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Trial record 5 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

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ClinicalTrials.gov Identifier: NCT01428063
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Interventions Drug: Daclatasvir
Drug: Asunaprevir
Drug: Pegylated interferon alfa-2a
Drug: Ribavirin
Enrollment 276
Recruitment Details The study was conducted at 92 centers in 20 countries.
Pre-assignment Details A total of 276 participants were enrolled, 228 were randomized and 227 received treatment. Participants were not treated because they no longer met study criteria (n=41), withdrew their consent (n=4), showed poor/non-compliance (n=1) or were lost to follow-up (n=2). One participant was randomized by mistake but received no treatment.
Arm/Group Title Daclatasvir + Asunaprevir Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Daclatasvir + pegIFN-2a+ Ribavirin
Hide Arm/Group Description Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Period Title: Overall Study
Started 99 122 6
Completed 89 112 5
Not Completed 10 10 1
Reason Not Completed
Lack of Efficacy             8             4             1
Adverse Event             2             3             0
Lost to Follow-up             0             2             0
No longer meets study criteria             0             1             0
Arm/Group Title Daclatasvir + Asunaprevir Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Daclatasvir + pegIFN-2a+ Ribavirin Total
Hide Arm/Group Description Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 99 122 6 227
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 122 participants 6 participants 227 participants
Younger than 65 years 80 114 6 200
65 years and older 19 8 0 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 122 participants 6 participants 227 participants
Female
48
  48.5%
84
  68.9%
2
  33.3%
134
  59.0%
Male
51
  51.5%
38
  31.1%
4
  66.7%
93
  41.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
Hide Description SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.
Time Frame Week 12 (Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with genotype 1 HCV who received at least 1 dose of study drug
Arm/Group Title Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)
Hide Arm/Group Description:
Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.6
(81.8 to 99.3)
2.Secondary Outcome
Title Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Hide Description SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
Time Frame Week 12 (Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 10 10 6 11 13 25 9 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
85.9
(77.4 to 92.0)
90.0
(55.5 to 99.7)
40.0
(12.2 to 73.8)
100.0
(54.1 to 100.0)
90.9
(58.7 to 99.8)
76.9
(46.2 to 95.0)
84.0
(63.9 to 95.5)
88.9
(51.8 to 99.7)
50.0
(11.8 to 88.2)
3.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
Hide Description RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 48 10 6 11 13 25 9 6
Measure Type: Number
Unit of Measure: Percentage of participants
72.7 91.7 70.0 83.3 90.9 76.9 76.0 88.9 83.3
4.Secondary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.
Time Frame Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 48 10 6 11 13 25 9 6
Measure Type: Number
Unit of Measure: Percentage of participants
67.7 87.5 70.0 83.3 81.8 76.9 64.0 88.9 83.3
5.Secondary Outcome
Title Percentage of Participants With Complete Early Virologic Response (cEVR)
Hide Description cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 48 10 6 11 13 25 9 6
Measure Type: Number
Unit of Measure: Percentage of participants
87.9 95.8 90.0 100.0 90.9 92.3 76.0 88.9 83.3
6.Secondary Outcome
Title Percentage of Participants With End of the Treatment Response (EOTR)
Hide Description EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.
Time Frame End of the study (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 48 10 6 11 13 25 9 6
Measure Type: Number
Unit of Measure: Percentage of participants
85.9 97.9 90.0 100.0 90.9 92.3 84.0 88.9 83.3
7.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Hide Description SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
Time Frame Week 24 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 48 10 6 11 13 25 9 6
Measure Type: Number
Unit of Measure: Percentage of participants
84.8 95.8 40.0 100.0 90.9 76.9 84.0 88.9 50.0
8.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir + Asunaprevir DCV + ASV + pegIFN-2a+ Ribavirin DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) DCV + pegIFN-2a+ RBV
Hide Arm/Group Description:
Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
Overall Number of Participants Analyzed 99 48 10 6 11 13 25 9 6
Measure Type: Number
Unit of Measure: Participants
SAEs 4 0 0 0 2 0 1 0 0
AEs leading to discontinuation of therapy 2 2 0 1 0 0 2 0 0
Death 0 0 0 0 0 0 0 0 0
Time Frame For AEs: From Day 1, first dose until participant’s last scheduled visit. For SAEs: Date of participant’s written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks).
Adverse Event Reporting Description On treatment period.
 
Arm/Group Title Daclatasvir + Asunaprevir Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Daclatasvir + pegIFN-2a+ Ribavirin
Hide Arm/Group Description Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks. Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
All-Cause Mortality
Daclatasvir + Asunaprevir Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Daclatasvir + pegIFN-2a+ Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir + Asunaprevir Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Daclatasvir + pegIFN-2a+ Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/99 (4.04%)   3/122 (2.46%)   0/6 (0.00%) 
Infections and infestations       
Staphylococcal bacteraemia  1  0/99 (0.00%)  1/122 (0.82%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Animal bite  1  0/99 (0.00%)  1/122 (0.82%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neuroendocrine carcinoma of the skin  1  1/99 (1.01%)  0/122 (0.00%)  0/6 (0.00%) 
Uterine leiomyoma  1  1/99 (1.01%)  0/122 (0.00%)  0/6 (0.00%) 
Basal cell carcinoma  1  1/99 (1.01%)  0/122 (0.00%)  0/6 (0.00%) 
Breast cancer  1  1/99 (1.01%)  0/122 (0.00%)  0/6 (0.00%) 
Nervous system disorders       
Radiculopathy  1  0/99 (0.00%)  1/122 (0.82%)  0/6 (0.00%) 
Psychiatric disorders       
Suicide attempt  1  1/99 (1.01%)  0/122 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonitis  1  0/99 (0.00%)  1/122 (0.82%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir + Asunaprevir Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Daclatasvir + pegIFN-2a+ Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   58/99 (58.59%)   118/122 (96.72%)   6/6 (100.00%) 
Blood and lymphatic system disorders       
Lymphopenia  1  0/99 (0.00%)  5/122 (4.10%)  1/6 (16.67%) 
Anaemia  1  1/99 (1.01%)  23/122 (18.85%)  0/6 (0.00%) 
Thrombocytopenia  1  0/99 (0.00%)  9/122 (7.38%)  1/6 (16.67%) 
Neutropenia  1  1/99 (1.01%)  30/122 (24.59%)  0/6 (0.00%) 
Cardiac disorders       
Angina pectoris  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Eye disorders       
Visual acuity reduced  1  0/99 (0.00%)  1/122 (0.82%)  1/6 (16.67%) 
Dry eye  1  0/99 (0.00%)  3/122 (2.46%)  1/6 (16.67%) 
Ocular icterus  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders       
Abdominal pain upper  1  6/99 (6.06%)  8/122 (6.56%)  0/6 (0.00%) 
Gastrooesophageal reflux disease  1  2/99 (2.02%)  2/122 (1.64%)  1/6 (16.67%) 
Abdominal pain  1  5/99 (5.05%)  9/122 (7.38%)  2/6 (33.33%) 
Nausea  1  14/99 (14.14%)  31/122 (25.41%)  1/6 (16.67%) 
Vomiting  1  5/99 (5.05%)  5/122 (4.10%)  1/6 (16.67%) 
Constipation  1  5/99 (5.05%)  4/122 (3.28%)  0/6 (0.00%) 
Diarrhoea  1  9/99 (9.09%)  33/122 (27.05%)  0/6 (0.00%) 
General disorders       
Asthenia  1  2/99 (2.02%)  15/122 (12.30%)  0/6 (0.00%) 
Influenza like illness  1  5/99 (5.05%)  45/122 (36.89%)  3/6 (50.00%) 
Fatigue  1  15/99 (15.15%)  65/122 (53.28%)  3/6 (50.00%) 
Pyrexia  1  4/99 (4.04%)  17/122 (13.93%)  2/6 (33.33%) 
Chills  1  1/99 (1.01%)  10/122 (8.20%)  2/6 (33.33%) 
Infections and infestations       
Viral rhinitis  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Nasopharyngitis  1  7/99 (7.07%)  3/122 (2.46%)  0/6 (0.00%) 
Upper respiratory tract infection  1  9/99 (9.09%)  0/122 (0.00%)  0/6 (0.00%) 
Investigations       
Transaminases increased  1  1/99 (1.01%)  1/122 (0.82%)  1/6 (16.67%) 
Weight decreased  1  1/99 (1.01%)  4/122 (3.28%)  1/6 (16.67%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/99 (1.01%)  20/122 (16.39%)  2/6 (33.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/99 (6.06%)  16/122 (13.11%)  2/6 (33.33%) 
Back pain  1  4/99 (4.04%)  7/122 (5.74%)  0/6 (0.00%) 
Limb discomfort  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Muscle spasms  1  0/99 (0.00%)  8/122 (6.56%)  0/6 (0.00%) 
Myalgia  1  5/99 (5.05%)  14/122 (11.48%)  2/6 (33.33%) 
Nervous system disorders       
Dysgeusia  1  0/99 (0.00%)  8/122 (6.56%)  1/6 (16.67%) 
Amnesia  1  0/99 (0.00%)  1/122 (0.82%)  1/6 (16.67%) 
Headache  1  17/99 (17.17%)  43/122 (35.25%)  3/6 (50.00%) 
Psychiatric disorders       
Depression  1  0/99 (0.00%)  6/122 (4.92%)  1/6 (16.67%) 
Insomnia  1  3/99 (3.03%)  25/122 (20.49%)  2/6 (33.33%) 
Irritability  1  1/99 (1.01%)  11/122 (9.02%)  1/6 (16.67%) 
Reproductive system and breast disorders       
Uterine polyp  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Vaginal haemorrhage  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/99 (0.00%)  12/122 (9.84%)  2/6 (33.33%) 
Cough  1  5/99 (5.05%)  14/122 (11.48%)  2/6 (33.33%) 
Nasal dryness  1  0/99 (0.00%)  1/122 (0.82%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
Petechiae  1  0/99 (0.00%)  0/122 (0.00%)  1/6 (16.67%) 
Rash  1  3/99 (3.03%)  15/122 (12.30%)  0/6 (0.00%) 
Dry skin  1  2/99 (2.02%)  22/122 (18.03%)  2/6 (33.33%) 
Pruritus  1  5/99 (5.05%)  23/122 (18.85%)  3/6 (50.00%) 
Rash generalised  1  0/99 (0.00%)  10/122 (8.20%)  0/6 (0.00%) 
Erythema  1  1/99 (1.01%)  3/122 (2.46%)  1/6 (16.67%) 
Alopecia  1  3/99 (3.03%)  13/122 (10.66%)  2/6 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01428063     History of Changes
Other Study ID Numbers: AI444-026
2011-000836-27 ( EudraCT Number )
First Submitted: September 1, 2011
First Posted: September 2, 2011
Results First Submitted: August 19, 2015
Results First Posted: May 27, 2016
Last Update Posted: May 27, 2016