Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus
 ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic
 genotype 1 or 4 hepatitis C virus (HCV) infection.

 -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;

 -  Cohort B: post-liver transplant, with or without cirrhosis;

 -  Group assignment within cohorts is based on severity of liver impairment at screening
 (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence
 of disease for fibrosing cholestatic hepatitis (FCH) groups)

 -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
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