Phase 4
N=415
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00353418 ↗Enrolled (actual)
415
Serious AEs
16.4%
Results posted
Jun 2010
Primary outcome: Primary: Sustained Virological Response (SVR) — 19; 22 Percentage of participants — p=0.6119
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Peginterferon alfa-2a (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virological Response (SVR) |
19; 22 | 0.6119 |
| PRIMARY Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia |
24; 32; 4; 4; 2; 3 | — |
| SECONDARY Virological Response at End of Treatment Period |
30; 35 | — |
| SECONDARY Virological Response at Weeks 4, 12 and 24 |
8; 7; 25; 25; 33; 40 | — |
| SECONDARY Relapse of Virological Response |
32; 36 | — |
| SECONDARY Rapid Virological Response (RVR) by Week 4 |
8; 7 | — |
| SECONDARY Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 |
51; 61; 25; 35; 26; 26 | — |
Summary
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥18 years of age
- CHC genotype 1
- Stable HIV-1 infection
Exclusion Criteria
- Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
- Medical condition associated with liver disease other than CHC infection
Data sourced from ClinicalTrials.gov (NCT00353418). 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.