Nezam Afdhal, Stefan Zeuzem, Paul Kwo, Mario Chojkier, Norman Gitlin, Massimo Puoti, Manuel Romero-Gomez, Jean-Pierre Zarski, Kosh Agarwal, Peter Buggisch, Graham R Foster, Norbert Bräu, Maria Buti, Ira M Jacobson, G Mani Subramanian, Xiao Ding, Hongmei Mo, Jenny C Yang, Phillip S Pang, William T Symonds, John G McHutchison, Andrew J Muir, Alessandra Mangia, Patrick Marcellin
BACKGROUND: In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection. METHODS: We conducted a phase 3, open-label study involving previously untreated patients with chronic HCV genotype 1 infection. Patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosbuvir plus ribavirin for 24 weeks...
May 15, 2014: New England Journal of Medicine