학술논문
Open, Randomized, Multicentre Italian Trial on Peg-Ifn plus Ribavirin versus Peg-Ifn Monotherapy for Chronic Hepatitis C in HIV-Coinfected Patients on Haart
Document Type
Article
Author
Cargnel, Antonietta; Angeli, Elena; Mainini, Annalisa; Gubertini, Guido; Giorgi, Riccardo; Schiavini, Monica; Duca, Piergiorgio; Scalise, G; Cesare, S Di; Chiodo, F; Verucchi, G; Farci, P; Serra, G; Sagnelli, E; Nacca, C; Ferraro, T; Scerbo, A; Santoro, D; Pusterla, L; Viganò, P; Magnani, C; Ghinelli, F; Sighinolfi, L; Vigevani, G; Pastecchia, C; Moroni, M; Milazzo, L; Esposito, R; Borghi, V; Piccinino, F; Filippini, P; Cadrobbi, P; Sattin, A; Ferrari, C; Antoni, A Degli; Stagni, G; Francisci, D; Petrelli, E; Alberici, F; Sacchini, D; Zauli, T; Donà, D De; Arlotti, M; Mori, F; Marranconi, F; Caramello, P; Lipani, F; Soranzo, ML; Macor, A; Vaglia, A; Rossi, MC; Grossi, P; Tambini, R; De Lalla, F; Tositti, G
Source
Antiviral Therapy; February 2005, Vol. 10 Issue: 2 p309-317, 9p
Subject
Language
ISSN
13596535
Abstract
Background Chronic hepatitis C is common and aggressive in HIV-positive patients, so the development of a well-tolerated HCV therapy is a priority. We evaluated the efficacy and safety of pegylated interferon a2b (PEG-IFN) plus ribavirin (RBV) versus PEG-IFN monotherapy in HIV/HCV-coinfected patients undergoing highly active antiretroviral therapy (HAART), and analysed the predictive factors of response.Methods An Italian, multicentre, open-label trial including 135 coinfected patients, randomized to PEG-IFN 1.5 µg/kg/week plus RBV 400 mg twice daily (n=69, arm A) or PEG-IFN 1.5 µg/kg/week (n=66, arm B) for 48 weeks. We assessed the predictive values of early virological response (EVR) at week 8 (HCV-RNA drop >2 log10compared with baseline or undetectable levels) on sustained virological response (SVR).Results Fifty-five patients (28 from arm A and 27 from arm B) completed 48 weeks of therapy. At the end of treatment, 20/28 patients in arm A and 11/27 in arm B had HCV-RNA <50 IU/ml. In a per-protocol analysis, SVR was reached by 54% of patients in arm A (genotype 2–3, 11/16; genotype 1–4, 4/12) and 22% in arm B (genotype 2–3, 3/15; genotype 1–4, 3/12). In an intention-to-treat analysis, the SVR was 22% in arm A (genotype 2–3, 11/32; genotype 1–4, 4/37) versus 9% in arm B (genotype 2–3, 3/32; genotype 1–4, 3/34). The best predictors of SVR were the use of combination therapy, infection with HCV genotype 3 versus genotype 1, and EVR at week 8. Thirty patients (15 from arm A and 15 from arm B) dropped out of the trial prematurely due to side effects. The positive predictive value of EVR at week 8 was 65%, the negative predictive value was 86%.Conclusions PEG-IFN plus RBV can be considered a solid option for the treatment of HIV/HCV-coinfected patients. The key to successfully improving efficacy is strong compliance through strict overall patient monitoring, in order to best manage drug toxicity. EVR assessment at week 8 may become a useful stategy in the management of therapy.