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

Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.

Time frame: Up to Week 72

Population: The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.

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.

Time frame: Week 72

Population: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.

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.

Time frame: Week 12

Population: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.

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.

Time frame: Week 4

Population: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.

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.

Time frame: Weeks 48 and 72

Population: Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients.

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.

Time frame: Week 48

Population: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.

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.

Time frame: Weeks 4, 12 and 24

Population: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.