Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

Trial ID or NCT#



not recruiting iconNOT RECRUITING


The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Official Title

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Age ≥ 18, with chronic genotype 1 HCV infection - HCV treatment-naive - HCV RNA > 10,000 IU/mL at screening - Cirrhosis determination; a liver biopsy may be required - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
  1. - Pregnant or nursing female or male with pregnant female partner - Co-infection with HIV or hepatitis B virus (HBV) - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) - 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


Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Contact us to find out if this trial is right for you.


Mindie H. Nguyen, MD