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

Annals of Hepatology

Moisés Diago¹  Gloria Sánchez-Antolín²  Carmen López-Núñez³  José Luis Calleja⁴  Susana Soto-Fernández⁵  Rosa Morillas⁶  Manuel Hernández-Guerra⁷  Joaquín Cabezas⁸  Teresa Broquetas⁹  Inmaculada Fernández^1,10  Sabela Lens^1,11  María Buti^1,12  Javier Crespo, MD, Ph.D.^1,13  Marina Berenguer^1,13  Juan José Sánchez^1,14  Juan Manuel Pascasio^1,15  Javier García-Samaniego^1,16  Federico Sáez-Royuela^1,17  Antonio Cuadrado^1,18  Francisco Jorquera^1,19  Conrado Fernández^2,20  Miguel Ángel Serra^2,21  Manuel Romero-Gómez^2,22  Begoña Sacristán^2,23 

[1] Correspondence and reprint request:;Complejo Asistencial Universitario León. Spain;Hospital 12 de Octubre. Madrid. Spain;Hospital Carlos III and CIBERehd. Madrid. Spain;Hospital Clinic, IDIBAPS and CIBERehd. Barcelona. Spain;Hospital Clínico Universitario-Universidad de Valencia. Valencia. Spain;Hospital Comarcal de Laredo. Spain;Hospital General Valencia. Spain;Hospital La Fé, University of Valencia and CIBERehd. Spain;Hospital San Pedro, Logroño. Spain;Hospital Toledo. Spain;Hospital Universitario Girona Dr. Josep Trueta. Spain;Hospital Universitario Marqués de Valdecilla and IDIVAL. Santander. Spain;Hospital Universitario Puerta Hierro. Madrid. Spain;Hospital Universitario Rio Hortega. Valladolid. Spain;Hospital Universitario Trías y Pujol and CIBERehd. Badalona. Spain;Hospital Universitario Valme and CIBERehd. Sevilla. Spain;Hospital Universitario Virgen del Rocío. Sevilla. Spain;Hospital Universitario de Alcorcón. Spain;Hospital Universitario de Burgos. Spain;Hospital Universitario del Mar. Barcelona. Spain;Hospital Universitario del Vall d’Hebrón and CIEBRehd. Barcelona. Spain;Hospital del Tajo, Aranjuez, Madrid. Spain;

关键词: Hepatitis C genotype 1;    Moderate fibrosis;    Telaprevir triple therapy;    Safety and efficacy;   

DOI  :  

来源: DOAJ

【 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 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.

【 授权许可】

Unknown