Efficacy of Pegylated Interferon plus Ribavirin Re-treatment in HIV-HCV Coinfected Patients By Liz Highleyman Patients with chronic hepatitis C virus (HCV) infection often do not clear the virus with their first attempt at treatment, and others relapse after an initial response. Many such individuals originally received suboptimal treatment with conventional interferon, conventional or pegylated interferon monotherapy, or inadequate doses of ribavirin. While several studies have shown that a substantial proportion of HCV monoinfected individuals can achieve sustained virological response with a subsequent attempt at therapy with pegylated interferon plus adequate ribavirin, there is less data on re-treatment of HIV-HCV coinfected patients, who tend to respond less well to interferon-based therapy. At the 46th ICAAC, held last week in San Francisco, Spanish researchers presented data from the PILOT study, which included 51 coinfected participants who were non-responders (74%) or relapsers (26%) to previous suboptimal hepatitis C therapy. Prior regimens consisted of conventional interferon monotherapy (27%), conventional interferon plus ribavirin (29%), or pegylated interferon plus 800 mg/day ribavirin (44%); the mean duration of prior therapy was 5.2 months. All patients were re-treated with 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus weight-based ribavirin: 1000 mg/day if less than 75 kg (about 165 lb) and 1200 mg/day if more than 75 kg. Interim data at 24 weeks were presented, but treatment is scheduled to continue through 48 weeks. Most subjects (75%) were men, with a mean age of 41 years. The mean CD4 cell count was 621 cells/mm3, 74% had HIV viral loads below 50 copies/mL, and 90% were on HAART. The mean HCV viral load was 5.9 log IU/mL, 72% had HCV genotypes 1 or 4, and the rest had genotypes 2 or 3. At the time of enrollment, 24% had absent or mild liver fibrosis (stage F0-F1), 18% had stage F2, 5% had stage F3, and 53% had advanced fibrosis or cirrhosis (stage F4). Fibrosis was measured using elastometry (FibroScan), a non-invasive method that performs fairly well at identifying minimal or significant fibrosis, but is not as good at estimating intermediate stages. Results
In a multivariate analysis, plasma ribavirin level was the strongest determinant of re-treatment response at Week 24.
Conclusion "Re-treatment of HIV-HCV coinfected patients with [pegylated interferon alfa-2a] plus ribavirin 1,000-1,200 mg/day provides early virological response in a substantial number of patients, which is encouraging and warrants further follow-up until completion of therapy." They recommended that monitoring of plasma ribavirin levels may be advisable in patients undergoing re-treatment for chronic hepatitis C. Hosp. Carlos III., Madrid, Spain. 10/03/06 Reference
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After 4 weeks of therapy, rates of rapid virological response (RVR), defined as
HCV viral load below 50 IU/mL, were as follows:
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