Abstract | BACKGROUND: METHODS: In this multicentre, double-blind trial, between Oct 21, 2013, and Oct 30, 2014, we enrolled patients with HCV genotype 1 and compensated cirrhosis who had not achieved SVR after successive treatments with pegylated interferon and protease-inhibitor regimens at 20 sites in France. With a computer-generated randomisation sequence, patients were assigned in a 1:1 ratio to receive placebo matched in appearance to study drugs for 12 weeks followed by once daily combination fixed-dose tablets of 90 mg ledipasvir and 400 mg sofosbuvir plus weight-based ribavirin for 12 weeks, or ledipasvir-sofosbuvir plus placebo once daily for 24 weeks. The primary endpoint was SVR 12 weeks after the end of treatment (SVR12), for which 95% CIs were calculated with the Clopper-Pearson method. This study is registered with ClinicalTrials.gov, number NCT01965535. FINDINGS: INTERPRETATION: FUNDING: Gilead Sciences.
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Authors | Marc Bourlière, Jean-Pierre Bronowicki, Victor de Ledinghen, Christophe Hézode, Fabien Zoulim, Philippe Mathurin, Albert Tran, Dominique G Larrey, Vlad Ratziu, Laurent Alric, Robert H Hyland, Deyuan Jiang, Brian Doehle, Phillip S Pang, William T Symonds, G Mani Subramanian, John G McHutchison, Patrick Marcellin, François Habersetzer, Dominique Guyader, Jean-Didier Grangé, Véronique Loustaud-Ratti, Lawrence Serfaty, Sophie Metivier, Vincent Leroy, Armand Abergel, Stanislas Pol |
Journal | The Lancet. Infectious diseases
(Lancet Infect Dis)
Vol. 15
Issue 4
Pg. 397-404
(Apr 2015)
ISSN: 1474-4457 [Electronic] United States |
PMID | 25773757
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 Elsevier Ltd. All rights reserved. |
Chemical References |
- Antiviral Agents
- Benzimidazoles
- Fluorenes
- Placebos
- RNA, Viral
- ledipasvir, sofosbuvir drug combination
- Ribavirin
- Uridine Monophosphate
- Sofosbuvir
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Topics |
- Adolescent
- Adult
- Aged
- Antiviral Agents
(therapeutic use)
- Benzimidazoles
(therapeutic use)
- Double-Blind Method
- Female
- Fluorenes
(therapeutic use)
- France
- Genotype
- Hepacivirus
(classification, genetics, isolation & purification)
- Hepatitis C, Chronic
(complications, drug therapy, virology)
- Humans
- Liver Cirrhosis
(drug therapy, virology)
- Male
- Middle Aged
- Placebos
(administration & dosage)
- RNA, Viral
(blood)
- Ribavirin
(therapeutic use)
- Sofosbuvir
- Treatment Outcome
- Uridine Monophosphate
(analogs & derivatives, therapeutic use)
- Viral Load
- Young Adult
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