학술논문
Sustained virological response in patients with HCV treated with daclatasvir plus sofosbuvir, with or without ribavirin: a large, field-practice study
Document Type
article
Author
Rodolfo Sacco; Vincenzo Messina; Umberto Vespasiani Gentilucci; Luigi Elio Adinolfi; Antonio Ascione; Giorgio Barbarini; Angelo Barlattani; Giuseppe Cariti; Raffaele Cozzolongo; Basilio Fimiani; Ruggiero Francavilla; Caterina Furlan; Giovanni Garrucciu; Vincenzo Iovinella; Luca Rinaldi; Massimo Marignani; Paola Begini; Valeria Pace Palitti; Adriano M Pellicelli; Gaetano Scifo; Antonio Facciorusso; Luca Giacomelli; Aashni Shah; Gaetano Bertino; Serena Perazzo; Giampaolo Bresci; Antonio Izzi
Source
Drugs in Context, Vol 9, Pp 1-6 (2020)
Subject
Language
English
ISSN
1740-4398
Abstract
Background: The once-daily oral combination of daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is effective and well tolerated in patients with hepatitis C virus (HCV). However, further field-practice studies are necessary to investigate the effectiveness and safety of the DCV+SOF combination in diverse subpopulations of patients with HCV, including those who are more challenging to treat such as patients with a genotype 3 (G3) infection. The aim of this retrospective, multicenter, field-practice study was to investigate the therapeutic efficacy and safety of the oral combination of DCV and SOF, with or without RBV (DCV+SOF±RBV), in a large unselected cohort of patients with chronic HCV infection (CHC). Patients and methods: Consecutive patients received DCV+SOF±RBV for 12 or 24 weeks. The efficacy endpoint was sustained virological response at 12 weeks after the end of treatment (SVR12). Safety factors were also considered. Results: A total of 620 patients were included in this study; the predominant genotype was G3 (55.3%). Of the total sample, 248 (40%) patients were treated with DCV+SOF+RBV and 372 (60%) did not receive RBV. The majority of patients assessed at week 12 (98%, 596/608) achieved SVR12. Among G3 patients, 98.8% (335/339) achieved SVR12. The most common adverse event was elevated bilirubin (30.6%), recorded in 4.9% of cases as a grade 3–4 adverse event. Conclusion: This study shows the high pan-genotypic effectiveness and safety of the DCV+SOF±RBV combination in a large, unselected sample of CHC patients with G1–4, including a wide proportion of G3 CHC patients.