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

Not Recruiting

Trial ID: NCT01701401


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.

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health


Inclusion Criteria:

   - 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:

   - 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


drug: RBV

drug: LDV/SOF

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD