1. Pegylated interferon alpha-2b plus ribavirin for the treatment of chronic hepatitis C in HIV-coinfected patients.
- Author
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Voigt, Esther, Schulz, Christian, Klausen, Gerd, Goelz, Joerg, Mauss, Stefan, Schmutz, Guenther, Jessen, Heiko, Weitner, Lutwin, Mutz, Antonius, Schranz, Dietmar, Rockstroh, Juergen K, and Kaad Study Group
- Subjects
THERAPEUTIC use of proteins ,HIV infection complications ,ANTIVIRAL agents ,COMBINATION drug therapy ,CLINICAL trials ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,POLYETHYLENE glycol ,PROTEINS ,RECOMBINANT proteins ,RESEARCH ,EVALUATION research ,RIBAVIRIN ,TREATMENT effectiveness ,CHRONIC hepatitis C ,DISEASE complications - Abstract
Objectives: HIV-coinfection accelerates the course of HCV-related liver disease. Since, highly active anti-retroviral therapy significantly improved survival of HIV-patients more coinfected patients develop end stage liver disease. Therefore, treatment options for chronic hepatitis C in HIV-coinfected patients need to be evaluated.Methods: Efficacy and safety of pegylated interferon alpha-2b (peg IFN) plus ribavirin (RBV) was examined within this prospective, uncontrolled, multicentre trial. Patients received peg IFN (1.5 microg/kg) once weekly plus RBV 800 mg daily for 48 weeks for HCV genotypes (GT) 1/4 and 24 weeks for GT 2/3.Results: One hundred and twenty-two patients were enrolled. Patients were predominantly male (68%) and former i.v. drug users (61%). Baseline characteristics (median) were as follows: age 39 years (range 23-58), CD4 count 494 cells/microl (range 150-1578/microl), HIV-RNA 2.3log copies/ml (range <1.7-5.4log copies/ml). 61% currently received anti-retroviral treatment. Fifty-six percent had HCV GT 1. EOT response was achieved by 52%. However, only 25% achieved sustained response (SR) due to a high relapse rate. SR rates were significantly higher among patients with GT 2/3 compared to those with GT 1/4 (44 vs. 18%). SR was observed in only one patient without early response (ER). Discontinuation rate was 30%, 21% discontinued due to adverse events.Conclusion: Peg IFN/RBV appears safe and effective in HIV/HCV-coinfected patients. GT 2/3 is associated with better SR. Lack of ER strongly predicts non-response. High relapse rates substantially reduce treatment success. In terms of toxicity neuro-psychiatric side effects frequently required treatment discontinuation. [ABSTRACT FROM AUTHOR]- Published
- 2006
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