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

Hoffmann-La Roche415 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

415

Conditions

Hepatitis C, Chronic

Interventions

Peginterferon alfa-2a

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sustained Virological Response (SVR)

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

Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia

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

Time frame: Up to Week 72

Secondary Outcomes

Virological Response at End of Treatment Period

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

Virological Response at 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.

Time frame: Weeks 4, 12 and 24

Relapse of Virological Response

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

Rapid Virological Response (RVR) by 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.

Time frame: Week 4

Early Virological Response (EVR), Partial EVR and Complete EVR by 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.

Time frame: Week 12