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

作者：Crespo Javier^*; Diago Moises; Cabezas Joaquin; Berenguer Marina; Broquetas Teresa; Angel Serra Miguel; Morillas Rosa; Garcia Samaniego Javier; Luis Calleja Jose; Jose Sanchez Juan; Lens Sabela; Soto Fernandez Susana; Sacristan Begona; Fernandez Inmaculada; Lopez Nunez Carmen; Buti Maria; Romero Gomez Manuel; Saez Royuela Federico; Fernandez Conrado; Jorquera Francisco; Sanchez Antolin Gloria; Manuel Pascasio Juan; Cuadrado Antonio; Hernandez Guerra Manuel

来源：Annals of Hepatology, 2015, 14(4): 477-486.

DOI：10.1016/s1665-2681(19)31169-x

• Hepatitis C genotype 1
• Moderate fibrosis
• Telaprevir triple therapy
• Safety and efficacy

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

• 出版日期2015-8