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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: Peg-Interferon Alpha-2A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02761629

ML18473

Details and patient eligibility

About

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).

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks

Experimental group

Description:

Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.

Treatment:

Drug: Peg-Interferon Alpha-2A

Drug: Ribavirin

Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks

Active Comparator group

Description:

Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.

Treatment:

Drug: Peg-Interferon Alpha-2A

Drug: Ribavirin