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

Study Overview
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Brief Summary
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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

Detailed Description
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Allocation: Randomized Stratified

Official Title
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A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Daclatasvir
* Drug: Telaprevir
* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Key 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daclatasvir + Peginterferon alfa-2a + Ribavirin<br> | Drug: Daclatasvir<br>* Film-coated tablet, oral, 60 mg, once daily, 24 weeks<br>* Other names: BMS-790052;Drug: Peginterferon alfa-2a<br>* Solution for injection, subcutaneous injection, 180 μg, weekly<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day<br>* Other names: Copegus®;|
| Experimental: Telaprevir + Peginterferon alfa-2a + Ribavirin<br> | Drug: Telaprevir<br>* Film-coated tablet, oral, 750 mg, 3 times daily<br>* Other names: Incivek®;Drug: Peginterferon alfa-2a<br>* Solution for injection, subcutaneous injection, 180 μg, weekly<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day<br>* Other names: Copegus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | 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. | Week 12 (Follow-up period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at 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. | Week 4 | 
| Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and 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. | Week 4, Week 12 | 
| Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR) | 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. | Week 12 | 
| Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24) | 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. | Week 24 (Follow-up period) | 
| Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | 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. | Week 12 (Follow-up period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus