Phase 4
N=180
Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02761629 ↗Enrolled (actual)
180
Serious AEs
11.3%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) — 23.8; 36.5 percentage of participants — p=0.0536
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Peg-Interferon Alpha-2A (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) |
23.8; 36.5 | 0.0536 |
| SECONDARY Percentage of Participants With Undetectable HCV RNA |
2.7; 12.0; 23.3; 28.4; 52.1; 53.8 | — |
| SECONDARY Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A |
23.8; 36.5 | — |
| SECONDARY Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment |
52.6; 24.3 | 0.0175 sig |
| SECONDARY Serum Human Immunodeficiency Virus (HIV) RNA Levels |
4.23; 4.64; 3.94; 3.98; 3.96; 4.21 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96 |
578.7; 546.2; -148.2; -88.0; -185.4; -164.5 | — |
| SECONDARY Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96 |
0.67; 0.68; 0.11; 0.09; 0.22; 0.20 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories |
50.0; 52.6; 40.0; 38.5; 10.0; 9.0 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02761629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.