Common TitleSIRIUS
Official Title Ledipasvir-sofosbuvir with or without Ribavirin to Treat Patients with HCV Genotype 1 Infection and Crrhosis Non-Responsive to Previous Protease-Inhibitor Therapy: a Randomised, Double-Blind, Phase 2 Trial (SIRIUS)
Purpose / DescriptionThis phase 2, double-blind trial compared the efficacy of a 12-week course of ledipasvir-sofosbuvir plus ribavirin versus a 24-week course of ledipasvir-sofosbuvir in treatment-experienced patients with genotype 1 HCV and compensated cirrhosis. Investigators enrolled 155 patients in the trial and all had previously sequentially failed dual therapy with peginterferon and ribavirin and triple therapy with peginterferon and ribavirin and an NS3/4A protease inhibitor. One patient dropped out of the study due to an adverse event that occurred while receiving placebo. Among patients who received a 12-week course of ledipasvir-sofosbuvir plus ribavirin, 96% achieved and SVR12 compared with 97% in the group that received a 24-week course of ledipasvir-sofosbuvir. Baseline NS5A resistant-associated variants did not significantly impact treatment response. This study suggests that in genotype 1 treatment-experienced patients with cirrhosis, a 12-week course of ledipasvir-sofosbuvir plus ribavirin provides similar SVR12 rates as a 24-week course of ledipasvir-sofosbuvir and this 12-week regimen provides a more cost-effective option.
Phase Phase II
ClinicalTrials.gov NCT01965535
Treatments
Ledipasvir-Sofosbuvir

Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences