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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: RBV
  • drug: LDV/SOF

Eligibility


Inclusion Criteria:

   - Age > 18, with chronic genotype 1 HCV infection

   - HCV treatment-experienced, including patients who have previously failed a
   nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV
   regimen

   - 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

   - Coinfection with HIV or hepatitis B virus

   - Current or prior history of clinical hepatic decompensation

   - Hepatocellular carcinoma 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD
650-498-7878
Not Recruiting