A5178: "PEG-IFN PLUS RBV FOR HCV CO-INFECTION"

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Design: This is a phase II, open-label, two-arm, long-term maintenance therapy study. This trial is designed to study whether long-term maintenance with pegylated-interferon alfa-2a (PEG-IFN) reduces the rate of liver fibrosis progression in subjects with HCV/HIV co-infection who have failed to achieve or maintain HCV loads below the limit of detection during treatment with PEG-IFN plus ribavirin. Both HCV treatment na¿ve and previously treated subjects will be enrolled. Duration: Subjects on Steps 1 and 2 will be followed for a maximum of 90 weeks. Subjects on Steps 1 and 3 will be followed for a maximum of 96 weeks. Sample Size: Depending on the proportion of na¿ve or previously treated vs. those rolled over from ongoing therapy, Step 1 may need to enroll up to 180 subjects. A total of 134 subjects will be randomized to Step 2: Arm B (67) and Arm (67). Population: Step 1: Two classes of HIV/HCV coinfected subjects will be admitted to Step 1: A. Subjects who are HCV treatment na¿ve or B. Subjects who failed to achieve HCV sustained virologic response to at least 12 weeks of any interferon-based therapy. Subjects must be ? 18 years of age, with reasonable likelihood for long-term follow-up and evaluation. Step 2: HIV/HCV coinfected subjects who have had exposure to and tolerated at least 12 weeks of PEG-IFN plus ribavirin and are currently: A. In Step 1 or B. On any other PEG-IFN plus ribavirin regimen. All subjects must have had at least 12 weeks of active therapy and demonstrate less than a 2-log drop in HCV RNA and have HCV RNA detectable in serum/plasma. Step 3: HCV/HIV coinfected subjects who achieved at least a 2 log-drop in HCV RNA or have undetectable HCV RNA after 12 weeks on Step 1, and who tolerated Step 1 therapy. Regimen: Step 1: all subjects will receive: Arm A consisting of: ? PEG-IFN 180 ¿g Q weekly for a minimum of 12 weeks (maximum of 18 weeks while awaiting the results required for randomization to Step 2) ? Ribavirin 1-1.2 g/day (weight based) for 12 weeks (maximum of 18 weeks while awaiting the results required for randomization to Step 2) Step 2: Subjects will be randomized to the following treatment arms: ? Arm B will be treated with PEG-IFN, given 180 ¿g once weekly for 72 weeks. ? Arm C is the observational control arm. Step 3: subjects registered to Step 3 will receive; Arm D, a continuation of Step 1 treatment (PEG-IFN 180 ¿g Q weekly plus ribavirin 1-1.2 g/day (weight based)) for a total of 72 weeks (12-18 weeks on Step 1 plus up to 60 weeks on Step 3). Subjects will then be followed for an additional 24 weeks.