Trial Outcomes & Findings for Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir (NCT NCT01598090)
NCT ID: NCT01598090
Last Updated: 2019-07-31
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
881 participants
Primary outcome timeframe
Assessed at Week 4 and Week 12, week 12 reported
Results posted on
2019-07-31
Participant Flow
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.
Participant milestones
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
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.
|
Part B: Peginterferon Lambda-1a + RBV + TVR
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
27
|
411
|
206
|
|
Treatment Period
COMPLETED
|
16
|
339
|
171
|
|
Treatment Period
NOT COMPLETED
|
11
|
72
|
35
|
|
Follow-up Period
STARTED
|
26
|
399
|
199
|
|
Follow-up Period
COMPLETED
|
21
|
364
|
171
|
|
Follow-up Period
NOT COMPLETED
|
5
|
35
|
28
|
Reasons for withdrawal
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
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.
|
Part B: Peginterferon Lambda-1a + RBV + TVR
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Treatment Period
Poor/non-compliance
|
0
|
2
|
0
|
|
Treatment Period
No longer meet study criteria
|
0
|
1
|
0
|
|
Treatment Period
Lack of Efficacy
|
5
|
14
|
6
|
|
Treatment Period
Adverse Event
|
2
|
33
|
17
|
|
Treatment Period
Other reasons
|
0
|
4
|
1
|
|
Treatment Period
Withdrawal by Subject
|
3
|
13
|
10
|
|
Treatment Period
Lost to Follow-up
|
1
|
5
|
1
|
|
Follow-up Period
Death
|
0
|
1
|
0
|
|
Follow-up Period
No longer required per protocol
|
1
|
3
|
2
|
|
Follow-up Period
Not reported
|
0
|
10
|
4
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
3
|
2
|
|
Follow-up Period
Other reasons
|
2
|
8
|
8
|
|
Follow-up Period
Lost to Follow-up
|
2
|
10
|
12
|
Baseline Characteristics
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
Baseline characteristics by cohort
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 Participants
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.
|
Part B: Peginterferon Lambda-1a + RBV + TVR
n=411 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 Participants
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
n=644 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<21 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
21 - <65 years
|
27 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
616 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
403 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed at Week 4 and Week 12, week 12 reportedPopulation: 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.
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).
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
|
51.9 Percentage of participants
Interval 31.9 to 71.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Follow-up Week 12Population: 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.
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).
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=411 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
|
76.2 Percentage of participants
Interval 72.0 to 80.3
|
82 Percentage of participants
Interval 76.8 to 87.3
|
—
|
PRIMARY outcome
Timeframe: Day 1 of treatment up to Week 48Population: Safety analysis included all treated participants.
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.
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
AEs
|
26 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
SAEs
|
6 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Drug related AEs
|
12 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Discontinuation due to AEs
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Death
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Dose reductions - Lambda
|
3 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Dose reductions - RBV
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 12Population: 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.
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).
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
|
48.1 Percentage of participants
Interval 28.7 to 68.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow up week 24Population: 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.
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.
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
|
40.7 Percentage of participants
Interval 22.4 to 61.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 12Population: 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.
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).
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=311 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=155 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
|
73.6 Percentage of participants
Interval 68.7 to 78.5
|
81.9 Percentage of participants
Interval 75.9 to 88.0
|
—
|
SECONDARY outcome
Timeframe: After Day 1 of treatment up to Week 48Population: 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.
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.
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=411 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
|
11.7 Percentage of participants
Interval 8.6 to 14.8
|
55.8 Percentage of participants
Interval 49.0 to 62.6
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: 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.
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).
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=411 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
|
64 Percentage of participants
Interval 59.3 to 68.6
|
70.9 Percentage of participants
Interval 64.7 to 77.1
|
—
|
SECONDARY outcome
Timeframe: After Day 1 of treatment up to Week 48Population: 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.
Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=411 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Flu-Like Symptoms
|
14.4 Percentage of participants
Interval 11.0 to 17.7
|
36.4 Percentage of participants
Interval 29.8 to 43.0
|
—
|
|
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Musculoskeletal symptoms
|
21.4 Percentage of participants
Interval 17.4 to 25.4
|
30.6 Percentage of participants
Interval 24.3 to 36.9
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 24Population: 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.
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).
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=223 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=108 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
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.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
|
83 Percentage of participants
Interval 78.0 to 87.9
|
87 Percentage of participants
Interval 80.7 to 93.4
|
—
|
SECONDARY outcome
Timeframe: After Day 1 of treatment up to Week 48Population: The analysis was performed in all treated participants.
All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Outcome measures
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=411 Participants
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Rash
|
63 Percentage of participants
|
36.3 Percentage of participants
|
38.3 Percentage of participants
|
Adverse Events
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Part B: Peginterferon Lambda-1a + RBV + TVR
Serious events: 43 serious events
Other events: 369 other events
Deaths: 1 deaths
Part B: Peginterferon Alfa-2a + RBV + TVR
Serious events: 20 serious events
Other events: 197 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 participants at risk
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.
|
Part B: Peginterferon Lambda-1a + RBV + TVR
n=411 participants at risk
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 participants at risk
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.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
General disorders
Strangulated hernia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Injury, poisoning and procedural complications
Overdose
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Lipase increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Investigations
Carotid bruit
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
1.5%
3/206 • Number of events 4 • Day 1 of treatment up to Week 48
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Nervous system disorders
Demyelination
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Eye disorders
Ocular icterus
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.73%
3/411 • Number of events 3 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.49%
2/411 • Number of events 2 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Jaundice
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
2.7%
11/411 • Number of events 11 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.97%
4/411 • Number of events 4 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.49%
2/411 • Number of events 2 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.49%
2/411 • Number of events 2 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.49%
2/411 • Number of events 2 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
2.4%
5/206 • Number of events 5 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.00%
0/411 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 1 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
Other adverse events
| Measure |
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
n=27 participants at risk
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.
|
Part B: Peginterferon Lambda-1a + RBV + TVR
n=411 participants at risk
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.
|
Part B: Peginterferon Alfa-2a + RBV + TVR
n=206 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
3.6%
15/411 • Number of events 16 • Day 1 of treatment up to Week 48
|
1.5%
3/206 • Number of events 3 • Day 1 of treatment up to Week 48
|
|
General disorders
Injection site rash
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
1.5%
6/411 • Number of events 6 • Day 1 of treatment up to Week 48
|
0.00%
0/206 • Day 1 of treatment up to Week 48
|
|
Psychiatric disorders
Insomnia
|
29.6%
8/27 • Number of events 8 • Day 1 of treatment up to Week 48
|
24.8%
102/411 • Number of events 110 • Day 1 of treatment up to Week 48
|
27.2%
56/206 • Number of events 63 • Day 1 of treatment up to Week 48
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
3.2%
13/411 • Number of events 14 • Day 1 of treatment up to Week 48
|
5.3%
11/206 • Number of events 11 • Day 1 of treatment up to Week 48
|
|
Psychiatric disorders
Depression
|
18.5%
5/27 • Number of events 6 • Day 1 of treatment up to Week 48
|
6.1%
25/411 • Number of events 26 • Day 1 of treatment up to Week 48
|
5.3%
11/206 • Number of events 11 • Day 1 of treatment up to Week 48
|
|
Psychiatric disorders
Irritability
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
8.0%
33/411 • Number of events 40 • Day 1 of treatment up to Week 48
|
3.9%
8/206 • Number of events 8 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Nausea
|
40.7%
11/27 • Number of events 12 • Day 1 of treatment up to Week 48
|
41.8%
172/411 • Number of events 195 • Day 1 of treatment up to Week 48
|
32.5%
67/206 • Number of events 78 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
48.1%
13/27 • Number of events 13 • Day 1 of treatment up to Week 48
|
14.8%
61/411 • Number of events 70 • Day 1 of treatment up to Week 48
|
18.0%
37/206 • Number of events 43 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Vomiting
|
18.5%
5/27 • Number of events 5 • Day 1 of treatment up to Week 48
|
16.1%
66/411 • Number of events 93 • Day 1 of treatment up to Week 48
|
12.1%
25/206 • Number of events 29 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Anal pruritus
|
14.8%
4/27 • Number of events 4 • Day 1 of treatment up to Week 48
|
14.4%
59/411 • Number of events 64 • Day 1 of treatment up to Week 48
|
10.7%
22/206 • Number of events 22 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Anorectal discomfort
|
18.5%
5/27 • Number of events 5 • Day 1 of treatment up to Week 48
|
6.8%
28/411 • Number of events 30 • Day 1 of treatment up to Week 48
|
8.3%
17/206 • Number of events 18 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
6.8%
28/411 • Number of events 30 • Day 1 of treatment up to Week 48
|
6.3%
13/206 • Number of events 17 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
4.1%
17/411 • Number of events 17 • Day 1 of treatment up to Week 48
|
5.3%
11/206 • Number of events 11 • Day 1 of treatment up to Week 48
|
|
Gastrointestinal disorders
Proctalgia
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
1.9%
8/411 • Number of events 9 • Day 1 of treatment up to Week 48
|
2.4%
5/206 • Number of events 6 • Day 1 of treatment up to Week 48
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
10.7%
44/411 • Number of events 56 • Day 1 of treatment up to Week 48
|
1.9%
4/206 • Number of events 4 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
48.1%
13/27 • Number of events 13 • Day 1 of treatment up to Week 48
|
45.5%
187/411 • Number of events 209 • Day 1 of treatment up to Week 48
|
48.5%
100/206 • Number of events 126 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
44.4%
12/27 • Number of events 13 • Day 1 of treatment up to Week 48
|
29.9%
123/411 • Number of events 131 • Day 1 of treatment up to Week 48
|
27.7%
57/206 • Number of events 62 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
12.7%
52/411 • Number of events 56 • Day 1 of treatment up to Week 48
|
13.1%
27/206 • Number of events 27 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
2.2%
9/411 • Number of events 9 • Day 1 of treatment up to Week 48
|
11.2%
23/206 • Number of events 24 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
18.5%
5/27 • Number of events 5 • Day 1 of treatment up to Week 48
|
0.97%
4/411 • Number of events 4 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
0.97%
4/411 • Number of events 4 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
11.9%
49/411 • Number of events 58 • Day 1 of treatment up to Week 48
|
20.9%
43/206 • Number of events 55 • Day 1 of treatment up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.8%
4/27 • Number of events 4 • Day 1 of treatment up to Week 48
|
11.9%
49/411 • Number of events 61 • Day 1 of treatment up to Week 48
|
20.9%
43/206 • Number of events 56 • Day 1 of treatment up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.8%
4/27 • Number of events 4 • Day 1 of treatment up to Week 48
|
3.4%
14/411 • Number of events 14 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
20.7%
85/411 • Number of events 93 • Day 1 of treatment up to Week 48
|
20.4%
42/206 • Number of events 47 • Day 1 of treatment up to Week 48
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
7.8%
32/411 • Number of events 43 • Day 1 of treatment up to Week 48
|
5.3%
11/206 • Number of events 11 • Day 1 of treatment up to Week 48
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
0.73%
3/411 • Number of events 4 • Day 1 of treatment up to Week 48
|
1.9%
4/206 • Number of events 4 • Day 1 of treatment up to Week 48
|
|
Infections and infestations
Gastroenteritis
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
1.2%
5/411 • Number of events 5 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Investigations
Amylase increased
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
5.1%
21/411 • Number of events 26 • Day 1 of treatment up to Week 48
|
1.5%
3/206 • Number of events 5 • Day 1 of treatment up to Week 48
|
|
Investigations
Blood bilirubin increased
|
7.4%
2/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
4.6%
19/411 • Number of events 25 • Day 1 of treatment up to Week 48
|
0.97%
2/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
7.3%
30/411 • Number of events 33 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
7.3%
30/411 • Number of events 38 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 2 • Day 1 of treatment up to Week 48
|
|
Investigations
Bilirubin conjugated increased
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
1.5%
6/411 • Number of events 9 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
7.5%
31/411 • Number of events 34 • Day 1 of treatment up to Week 48
|
18.0%
37/206 • Number of events 41 • Day 1 of treatment up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
2.9%
12/411 • Number of events 13 • Day 1 of treatment up to Week 48
|
11.7%
24/206 • Number of events 27 • Day 1 of treatment up to Week 48
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
12.9%
53/411 • Number of events 55 • Day 1 of treatment up to Week 48
|
48.5%
100/206 • Number of events 111 • Day 1 of treatment up to Week 48
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
2.4%
10/411 • Number of events 17 • Day 1 of treatment up to Week 48
|
17.0%
35/206 • Number of events 45 • Day 1 of treatment up to Week 48
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
2.2%
9/411 • Number of events 13 • Day 1 of treatment up to Week 48
|
15.5%
32/206 • Number of events 41 • Day 1 of treatment up to Week 48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
0.24%
1/411 • Number of events 2 • Day 1 of treatment up to Week 48
|
8.3%
17/206 • Number of events 22 • Day 1 of treatment up to Week 48
|
|
Nervous system disorders
Headache
|
29.6%
8/27 • Number of events 9 • Day 1 of treatment up to Week 48
|
16.1%
66/411 • Number of events 76 • Day 1 of treatment up to Week 48
|
20.4%
42/206 • Number of events 54 • Day 1 of treatment up to Week 48
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
12.7%
52/411 • Number of events 55 • Day 1 of treatment up to Week 48
|
11.7%
24/206 • Number of events 33 • Day 1 of treatment up to Week 48
|
|
Nervous system disorders
Dysgeusia
|
11.1%
3/27 • Number of events 3 • Day 1 of treatment up to Week 48
|
2.7%
11/411 • Number of events 11 • Day 1 of treatment up to Week 48
|
4.4%
9/206 • Number of events 11 • Day 1 of treatment up to Week 48
|
|
Nervous system disorders
Syncope
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
1.2%
5/411 • Number of events 5 • Day 1 of treatment up to Week 48
|
0.49%
1/206 • Number of events 1 • Day 1 of treatment up to Week 48
|
|
General disorders
Fatigue
|
59.3%
16/27 • Number of events 16 • Day 1 of treatment up to Week 48
|
34.8%
143/411 • Number of events 162 • Day 1 of treatment up to Week 48
|
36.4%
75/206 • Number of events 92 • Day 1 of treatment up to Week 48
|
|
General disorders
Asthenia
|
0.00%
0/27 • Day 1 of treatment up to Week 48
|
19.7%
81/411 • Number of events 95 • Day 1 of treatment up to Week 48
|
29.6%
61/206 • Number of events 69 • Day 1 of treatment up to Week 48
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
7.5%
31/411 • Number of events 37 • Day 1 of treatment up to Week 48
|
25.7%
53/206 • Number of events 61 • Day 1 of treatment up to Week 48
|
|
General disorders
Influenza like illness
|
11.1%
3/27 • Number of events 4 • Day 1 of treatment up to Week 48
|
6.3%
26/411 • Number of events 29 • Day 1 of treatment up to Week 48
|
17.5%
36/206 • Number of events 39 • Day 1 of treatment up to Week 48
|
|
General disorders
Chills
|
3.7%
1/27 • Number of events 1 • Day 1 of treatment up to Week 48
|
8.5%
35/411 • Number of events 42 • Day 1 of treatment up to Week 48
|
17.0%
35/206 • Number of events 41 • Day 1 of treatment up to Week 48
|
|
General disorders
Injection site reaction
|
14.8%
4/27 • Number of events 4 • Day 1 of treatment up to Week 48
|
1.7%
7/411 • Number of events 7 • Day 1 of treatment up to Week 48
|
2.9%
6/206 • Number of events 6 • Day 1 of treatment up to Week 48
|
|
General disorders
Pain
|
7.4%
2/27 • Number of events 2 • Day 1 of treatment up to Week 48
|
1.5%
6/411 • Number of events 6 • Day 1 of treatment up to Week 48
|
2.9%
6/206 • Number of events 6 • Day 1 of treatment up to Week 48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER