Javier Crespo, Moisés Diago, Joaquín Cabezas, Marina Berenguer, Teresa Broquetas, Miguel Ángel Serra, Rosa Morillas, Javier García-Samaniego, José Luis Calleja, Juan José Sánchez, Sabela Lens, Susana Soto-Fernández, Begoña Sacristán, Inmaculada Fernández, Carmen López-Núñez, María Buti, Manuel Romero-Gómez, Federico Sáez-Royuela, Conrado Fernández, Francisco Jorquera, Gloria Sánchez-Antolín, Juan Manuel Pascasio, Antonio Cuadrado, Manuel Hernández-Guerra
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% naïve, 57% relapsers, and 21% partial/null responders, 69% had high viral load (> 800,000 IU/mL). HCV genotypes were 1a (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-naïve patients (78%) compared with F3/F4-naïve 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.
Key words. Hepatitis C genotype 1., Moderate fibrosis., Telaprevir triple therapy., Safety and efficacy.