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
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT00353418
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 415
- Adult patients, ≥18 years of age
- CHC genotype 1
- Stable HIV-1 infection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg Peginterferon alfa-2a - PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg Ribavirin - PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg Peginterferon alfa-2a - PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg Ribavirin -
- Primary Outcome Measures
Name Time Method Sustained Virological Response (SVR) Week 72 SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA \< 20 IU/mL measured ≥ Day 477 \[≥ Week 68\]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia Up to Week 72 Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
- Secondary Outcome Measures
Name Time Method Virological Response at End of Treatment Period Week 48 Virological response at the end of the treatment period was defined as a single last HCV RNA measurement \<20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
Virological Response at Weeks 4, 12 and 24 Weeks 4, 12 and 24 Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (\< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
Relapse of Virological Response Weeks 48 and 72 Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
Rapid Virological Response (RVR) by Week 4 Week 4 RVR was defined as an undetectable HCV RNA \< 20 IU/mL (a single last HCV RNA \< 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 Week 12 EVR: Undetectable HCV RNA \<20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA \<20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA \<20 IU/mL, by Week 12 (a single last HCV RNA \<20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.