BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Ribavirin; Drug: Daclatasvir; Drug: Peg-Interferon Alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01389323

AI444-038

Details and patient eligibility

About

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants chronically infected with Hepatitis C virus (HCV) genotype 1
• HCV RNA viral load of ≥10,000 IU/mL at screening
• No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
• Self-described as Black-African American, Latino or White-Caucasian
• Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.

Compensated cirrhotics were capped at approximately 25%

Exclusion criteria

• Evidence of decompensated liver disease
• Documented or suspected Hepatocellular carcinoma (HCC)
• Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

448 participants in 1 patient group

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin

Experimental group

Treatment:

Drug: Peg-Interferon Alfa-2a

Drug: Daclatasvir

Drug: Ribavirin