| Autor: |
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 |
| Zdroj: |
Antiviral Therapy; February 2005, Vol. 10 Issue: 2 p309-317, 9p |
| Abstrakt: |
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. |
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