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

• Sustained Virological Response (SVR) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to Week 72 ] [ Designated as safety issue: Yes ]
  Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.

• Virological Response at End of Treatment Period [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Weeks 4, 12 and 24 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Weeks 48 and 72 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  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.

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.

• Drug: Peginterferon alfa-2a
  180 µg subcutaneously weekly for 48 weeks
  Other Name: Pegasys
• Drug: Ribavirin
  800 mg orally daily for 48 weeks
  Other Name: Copegus
• Drug: Ribavirin
  1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
  Other Name: Copegus

• Experimental: PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg
  Interventions:

  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin
• Active Comparator: PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
  Interventions:

  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin

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