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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: Asunaprevir; Drug: Daclatasvir; Drug: Ribavirin; Drug: Pegylated interferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01428063

AI444-026

2011-000836-27 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

• 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

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
• Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
• HCV RNA viral load detectable

Key Exclusion Criteria:

• Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
• Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
• Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
• Evidence of medical condition associated with chronic liver disease other than HCV infection
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

276 participants in 3 patient groups

Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin

Experimental group

Description:

Patients 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

Treatment:

Drug: Pegylated interferon alfa-2a

Drug: Ribavirin

Drug: Daclatasvir

Drug: Asunaprevir

Daclatasvir + PegIFNα-2a + Ribavirin

Experimental group

Description:

Patients received daclatasvir, (two 30-mg tablets or one 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

Treatment:

Drug: Pegylated interferon alfa-2a

Drug: Ribavirin

Drug: Daclatasvir

Daclatasvir + Asunaprevir

Experimental group

Description:

Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks

Treatment:

Drug: Daclatasvir

Drug: Asunaprevir