Ledipasvir/Sofosbuvir + Ribavirin for Treatment of HCV in Advanced Liver Disease and Post Liver Transplant

Protocol: 
GS-US-337-0123
Phase: 
II

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Transplant

The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

Trial Website: https://clinicaltrials.gov/show/NCT01938430

Are you Eligible? (Inclusion Criteria)

Inclusion Criteria:

  • Able to provide written informed consent
  • Chronic genotype 1 or 4 HCV infection
  • Normal ECG
  • Negative serum pregnancy test for female subjects
  • Male subjects and female subjects of childbearing potential must agree to use contraception
  • Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion Criteria:

  • Serious or active medical or psychiatric illness
  • HIV or hepatitis B viral (HBV) infection
  • Stomach disorder that could interfere with the absorption of the study drug
  • Treated with an anti-HCV medication in the last 30 days
  • Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
  • Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
  • History of clinically significant medical condition associated with other chronic liver disease
  • Active spontaneous bacterial peritonitis at screening
  • Females who are breastfeeding
  • Infection requiring systemic antibiotics
  • Participated in a clinical study with an investigational drug or biologic within the last 30 days
  • Active or history (last 6 months) of drug or alcohol abuse
  • History of organ transplant other than liver or kidney

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States