Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus

Randomized, Multi-Center, Phase IV, Comparative Study to Assess the Efficacy and Safety of Combined Peg-Interferon Alpha-2a (40 kD) With Ribavirin Combined Therapy for 48 or 72 Weeks of Treatment and 24 Weeks of Follow-Up in Patients With Chronic Hepatitis C, Genotype 1, Co-Infected With Human Immunodeficiency Virus

This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).

Inclusion Criteria:

• Serological evidence of chronic hepatitis C infection by anti-hepatitis C virus (HCV) test
• Detectable HCV-ribonucleic acid (RNA) plasma level testing by Roche AMPLICOR HCV (<50 International Units per milliliter [IU/mL]) (qualitative test)
• Chronic liver disease consistent with infection of CHC
• Compensated liver disease (Child-Pugh Grade A)
• Serological evidence of infection by HIV-1 test, anti-HIV-1 or HIV-1 RNA detection
• Negative pregnancy urine or blood test (for women in childbearing age); additionally, all men and women of childbearing potential must agree to use two effective forms of contraception during the treatment and during the 6 months after the end of treatment

Exclusion Criteria:

• Pregnant or nursing women and male partners of pregnant women
• Prior therapy with interferon (IFN) or ribavirin and any investigational medication less than or equal to (</=) 6 weeks before the first dose of the study drug
• History or other evidence of a medical condition associated with chronic liver disease further than HCV
• Active opportunistic infection associated with HIV and / or cancer requiring systemic therapy
• History of any other significant illness which in the investigator's opinion, could result in the participant's inability to meet the Protocol requirements