Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Hepatitis C, Genotype 1

Treatments

Drug: PEG-Interferon alfa 2a

Drug: Ribavirin

Drug: Daclatasvir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01471574

2011-003067-30 (EudraCT Number)

AI444-043

Details and patient eligibility

About

The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

Enrollment

549 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

Males and females, 18 to 70 years of age
Hepatitis C virus (HCV) genotype 1a or 1b
HCV-treatment naive
HCV RNA >10,000 IU/mL at screening
HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy [HAART], up to 50 patients not receiving HAART)
For patients receiving HAART, HIV RNA must be below <40 copies/mL at screening and must be <400 copies/ml for at least 6 months prior to screening

Key Exclusion Criteria:

Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/ mL
Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
Laboratory values:
1. Neutrophil count <1500 cells/μL (<1200 cells/ μL for Blacks)
2. Platelet count <90,000 cells/μL
3. Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
4. Total bilirubin ≥34 μmol/L (or ≥2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir
5. Alanine aminotransferase ≥5*upper limit of normal