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

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.

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-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

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