Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

Key Inclusion Criteria:

- Willing and able to provide written informed consent or for those individuals where
hepatic encephalopathy affects their ability to provide initial or ongoing consent,
has an appropriate and legally-authorized representative (LAR) willing and able to
provide consent on behalf of the individual.

- HCV RNA infection with quantifiable virus at screening

- Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or
liver biopsy

- Currently on the liver transplantation wait list

- Screening electrocardiogram (ECG) without clinically significant abnormalities.

- A negative serum pregnancy test result is required for females

Key Exclusion Criteria:

- Any previous solid organ transplant

- Any serious or active medical or psychiatric illness which, in the opinion of the
investigator, would interfere with participant's treatment, assessment, or compliance

- HIV infection or a positive hepatitis B virus surface antigen result

- History of malignancy (with exception of hepatocellular carcinoma within Milan
criteria, certain resolved skin cancers or other early cancer for which surgical
resection is considered to be completely curative)

- Treatment with any approved or experimental medication with known anti-HCV activity
within 1 month prior to screening date

- Prior exposure to an HCV non-structural protein (NS)5A inhibitor

- Patients on hemodialysis prior to or at the time of transplantation will be excluded

- Creatinine clearance (CLcr) < 40 mL/min at screening or < 40 mL/min on day of
transplant

- Participation in a clinical study with an investigational drug or biologic within 28
days prior to screening visit

- Receipt or planned receipt of an organ from an HCV positive donor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.