Authors
Michael Charlton, Gregory T Everson, Steven L Flamm, Princy Kumar, Charles Landis, Robert S Brown Jr, Michael W Fried, Norah A Terrault, Jacqueline G O'Leary, Hugo E Vargas, Alexander Kuo, Eugene Schiff, Mark S Sulkowski, Richard Gilroy, Kymberly D Watt, Kimberly Brown, Paul Kwo, Surakit Pungpapong, Kevin M Korenblat, Andrew J Muir, Lewis Teperman, Robert J Fontana, Jill Denning, Sarah Arterburn, Hadas Dvory-Sobol, Theo Brandt-Sarif, Phillip S Pang, John G McHutchison, K Rajender Reddy, Nezam Afdhal, Robert S Brown, Michael Fried, Kris Kowdley, Norah Terrault, Steve Flamm, John Lake, Greg Everson, Mark Sulkowski, Michael Curry, Rajender Reddy, Hugo Vargas, Andrew Muir, Atif Zaman, Robert Fontana, Jacqueline O'Leary, Obaid Shaikh, Kevin Korenblat, Richard Stravitz, Kymberly Watt, Narayanan Menon, James Bredfeldt, Carlos Romero-Marrero
Publication date
2015/9/1
Journal
Gastroenterology
Volume
149
Issue
3
Pages
649-659
Publisher
WB Saunders
Description
Background & Aims
There are no effective and safe treatments for chronic hepatitis C virus (HCV) infection of patients who have advanced liver disease.
Methods
In this phase 2, open-label study, we assessed treatment with the NS5A inhibitor ledipasvir, the nucleotide polymerase inhibitor sofosbuvir, and ribavirin in patients infected with HCV genotypes 1 or 4. Cohort A enrolled patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation. Cohort B enrolled patients who had undergone liver transplantation: those without cirrhosis; those with cirrhosis and mild, moderate, or severe hepatic impairment; and those with fibrosing cholestatic hepatitis. Patients were assigned randomly (1:1) to receive 12 or 24 weeks of a fixed-dose combination tablet containing ledipasvir and sofosbuvir, once daily, plus ribavirin. The primary end point was sustained virologic response at …
Total citations
Scholar articles
M Charlton, GT Everson, SL Flamm, P Kumar, C Landis… - Gastroenterology, 2015