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

Phase 4

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Peg-Interferon Alpha-2A; Drug: Ribavirin

• Registration Number: NCT02761629
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Status Verified: 2016-07
• Results First Submitted: 2016-07-05
• Results First Submitted QC: 2016-07-05
• Last Update Submitted: 2016-07-05
• Results First Posted: 2016-08-16
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks	Peg-Interferon Alpha-2A	Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks	Peg-Interferon Alpha-2A	Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks	Ribavirin	Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks	Ribavirin	Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR)	24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)	SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter \[IU/mL\]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.

Secondary Outcome Measures

Name	Time	Method
Serum Human Immunodeficiency Virus (HIV) RNA Levels	For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96	HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96	For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96	Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A	12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 84 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)	HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.
Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment	24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)	SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm).
Percentage of Participants With Undetectable HCV RNA	For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, and 48; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, and 72	HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96	For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96	Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories	For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96	ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), \>1-2 Upper Normal Limit (ULN), \>2-5 ULN, \>5-10 ULN, and \>10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).