The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
* Intervention Model: * Parallel: for all patients entering the trial * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study * Peginterferon alfa-2a * Ribavirin * Daclatasvir * Asunaprevir
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
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)
Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
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)
Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
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
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
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
Percentage of Participants With Complete Early Virologic Response (cEVR)
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
Percentage of Participants With End of the Treatment Response (EOTR)
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.
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Baptist Medical Center South
Montgomery, Alabama, United States
Scripps Clinic
La Jolla, California, United States
Scpmg/ Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Uf Hepatology Research At Ctrb
Gainesville, Florida, United States
Schiff Center For Liver Diseases
Miami, Florida, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
...and 96 more locations
Time frame: End of the study (Week 24)
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
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)
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study
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