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CONCISE: Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT01459913
Collaborator
(none)
239
Enrollment
83
Locations
4
Arms
26
Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
239 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)

Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.

Drug: Telaprevir
Tablet
Other Names:
  • INCIVEK
  • INCIVO
  • VX-950

    • Drug: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Names:
  • Pegasys
  • Peg-IFN-Alfa-2a

    • Drug: Ribavirin
    Tablet
    Other Names:
  • Copegus
  • RBV

    		•
    Experimental: Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)

    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

    Drug: Telaprevir
    Tablet
    Other Names:
  • INCIVEK
  • INCIVO
  • VX-950

    • Drug: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Names:
  • Pegasys
  • Peg-IFN-Alfa-2a

    • Drug: Ribavirin
    Tablet
    Other Names:
  • Copegus
  • RBV

    		•
    Experimental: Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)

    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.

    Drug: Telaprevir
    Tablet
    Other Names:
  • INCIVEK
  • INCIVO
  • VX-950

    • Drug: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Names:
  • Pegasys
  • Peg-IFN-Alfa-2a

    • Drug: Ribavirin
    Tablet
    Other Names:
  • Copegus
  • RBV

    		•
    Experimental: Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)

    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.

    Drug: Telaprevir
    Tablet
    Other Names:
  • INCIVEK
  • INCIVO
  • VX-950

    • Drug: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Names:
  • Pegasys
  • Peg-IFN-Alfa-2a

    • Drug: Ribavirin
    Tablet
    Other Names:
  • Copegus
  • RBV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) [12 weeks after last planned dose of study drug (up to Week 36)]

      SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    Secondary Outcome Measures

    1. Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4) [4 weeks after last planned dose of study drug (up to Week 28)]

      SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    2. Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) [24 weeks after last planned dose of study drug (up to Week 48)]

      SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    3. Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72) [Week 72]

      SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    4. Percentage of Subjects With Viral Relapse [After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up]

      Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    5. Percentage of Subjects With On-Treatment Virologic Failure [Baseline up to Week 48]

      On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.

    6. Number of Subjects With Rapid Viral Response (RVR) [Week 4]

      The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    7. Number of Subjects With Extended Rapid Viral Response (eRVR) [Week 4 and Week 12]

      The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

    8. Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 48]

      AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study.

    Eligibility Criteria

    Criteria

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

    • Male and female subjects, 18 to 70 years of age, inclusive

    • Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration

    • Subjects have IL28B CC genotype determined during screening

    • Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required

    Exclusion Criteria:

    • Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C

    • Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment

    • Subjects have evidence of hepatic decompensation

    • Subjects have evidence of cirrhosis

    • Subjects have diagnosed or suspected hepatocellular carcinoma

    • Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35209
    2 Birmingham Alabama United States 35294
    3 Phoenix Arizona United States 85054
    4 La Jolla California United States 93037
    5 Los Angeles California United States 90027
    6 California Los Angeles California United States 90048
    7 Sacramento California United States 95817
    8 San Diego California United States 92103
    9 San Diego California United States 92105
    10 San Diego California United States 92154
    11 California San Francisco California United States 94115
    12 Farmington Connecticut United States 06030
    13 New Haven Connecticut United States 06511
    14 Bradenton Florida United States 34209
    15 Gainesville Florida United States 32224
    16 Jacksonville Florida United States 32224
    17 Jacksonville Florida United States 32256
    18 Orlando Florida United States 32803
    19 Atlanta Georgia United States 30308
    20 Marietta Georgia United States 30060
    21 Honolulu Hawaii United States 96817
    22 Chicago Illinois United States 60611
    23 Chicago Illinois United States 60612
    24 Baltimore Maryland United States 21202
    25 Baltimore Maryland United States 21287
    26 Columbia Maryland United States 21045
    27 Boston Massachusetts United States 02215
    28 Brockton Massachusetts United States 02302
    29 Burlington Massachusetts United States 01805
    30 Worcester Massachusetts United States 01605
    31 Novi Michigan United States 48202
    32 Kansas City Missouri United States 64131
    33 Lebanon New Hampshire United States 03756
    34 Egg Harbor Township New Jersey United States 08234
    35 Vineland New Jersey United States 08360
    36 Flushing New York United States 11355
    37 Manhasset New York United States 10030
    38 New York New York United States 10003
    39 New York New York United States 10021
    40 New York New York United States 10029
    41 Chapel Hill North Carolina United States 27599
    42 Charlotte North Carolina United States 28203
    43 Durham North Carolina United States 27710
    44 Pennsylvania Hershey Pennsylvania United States 17033
    45 Arlington Texas United States 76012
    46 Houston Texas United States 77030
    47 San Antonio Texas United States 78215
    48 Virginia Fairfax Virginia United States 22031
    49 Falls Church Virginia United States 22042
    50 Norfolk Virginia United States 23502
    51 Richmond Virginia United States 23249
    52 Seattle Washington United States 98101
    53 Madison Wisconsin United States 53715
    54 Madison Wisconsin United States 53792
    55 Milwaukee Wisconsin United States 53226
    56 Linz Austria 4010
    57 Vienna Austria 1090
    58 Vienna Austria 1160
    59 Calgary Alberta Canada T2N 4Z6
    60 Edmonton Alberta Canada T5M 1J7
    61 Edmonton Alberta Canada T6G 2X8
    62 Vancouver British Columbia Canada V6T 1Z3
    63 Winnipeg Manitoba Canada R3E 3P4
    64 Toronto Ontario Canada M5G 2N2
    65 Toronto Ontario Canada M5T 2S8
    66 Berlin Germany 10969
    67 Dusseldorf Germany 40237
    68 Frankfurt Germany 60590
    69 Hamburg Germany 20099
    70 Hannover Germany 30625
    71 Koeln Germany 50937
    72 Leipzig Germany 4103
    73 Munich Germany 81377
    74 Haifa Israel 31096
    75 Haifa Israel 34362
    76 Israel Jerusalem Israel 91120
    77 Nazareth Israel 16100
    78 Petah Tikva Israel 49100
    79 Tel Hashomer Israel 52621
    80 Bialystok Poland 16-540
    81 Czeladz Poland 41-250
    82 Myslowice Poland 41-400
    83 Wroclaw Poland 50-220

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    • Study Director: Mark Friedman, M.D., Vertex Pharmaceuticals Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01459913
    Other Study ID Numbers:
    • VX11-950-114
    First Posted:
    Oct 26, 2011
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Vertex Pharmaceuticals Incorporated
    VX-950
    INCIVEK
    INCIVO
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Interferons
    Ribavirin
    Interferon-alpha
    Interferon alpha-2
    Peginterferon alfa-2a

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Subjects received telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a)/ ribavirin (RBV). Planned duration of telaprevir treatment was 12 weeks. Minimum planned duration of Peg-IFN-alfa-2a/RBV treatment was 12 weeks; however, was dependent on virologic response during initial 12 weeks of telaprevir plus Peg-IFN-alfa-2a/RBV.
    Arm/Group Title Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Arm/Group Description Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
    Period Title: Overall Study
    STARTED 106 52 19 62
    COMPLETED 65 32 6 29
    NOT COMPLETED 41 20 13 33

    Baseline Characteristics

    Arm/Group Title Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Total
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned. Total of all reporting groups
    Overall Participants 106 52 19 61 238
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.1
    (12.82)
    44.8
    (12.89)
    54.4
    (8.70)
    49.8
    (10.56)
    47.4
    (12.26)
    Sex: Female, Male (Count of Participants)
    Female
    39
    36.8%
    16
    30.8%
    11
    57.9%
    29
    47.5%
    95
    39.9%
    Male
    67
    63.2%
    36
    69.2%
    8
    42.1%
    32
    52.5%
    143
    60.1%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
    Description SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame 12 weeks after last planned dose of study drug (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis (FA) Set.
    Arm/Group Title Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 106 52
    Number [percentage of participants]
    88.7
    83.7%
    96.2
    185%
    2. Secondary Outcome
    Title Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
    Description SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame 4 weeks after last planned dose of study drug (up to Week 28)

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 106 52
    Number [percentage of participants]
    89.6
    84.5%
    98.1
    188.7%
    3. Secondary Outcome
    Title Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
    Description SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame 24 weeks after last planned dose of study drug (up to Week 48)

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 106 52
    Number [percentage of participants]
    85.8
    80.9%
    92.3
    177.5%
    4. Secondary Outcome
    Title Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
    Description SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame Week 72

    Outcome Measure Data

    Analysis Population Description
    FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to 'Study Terminated by the Sponsor' are excluded from this analysis.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 76 37
    Number [percentage of participants]
    72.4
    68.3%
    86.5
    166.3%
    5. Secondary Outcome
    Title Percentage of Subjects With Viral Relapse
    Description Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 106 52
    4 Weeks
    1.9
    1.8%
    0.0
    0%
    12 Weeks
    7.5
    7.1%
    0.0
    0%
    24 Weeks
    10.4
    9.8%
    0.0
    0%
    6. Secondary Outcome
    Title Percentage of Subjects With On-Treatment Virologic Failure
    Description On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
    Time Frame Baseline up to Week 48

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned. All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
    Measure Participants 106 52 19 61 238
    Number [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    3.3
    5.4%
    0.8
    0.3%
    7. Secondary Outcome
    Title Number of Subjects With Rapid Viral Response (RVR)
    Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 106 52
    Number [participants]
    106
    100%
    52
    100%
    8. Secondary Outcome
    Title Number of Subjects With Extended Rapid Viral Response (eRVR)
    Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
    Time Frame Week 4 and Week 12

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Measure Participants 106 52
    Number [participants]
    105
    99.1%
    51
    98.1%
    9. Secondary Outcome
    Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Description AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study.
    Time Frame Baseline up to Week 48

    Outcome Measure Data

    Analysis Population Description
    Safety set included all subjects who received at least 1 dose of study drug.
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
    Measure Participants 106 52 19 62
    AEs
    104
    98.1%
    51
    98.1%
    19
    100%
    61
    100%
    SAEs
    5
    4.7%
    4
    7.7%
    3
    15.8%
    13
    21.3%

    Adverse Events

    Time Frame Baseline up to Week 48
    Adverse Event Reporting Description
    Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
    All Cause Mortality
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/106 (4.7%) 4/52 (7.7%) 3/19 (15.8%) 13/62 (21%)
    Blood and lymphatic system disorders
    Anaemia 2/106 (1.9%) 3/52 (5.8%) 2/19 (10.5%) 7/62 (11.3%)
    Gastrointestinal disorders
    Colitis microscopic 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Pancreatitis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Pancreatitis chronic 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    General disorders
    Asthenia 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Chest pain 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Fatigue 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Pyrexia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Infections and infestations
    Abscess oral 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Bacteraemia 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Perirectal abscess 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Pneumonia 0/106 (0%) 0/52 (0%) 0/19 (0%) 3/62 (4.8%)
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Nervous system disorders
    Syncope 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Psychiatric disorders
    Anxiety 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Renal and urinary disorders
    Renal failure acute 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Respiratory, thoracic and mediastinal disorders
    Hypoxia 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Pulmonary embolism 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Skin and subcutaneous tissue disorders
    Drug reaction with eosinophilia and systemic symptoms 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Vascular disorders
    Deep vein thrombosis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hypotension 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Thrombosis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Other (Not Including Serious) Adverse Events
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 104/106 (98.1%) 51/52 (98.1%) 19/19 (100%) 61/62 (98.4%)
    Blood and lymphatic system disorders
    Anaemia 42/106 (39.6%) 22/52 (42.3%) 10/19 (52.6%) 20/62 (32.3%)
    Neutropenia 5/106 (4.7%) 4/52 (7.7%) 4/19 (21.1%) 1/62 (1.6%)
    Leukopenia 1/106 (0.9%) 2/52 (3.8%) 0/19 (0%) 2/62 (3.2%)
    Lymphopenia 2/106 (1.9%) 1/52 (1.9%) 1/19 (5.3%) 1/62 (1.6%)
    Thrombocytopenia 3/106 (2.8%) 0/52 (0%) 1/19 (5.3%) 1/62 (1.6%)
    Lymphadenopathy 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Increased tendency to bruise 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Pancytopenia 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Cardiac disorders
    Palpitations 3/106 (2.8%) 1/52 (1.9%) 2/19 (10.5%) 2/62 (3.2%)
    Tachycardia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 3/62 (4.8%)
    Arrhythmia supraventricular 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Atrial fibrillation 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Sinus bradycardia 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Supraventricular extrasystoles 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Ear and labyrinth disorders
    Vertigo 4/106 (3.8%) 2/52 (3.8%) 0/19 (0%) 4/62 (6.5%)
    Tinnitus 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 2/62 (3.2%)
    Ear pruritus 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Ear discomfort 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Ear pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hyperacusis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hypoacusis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Otorrhoea 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Endocrine disorders
    Hypothyroidism 0/106 (0%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Eye disorders
    Vision blurred 8/106 (7.5%) 2/52 (3.8%) 3/19 (15.8%) 2/62 (3.2%)
    Photophobia 6/106 (5.7%) 3/52 (5.8%) 0/19 (0%) 0/62 (0%)
    Dry eye 4/106 (3.8%) 0/52 (0%) 0/19 (0%) 4/62 (6.5%)
    Eye pruritus 3/106 (2.8%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Ocular hyperaemia 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Visual impairment 0/106 (0%) 2/52 (3.8%) 0/19 (0%) 1/62 (1.6%)
    Diplopia 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Eye irritation 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Eye pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Retinal exudates 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Abnormal sensation in eye 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Conjunctival haemorrhage 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Conjunctivitis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Eye haemorrhage 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Eyelid oedema 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Ocular discomfort 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Periorbital oedema 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Retinal haemorrhage 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Retinopathy 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Vitreous floaters 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Gastrointestinal disorders
    Nausea 49/106 (46.2%) 19/52 (36.5%) 13/19 (68.4%) 33/62 (53.2%)
    Diarrhoea 19/106 (17.9%) 6/52 (11.5%) 6/19 (31.6%) 11/62 (17.7%)
    Vomiting 17/106 (16%) 6/52 (11.5%) 6/19 (31.6%) 11/62 (17.7%)
    Anorectal discomfort 22/106 (20.8%) 9/52 (17.3%) 3/19 (15.8%) 5/62 (8.1%)
    Anal pruritus 10/106 (9.4%) 8/52 (15.4%) 3/19 (15.8%) 4/62 (6.5%)
    Haemorrhoids 8/106 (7.5%) 4/52 (7.7%) 1/19 (5.3%) 6/62 (9.7%)
    Dry mouth 5/106 (4.7%) 3/52 (5.8%) 3/19 (15.8%) 7/62 (11.3%)
    Dyspepsia 9/106 (8.5%) 2/52 (3.8%) 1/19 (5.3%) 3/62 (4.8%)
    Proctalgia 5/106 (4.7%) 4/52 (7.7%) 0/19 (0%) 3/62 (4.8%)
    Constipation 4/106 (3.8%) 1/52 (1.9%) 3/19 (15.8%) 3/62 (4.8%)
    Abdominal pain upper 3/106 (2.8%) 0/52 (0%) 0/19 (0%) 5/62 (8.1%)
    Abdominal pain 3/106 (2.8%) 2/52 (3.8%) 0/19 (0%) 1/62 (1.6%)
    Aphthous stomatitis 2/106 (1.9%) 2/52 (3.8%) 0/19 (0%) 1/62 (1.6%)
    Cheilitis 2/106 (1.9%) 2/52 (3.8%) 0/19 (0%) 0/62 (0%)
    Flatulence 3/106 (2.8%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Gastrooesophageal reflux disease 0/106 (0%) 0/52 (0%) 0/19 (0%) 4/62 (6.5%)
    Haematochezia 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Rectal haemorrhage 0/106 (0%) 2/52 (3.8%) 1/19 (5.3%) 1/62 (1.6%)
    Stomatitis 2/106 (1.9%) 1/52 (1.9%) 1/19 (5.3%) 0/62 (0%)
    Abdominal discomfort 3/106 (2.8%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Abdominal distension 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 2/62 (3.2%)
    Gingival bleeding 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Toothache 1/106 (0.9%) 1/52 (1.9%) 1/19 (5.3%) 0/62 (0%)
    Anal haemorrhage 0/106 (0%) 1/52 (1.9%) 1/19 (5.3%) 0/62 (0%)
    Epigastric discomfort 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Glossodynia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Oral pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Proctitis 1/106 (0.9%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Retching 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Abdominal pain lower 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Abdominal tenderness 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Anal fissure 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Ascites 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Bowel movement irregularity 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Duodenal ulcer 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Eructation 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Faeces pale 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Frequent bowel movements 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Gastrointestinal motility disorder 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Gingival pain 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Glossitis 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Haemorrhoidal haemorrhage 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hyperchlorhydria 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Lip dry 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Lip pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Oral discomfort 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Oral disorder 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Perianal erythema 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Sensitivity of teeth 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Steatorrhoea 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Swollen tongue 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Tongue coated 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Tongue disorder 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Tooth impacted 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    General disorders
    Fatigue 55/106 (51.9%) 25/52 (48.1%) 12/19 (63.2%) 26/62 (41.9%)
    Pyrexia 26/106 (24.5%) 13/52 (25%) 4/19 (21.1%) 15/62 (24.2%)
    Influenza like illness 28/106 (26.4%) 10/52 (19.2%) 8/19 (42.1%) 9/62 (14.5%)
    Asthenia 14/106 (13.2%) 8/52 (15.4%) 3/19 (15.8%) 13/62 (21%)
    Irritability 9/106 (8.5%) 7/52 (13.5%) 2/19 (10.5%) 9/62 (14.5%)
    Chills 6/106 (5.7%) 6/52 (11.5%) 0/19 (0%) 9/62 (14.5%)
    Injection site erythema 5/106 (4.7%) 4/52 (7.7%) 0/19 (0%) 3/62 (4.8%)
    Pain 5/106 (4.7%) 3/52 (5.8%) 1/19 (5.3%) 3/62 (4.8%)
    Malaise 0/106 (0%) 1/52 (1.9%) 1/19 (5.3%) 5/62 (8.1%)
    Oedema peripheral 1/106 (0.9%) 4/52 (7.7%) 1/19 (5.3%) 1/62 (1.6%)
    Chest pain 2/106 (1.9%) 2/52 (3.8%) 1/19 (5.3%) 0/62 (0%)
    Injection site reaction 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 4/62 (6.5%)
    Injection site rash 1/106 (0.9%) 2/52 (3.8%) 0/19 (0%) 2/62 (3.2%)
    Chest discomfort 0/106 (0%) 4/52 (7.7%) 0/19 (0%) 0/62 (0%)
    Injection site pruritus 1/106 (0.9%) 2/52 (3.8%) 1/19 (5.3%) 0/62 (0%)
    Local swelling 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Thirst 1/106 (0.9%) 0/52 (0%) 1/19 (5.3%) 1/62 (1.6%)
    Feeling abnormal 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Injection site bruising 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Enanthema 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Feeling cold 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Feeling hot 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Injection site pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Non-cardiac chest pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Temperature intolerance 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hepatobiliary disorders
    Cholelithiasis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Periportal oedema 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Immune system disorders
    Seasonal allergy 0/106 (0%) 4/52 (7.7%) 0/19 (0%) 0/62 (0%)
    Infections and infestations
    Urinary tract infection 5/106 (4.7%) 1/52 (1.9%) 2/19 (10.5%) 3/62 (4.8%)
    Nasopharyngitis 2/106 (1.9%) 1/52 (1.9%) 1/19 (5.3%) 2/62 (3.2%)
    Pneumonia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Upper respiratory tract infection 0/106 (0%) 3/52 (5.8%) 1/19 (5.3%) 0/62 (0%)
    Cellulitis 0/106 (0%) 3/52 (5.8%) 0/19 (0%) 0/62 (0%)
    Ear infection 1/106 (0.9%) 2/52 (3.8%) 0/19 (0%) 0/62 (0%)
    Oral herpes 3/106 (2.8%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Cystitis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Influenza 1/106 (0.9%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Sinusitis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Skin infection 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Tooth abscess 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Vulvovaginal candidiasis 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Bronchitis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Candida infection 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Dermatitis infected 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Folliculitis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Genital herpes 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Gingivitis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Herpes pharyngitis 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Parotitis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Rash pustular 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Rhinitis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Scrotal abscess 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Subcutaneous abscess 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Tinea cruris 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Tooth infection 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Vulvovaginal mycotic infection 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Injury, poisoning and procedural complications
    Contusion 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Laceration 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Scratch 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Arthropod bite 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Excoriation 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Procedural pain 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Investigations
    Weight decreased 8/106 (7.5%) 2/52 (3.8%) 2/19 (10.5%) 4/62 (6.5%)
    Lymphocyte count decreased 3/106 (2.8%) 1/52 (1.9%) 1/19 (5.3%) 1/62 (1.6%)
    Blood uric acid increased 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 3/62 (4.8%)
    Blood pressure increased 1/106 (0.9%) 0/52 (0%) 1/19 (5.3%) 1/62 (1.6%)
    Haemoglobin decreased 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Platelet count decreased 1/106 (0.9%) 0/52 (0%) 2/19 (10.5%) 0/62 (0%)
    Amylase increased 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Blood potassium decreased 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Blood thyroid stimulating hormone increased 1/106 (0.9%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Blood urine present 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Neutrophil count decreased 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Transaminases increased 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    White blood cell count decreased 1/106 (0.9%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Alanine aminotransferase increased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Aspartate aminotransferase increased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Blood alkaline phosphatase increased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Blood calcium decreased 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Blood creatinine increased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Body temperature increased 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Electrocardiogram QT prolonged 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Electrocardiogram ST-T change 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Eosinophil count increased 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Haematocrit decreased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Haemoglobin increased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Lipase increased 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Liver function test abnormal 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Red blood cell count decreased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Respiratory rate increased 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Metabolism and nutrition disorders
    Decreased appetite 21/106 (19.8%) 6/52 (11.5%) 4/19 (21.1%) 10/62 (16.1%)
    Dehydration 3/106 (2.8%) 1/52 (1.9%) 0/19 (0%) 2/62 (3.2%)
    Hyponatraemia 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Abnormal loss of weight 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Gout 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Hyperuricaemia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Hypocalcaemia 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Hypokalaemia 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Hypomagnesaemia 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 9/106 (8.5%) 7/52 (13.5%) 2/19 (10.5%) 8/62 (12.9%)
    Myalgia 6/106 (5.7%) 7/52 (13.5%) 0/19 (0%) 11/62 (17.7%)
    Back pain 6/106 (5.7%) 2/52 (3.8%) 0/19 (0%) 4/62 (6.5%)
    Muscle spasms 3/106 (2.8%) 4/52 (7.7%) 0/19 (0%) 1/62 (1.6%)
    Pain in extremity 2/106 (1.9%) 2/52 (3.8%) 1/19 (5.3%) 3/62 (4.8%)
    Joint swelling 1/106 (0.9%) 2/52 (3.8%) 0/19 (0%) 1/62 (1.6%)
    Muscular weakness 1/106 (0.9%) 1/52 (1.9%) 2/19 (10.5%) 0/62 (0%)
    Musculoskeletal pain 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Bone pain 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Neck pain 3/106 (2.8%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Musculoskeletal chest pain 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Costochondritis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Joint stiffness 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Musculoskeletal discomfort 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Musculoskeletal stiffness 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Plantar fasciitis 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Spinal pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Melanocytic naevus 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Nervous system disorders
    Headache 30/106 (28.3%) 16/52 (30.8%) 5/19 (26.3%) 17/62 (27.4%)
    Dizziness 17/106 (16%) 6/52 (11.5%) 6/19 (31.6%) 14/62 (22.6%)
    Dysgeusia 13/106 (12.3%) 2/52 (3.8%) 2/19 (10.5%) 5/62 (8.1%)
    Hypoaesthesia 2/106 (1.9%) 5/52 (9.6%) 0/19 (0%) 1/62 (1.6%)
    Migraine 2/106 (1.9%) 3/52 (5.8%) 1/19 (5.3%) 1/62 (1.6%)
    Disturbance in attention 3/106 (2.8%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Memory impairment 3/106 (2.8%) 2/52 (3.8%) 0/19 (0%) 0/62 (0%)
    Hyperaesthesia 1/106 (0.9%) 1/52 (1.9%) 1/19 (5.3%) 0/62 (0%)
    Paraesthesia 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Somnolence 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Syncope 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Lethargy 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Burning sensation 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Carpal tunnel syndrome 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Cognitive disorder 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Dizziness exertional 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Drooling 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Mental impairment 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Neuropathy peripheral 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Parosmia 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Sciatica 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Tremor 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Psychiatric disorders
    Insomnia 22/106 (20.8%) 11/52 (21.2%) 6/19 (31.6%) 12/62 (19.4%)
    Depression 12/106 (11.3%) 8/52 (15.4%) 4/19 (21.1%) 10/62 (16.1%)
    Anxiety 6/106 (5.7%) 2/52 (3.8%) 2/19 (10.5%) 3/62 (4.8%)
    Depressed mood 4/106 (3.8%) 2/52 (3.8%) 0/19 (0%) 0/62 (0%)
    Mood swings 2/106 (1.9%) 2/52 (3.8%) 0/19 (0%) 1/62 (1.6%)
    Affect lability 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Agitation 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Anger 1/106 (0.9%) 2/52 (3.8%) 0/19 (0%) 0/62 (0%)
    Mood altered 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Sleep disorder 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Apathy 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Drug dependence 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Emotional disorder 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Initial insomnia 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Nervousness 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Restlessness 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Aggression 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Confusional state 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Disorientation 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Libido decreased 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Loss of libido 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Personality disorder 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Suicide attempt 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Renal and urinary disorders
    Urinary retention 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Dysuria 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Reproductive system and breast disorders
    Menorrhagia 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Metrorrhagia 0/106 (0%) 2/52 (3.8%) 0/19 (0%) 0/62 (0%)
    Amenorrhoea 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Erectile dysfunction 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Menstrual disorder 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Pruritus genital 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Scrotal erythema 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Scrotal pain 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 18/106 (17%) 11/52 (21.2%) 5/19 (26.3%) 9/62 (14.5%)
    Cough 9/106 (8.5%) 5/52 (9.6%) 0/19 (0%) 9/62 (14.5%)
    Oropharyngeal pain 7/106 (6.6%) 1/52 (1.9%) 1/19 (5.3%) 2/62 (3.2%)
    Dyspnoea exertional 5/106 (4.7%) 0/52 (0%) 1/19 (5.3%) 3/62 (4.8%)
    Epistaxis 3/106 (2.8%) 1/52 (1.9%) 1/19 (5.3%) 3/62 (4.8%)
    Nasal congestion 0/106 (0%) 1/52 (1.9%) 2/19 (10.5%) 0/62 (0%)
    Rhinorrhoea 1/106 (0.9%) 1/52 (1.9%) 1/19 (5.3%) 0/62 (0%)
    Productive cough 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Respiratory tract congestion 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Sinus congestion 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Sneezing 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Dysphonia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Hiccups 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Nasal discomfort 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Nasal disorder 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Nasal dryness 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Nasal inflammation 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Nasal mucosal disorder 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Oropharyngeal discomfort 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Painful respiration 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Paranasal sinus discomfort 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Pharyngeal oedema 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Rales 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Respiration abnormal 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 44/106 (41.5%) 17/52 (32.7%) 8/19 (42.1%) 24/62 (38.7%)
    Rash 31/106 (29.2%) 15/52 (28.8%) 9/19 (47.4%) 13/62 (21%)
    Alopecia 13/106 (12.3%) 11/52 (21.2%) 4/19 (21.1%) 7/62 (11.3%)
    Dry skin 11/106 (10.4%) 11/52 (21.2%) 6/19 (31.6%) 4/62 (6.5%)
    Pruritus generalised 4/106 (3.8%) 3/52 (5.8%) 3/19 (15.8%) 3/62 (4.8%)
    Rash maculo-papular 5/106 (4.7%) 2/52 (3.8%) 3/19 (15.8%) 3/62 (4.8%)
    Rash papular 5/106 (4.7%) 1/52 (1.9%) 4/19 (21.1%) 3/62 (4.8%)
    Rash erythematous 4/106 (3.8%) 1/52 (1.9%) 2/19 (10.5%) 4/62 (6.5%)
    Rash pruritic 2/106 (1.9%) 2/52 (3.8%) 2/19 (10.5%) 1/62 (1.6%)
    Dermatitis 1/106 (0.9%) 2/52 (3.8%) 0/19 (0%) 2/62 (3.2%)
    Rash generalised 1/106 (0.9%) 2/52 (3.8%) 1/19 (5.3%) 1/62 (1.6%)
    Swelling face 2/106 (1.9%) 0/52 (0%) 2/19 (10.5%) 1/62 (1.6%)
    Erythema 1/106 (0.9%) 1/52 (1.9%) 1/19 (5.3%) 1/62 (1.6%)
    Night sweats 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 1/62 (1.6%)
    Psoriasis 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Eczema 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Rash macular 2/106 (1.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Skin irritation 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Urticaria 1/106 (0.9%) 1/52 (1.9%) 1/19 (5.3%) 0/62 (0%)
    Drug eruption 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Drug reaction with eosinophilia and systemic symptoms 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hyperhidrosis 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Blister 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Dermatitis acneiform 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Hair growth abnormal 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hair texture abnormal 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Onychoclasis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Pain of skin 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Palmar-plantar erythrodysaesthesia syndrome 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Photosensitivity reaction 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Purpura 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Rash follicular 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Rash vesicular 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Scab 0/106 (0%) 0/52 (0%) 1/19 (5.3%) 0/62 (0%)
    Seborrhoea 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Seborrhoeic dermatitis 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Skin burning sensation 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Skin exfoliation 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Skin fragility 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Skin lesion 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Stasis dermatitis 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Telangiectasia 0/106 (0%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Vascular disorders
    Hypotension 0/106 (0%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Pallor 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Circulatory collapse 0/106 (0%) 0/52 (0%) 0/19 (0%) 2/62 (3.2%)
    Hot flush 2/106 (1.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Hypertension 1/106 (0.9%) 1/52 (1.9%) 0/19 (0%) 0/62 (0%)
    Orthostatic hypotension 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Haematoma 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Orthostatic hypertension 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)
    Peripheral coldness 1/106 (0.9%) 0/52 (0%) 0/19 (0%) 0/62 (0%)
    Vascular pain 0/106 (0%) 0/52 (0%) 0/19 (0%) 1/62 (1.6%)

    Limitations/Caveats

    The study was terminated early at the primary efficacy endpoint (SVR12), by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.

    More Information

    Certain Agreements

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

    PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.

    Results Point of Contact

    Name/Title Medical Monitor
    Organization Vertex Pharmaceuticals Incorporated
    Phone 617-341-6777
    Email medicalinfo@vrtx.com
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01459913
    Other Study ID Numbers:
    • VX11-950-114
    First Posted:
    Oct 26, 2011
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    May 1, 2015