Open, randomized, multicentre italian trial on PEG-IFN plus ribavirin versus PEG-IFN monotherapy for chronic hepatitis C in HIV-coinfected patients on HAART.

摘要: BACKGROUND Chronic hepatitis C is common and aggressive in HIV-positive patients, so the development of a well-tolerated HCV therapy priority. We evaluated efficacy safety pegylated interferon alpha2b (PEG-IFN) plus ribavirin (RBV) versus PEG-IFN monotherapy HIV/HCV-coinfected patients undergoing highly active antiretroviral (HAART), analysed predictive factors response. METHODS An Italian, multicentre, open-label trial including 135 coinfected randomized to 1.5 microg/kg/week RBV 400 mg twice daily (n=69, arm A) or (n=66, B) for 48 weeks. assessed values early virological response (EVR) at week 8 (HCV-RNA drop >2 log10 compared with baseline undetectable levels) on sustained (SVR). RESULTS Fifty-five (28 from A 27 completed weeks therapy. At end treatment, 20/28 11/27 B had HCV-RNA <50 IU/ml. In per-protocol analysis, SVR was reached by 54% (genotype 2-3, 11/16; genotype 1-4, 4/12) 22% 3/15; 3/12). an intention-to-treat 11/32; 4/37) 9% 3/32; 3/34). The best predictors were use combination therapy, infection 3 1, EVR 8. Thirty (15 15 dropped out prematurely due side effects. positive value 65%, negative 86%. CONCLUSIONS can be considered solid option treatment patients. key successfully improving strong compliance through strict overall patient monitoring, order manage drug toxicity. assessment may become useful stategy management