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

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