COSMOS: A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients

• Sponsor: Janssen R&D Ireland (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01466790
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 168
• Locations: 23
• Arms: 4
• Duration (Months): 24
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: TMC435; Drug: PSI-7977 (GS7977); Drug: Ribavirin	Phase 2

Detailed Description

This is a Phase IIa, randomized (the study medications are assigned by chance), open label (all people know the identity of the intervention) study of TMC435 plus PSI-7977 (GS7977) with or without ribavirin. The study consists of a screening phase (6 weeks); a treatment phase (12 or 24 week period); and a posttreatment phase (follow-up period up to Week 48). Approximately 180 patients will be enrolled in this study. Patients will be sequentially enrolled into two cohorts in this study. Cohort 1 (90 patients) will include patients without advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy and Cohort 2 (90 patients) will include only patients with advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy or are HCV treatment-naive. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The entire study duration for each participant will be approximately 48 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 30 patients will receive TMC435 (150 mg once a day) plus PSI-7977(GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 24 weeks and followed by a 24-week follow-up phase.	Drug: TMC435; TMC435 will be administered as one oral capsule of 150 mg once a day.; Drug: PSI-7977 (GS7977); PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.; Other Names: GS7977 ; Drug: Ribavirin; Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).
Experimental: Arm 2 15 patients wiil receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 24 weeks of and followed by a 24-week follow-up phase.	Drug: TMC435; TMC435 will be administered as one oral capsule of 150 mg once a day.; Drug: PSI-7977 (GS7977); PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.; Other Names: GS7977
Experimental: Arm 3 30 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 12 weeks and followed by a 36-week follow-up phase.	Drug: TMC435; TMC435 will be administered as one oral capsule of 150 mg once a day.; Drug: PSI-7977 (GS7977); PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.; Other Names: GS7977 ; Drug: Ribavirin; Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).
Experimental: Arm 4 15 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 12 weeks and followed by a 36-week follow-up phase.	Drug: TMC435; TMC435 will be administered as one oral capsule of 150 mg once a day.; Drug: PSI-7977 (GS7977); PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.; Other Names: GS7977

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) [Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)]

   Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.

Secondary Outcome Measures

1. Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT) [Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)]

   Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.

2. Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT) [Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)]

   Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.

3. Number of Participants With a Sustained Virologic Response (SVR) at Week 48 [Week 48]

   Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.

4. Number of Participants With Viral Breakthrough [Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]]

   Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.

5. Number of Participants With Inadequate Virologic Response [Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]]

   Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.

6. Number of Participants With Viral Relapse [During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]]

   Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Chronic genotype 1 hepatitis C virus (HCV) infection

• Plasma HCV RNA of more than 10,000 IU/mL at screening

• Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks

• Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks and could also be HCV treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of HCV

• Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 of the most recent PegIFN/ribavirin therapy

• Patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed Metavir F3 or F4 fibrosis

• Must agree to use 2 forms of effective contraception throughout the study (male and female)

Exclusion Criteria:

• Has evidence of hepatic decompensation

• Has any liver disease of non-HCV etiology

• Has an infection/co-infection with non-genotype 1 HCV

• Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)

• Has a co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)

• Has a history of malignancy within 5 years of the screening visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hoover	Alabama	United States
2		Bakersfield	California	United States
3		La Jolla	California	United States
4		San Diego	California	United States
5		New Haven	Connecticut	United States
6		Brandenton	Florida	United States
7		Jacksonville	Florida	United States
8		Orlando	Florida	United States
9		Tampa	Florida	United States
10		Wellington	Florida	United States
11		Atlanta	Georgia	United States
12		Chicago	Illinois	United States
13		Lutherville	Maryland	United States
14		Lebanon	New Hampshire	United States
15		New York	New York	United States
16		Pittsburgh	Pennsylvania	United States
17		Arlington	Texas	United States
18		Dallas	Texas	United States
19		San Antonio	Texas	United States
20		Falls Church	Virginia	United States
21		Norfolk	Virginia	United States
22		Seatle	Washington	United States
23		Santurce		Puerto Rico

Sponsors and Collaborators

• Janssen R&D Ireland
• Gilead Sciences

Investigators

• Study Director: Janssen R&D Ireland Clinical Trial, Janssen R&D Ireland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen R&D Ireland
• ClinicalTrials.gov Identifier: NCT01466790
• Other Study ID Numbers: CR018724; TMC435HPC2002
• First Posted: Nov 8, 2011
• Last Update Posted: Feb 9, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Janssen R&D Ireland: Hepatitis C; TMC435; PSI-7977; GS7977; Ribavirin; HCV; Hep C; Genotype 1
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Sofosbuvir; Simeprevir

Study Results

Participant Flow

Pre-assignment Detail	A total of 168 participants enrolled to study. 1 participant who was randomized to Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks group, but never received treatment.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Period Title: Overall Study
STARTED	24	15	27	14	30	16	27	14
COMPLETED	20	14	27	14	27	16	26	13
NOT COMPLETED	4	1	0	0	3	0	1	1

Baseline Characteristics

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks	Total
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Total of all reporting groups
Overall Participants	24	15	27	14	30	16	27	14	167
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	56	56	55	55.5	58	57.5	57	57.5	57
Sex: Female, Male (Count of Participants)
Female	9 37.5%	9 60%	7 25.9%	6 42.9%	9 30%	9 56.3%	7 25.9%	4 28.6%	60 35.9%
Male	15 62.5%	6 40%	20 74.1%	8 57.1%	21 70%	7 43.8%	20 74.1%	10 71.4%	107 64.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
Description	Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.
Time Frame	Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	19 79.2%	14 93.3%	26 96.3%	13 92.9%	28 93.3%	16 100%	25 92.6%	13 92.9%

2. Secondary Outcome

Title	Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
Description	Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.
Time Frame	Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	20 83.3%	14 93.3%	26 96.3%	13 92.9%	28 93.3%	16 100%	26 96.3%	14 100%

3. Secondary Outcome

Title	Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
Description	Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.
Time Frame	Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	19 79.2%	14 93.3%	26 96.3%	13 92.9%	28 93.3%	16 100%	25 92.6%	13 92.9%

4. Secondary Outcome

Title	Number of Participants With a Sustained Virologic Response (SVR) at Week 48
Description	Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	19 79.2%	14 93.3%	26 96.3%	13 92.9%	27 90%	16 100%	24 88.9%	13 92.9%

5. Secondary Outcome

Title	Number of Participants With Viral Breakthrough
Description	Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.
Time Frame	Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Inadequate Virologic Response
Description	Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.
Time Frame	Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Viral Relapse
Description	Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.
Time Frame	During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.

Arm/Group Title	Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 1: TMC435 and PSI-7977 for 24 Weeks	Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 1: TMC435 and PSI-7977 for 12 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks	Cohort 2: TMC435 and PSI-7977 for 24 Weeks	Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks	Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.	Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Measure Participants	24	15	27	14	30	16	27	14
Number [Participants]	1 4.2%	0 0%	1 3.7%	1 7.1%	0 0%	0 0%	2 7.4%	1 7.1%

Adverse Events

Time Frame	Up to Week 48
Arm/Group Title	Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks		Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
Arm/Group Description	Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.		Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.		Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.		Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
All Cause Mortality
	Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks		Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks		Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/54 (5.6%)		1/31 (3.2%)		0/54 (0%)		0/28 (0%)
Blood and lymphatic system disorders
Anaemia	0/54 (0%)		1/31 (3.2%)		0/54 (0%)		0/28 (0%)
Eye disorders
Retinal tear	1/54 (1.9%)		0/31 (0%)		0/54 (0%)		0/28 (0%)
Visual impairment	1/54 (1.9%)		0/31 (0%)		0/54 (0%)		0/28 (0%)
Hepatobiliary disorders
Cholelithiasis	1/54 (1.9%)		0/31 (0%)		0/54 (0%)		0/28 (0%)
Injury, poisoning and procedural complications
Toxicity to various agents	1/54 (1.9%)		0/31 (0%)		0/54 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks		Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks		Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/54 (88.9%)		25/31 (80.6%)		42/54 (77.8%)		17/28 (60.7%)
Blood and lymphatic system disorders
Anaemia	13/54 (24.1%)		0/31 (0%)		6/54 (11.1%)		0/28 (0%)
Cardiac disorders
Sinus bradycardia	0/54 (0%)		2/31 (6.5%)		0/54 (0%)		0/28 (0%)
Gastrointestinal disorders
Abdominal pain	2/54 (3.7%)		3/31 (9.7%)		0/54 (0%)		0/28 (0%)
Abdominal pain upper	5/54 (9.3%)		0/31 (0%)		2/54 (3.7%)		0/28 (0%)
Constipation	4/54 (7.4%)		1/31 (3.2%)		4/54 (7.4%)		1/28 (3.6%)
Diarrhoea	1/54 (1.9%)		5/31 (16.1%)		3/54 (5.6%)		2/28 (7.1%)
Dry mouth	3/54 (5.6%)		0/31 (0%)		2/54 (3.7%)		0/28 (0%)
Dyspepsia	3/54 (5.6%)		1/31 (3.2%)		2/54 (3.7%)		0/28 (0%)
Gastrooesophageal reflux disease	5/54 (9.3%)		0/31 (0%)		0/54 (0%)		2/28 (7.1%)
Nausea	7/54 (13%)		4/31 (12.9%)		9/54 (16.7%)		6/28 (21.4%)
Toothache	0/54 (0%)		2/31 (6.5%)		1/54 (1.9%)		0/28 (0%)
Vomiting	3/54 (5.6%)		1/31 (3.2%)		1/54 (1.9%)		0/28 (0%)
General disorders
Chills	3/54 (5.6%)		0/31 (0%)		1/54 (1.9%)		0/28 (0%)
Fatigue	21/54 (38.9%)		10/31 (32.3%)		14/54 (25.9%)		7/28 (25%)
Influenza like illness	1/54 (1.9%)		2/31 (6.5%)		0/54 (0%)		0/28 (0%)
Oedema peripheral	4/54 (7.4%)		0/31 (0%)		0/54 (0%)		0/28 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	2/54 (3.7%)		1/31 (3.2%)		4/54 (7.4%)		0/28 (0%)
Immune system disorders
Seasonal allergy	3/54 (5.6%)		0/31 (0%)		0/54 (0%)		1/28 (3.6%)
Infections and infestations
Bronchitis	2/54 (3.7%)		2/31 (6.5%)		0/54 (0%)		0/28 (0%)
Oral herpes	4/54 (7.4%)		0/31 (0%)		0/54 (0%)		0/28 (0%)
Sinusitis	1/54 (1.9%)		2/31 (6.5%)		3/54 (5.6%)		0/28 (0%)
Upper respiratory tract infection	3/54 (5.6%)		2/31 (6.5%)		6/54 (11.1%)		1/28 (3.6%)
Urinary tract infection	3/54 (5.6%)		2/31 (6.5%)		1/54 (1.9%)		0/28 (0%)
Injury, poisoning and procedural complications
Sunburn	1/54 (1.9%)		0/31 (0%)		2/54 (3.7%)		2/28 (7.1%)
Investigations
Blood amylase increased	2/54 (3.7%)		2/31 (6.5%)		4/54 (7.4%)		0/28 (0%)
Blood creatine phosphokinase increased	4/54 (7.4%)		2/31 (6.5%)		6/54 (11.1%)		1/28 (3.6%)
Lipase increased	2/54 (3.7%)		1/31 (3.2%)		3/54 (5.6%)		0/28 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/54 (1.9%)		1/31 (3.2%)		2/54 (3.7%)		2/28 (7.1%)
Back pain	2/54 (3.7%)		1/31 (3.2%)		1/54 (1.9%)		2/28 (7.1%)
Myalgia	3/54 (5.6%)		3/31 (9.7%)		3/54 (5.6%)		1/28 (3.6%)
Neck pain	3/54 (5.6%)		0/31 (0%)		2/54 (3.7%)		1/28 (3.6%)
Pain in extremity	4/54 (7.4%)		2/31 (6.5%)		2/54 (3.7%)		0/28 (0%)
Nervous system disorders
Dizziness	7/54 (13%)		5/31 (16.1%)		3/54 (5.6%)		1/28 (3.6%)
Headache	11/54 (20.4%)		7/31 (22.6%)		9/54 (16.7%)		6/28 (21.4%)
Memory impairment	1/54 (1.9%)		2/31 (6.5%)		1/54 (1.9%)		0/28 (0%)
Psychiatric disorders
Abnormal dreams	0/54 (0%)		0/31 (0%)		3/54 (5.6%)		1/28 (3.6%)
Insomnia	9/54 (16.7%)		2/31 (6.5%)		5/54 (9.3%)		4/28 (14.3%)
Respiratory, thoracic and mediastinal disorders
Cough	8/54 (14.8%)		2/31 (6.5%)		3/54 (5.6%)		1/28 (3.6%)
Dyspnoea exertional	3/54 (5.6%)		0/31 (0%)		3/54 (5.6%)		0/28 (0%)
Oropharyngeal pain	0/54 (0%)		2/31 (6.5%)		2/54 (3.7%)		1/28 (3.6%)
Skin and subcutaneous tissue disorders
Alopecia	1/54 (1.9%)		3/31 (9.7%)		3/54 (5.6%)		1/28 (3.6%)
Dermatitis	1/54 (1.9%)		0/31 (0%)		3/54 (5.6%)		0/28 (0%)
Dry skin	4/54 (7.4%)		1/31 (3.2%)		2/54 (3.7%)		2/28 (7.1%)
Photosensitivity reaction	1/54 (1.9%)		2/31 (6.5%)		1/54 (1.9%)		0/28 (0%)
Pruritus	9/54 (16.7%)		1/31 (3.2%)		5/54 (9.3%)		3/28 (10.7%)
Rash	7/54 (13%)		3/31 (9.7%)		8/54 (14.8%)		1/28 (3.6%)
Vascular disorders
Hypertension	2/54 (3.7%)		2/31 (6.5%)		5/54 (9.3%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.