1353)	-0.087 (0.1489)
Inorganic Phosphorus; Week2; n=41,38,14,13	-0.141 (0.181)	-0.108 (0.1754)	-0.081 (0.1194)	-0.105 (0.1159)
Inorganic Phosphorus; Week4; n=41,39,14,13	-0.151 (0.1666)	-0.125 (0.1421)	-0.077 (0.1669)	-0.078 (0.1871)
Inorganic Phosphorus; Week6; n=41,38,13,13	-0.171 (0.1939)	-0.181 (0.1823)	-0.121 (0.1549)	-0.159 (0.121)
Inorganic Phosphorus; Week8; n=40,39,13,13	-0.169 (0.2025)	-0.23 (0.1937)	-0.112 (0.1563)	-0.14 (0.167)
Inorganic Phosphorus; Week12; n=37,35,12,13	-0.172 (0.1708)	-0.168 (0.2047)	-0.117 (0.1123)	-0.136 (0.1943)
Urea/BUN; Week1; n=40, 39, 15, 13	0.24 (0.996)	0.04 (1.002)	0.19 (1.287)	-0.01 (1.188)
Urea/BUN; Week2; n=41, 38, 14, 13	0.2 (1.012)	-0.13 (1.05)	0.08 (1.309)	-0.12 (1.244)
Urea/BUN; Week4; n=41, 39, 14, 13	0.03 (1.145)	-0.4 (1.047)	0.11 (1.436)	-0.88 (1.137)
Urea/BUN; Week6; n=41, 38, 13, 13	-0.04 (1.09)	-0.29 (1.13)	-0.39 (0.883)	-1.02 (0.667)
Urea/BUN; Week8; n=40, 39, 13, 13	-0.16 (1.088)	-0.46 (1.337)	-0.07 (1.206)	-0.85 (1.067)
Urea/BUN; Week12; n=37, 35, 12, 13	-0.08 (1.164)	-0.31 (1.276)	-0.11 (1.272)	-0.64 (1.81)

14. Primary Outcome

Title	Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Description	Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Creatinine Clearance; Week1; n=40, 39, 15, 13	1.5 (9.79)	-2.1 (19.51)	-9.5 (10.09)	5.7 (10.18)
Creatinine Clearance; Week2; n=41, 38,14,13	3.3 (13.48)	4.7 (11.33)	-9 (12.55)	-1.8 (15.27)
Creatinine Clearance; Week4; n=41, 39,14,13	5 (12.45)	1.9 (14.72)	-9.1 (13.42)	4.5 (16.19)
Creatinine Clearance; Week6; n=41, 38,13,13	2.7 (11.93)	-0.7 (16.25)	-19.1 (20.54)	1.5 (13.12)
Creatinine Clearance; Week8; n=40, 39,13,13	1.9 (10.49)	3.4 (19.94)	-17.8 (16.1)	-3 (14.54)
Creatinine Clearance; Week12; n=38,35,12,13	-0.2 (15.06)	2.2 (17.27)	-14.3 (16.99)	1.2 (20.49)

15. Primary Outcome

Title	Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Description	Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0), Weeks 2 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13	37 90.2%	34 85%	12 70.6%	13 100%
Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13	37 90.2%	34 85%	12 70.6%	13 100%
Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13	37 90.2%	34 85%	12 70.6%	13 100%
Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13	37 90.2%	34 85%	12 70.6%	13 100%
Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0	1 2.4%	1 2.5%	0 0%	0 0%
Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2	4 9.8%	5 12.5%	2 11.8%	2 15.4%
Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2	4 9.8%	5 12.5%	2 11.8%	2 15.4%
Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13	37 90.2%	34 85%	12 70.6%	13 100%
Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13	37 90.2%	34 85%	12 70.6%	13 100%
Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, UPH, BL NL to PBL NL, n=37,34,12,13	36 87.8%	34 85%	12 70.6%	13 100%
Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13	1 2.4%	0 0%	0 0%	0 0%
Week 2, USG, BL NL to PBL NL, n=1, 0,0,0	1 2.4%	0 0%	0 0%	0 0%
Week 12, USG, BL NL to PBL NL, n=37,34,12,13	37 90.2%	34 85%	12 70.6%	12 92.3%
Week 12, USG, BL NL to PBL ANL,n=37,34,12,13	0 0%	0 0%	0 0%	1 7.7%

16. Primary Outcome

Title	Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12
Description	The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Week 1, n=41, 40, 15, 12	3.3 (8.28)	0.8 (8.49)	4.1 (9.52)	4.8 (10.62)
Week 12, n=38, 35, 12, 13	8.3 (8.37)	5.1 (10.86)	9.3 (10.15)	8.5 (8)

17. Primary Outcome

Title	Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
Description	The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 1 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
PR interval, Week 1, n=41, 40, 15, 12	0.5 (19.43)	1.2 (13.57)	2.7 (7.27)	-1.6 (20.92)
PR interval, Week 12, n=38, 35, 12, 13	2.9 (13.36)	3.2 (12.07)	5.5 (8.73)	0.2 (14.68)
QRS duration, Week 1, n=41, 40, 15,12	-6.6 (50.28)	0.4 (7.69)	2.9 (6.61)	0.4 (4.03)
QRS duration, Week 12, n=38, 35, 12,13	-8.2 (51.69)	-1.8 (6.44)	0.4 (7.54)	-2 (4.4)
Uncorrected QT Interval, Week 1, n=41,40,15,12	-2.3 (27.29)	-2.6 (22.29)	-2.1 (22.39)	5.9 (25.68)
Uncorrected QT interval, Week 12,n=38,35,12,13	-11.8 (31.28)	-12 (25.22)	-17 (18.01)	-4.6 (23.36)
QTcB interval, Week 1, n=41,40,15,12	7.7087 (25.63001)	0.2491 (22.90285)	9.8112 (20.6771)	19.8879 (40.13504)
QTcB interval, Week 12,n=38,35,12,13	11.5512 (26.5644)	1.7615 (20.3859)	11.2801 (25.54652)	18.9943 (16.76576)
QTcF interval, Week 1, n=41,40,15,12	4.1995 (23.18239)	-0.7151 (19.69091)	5.7676 (17.06472)	14.9187 (32.2737)
QTcF interval, Week 12,n=38,35,12,13	3.3516 (26.34546)	-3.1442 (17.38368)	1.6147 (18.38188)	10.7637 (17.07259)

18. Secondary Outcome

Title	Number of Participants With Any AEs and Any SAEs After Week 12
Description	An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time Frame	From Week 12 up to PT Week 24 FU

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Any AE	21 51.2%	22 55%	8 47.1%	9 69.2%
Any SAE	2 4.9%	1 2.5%	0 0%	0 0%

19. Secondary Outcome

Title	Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
Description	Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.
Time Frame	From the start of the treatment up to PT FU Week 24

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
vRVR	8 19.5%	12 30%	8 47.1%	6 46.2%
RVR	23 56.1%	23 57.5%	10 58.8%	9 69.2%
cEVR	33 80.5%	30 75%	11 64.7%	13 100%
SVR12	30 73.2%	26 65%	10 58.8%	0 0%
SVR24	27 65.9%	25 62.5%	10 58.8%	0 0%
SVR24 with RGT	17 41.5%	17 42.5%	9 52.9%	0 0%

20. Secondary Outcome

Title	Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Description	Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.
Time Frame	Day 1, Day 2, Week 4, and Week 12

Outcome Measure Data

Analysis Population Description

PK Population included all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
Measure Participants	41	53
Day 1 (0h-1h), n=1, 3	NA (NA)	604 (392.763)
Day 1 (1h-4h), n=35, 42	290.39 (241.05)	445.18 (314.624)
Day 1 (4h-8h), n=0, 3	NA (NA)	221.33 (191.996)
Day 1 (8h-20h), n=0, 1	NA (NA)	NA (NA)
Day 2 Predose (20-28h), n=36, 43	53.79 (52.629)	123.89 (257.575)
Week 4 Predose (20-28h), n=33, 42	81.18 (153.462)	146.85 (243.331)
Week 4 (0h-1h), n=2, 6	198.4 (242.679)	553 (536.451)
Week 4 (1h-4h), n=46, 52	392.78 (275.504)	591.07 (402.442)
Week 4 (4h-8h), n=22, 19	215.55 (127.737)	411.68 (251.604)
Week 4 (8h-20h), n=1, 2	NA (NA)	192.5 (94.045)
Week 4 (20h-28h), n=11, 10	51.24 (57.261)	66.29 (53.604)
Week 12 (Predose [20-28h]), n=26, 35	45.99 (42.034)	142.59 (178.252)

21. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4
Description	Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.
Time Frame	Week 4 (24 h post dose)

Outcome Measure Data

Analysis Population Description

Intensive PK Summary Population: Intensive PK Summary Population comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
Measure Participants	11	10
Cmax, n=11, 10	335.35 (69.4)	618.75 (46.1)
Ctau, n=11, 10	31.37 (135.9)	49.31 (97.6)

22. Secondary Outcome

Title	Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4
Description	Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.
Time Frame	Week 4 (24 h post dose)

Outcome Measure Data

Analysis Population Description

Intensive PK Summary Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2divided doses with food.
Measure Participants	11	10
Median (Full Range) [hour]	2	2

23. Secondary Outcome

Title	Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4
Description	Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.
Time Frame	Week 4 (24 h post dose)

Outcome Measure Data

Analysis Population Description

Intensive PK Summary Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
Measure Participants	11	10
Geometric Mean (Geometric Coefficient of Variation) [hour*nanogram per milliliter(hr*ng/mL)]	2733.34 (82)	4948.23 (66.3)

24. Secondary Outcome

Title	Apparent Clearance (CL/F) at Week 4
Description	Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).
Time Frame	Week 4 (24 h post dose)

Outcome Measure Data

Analysis Population Description

Intensive PK Summary Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
Measure Participants	11	10
Geometric Mean (Geometric Coefficient of Variation) [Liter per hour (L/hr)]	14.63 (82)	12.13 (66.3)

25. Secondary Outcome

Title	Apparent Volume of Distribution (Vz/F) at Week 4
Description	Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.
Time Frame	Week 4 (24 h post dose)

Outcome Measure Data

Analysis Population Description

Intensive PK Summary Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
Measure Participants	11	10
Geometric Mean (Geometric Coefficient of Variation) [Liter per hour (L/hr)]	172.81 (76.6)	125.09 (67.9)

26. Secondary Outcome

Title	Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Basophils; Week18; n=37, 33, 13, 12	-0.019 (0.0178)	-0.01 (0.0194)	-0.014 (0.0112)	-0.012 (0.0119)
Basophils; Week24; n=34, 32, 12, 11	-0.018 (0.0177)	-0.01 (0.0166)	-0.013 (0.0129)	-0.013 (0.011)
Basophils; Week30; n=13, 10, 2, 2	-0.018 (0.0142)	-0.012 (0.0148)	-0.02 (0)	-0.02 (0)
Basophils; Week36; n=12, 7, 1, 2	-0.02 (0.0165)	-0.006 (0.019)	-0.02 (NA)	-0.01 (0.0141)
Basophils; Week42; n=10, 6, 2, 2	-0.015 (0.0242)	-0.005 (0.0187)	0 (0.0424)	-0.015 (0.0071)
Basophils; Week48; n=7, 6, 1, 2	-0.007 (0.0214)	-0.007 (0.0197)	0.02 (NA)	0.005 (0.0071)
Basophils; PT Week4; n=32, 34, 11, 11	-0.007 (0.0162)	-0.003 (0.0189)	-0.001 (0.0181)	-0.003 (0.0119)
Eosinophils; Week18; n=37, 33, 13, 12	-0.119 (0.1006)	-0.127 (0.1207)	-0.087 (0.0507)	-0.068 (0.0746)
Eosinophils; Week24; n=34, 32, 12, 11	-0.128 (0.101)	-0.131 (0.1103)	-0.118 (0.0612)	-0.041 (0.1003)
Eosinophils; Week30; n=13, 10, 2, 2	-0.124 (0.0982)	-0.116 (0.1117)	-0.13 (0.0849)	-0.04 (0.0141)
Eosinophils; Week36; n=12, 7, 1, 2	-0.081 (0.1459)	-0.123 (0.1003)	-0.06 (NA)	-0.05 (0.0141)
Eosinophils; Week42; n=10, 6, 2, 2	-0.105 (0.074)	-0.1 (0.12)	-0.02 (0.0424)	-0.04 (0)
Eosinophils; Week48; n=8, 6, 1, 2	-0.071 (0.0889)	-0.11 (0.1223)	0.13 (NA)	-0.05 (0.0141)
Eosinophils; PT Week4; n=32, 34, 11,11	-0.069 (0.0925)	-0.085 (0.1208)	-0.07 (0.0694)	-0.018 (0.0808)
Lymphocytes; Week18; n=37, 33, 13,12	-1.081 (0.5533)	-1.157 (0.5373)	-0.999 (0.4672)	-0.973 (0.5328)
Lymphocytes; Week24; n=34, 32, 12,11	-1.181 (0.4795)	-1.092 (0.5598)	-1.405 (0.5912)	-1.057 (0.4832)
Lymphocytes; Week30; n=13, 10, 2, 2	-1.225 (0.7588)	-1.085 (0.798)	-1.905 (0.1768)	-1.845 (0.2899)
Lymphocytes; Week36; n=12, 7, 1, 2	-1.267 (0.6828)	-1.286 (0.8983)	-1.97 (NA)	-1.92 (0.4808)
Lymphocytes; Week42; n=10, 6, 2, 2	-1.135 (0.8657)	-1.22 (0.9909)	-1.125 (1.0253)	-1.93 (0.1414)
Lymphocytes; Week48; n=7, 6, 1, 2	-0.779 (1.0639)	-1.4 (1.0384)	0.09 (NA)	-2.2 (0.0424)
Lymphocytes; PT Week4; n=32, 34, 11,11	-0.681 (0.4594)	-0.7 (0.6163)	-0.756 (0.5874)	-0.737 (0.5666)
Monocytes; Week18; n=37, 33, 13, 12	-0.186 (0.1588)	-0.141 (0.1339)	-0.088 (0.1663)	-0.143 (0.1776)
Monocytes; Week24; n=34, 32, 12, 11	-0.206 (0.1692)	-0.156 (0.1574)	-0.151 (0.1474)	-0.121 (0.1902)
Monocytes; Week30; n=13, 10, 2, 2	-0.151 (0.1655)	-0.135 (0.091)	-0.4 (0.3111)	-0.06 (0.0141)
Monocytes; Week36; n=12, 7, 1, 2	-0.255 (0.1474)	-0.18 (0.0987)	-0.2 (NA)	0.015 (0.1061)
Monocytes; Week42; n=10, 6, 2, 2	-0.184 (0.234)	-0.093 (0.1743)	-0.025 (0.2192)	-0.01 (0.099)
Monocytes; Week48; n=7, 6, 1, 2	-0.066 (0.1744)	-0.147 (0.088)	0.02 (NA)	-0.085 (0.1909)
Monocytes; PT Week4; n=32, 34, 11,11	-0.047 (0.1773)	-0.031 (0.165)	0.032 (0.1543)	-0.053 (0.1536)
Total Neutrophils; Week18; n=37, 33,13,12	-2.702 (1.9136)	-2.378 (1.6735)	-1.652 (0.852)	-1.463 (0.7174)
Total Neutrophils; Week24; n=34, 32,12,11	-2.527 (1.9492)	-2.187 (1.7758)	-1.308 (0.7148)	-1.3 (0.9956)
Total Neutrophils; Week30; n=13, 10,2,2	-2.402 (1.7954)	-2.252 (2.3658)	-2.24 (1.2869)	-2.085 (0.1909)
Total Neutrophils; Week36; n=12, 7, 1,2	-2.503 (1.6709)	-2.777 (2.4215)	-1.61 (NA)	-1.63 (0.297)
Total Neutrophils; Week42; n=10, 6, 2,2	-2.23 (2.0311)	-3.085 (2.7313)	-0.565 (0.7849)	-1.815 (0.4455)
Total Neutrophils; Week48; n=7, 6, 1, 2	-1.129 (2.2597)	-2.488 (3.397)	0.02 (NA)	-1.445 (0.4596)
Total Neutrophils; PT Week4; n=32, 34,11,11	-1.158 (1.8855)	-0.808 (1.6104)	-0.744 (1.1276)	-0.671 (0.8001)
Platelet Count; Week18; n=38, 34, 13,12	-73.7 (43.93)	-87.5 (38.4)	-55.7 (56.96)	-52.1 (39.87)
Platelet Count; Week24; n=35, 33, 12,11	-67.5 (43.22)	-78.8 (44.15)	-60.3 (56.5)	-51.9 (44.19)
Platelet Count; Week30; n=13, 10, 1, 2	-70 (60.5)	-71.9 (59.35)	-112 (NA)	-36.5 (47.38)
Platelet Count; Week36; n=12, 7, 1, 2	-64.1 (41.52)	-75.7 (65.89)	-115 (NA)	-34 (52.33)
Platelet Count; Week42; n=10, 6, 2, 2	-56.1 (53.01)	-67.3 (62.09)	-112 (0)	-22 (52.33)
Platelet Count; Week48; n=9, 6, 1, 2	-37.7 (66.18)	-68.8 (65.74)	33 (NA)	-14 (22.63)
Platelet Count; PT Week4; n=32, 34,11,11	-20.4 (44.37)	-28.9 (45.92)	-12.4 (34.3)	-12.9 (42.3)
White Blood Cell count; Week18; n=37,33,13,12	-4.1 (2.258)	-3.81 (1.884)	-2.84 (0.961)	-2.65 (0.923)
White Blood Cell count ; Week24; n=34,32,12,11	-4.06 (2.251)	-3.58 (1.977)	-3 (1.047)	-2.52 (1.272)
White Blood Cell count ; Week30; n=13,10,2,2	-3.92 (2.258)	-3.59 (3.051)	-4.7 (1.838)	-4.05 (0.495)
White Blood Cell count ; Week36; n=12,7,1,2	-4.13 (2.188)	-4.39 (3.168)	-3.9 (NA)	-3.55 (0.919)
White Blood Cell count ; Week42; n=10,6,2,2	-3.67 (2.807)	-4.52 (3.68)	-1.75 (2.051)	-3.8 (0.707)
White Blood Cell count; Week48; n=7,6,1,2	-2.09 (3.304)	-4.17 (4.172)	0.2 (NA)	-3.8 (0.141)
White Blood Cell count; PT Week4;n=32,34,11,11	-1.97 (1.938)	-1.64 (1.907)	-1.54 (1.638)	-1.45 (0.884)

27. Secondary Outcome

Title	Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Red Blood Cell count; Week 18; n=38, 34, 13, 12	-1.13 (0.494)	-0.88 (0.591)	-1.19 (0.638)	-0.99 (0.498)
Red Blood Cell count; Week 24; n=35, 33, 12, 11	-1.13 (0.482)	-0.94 (0.513)	-1.19 (0.552)	-1.14 (0.528)
Red Blood Cell count; Week 30; n=13,10,2,2	-1.05 (0.511)	-0.75 (0.809)	-1.45 (0.071)	-1.45 (0.354)
Red Blood Cell count; Week 36; n=12,7,1,2	-0.88 (0.67)	-1.06 (0.761)	-1 (NA)	-1.3 (0.283)
Red Blood Cell count; Week 42; n=10,6,2,2	-0.91 (0.674)	-1.17 (0.769)	-0.55 (0.636)	-1.45 (0.354)
Red Blood Cell count; Week 48; n=9, 6,1,2	-0.83 (0.791)	-1.03 (0.794)	-0.4 (NA)	-1.5 (0.566)
Red Blood Cell count; PT Week 4; n=32,34,11,11	-0.57 (0.435)	-0.37 (0.353)	-0.66 (0.437)	-0.65 (0.474)

28. Secondary Outcome

Title	Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Hemoglobin; Week 18; n=38, 34, 13, 12	-33.6 (12.34)	-26.7 (14.65)	-35 (16.38)	-29 (10.61)
Hemoglobin; Week 24; n=35, 33, 12,11	-33.4 (12.16)	-28 (12.44)	-35.6 (13.48)	-32.3 (14.98)
Hemoglobin; Week 30; n=13, 10, 2, 2	-30.2 (16.13)	-21 (20.02)	-40 (12.73)	-40 (1.41)
Hemoglobin; Week 36; n=12, 7, 1, 2	-26.7 (18.86)	-30 (16.37)	-37 (NA)	-35 (1.41)
Hemoglobin; Week 42; n=10, 6, 2, 2	-27.1 (18.51)	-31.7 (19.82)	-25 (22.63)	-40 (1.41)
Hemoglobin; Week 48; n=9, 6, 1, 2	-25.9 (21.47)	-29.3 (20.33)	-18 (NA)	-41 (8.49)
Hemoglobin; PT Week 4; n=32, 34, 11,11	-16.5 (11.43)	-11.7 (9.57)	-21.4 (8.59)	-16.8 (11.99)

29. Secondary Outcome

Title	Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Hematocrit; Week 18; n=38, 34, 13, 12	-0.083 (0.03831)	-0.0622 (0.04289)	-0.0776 (0.04313)	-0.0699 (0.02801)
Hematocrit; Week 24; n=35, 33, 12, 11	-0.0782 (0.04021)	-0.0635 (0.03499)	-0.0808 (0.03543)	-0.0823 (0.03968)
Hematocrit; Week 30; n=13, 10, 2, 2	-0.0713 (0.0486)	-0.0397 (0.05793)	-0.0955 (0.03323)	-0.1125 (0.00636)
Hematocrit; Week 36; n=12, 7, 1, 2	-0.0567 (0.05031)	-0.069 (0.04724)	-0.087 (NA)	-0.0895 (0.00354)
Hematocrit; Week 42; n=10, 6, 2, 2	-0.0623 (0.05449)	-0.0802 (0.0562)	-0.0535 (0.07)	-0.111 (0.00566)
Hematocrit; Week 48; n=9, 6, 1, 2	-0.0624 (0.06203)	-0.0753 (0.05285)	-0.047 (NA)	-0.1095 (0.03041)
Hematocrit; PT Week 4; n=32, 34, 11,11	-0.0293 (0.03575)	-0.0135 (0.03178)	-0.0362 (0.02907)	-0.0354 (0.0358)

30. Secondary Outcome

Title	Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Mean Corpuscle Volume ; Week 18;n=38,34,13,12	7.5 (6.37)	6.2 (8.19)	8.5 (5.78)	5.3 (5.28)
Mean Corpuscle Volume ; Week 24;n=35,33,12,11	8.5 (6.14)	7.5 (8.89)	7.6 (5.9)	5.8 (5.08)
Mean Corpuscle Volume ; Week 30; n=13,10,2,2	7.8 (7.24)	9.5 (12.02)	11.5 (7.78)	3 (2.83)
Mean Corpuscle Volume ; Week 36; n=12,7,1,2	8.1 (5.92)	11.4 (13.6)	2 (NA)	5.5 (2.12)
Mean Corpuscle Volume ; Week 42;n=10,6,2,2	6.9 (5.7)	10.7 (14.47)	1 (2.83)	4 (2.83)
Mean Corpuscle Volume ; Week 48;n=9,6,1,2	5.2 (5.76)	9 (14.04)	-1 (NA)	5 (1.41)
Mean Corpuscle Volume; PT Week 4; n=32,34,11,11	6.1 (5.56)	5.1 (4.86)	5.8 (3.79)	5.3 (5.1)

31. Secondary Outcome

Title	Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Albumin; Week 18; n=38, 34, 13, 12	-2.3 (2.78)	-1.4 (2.65)	-1.8 (2.86)	-1 (2.89)
Albumin; Week 24; n=35, 33, 12, 11	-2.1 (3.08)	-1.6 (2.82)	-2.3 (2.81)	-1.1 (2.81)
Albumin; Week 30; n=13, 10, 3, 2	-1.8 (2.09)	-0.7 (4.22)	-3 (2.65)	-4.5 (0.71)
Albumin; Week 36; n=10, 7, 2, 2	-1.7 (3.92)	-1.1 (2.85)	2 (1.41)	-2 (0)
Albumin; Week 42; n=9, 6, 1, 2	-1.3 (2.5)	-1.3 (1.63)	-1 (NA)	-3 (0)
Albumin; Week 48; n=6, 6, 0, 2	-1.3 (3.61)	-0.3 (2.16)	NA (NA)	-4 (1.41)
Albumin; PT Week 4; n=33, 34, 11, 11	-0.7 (3.93)	-0.2 (2.84)	0.5 (2.3)	-0.7 (1.79)

32. Secondary Outcome

Title	Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
ALP; Week 18; n=38, 34, 13, 12	2.5 (17.25)	1.1 (16.95)	2.2 (21.77)	6.4 (20.08)
ALP; Week 24; n=35, 33, 12, 11	0.8 (19.71)	3.3 (18.83)	2.1 (20.24)	4.5 (22.82)
ALP; Week 30; n=13, 10, 3, 2	1.8 (15.79)	-6.4 (18.62)	-8 (8.54)	22.5 (14.85)
ALP; Week 36; n=10, 7, 2, 2	2 (17.49)	2.7 (9.45)	2.5 (0.71)	18 (7.07)
ALP; Week 42; n=9, 6, 1, 2	5.3 (13.4)	3.3 (8.45)	-2 (NA)	17.5 (2.12)
ALP; Week 48; n=6, 6, 0, 2	9.8 (17.36)	4.2 (9.62)	NA (NA)	30 (24.04)
ALP; PT Week 4; n=33, 34, 11, 11	-4.9 (19.71)	-6.3 (17.88)	-7 (17.93)	-3.9 (22.15)
ALT; Week 18; n=38, 34, 13, 12	-38.9 (61.39)	-22.9 (61.65)	-38.6 (40.89)	-38.4 (32.63)
ALT; Week 24; n=35, 33, 12, 11	-43.9 (62.25)	-31.3 (56.12)	-39.7 (38.19)	-41.7 (28.32)
ALT; Week 30; n=13, 10, 3, 2	-34.8 (30.82)	-45.1 (95.76)	-57.7 (58.31)	-26 (22.63)
ALT; Week 36; n=10, 7, 2, 2	-30.2 (28.15)	-16.6 (13.7)	-69 (74.95)	-20.5 (16.26)
ALT; Week 42; n=9, 6, 1, 2	-34.3 (35.15)	-14.3 (20.07)	-122 (NA)	-28 (25.46)
ALT; Week 48; n=6, 6, 0, 2	-38.8 (42.1)	-10.8 (27.11)	NA (NA)	-26.5 (26.16)
ALT; PT Week 4; n=33, 34, 11, 11	-45.5 (62.76)	-33.3 (56.81)	-31.5 (22.68)	-43.9 (27.71)
AST; Week 18; n=38, 34, 13, 12	-13.1 (27.49)	-3.5 (37.25)	-18.8 (27.32)	-16.3 (15.11)
AST; Week 24; n=35, 33, 12, 11	-16.5 (26.86)	-11.8 (30.51)	-23.8 (26.91)	-15.7 (18.91)
AST; Week 30; n=13, 10, 3, 2	-15.1 (17.35)	-18.7 (43.89)	-27.7 (20.13)	-6.5 (7.78)
AST; Week 36; n=10, 7, 2, 2	-11.8 (13.81)	-7.3 (9.5)	-27.5 (31.82)	-2.5 (2.12)
AST; Week 42; n=9, 6, 1, 2	-14.2 (16.81)	-5.8 (10.03)	-54 (NA)	-9 (7.07)
AST; Week 48; n=6, 6, 0, 2	-12.8 (18.65)	-2.2 (13.61)	NA (NA)	-6.5 (9.19)
AST; PT Week 4; n=33, 34, 11, 11	-19.5 (26.41)	-15.6 (34.38)	-17.7 (14.67)	-16 (31.8)
CK; Week 18; n=38, 34, 13, 12	-44 (55.77)	-28.3 (36.59)	-38.7 (45.46)	-60.7 (75.8)
CK; Week 24; n=35, 33, 12, 11	-34.5 (66.48)	-18.7 (77.24)	-39 (36.68)	60.1 (475.39)
CK; Week 30; n=13, 10, 3, 2	-33 (83.25)	-15.8 (51.92)	-30 (24.27)	-78.5 (55.86)
CK; Week 36; n=10, 7, 2, 2	-18.9 (34.18)	-26.7 (32.22)	-37.5 (6.36)	-69 (53.74)
CK; Week 42; n=9, 6, 1, 2	-0.2 (51.5)	-29.7 (43.42)	-32 (NA)	-81 (57.98)
CK; Week 48; n=6, 6, 0, 2	10.5 (71.39)	22.3 (77.32)	NA (NA)	-82.5 (70)
CK; PT Week 4; n=33, 34, 11, 11	-17.9 (48.82)	-26.4 (49.42)	-21.7 (42.62)	258.7 (994.88)
GGT; Week 18; n=38, 34, 13, 12	-37.3 (71.19)	-12.3 (60.35)	-30.2 (42.04)	-34.2 (56.52)
GGT; Week 24; n=35, 33, 12, 11	-38.3 (72.79)	-12.5 (86.73)	-37.4 (45.44)	-35.7 (59.63)
GGT; Week 30; n=13, 10, 3, 2	-44.2 (41.3)	-32.8 (31.81)	-38.7 (36.02)	-12 (4.24)
GGT; Week 36; n=10, 7, 2, 2	-51.5 (45.03)	-19.7 (24.52)	-40.5 (33.23)	-10 (4.24)
GGT; Week 42; n=9, 6, 1, 2	-44.6 (46.61)	-19.7 (25.06)	-17 (NA)	-9 (1.41)
GGT; Week 48; n=6, 6, 0, 2	-37.8 (28.74)	-16.8 (24.38)	NA (NA)	-9.5 (6.36)
GGT; PT Week 4; n=33, 34, 11, 11	-43.4 (78.29)	-17.7 (78.22)	-30.7 (41.91)	-41.4 (61.06)

33. Secondary Outcome

Title	Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Total bilirubin; Week 18; n=38, 34, 13, 12	0.5 (5.01)	1.7 (5.32)	-1.4 (11.37)	0.6 (6.49)
Total bilirubin; Week 24; n=35, 33, 12,11	-0.1 (5.73)	1 (4.08)	-1.3 (11.9)	1.3 (6.26)
Total bilirubin; Week 30; n=13, 10, 3, 2	-0.2 (5.99)	0.8 (4.76)	-2.3 (9.29)	-4 (5.66)
Total bilirubin; Week 36; n=10, 7, 2, 2	0 (4.29)	1.9 (4.95)	-3 (11.31)	-3 (7.07)
Total bilirubin; Week 42; n=9, 6, 1, 2	0.1 (5.11)	1.5 (5.79)	-14 (NA)	-4 (5.66)
Total bilirubin; Week 48; n=6, 6, 0, 2	-0.7 (4.72)	3.5 (7.2)	NA (NA)	-4 (2.83)
Total bilirubin PT Week 4; n=33, 34, 11,11	-4.6 (3.57)	-2.4 (3.3)	-0.4 (5.68)	-2.2 (2.71)
Creatinine; Week 24; n=35, 33, 12, 11	-1.55 (9.507)	-2.4 (8.413)	-3.12 (9.408)	1.31 (10.377)
Creatinine; Week 18; n=38, 34, 13, 12	-2.24 (9.186)	-1.97 (9.65)	-1.75 (9.874)	0.09 (10.668)
Creatinine; Week 30; n=13, 10, 3, 2	0.66 (4.603)	2.82 (8.123)	-8.47 (8.693)	-8.85 (3.748)
Creatinine; Week 36; n=10, 7, 2, 2	2.33 (11.096)	2.99 (8.179)	-5.5 (16.829)	-8 (1.273)
Creatinine; Week 42; n=9, 6, 1, 2	1.23 (10.32)	4.97 (11.697)	-14.3 (NA)	-7.55 (5.586)
Creatinine; Week 48; n=6, 6, 0, 2	-2.35 (4.222)	10.07 (17.173)	NA (NA)	-7.1 (1.273)
Creatinine; PT Week 4; n=33, 34, 11,11	1.23 (8.22)	-0.34 (7.624)	-1.7 (6.897)	-1.25 (6.228)

34. Secondary Outcome

Title	Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12
Description	Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0	0	0

35. Secondary Outcome

Title	Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12
Description	Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0	0	0

36. Secondary Outcome

Title	Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12
Description	The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0	0	0

37. Secondary Outcome

Title	Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12
Description	The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0	0	0

38. Secondary Outcome

Title	Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Chloride; Week 18; n=38, 34, 13, 12	1.9 (2.75)	1 (2.5)	1.8 (2.41)	0.5 (2.94)
Chloride; Week 24; n=35, 33, 12, 11	2 (2.33)	0.7 (2.73)	2.9 (2.81)	-0.2 (3.52)
Chloride; Week 30; n=13, 10, 3, 2	1.9 (2.72)	0.3 (2.87)	5.3 (3.21)	3 (0)
Chloride; Week 36; n=10, 7, 2, 2	1.3 (2.11)	-0.1 (2.54)	4.5 (6.36)	1 (0)
Chloride; Week 42; n=9, 6, 1, 2	1.3 (2.78)	0 (2)	10 (NA)	0.5 (0.71)
Chloride; Week 48; n=6, 6, 0, 2	1.3 (2.34)	-1 (3.16)	NA (NA)	0 (0)
Chloride; PT Week 4; n=33, 34, 11, 11	0.5 (2.69)	0.2 (2.54)	0.6 (2.29)	-1.5 (2.25)
Bicarbonate; Week 18; n=38, 34, 13,12	-0.3 (2.18)	-1 (2.16)	-1.2 (2.27)	0 (2.95)
Bicarbonate; Week 24; n=35, 33, 12,11	-1 (2.41)	-1.2 (2.21)	-1.8 (2.41)	-0.4 (3.35)
Bicarbonate; Week 30; n=13, 10, 3, 2	0.4 (2.33)	-2.2 (4.02)	-1.3 (1.53)	-2 (2.83)
Bicarbonate; Week 36; n=10, 7, 2, 2	-0.9 (2.92)	0.1 (1.86)	-2.5 (2.12)	-1.5 (2.12)
Bicarbonate; Week 42; n=9, 6, 1, 2	-0.7 (1.73)	-0.2 (2.04)	-4 (NA)	-1 (2.83)
Bicarbonate; Week 48; n=6, 6, 0, 2	-1 (1.67)	-1.3 (2.66)	NA (NA)	-0.5 (3.54)
Bicarbonate; PT Week 4; n=33, 34, 11,11	-0.7 (2.1)	-0.5 (2.46)	-0.9 (2.43)	1 (3.07)
Glucose; Week 18; n=38, 34, 13, 12	-0.28 (1.326)	-0.13 (1.188)	-0.06 (0.702)	-0.23 (2.134)
Glucose; Week 24; n=35, 33, 12, 11	-0.33 (1.552)	0.27 (2.986)	-0.23 (0.672)	-0.22 (1.349)
Glucose; Week 30; n=13, 10, 3, 2	0.03 (1.383)	-0.26 (0.587)	-0.13 (0.252)	0.9 (0.707)
Glucose; Week 36; n=10, 7, 2, 2	-0.38 (0.758)	-0.37 (1.09)	-0.1 (0.99)	-0.7 (0.283)
Glucose; Week 42; n=9, 6, 1, 2	-0.28 (1.663)	-0.12 (0.794)	0.4 (NA)	-0.15 (0.919)
Glucose; Week 48; n=6, 6, 0, 2	0.25 (1.358)	-0.3 (0.867)	NA (NA)	4.55 (4.596)
Glucose; PT Week 4; n=33, 34, 11, 11	0.24 (3.122)	0.18 (0.684)	-0.12 (0.735)	-0.07 (1.234)
Potassium; Week 18; n=38, 34, 13, 12	-0.19 (0.399)	-0.24 (0.376)	-0.41 (0.236)	-0.2 (0.424)
Potassium; Week 24; n=35, 33, 12, 11	-0.13 (0.452)	-0.12 (0.459)	-0.34 (0.403)	-0.32 (0.494)
Potassium; Week 30; n=13, 10, 3, 2	-0.03 (0.48)	-0.23 (0.377)	-0.1 (0.2)	-0.1 (0.424)
Potassium; Week 36; n=10, 7, 2, 2	0.24 (0.599)	-0.1 (0.365)	0.15 (0.071)	0.2 (0.424)
Potassium; Week 42; n=9, 6, 1, 2	-0.1 (0.555)	-0.2 (0.415)	-0.1 (NA)	0.1 (0.566)
Potassium; Week 48; n=6, 6, 0, 2	0.1 (0.566)	-0.3 (0.322)	NA (NA)	0.05 (0.495)
Potassium; PT Week 4; n=33, 34, 11,11	-0.16 (0.382)	-0.13 (0.398)	-0.25 (0.532)	-0.1 (0.316)
Sodium; Week 18; n=38, 34, 13, 12	0.7 (2.04)	0.1 (2.27)	0.7 (2.32)	0.4 (3.37)
Sodium; Week 24; n=35, 33, 12, 11	0.4 (1.86)	-0.1 (2.61)	1.5 (2.24)	0.4 (3.53)
Sodium; Week 30; n=13, 10, 3, 2	1.1 (3.25)	-1.4 (2.72)	1.3 (1.53)	0 (1.41)
Sodium; Week 36; n=10, 7, 2, 2	0.4 (2.67)	-0.7 (1.98)	2 (2.83)	-0.5 (0.71)
Sodium; Week 42; n=9, 6, 1, 2	0.4 (2.07)	-0.5 (1.38)	3 (NA)	-1.5 (0.71)
Sodium; Week 48; n=6, 6, 0, 2	-0.2 (2.14)	-1.2 (2.79)	NA (NA)	-2.5 (3.54)
Sodium; PT Week 4; n=33, 34, 11, 11	-0.1 (2.3)	0.1 (2.45)	1.1 (2.47)	-0.5 (2.7)
Inorganic phosphorus; Week 18; n=38,34,13,12	-0.161 (0.1971)	-0.13 (0.1928)	-0.092 (0.1537)	-0.111 (0.2648)
Inorganic phosphorus; Week 24; n=35,33,12,11	-0.139 (0.2268)	-0.13 (0.2354)	-0.119 (0.1991)	-0.107 (0.2205)
Inorganic phosphorus; Week 30; n=13,10,3,2	-0.156 (0.1644)	-0.118 (0.2071)	-0.267 (0.2023)	-0.225 (0.1768)
Inorganic phosphorus; Week 36; n=10,7,2,2	-0.121 (0.2564)	-0.167 (0.1906)	-0.195 (0.0495)	-0.125 (0.2475)
Inorganic phosphorus; Week 42; n=9,6,1,2	-0.08 (0.2248)	-0.108 (0.0794)	-0.15 (NA)	-0.1 (0.3536)
Inorganic phosphorus; Week 48; n=6,6,0,2	-0.167 (0.1715)	-0.108 (0.1665)	NA (NA)	-0.35 (0.0707)
Inorganic phosphorus; PT Week 4;n=33,34,11,11	-0.084 (0.2375)	-0.003 (0.2162)	0.009 (0.0798)	-0.085 (0.2247)
Urea/BUN; Week 18; n=38, 34, 13, 12	-0.19 (1.166)	-0.23 (1.403)	-0.49 (1.233)	-0.25 (1.688)
Urea/BUN; Week 24; n=35, 33, 12, 11	-0.22 (1.263)	-0.55 (1.252)	-0.43 (1.106)	0.02 (2.007)
Urea/BUN; Week 30; n=13, 10, 3, 2	0.69 (1.107)	-0.16 (1.027)	-0.5 (1.082)	-0.5 (0)
Urea/BUN; Week 36; n=10, 7, 2, 2	0.65 (1.775)	0.04 (1.172)	-0.15 (0.636)	-0.25 (1.061)
Urea/BUN; Week 42; n=9, 6, 1, 2	0.34 (1.65)	0.5 (1.239)	0.5 (NA)	-0.5 (1.414)
Urea/BUN; Week 48; n=6, 6, 0, 2	0.67 (1.353)	0.4 (1.607)	NA (NA)	-0.5 (0.707)
Urea/BUN; PT Week 4; n=33, 34, 11,11	0.35 (1.284)	-0.19 (1.311)	-0.62 (1.012)	-0.47 (0.969)

39. Secondary Outcome

Title	Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Description	Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time Frame	Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 HCV	Telaprevir, Genotype 1 HCV	GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.	Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	41	40	17	13
Creatinine clearance; Week 18; n=38, 34, 13, 12	-0.1 (17.36)	-1.1 (20.69)	-2.5 (16.25)	-4.3 (19.37)
Creatinine clearance; Week 24; n=35, 33, 12, 11	-1.9 (16.77)	-1 (18.53)	-4.1 (15.11)	-6.1 (19.05)
Creatinine clearance; Week 30; n=13,10,3,2	-4.8 (13.91)	-10.4 (14.41)	-3.7 (13.58)	7 (0)
Creatinine clearance; Week 36; n=10,7,2,2	-11 (23.3)	-8.1 (13.28)	-1 (29.7)	1.5 (9.19)
Creatinine clearance; Week 42; n=9, 6,1,2	-6.1 (16.86)	-13.3 (16.13)	9 (NA)	-1.5 (0.71)
Creatinine clearance; Week 48; n=6, 6,0,2	3.2 (10.23)	-15.8 (16.18)	NA (NA)	-4 (11.31)
Creatinine clearance; PT Week 4; n=33,34,11,11	-1.5 (34.53)	-1.3 (23.85)	-2.7 (11.38)	-5.3 (13.95)

40. Secondary Outcome

Title	Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status
Description	Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time Frame	Week 4 and Week 12

Outcome Measure Data

Analysis Population Description

Intensive PK Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0

41. Secondary Outcome

Title	Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status
Description	Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time Frame	Week 4 and Week 12

Outcome Measure Data

Analysis Population Description

Intensive PK Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0

42. Secondary Outcome

Title	Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status
Description	Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Intensive PK Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0

43. Secondary Outcome

Title	Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status
Description	Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Intensive PK Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0

44. Secondary Outcome

Title	Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status
Description	Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time Frame	Week 4 and Week 12

Outcome Measure Data

Analysis Population Description

PK/PD Analysis Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0

45. Secondary Outcome

Title	Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2
Description	Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

PK/PD Analysis Population

Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV	GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.	Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
Measure Participants	0	0

Adverse Events

Time Frame	SAEs and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
Adverse Event Reporting Description	SAEs and non-SAEs were collected in participants of the safety population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
Arm/Group Title	GSK2336805 40 mg, Genotype 1 HCV		GSK2336805 60 mg, Genotype 1 HCV		Telaprevir, Genotype 1 HCV		GSK2336805 60 mg, Genotype 4 HCV
Arm/Group Description	Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.		Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.		Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.		Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
All Cause Mortality
	GSK2336805 40 mg, Genotype 1 HCV		GSK2336805 60 mg, Genotype 1 HCV		Telaprevir, Genotype 1 HCV		GSK2336805 60 mg, Genotype 4 HCV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	GSK2336805 40 mg, Genotype 1 HCV		GSK2336805 60 mg, Genotype 1 HCV		Telaprevir, Genotype 1 HCV		GSK2336805 60 mg, Genotype 4 HCV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/41 (4.9%)		2/40 (5%)		3/17 (17.6%)		1/13 (7.7%)
Gastrointestinal disorders
Haemorrhoids	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Infections and infestations
Anal abscess	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Clostridium difficile infection	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Erysipelas	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Injection site abscess	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Otitis externa	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		0/13 (0%)
Injury, poisoning and procedural complications
Overdose	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		0/13 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	GSK2336805 40 mg, Genotype 1 HCV		GSK2336805 60 mg, Genotype 1 HCV		Telaprevir, Genotype 1 HCV		GSK2336805 60 mg, Genotype 4 HCV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/41 (100%)		38/40 (95%)		17/17 (100%)		13/13 (100%)
Blood and lymphatic system disorders
Anaemia	22/41 (53.7%)		14/40 (35%)		9/17 (52.9%)		2/13 (15.4%)
Coagulopathy	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		1/13 (7.7%)
Eosinopenia	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Leukopenia	6/41 (14.6%)		10/40 (25%)		6/17 (35.3%)		1/13 (7.7%)
Lymphadenopathy	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Lymphopenia	5/41 (12.2%)		2/40 (5%)		0/17 (0%)		1/13 (7.7%)
Monocytopenia	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Neutropenia	12/41 (29.3%)		12/40 (30%)		2/17 (11.8%)		3/13 (23.1%)
Thrombocytopenia	11/41 (26.8%)		5/40 (12.5%)		4/17 (23.5%)		1/13 (7.7%)
Cardiac disorders
Palpitations	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Tachycardia	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Ear and labyrinth disorders
Ear discomfort	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Ear pain	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Tinnitus	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Vertigo	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Endocrine disorders
Hyperthyroidism	0/41 (0%)		1/40 (2.5%)		1/17 (5.9%)		0/13 (0%)
Hypothyroidism	2/41 (4.9%)		2/40 (5%)		0/17 (0%)		0/13 (0%)
Eye disorders
Conjunctivitis	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Dry eye	2/41 (4.9%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Eye pain	1/41 (2.4%)		1/40 (2.5%)		1/17 (5.9%)		0/13 (0%)
Eye pruritus	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Vision blurred	0/41 (0%)		3/40 (7.5%)		0/17 (0%)		0/13 (0%)
Gastrointestinal disorders
Abdominal pain	2/41 (4.9%)		3/40 (7.5%)		0/17 (0%)		0/13 (0%)
Abdominal pain upper	2/41 (4.9%)		0/40 (0%)		1/17 (5.9%)		3/13 (23.1%)
Anal pruritus	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Constipation	3/41 (7.3%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Diarrhoea	6/41 (14.6%)		2/40 (5%)		4/17 (23.5%)		3/13 (23.1%)
Dry mouth	2/41 (4.9%)		0/40 (0%)		1/17 (5.9%)		2/13 (15.4%)
Dyspepsia	2/41 (4.9%)		1/40 (2.5%)		0/17 (0%)		3/13 (23.1%)
Gastrooesophageal reflux disease	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Gingival bleeding	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		1/13 (7.7%)
Lip swelling	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Nausea	7/41 (17.1%)		8/40 (20%)		7/17 (41.2%)		4/13 (30.8%)
Stomatitis	0/41 (0%)		0/40 (0%)		0/17 (0%)		2/13 (15.4%)
Toothache	1/41 (2.4%)		2/40 (5%)		0/17 (0%)		1/13 (7.7%)
Vomiting	3/41 (7.3%)		4/40 (10%)		4/17 (23.5%)		2/13 (15.4%)
General disorders
Asthenia	5/41 (12.2%)		1/40 (2.5%)		0/17 (0%)		1/13 (7.7%)
Chills	5/41 (12.2%)		0/40 (0%)		1/17 (5.9%)		1/13 (7.7%)
Drug withdrawal syndrome	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Fatigue	9/41 (22%)		12/40 (30%)		7/17 (41.2%)		4/13 (30.8%)
Feeling hot	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Influenza like illness	8/41 (19.5%)		9/40 (22.5%)		3/17 (17.6%)		8/13 (61.5%)
Injection site bruising	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		1/13 (7.7%)
Injection site erythema	6/41 (14.6%)		3/40 (7.5%)		1/17 (5.9%)		0/13 (0%)
Injection site pain	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Injection site pruritus	0/41 (0%)		2/40 (5%)		0/17 (0%)		0/13 (0%)
Injection site reaction	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Injury associated with device	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Irritability	4/41 (9.8%)		0/40 (0%)		0/17 (0%)		2/13 (15.4%)
Mucosal dryness	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Non-cardiac chest pain	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Pain	4/41 (9.8%)		0/40 (0%)		2/17 (11.8%)		0/13 (0%)
Pyrexia	11/41 (26.8%)		8/40 (20%)		5/17 (29.4%)		2/13 (15.4%)
Temperature intolerance	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	1/41 (2.4%)		1/40 (2.5%)		1/17 (5.9%)		0/13 (0%)
Infections and infestations
Asymptomatic bacteriuria	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Body tinea	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Herpes simplex	0/41 (0%)		1/40 (2.5%)		1/17 (5.9%)		0/13 (0%)
Hordeolum	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Influenza	1/41 (2.4%)		1/40 (2.5%)		0/17 (0%)		2/13 (15.4%)
Nasopharyngitis	2/41 (4.9%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Oral herpes	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Periodontitis	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Pharyngitis	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Tooth abscess	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Upper respiratory tract infection	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Urinary tract infection	2/41 (4.9%)		0/40 (0%)		2/17 (11.8%)		0/13 (0%)
Injury, poisoning and procedural complications
Gingival injury	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Laceration	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Post procedural complication	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Procedural pain	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Road traffic accident	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Investigations
Blood thyroid stimulating hormone increased	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Body temperature increased	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
International normalised ratio decreased	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Weight decreased	1/41 (2.4%)		2/40 (5%)		0/17 (0%)		1/13 (7.7%)
White blood cell count increased	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Metabolism and nutrition disorders
Decreased appetite	4/41 (9.8%)		3/40 (7.5%)		2/17 (11.8%)		3/13 (23.1%)
Dehydration	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Hyperphosphataemia	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Hypokalaemia	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Hypophosphataemia	2/41 (4.9%)		2/40 (5%)		1/17 (5.9%)		0/13 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/41 (4.9%)		3/40 (7.5%)		2/17 (11.8%)		1/13 (7.7%)
Arthritis	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Back pain	3/41 (7.3%)		3/40 (7.5%)		0/17 (0%)		0/13 (0%)
Costochondritis	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Myalgia	5/41 (12.2%)		7/40 (17.5%)		2/17 (11.8%)		3/13 (23.1%)
Pain in extremity	2/41 (4.9%)		0/40 (0%)		0/17 (0%)		0/13 (0%)
Nervous system disorders
Disturbance in attention	1/41 (2.4%)		1/40 (2.5%)		0/17 (0%)		1/13 (7.7%)
Dizziness	1/41 (2.4%)		5/40 (12.5%)		2/17 (11.8%)		1/13 (7.7%)
Dysgeusia	2/41 (4.9%)		2/40 (5%)		1/17 (5.9%)		1/13 (7.7%)
Headache	15/41 (36.6%)		14/40 (35%)		5/17 (29.4%)		4/13 (30.8%)
Hyperaesthesia	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Restless legs syndrome	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Syncope	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Psychiatric disorders
Anxiety	5/41 (12.2%)		3/40 (7.5%)		1/17 (5.9%)		1/13 (7.7%)
Depressed mood	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Depression	4/41 (9.8%)		3/40 (7.5%)		1/17 (5.9%)		0/13 (0%)
Insomnia	7/41 (17.1%)		8/40 (20%)		0/17 (0%)		3/13 (23.1%)
Libido decreased	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Mood swings	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		1/13 (7.7%)
Nervousness	3/41 (7.3%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Nightmare	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Panic attack	0/41 (0%)		1/40 (2.5%)		1/17 (5.9%)		0/13 (0%)
Reproductive system and breast disorders
Erectile dysfunction	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		1/13 (7.7%)
Respiratory, thoracic and mediastinal disorders
Cough	5/41 (12.2%)		3/40 (7.5%)		2/17 (11.8%)		2/13 (15.4%)
Dyspnoea	1/41 (2.4%)		3/40 (7.5%)		1/17 (5.9%)		1/13 (7.7%)
Dyspnoea exertional	1/41 (2.4%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)
Epistaxis	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		1/13 (7.7%)
Oropharyngeal pain	0/41 (0%)		2/40 (5%)		0/17 (0%)		1/13 (7.7%)
Wheezing	2/41 (4.9%)		2/40 (5%)		0/17 (0%)		0/13 (0%)
Skin and subcutaneous tissue disorders
Alopecia	2/41 (4.9%)		4/40 (10%)		3/17 (17.6%)		2/13 (15.4%)
Dermal cyst	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Dermatitis	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Dermatitis allergic	0/41 (0%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Dry skin	2/41 (4.9%)		5/40 (12.5%)		1/17 (5.9%)		1/13 (7.7%)
Erythema	1/41 (2.4%)		1/40 (2.5%)		2/17 (11.8%)		0/13 (0%)
Pruritus	3/41 (7.3%)		5/40 (12.5%)		2/17 (11.8%)		1/13 (7.7%)
Pruritus generalised	6/41 (14.6%)		4/40 (10%)		7/17 (41.2%)		0/13 (0%)
Rash	8/41 (19.5%)		5/40 (12.5%)		7/17 (41.2%)		3/13 (23.1%)
Rash generalised	0/41 (0%)		4/40 (10%)		2/17 (11.8%)		0/13 (0%)
Rash macular	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Rash maculo-papular	1/41 (2.4%)		0/40 (0%)		1/17 (5.9%)		0/13 (0%)
Rash pruritic	0/41 (0%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Vascular disorders
Hypertension	3/41 (7.3%)		1/40 (2.5%)		0/17 (0%)		0/13 (0%)
Hypotension	0/41 (0%)		0/40 (0%)		0/17 (0%)		1/13 (7.7%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.