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01/28 - Indagine Multicentrica sul Profilo duso della Ribavirina un Osservatorio per la Valutazione degli Esiti (IMPROVE). Unità operativa IMPROVE-ISS 2001, iii, 40 p.
Multicenter study on Ribavirin use: a monitoring unit for outcome evaluation (IMPROVE ).
Working group IMPROVE-ISS
2001, iii, 40 p. Rapporti ISTISAN 01/28 (in Italian)
In December 1999, Ribavirin was marketed in Italy for the treatment, in combination with Interferon, of hepatitis C. A multicenter observational study was promoted by Health Authorities with the aim of: improving the knowledge on the patients treated in clinical practice; evaluating appropriateness of the treatment; defining the risk profile; comparing efficacy results with those obtained in clinical trials. 482 hospitals from all over Italy participated in the study. In July 2001, 4829 patients were enrolled in the study; this is probably an underestimation of the population treated because of the delay in data delivering. 50% of patients were not previously treated with interferon (naïve) and 39% relapsed after a response to Interferon therapy (relapser). Adverse event profile does not seem different from what expected.
Key words: Hepatitis C, Ribavirin, Cohort study
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