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PEDESTAL: Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01598090
Collaborator
(none)
881
Enrollment
104
Locations
3
Arms
35
Actual Duration (Months)
8.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
881 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin
Actual Study Start Date :
Jun 14, 2012
Actual Primary Completion Date :
Feb 4, 2015
Actual Study Completion Date :
May 15, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Peginterferon Lambda-1a + RBV + TVR

Biological: Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response

Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response

Drug: Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Other Names:
  • Incivek

    		•
    Experimental: Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR

    Biological: Peginterferon Lambda-1a
    Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response

    Drug: Ribavirin
    Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response

    Drug: Telaprevir
    Tablets, Oral, 750 mg, three times a day, 12 weeks only
    Other Names:
  • Incivek

    		•
    Experimental: Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR

    Biological: Peginterferon Alfa-2a
    Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
    Other Names:
  • Pegasys

    • Drug: Ribavirin
    Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response

    Drug: Telaprevir
    Tablets, Oral, 750 mg, three times a day, 12 weeks only
    Other Names:
  • Incivek

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A [Assessed at Week 4 and Week 12, week 12 reported]

      eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

    2. Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B [Follow-up Week 12]

      SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

    3. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A [Day 1 of treatment up to Week 48]

      An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A [Follow-up Week 12]

      SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL).

    2. Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A [Follow up week 24]

      SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.

    3. Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B [Follow-up Week 12]

      SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

    4. Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B [After Day 1 of treatment up to Week 48]

      Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3.

    5. Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B [Week 4 and Week 12]

      eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

    6. Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B [After Day 1 of treatment up to Week 48]

      Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.

    7. Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B [Follow-up Week 24]

      SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL).

    8. Percentage of Participants With Rash [After Day 1 of treatment up to Week 48]

      All skin reactions involving rash or rash-like events that occurred on treatment were reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

    Inclusion Criteria:

    • Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects

    • Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]

    • Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%

    • HCV RNA ≥ 100,000 IU/mL

    • Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%

    • Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)

    • Men or women, 18-70 years of age

    Exclusion Criteria:

    • Chronic liver disease due to causes other than chronic HCV

    • Current or past evidence of decompensation

    • Conditions that preclude the use of Alfa/RBV/TVR per respective labels

    • Diagnosed or suspected hepatocellular carcinoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Gastroenterology Associates, P.C. Birmingham Alabama United States 35209
    2 The Kirklin Clinic Birmingham Alabama United States 35294
    3 The University Of Alabama Of Birmingham Birmingham Alabama United States 35294
    4 Anaheim Clinical Trials Llc Anaheim California United States 92801
    5 Sc Clinical Research, Inc. Garden Grove California United States 92844
    6 Va Long Beach Healthcare System Long Beach California United States 90822
    7 Cedars Sinai Medical Center Los Angeles California United States 90048
    8 Va Greater Los Angeles Healthcare System Los Angeles California United States 90073
    9 University Of California, San Francisco/Sf General Hospital San Francisco California United States 94110
    10 South Bay Ge Medical Group Torrance California United States 90505
    11 Orlando Va Medical Center Orlando Florida United States 32803
    12 Orlando Clinical Research Center Orlando Florida United States 32809
    13 Infectious Disease Research Institute, Inc. Tampa Florida United States 33614
    14 Gastrointestinal Specialists Of Georgia Pc Marietta Georgia United States 30060
    15 Mercy Medical Center Baltimore Maryland United States 21202
    16 Saint Luke'S Transplant Specialists Kansas City Missouri United States 64111
    17 Saint Louis University Saint Louis Missouri United States 63104
    18 Carolinas Medical Center Charlotte North Carolina United States 28204
    19 Options Health Research, Llc Tulsa Oklahoma United States 74104
    20 Healthcare Research Consultants Tulsa Oklahoma United States 74135
    21 Gastro One Germantown Tennessee United States 38138
    22 Texas Clinical Research Institute Arlington Texas United States 76012
    23 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    24 Alamo Medical Research San Antonio Texas United States 78215
    25 Clinical Research Centers Of America Murray Utah United States 84123
    26 Metropolitan Research Annandale Virginia United States 22003
    27 Bon Secours St. Mary'S Hospital Of Richmond, Inc. Newport News Virginia United States 23602
    28 Digestive And Liver Disease Specialists Norfolk Virginia United States 23502
    29 Local Institution Graz Austria 8036
    30 Local Institution Linz Austria 4010
    31 Local Institution Bruxelles Belgium 1200
    32 Local Institution Edegem Belgium 2650
    33 Local Institution Leuven Belgium 3000
    34 Local Institution Liege Belgium 4000
    35 Local Institution Salvador Bahia Brazil 40110-160
    36 Local Institution Salvador Bahia Brazil 40110
    37 Local Institution Curitiba Parana Brazil 80240-280
    38 Local Institution Curitiba Parana Brazil 80240
    39 Local Institution Porto Alegre RIO Grande DO SUL Brazil 90035-003
    40 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90035
    41 Local Institution Botucatu SAO Paulo Brazil 18618-000
    42 Local Institution Botucatu Sao Paulo Brazil 18618
    43 Local Institution Rio De Janeiro Brazil 21040-000
    44 Local Institution Rio De Janeiro Brazil 21040
    45 Local Institution Sao Paulo Brazil 04035-970
    46 Local Institution Sao Paulo Brazil 04035
    47 University Of Calgary Calgary Alberta Canada T2N 4Z6
    48 Liver And Intestinal Research Centre (Lair) Vancouver British Columbia Canada V5Z 1H2
    49 Gastrointestinal Research Institute (G.I.R.I.) Vancouver British Columbia Canada V6Z 2K5
    50 Percuro Clinical Research Ltd Victoria British Columbia Canada V8V 3P9
    51 Toronto General Hospital Toronto Ontario Canada M5G 2N2
    52 Hopital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
    53 Local Institution Hradec Kralove Czechia 500 05
    54 Local Institution Praha 2 Czechia 120 00
    55 Local Institution Praha 4 Czechia 140 21
    56 Local Institution Orleans Cedex 2 France 45067
    57 Local Institution Poitiers France 86021
    58 Local Institution Rennes Cedex 9 France 35033
    59 Local Institution Rouen Cedex France 76031
    60 Local Institution Toulouse Cedex France 31059
    61 Local Institution Villejuif France 94804
    62 Local Institution Berlin Germany 10969
    63 Local Institution Essen Germany 45122
    64 Local Institution Frankfurt Germany 60590
    65 Local Institution Hamburg Germany 20246
    66 Local Institution Hannover Germany 30625
    67 Local Institution Muenster Germany 48149
    68 Local Institution Ulm Germany 89081
    69 Local Institution Haifa Israel 31096
    70 Local Institution Haifa Israel 34362
    71 Local Institution Jerusalem Israel 91031
    72 Local Institution Nazareth Israel 16100
    73 Local Institution Ramat Gan Israel 52621
    74 Local Institution Bergamo Italy 24127
    75 Local Institution Cisanello (pisa) Italy 56124
    76 Local Institution Milano Italy 20121
    77 Local Institution Roma Italy 00149
    78 Local Institution Torino Italy 10126
    79 Local Institution Bialystok Poland 15-540
    80 Local Institution Kielce Poland 25-726
    81 Local Institution Lancut Poland 37-100
    82 Local Institution Myslowice Poland 41-400
    83 Local Institution Raciborz Poland 47-400
    84 Local Institution Wroclaw Poland 50-220
    85 Local Institution Kazan Republic OF Tatarstan Russian Federation 420012
    86 Local Institution Moscow Russian Federation 105275
    87 Local Institution Moscow Russian Federation 107996
    88 Local Institution Moscow Russian Federation 111123
    89 Local Institution Moscow Russian Federation 115446
    90 Local Institution Moscow Russian Federation 117198
    91 Local Institution Moscow Russian Federation 117593
    92 Local Institution Moscow Russian Federation 127015
    93 Local Institution Saint Petersburg Russian Federation 194100
    94 Local Institution St-petersburg Russian Federation 198103
    95 Local Institution Stavropol Russian Federation 355017
    96 Local Institution A Coruna Spain 15006
    97 Local Institution Alicante Spain 03010
    98 Local Institution San Sebastian Spain 20014
    99 Local Institution Santiago De Compostela Spain 15706
    100 Local Institution Sevilla Spain 41013
    101 Local Institution Sevilla Spain 41014
    102 Local Institution Basel Switzerland 4031
    103 Local Institution Zurich Switzerland 8091
    104 Local Institution Birmingham WEST Midlands United Kingdom B15 2TH

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01598090
    Other Study ID Numbers:
    • AI452-020
    • 2011-004695-11
    First Posted:
    May 15, 2012
    Last Update Posted:
    Jul 31, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Ribavirin
    Peginterferon alfa-2a

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Out of 881 participants who were enrolled, 648 were randomized and only 644 were treated. 27 participants were treated in Part A and 617 participants were treated in Part B of the study.
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Period Title: Treatment Period
    STARTED 27 411 206
    COMPLETED 16 339 171
    NOT COMPLETED 11 72 35
    Period Title: Treatment Period
    STARTED 26 399 199
    COMPLETED 21 364 171
    NOT COMPLETED 5 35 28

    Baseline Characteristics

    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR Total
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Total of all reporting groups
    Overall Participants 27 411 206 644
    Age, Customized (Count of Participants)
    <21 years
    0
    0%
    5
    1.2%
    2
    1%
    7
    1.1%
    21 - <65 years
    27
    100%
    392
    95.4%
    197
    95.6%
    616
    95.7%
    >=65 years
    0
    0%
    14
    3.4%
    7
    3.4%
    21
    3.3%
    Sex: Female, Male (Count of Participants)
    Female
    9
    33.3%
    152
    37%
    80
    38.8%
    241
    37.4%
    Male
    18
    66.7%
    259
    63%
    126
    61.2%
    403
    62.6%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
    Description eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
    Time Frame Assessed at Week 4 and Week 12, week 12 reported

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 27
    Number (95% Confidence Interval) [Percentage of participants]
    51.9
    192.2%
    2. Primary Outcome
    Title Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
    Description SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
    Time Frame Follow-up Week 12

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 411 206
    Number (95% Confidence Interval) [Percentage of participants]
    76.2
    282.2%
    82
    20%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label), Part B: Peginterferon Alfa-2a + RBV + TVR
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.
    Statistical Test of Hypothesis p-Value 0.0855
    Comments Non-inferiority testing is based on lower limit of confidence interval.
    Method Mantel Haenszel
    Comments
    3. Primary Outcome
    Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
    Description An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.
    Time Frame Day 1 of treatment up to Week 48

    Outcome Measure Data

    Analysis Population Description
    Safety analysis included all treated participants.
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 27
    AEs
    26
    96.3%
    SAEs
    6
    22.2%
    Drug related AEs
    12
    44.4%
    Discontinuation due to AEs
    2
    7.4%
    Death
    0
    0%
    Dose reductions - Lambda
    3
    11.1%
    Dose reductions - RBV
    7
    25.9%
    4. Secondary Outcome
    Title Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
    Description SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL).
    Time Frame Follow-up Week 12

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Arm/Group Description Participants were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Measure Participants 27
    Number (95% Confidence Interval) [Percentage of participants]
    48.1
    178.1%
    5. Secondary Outcome
    Title Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
    Description SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Time Frame Follow up week 24

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 27
    Number (95% Confidence Interval) [Percentage of participants]
    40.7
    150.7%
    6. Secondary Outcome
    Title Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
    Description SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
    Time Frame Follow-up Week 12

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treatment-naive treated participants.
    Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 311 155
    Number (95% Confidence Interval) [Percentage of participants]
    73.6
    272.6%
    81.9
    19.9%
    7. Secondary Outcome
    Title Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
    Description Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3.
    Time Frame After Day 1 of treatment up to Week 48

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 411 206
    Number (95% Confidence Interval) [Percentage of participants]
    11.7
    43.3%
    55.8
    13.6%
    8. Secondary Outcome
    Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
    Description eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
    Time Frame Week 4 and Week 12

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 411 206
    Number (95% Confidence Interval) [Percentage of participants]
    64
    237%
    70.9
    17.3%
    9. Secondary Outcome
    Title Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
    Description Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
    Time Frame After Day 1 of treatment up to Week 48

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
    Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 411 206
    Flu-Like Symptoms
    14.4
    53.3%
    36.4
    8.9%
    Musculoskeletal symptoms
    21.4
    79.3%
    30.6
    7.4%
    10. Secondary Outcome
    Title Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
    Description SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL).
    Time Frame Follow-up Week 24

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.
    Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 223 108
    Number (95% Confidence Interval) [Percentage of participants]
    83
    307.4%
    87
    21.2%
    11. Secondary Outcome
    Title Percentage of Participants With Rash
    Description All skin reactions involving rash or rash-like events that occurred on treatment were reported.
    Time Frame After Day 1 of treatment up to Week 48

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed in all treated participants.
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    Measure Participants 27 411 206
    Number [Percentage of participants]
    63
    233.3%
    36.3
    8.8%
    38.3
    18.6%

    Adverse Events

    Time Frame Day 1 of treatment up to Week 48
    Adverse Event Reporting Description
    Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
    All Cause Mortality
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 1/411 (0.2%) 1/206 (0.5%)
    Serious Adverse Events
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/27 (22.2%) 43/411 (10.5%) 20/206 (9.7%)
    Blood and lymphatic system disorders
    Anaemia 0/27 (0%) 0 1/411 (0.2%) 1 3/206 (1.5%) 4
    Pancytopenia 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Cardiac disorders
    Atrial fibrillation 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Myocardial infarction 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Endocrine disorders
    Hyperthyroidism 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Eye disorders
    Ocular icterus 0/27 (0%) 0 3/411 (0.7%) 3 0/206 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/27 (3.7%) 1 0/411 (0%) 0 0/206 (0%) 0
    Peptic ulcer haemorrhage 1/27 (3.7%) 1 0/411 (0%) 0 0/206 (0%) 0
    Pancreatitis acute 0/27 (0%) 0 2/411 (0.5%) 2 1/206 (0.5%) 1
    Ileus 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Nausea 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Vomiting 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Colitis 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Diarrhoea 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Gastrointestinal vascular malformation 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    General disorders
    Strangulated hernia 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Hepatobiliary disorders
    Jaundice 3/27 (11.1%) 3 11/411 (2.7%) 11 2/206 (1%) 2
    Drug-induced liver injury 0/27 (0%) 0 4/411 (1%) 4 0/206 (0%) 0
    Hepatotoxicity 0/27 (0%) 0 2/411 (0.5%) 2 0/206 (0%) 0
    Hypertransaminasaemia 0/27 (0%) 0 2/411 (0.5%) 2 0/206 (0%) 0
    Jaundice cholestatic 0/27 (0%) 0 2/411 (0.5%) 2 0/206 (0%) 0
    Hyperbilirubinaemia 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Infections and infestations
    Pneumonia 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Injury, poisoning and procedural complications
    Overdose 1/27 (3.7%) 1 1/411 (0.2%) 1 0/206 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Aspartate aminotransferase increased 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Blood creatinine increased 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Electrocardiogram QT prolonged 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Hepatic enzyme increased 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Lipase increased 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Pancreatic enzymes increased 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Carotid bruit 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/27 (0%) 0 1/411 (0.2%) 1 0/206 (0%) 0
    Nervous system disorders
    Syncope 0/27 (0%) 0 1/411 (0.2%) 1 1/206 (0.5%) 1
    Demyelination 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Psychiatric disorders
    Substance-induced psychotic disorder 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/27 (0%) 0 0/411 (0%) 0 2/206 (1%) 2
    Hypoxia 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Skin and subcutaneous tissue disorders
    Rash 0/27 (0%) 0 1/411 (0.2%) 1 5/206 (2.4%) 5
    Drug reaction with eosinophilia and systemic symptoms 0/27 (0%) 0 0/411 (0%) 0 1/206 (0.5%) 1
    Other (Not Including Serious) Adverse Events
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 26/27 (96.3%) 369/411 (89.8%) 197/206 (95.6%)
    Blood and lymphatic system disorders
    Anaemia 3/27 (11.1%) 3 53/411 (12.9%) 55 100/206 (48.5%) 111
    Neutropenia 0/27 (0%) 0 10/411 (2.4%) 17 35/206 (17%) 45
    Leukopenia 0/27 (0%) 0 9/411 (2.2%) 13 32/206 (15.5%) 41
    Thrombocytopenia 0/27 (0%) 0 1/411 (0.2%) 2 17/206 (8.3%) 22
    Gastrointestinal disorders
    Nausea 11/27 (40.7%) 12 172/411 (41.8%) 195 67/206 (32.5%) 78
    Diarrhoea 13/27 (48.1%) 13 61/411 (14.8%) 70 37/206 (18%) 43
    Vomiting 5/27 (18.5%) 5 66/411 (16.1%) 93 25/206 (12.1%) 29
    Anal pruritus 4/27 (14.8%) 4 59/411 (14.4%) 64 22/206 (10.7%) 22
    Anorectal discomfort 5/27 (18.5%) 5 28/411 (6.8%) 30 17/206 (8.3%) 18
    Dyspepsia 2/27 (7.4%) 2 28/411 (6.8%) 30 13/206 (6.3%) 17
    Haemorrhoids 1/27 (3.7%) 1 17/411 (4.1%) 17 11/206 (5.3%) 11
    Proctalgia 2/27 (7.4%) 2 8/411 (1.9%) 9 5/206 (2.4%) 6
    General disorders
    Fatigue 16/27 (59.3%) 16 143/411 (34.8%) 162 75/206 (36.4%) 92
    Asthenia 0/27 (0%) 0 81/411 (19.7%) 95 61/206 (29.6%) 69
    Pyrexia 2/27 (7.4%) 2 31/411 (7.5%) 37 53/206 (25.7%) 61
    Influenza like illness 3/27 (11.1%) 4 26/411 (6.3%) 29 36/206 (17.5%) 39
    Chills 1/27 (3.7%) 1 35/411 (8.5%) 42 35/206 (17%) 41
    Injection site reaction 4/27 (14.8%) 4 7/411 (1.7%) 7 6/206 (2.9%) 6
    Pain 2/27 (7.4%) 2 6/411 (1.5%) 6 6/206 (2.9%) 6
    Oedema peripheral 2/27 (7.4%) 2 15/411 (3.6%) 16 3/206 (1.5%) 3
    Injection site rash 3/27 (11.1%) 3 6/411 (1.5%) 6 0/206 (0%) 0
    Hepatobiliary disorders
    Hyperbilirubinaemia 3/27 (11.1%) 3 44/411 (10.7%) 56 4/206 (1.9%) 4
    Infections and infestations
    Upper respiratory tract infection 2/27 (7.4%) 2 3/411 (0.7%) 4 4/206 (1.9%) 4
    Gastroenteritis 2/27 (7.4%) 2 5/411 (1.2%) 5 2/206 (1%) 2
    Investigations
    Amylase increased 0/27 (0%) 0 21/411 (5.1%) 26 3/206 (1.5%) 5
    Blood bilirubin increased 2/27 (7.4%) 3 19/411 (4.6%) 25 2/206 (1%) 2
    Alanine aminotransferase increased 2/27 (7.4%) 2 30/411 (7.3%) 33 1/206 (0.5%) 2
    Aspartate aminotransferase increased 1/27 (3.7%) 1 30/411 (7.3%) 38 1/206 (0.5%) 2
    Bilirubin conjugated increased 2/27 (7.4%) 2 6/411 (1.5%) 9 1/206 (0.5%) 1
    Metabolism and nutrition disorders
    Decreased appetite 1/27 (3.7%) 1 85/411 (20.7%) 93 42/206 (20.4%) 47
    Hyperuricaemia 1/27 (3.7%) 1 32/411 (7.8%) 43 11/206 (5.3%) 11
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/27 (3.7%) 1 49/411 (11.9%) 58 43/206 (20.9%) 55
    Myalgia 4/27 (14.8%) 4 49/411 (11.9%) 61 43/206 (20.9%) 56
    Muscle spasms 4/27 (14.8%) 4 14/411 (3.4%) 14 2/206 (1%) 2
    Nervous system disorders
    Headache 8/27 (29.6%) 9 66/411 (16.1%) 76 42/206 (20.4%) 54
    Dizziness 2/27 (7.4%) 2 52/411 (12.7%) 55 24/206 (11.7%) 33
    Dysgeusia 3/27 (11.1%) 3 11/411 (2.7%) 11 9/206 (4.4%) 11
    Syncope 2/27 (7.4%) 2 5/411 (1.2%) 5 1/206 (0.5%) 1
    Psychiatric disorders
    Insomnia 8/27 (29.6%) 8 102/411 (24.8%) 110 56/206 (27.2%) 63
    Anxiety 0/27 (0%) 0 13/411 (3.2%) 14 11/206 (5.3%) 11
    Depression 5/27 (18.5%) 6 25/411 (6.1%) 26 11/206 (5.3%) 11
    Irritability 3/27 (11.1%) 3 33/411 (8%) 40 8/206 (3.9%) 8
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 2/27 (7.4%) 2 31/411 (7.5%) 34 37/206 (18%) 41
    Cough 3/27 (11.1%) 3 12/411 (2.9%) 13 24/206 (11.7%) 27
    Skin and subcutaneous tissue disorders
    Pruritus 13/27 (48.1%) 13 187/411 (45.5%) 209 100/206 (48.5%) 126
    Rash 12/27 (44.4%) 13 123/411 (29.9%) 131 57/206 (27.7%) 62
    Dry skin 1/27 (3.7%) 1 52/411 (12.7%) 56 27/206 (13.1%) 27
    Alopecia 1/27 (3.7%) 1 9/411 (2.2%) 9 23/206 (11.2%) 24
    Rash generalised 5/27 (18.5%) 5 4/411 (1%) 4 2/206 (1%) 2
    Skin exfoliation 2/27 (7.4%) 2 4/411 (1%) 4 2/206 (1%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title Bristol-Myers Squibb Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email clinical.trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01598090
    Other Study ID Numbers:
    • AI452-020
    • 2011-004695-11
    First Posted:
    May 15, 2012
    Last Update Posted:
    Jul 31, 2019
    Last Verified:
    Jul 1, 2019