High efficacy and safety of triple therapy in HCV genotype 1 and moderate fibrosis: a multicenter study of clinical practice in Spain.

摘要: Background and rational. Telaprevir-based therapy (TBT) has been extensively evaluated in clinical trials. So we designed a study to compare the efficacy safety of TBT between patients with moderate fibrosis those suffering from advanced practice. A multicenter observational ambispective was conducted. It included 582 chronic hepatitis C genotype 1, 214 F2, 368 F3/F4 (F3: 148; F4: 220). Results. The mean patient age 55 years, 67% male. Type prior response 22% naive, 57% relapsers, 21% partial/null responders, 69% had high viral load (> 800,000 IU/mL). HCV genotypes were 1a (19%), 1b (69%), 1 (12%), respectively. Sixty-five percent non-CC IL28B genotype. Week-12 sustained virologic (SVR12) significantly higher among F2-naive (78%) compared F3/F4-naive (60%; p = 0.039) F2 non-responders (67%) (42%; 0.014). SVR12 relapsers remarkably both groups (F2:89% vs. F3/F4:78%). Severe anemia thrombocytopenia more frequent than (p < 0.01). Overall, 132 (22%) discontinued treatment: 58 due adverse effects, 42 stopping-rule, 32 breakthrough. Premature discontinuation 0.028), especially breakthrough 0.001). Conclusions. This demonstrates an acceptable profile regard F2-patients