作者
Michael Manns, Didier Samuel, Edward J Gane, David Mutimer, Geoff McCaughan, Maria Buti, Martín Prieto, José Luis Calleja, Markus Peck-Radosavljevic, Beat Müllhaupt, Kosh Agarwal, Peter Angus, Eric M Yoshida, Massimo Colombo, Mario Rizzetto, Hadas Dvory-Sobol, Jill Denning, Sarah Arterburn, Phillip S Pang, Diana Brainard, John G McHutchison, Jean-François Dufour, Hans Van Vlierberghe, Bart van Hoek, Xavier Forns
发表日期
2016/6/1
期刊
The Lancet Infectious Diseases
卷号
16
期号
6
页码范围
685-697
出版商
Elsevier
简介
Background
Treatment options are limited for patients infected by hepatitis C virus (HCV) with advanced liver disease. We assessed the safety and efficacy of ledipasvir, sofosbuvir, and ribavirin in patients with HCV genotype 1 or 4 and advanced liver disease.
Methods
We did an open-label study at 34 sites in Europe, Canada, Australia, and New Zealand. Cohort A included patients with Child-Turcotte-Pugh class B (CTP-B) or CTP-C cirrhosis who had not undergone liver transplantation. Cohort B included post-transplantation patients who had either no cirrhosis; CTP-A, CTP-B, or CTP-C cirrhosis; or fibrosing cholestatic hepatitis. Patients in each group were randomly assigned (1:1) using a computer-generated randomisation sequence to receive 12 or 24 weeks of ledipasvir (90 mg) and sofosbuvir (400 mg) once daily (combination tablet), plus ribavirin (600–1200 mg daily). The primary endpoint was the proportion …
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M Manns, D Samuel, EJ Gane, D Mutimer… - The Lancet Infectious Diseases, 2016