Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

Phase 3

Completed

Interventions: Drug: Daclatasvir
Drug: Telaprevir
Drug: Peginterferon alfa-2a
Drug: Ribavirin

Brief Summary: The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Recruitment & Eligibility

Inclusion Criteria

Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
HCV RNA viral load ≥10,000 IU/mL
No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
Body mass index of 18 to 35 kg/m^2
Negative for HIV and hepatitis B virus

Key

Exclusion Criteria

Evidence of decompensated liver disease
Evidence of medical condition other than HCV contributing to chronic liver disease

Arm && Interventions

Group	Intervention	Description
Daclatasvir + Peginterferon alfa-2a + Ribavirin	Daclatasvir	-
Daclatasvir + Peginterferon alfa-2a + Ribavirin	Peginterferon alfa-2a	-
Daclatasvir + Peginterferon alfa-2a + Ribavirin	Ribavirin	-
Telaprevir + Peginterferon alfa-2a + Ribavirin	Telaprevir	-
Telaprevir + Peginterferon alfa-2a + Ribavirin	Peginterferon alfa-2a	-
Telaprevir + Peginterferon alfa-2a + Ribavirin	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)	Week 12 (Follow-up period)	SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.

Secondary Outcome Measures

Name	Time	Method
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4	Week 4	RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12	Week 4, Week 12	eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)	Week 12 (Follow-up period)	SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)	Week 12	cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)	Week 24 (Follow-up period)	SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.

Locations (26): The Kirklin Clinic
🇺🇸
Birmingham, Alabama, United States
Mayo Clinic Arizona
🇺🇸
Phoenix, Arizona, United States
Va Long Beach Healthcare System
🇺🇸
Long Beach, California, United States
Medical Associates Research Group
🇺🇸
San Diego, California, United States
Yale University School Of Medicine
🇺🇸
New Haven, Connecticut, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Atlanta Medical Center
🇺🇸
Atlanta, Georgia, United States
Gastrointestinal Specialists Of Georgia
🇺🇸
Marietta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
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The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States