Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

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