Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Molecular Mechanisms of Pharmacological Action; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Age > 18, with chronic genotype 1 HCV infection

• HCV treatment-naive

• HCV RNA > 10,000 IU/mL at screening

• Screening laboratory values within defined thresholds

• Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Presence of cirrhosis

• Coinfection with HIV or hepatitis B virus (HBV)

• Current or prior history of clinical hepatic decompensation

• Chronic use of systemic immunosuppressive agents

• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol