Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

Inclusion Criteria:

- HCV RNA ≥ 10,000 IU/mL at screening

- HCV genotype 1 or 4

- HIV-1 infection

- Cirrhosis determination, a fibroscan or liver biopsy may be required

- Screening laboratory values within defined thresholds

- Use of protocol specified method(s) of contraception if female of childbearing
potential or sexually active male

Exclusion Criteria:

- Clinically-significant illness (other than HCV or HIV) or any other major medical
disorder that may interfere with subject treatment, assessment, or compliance with the
protocol

- Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma
(HCC), or other malignancy (with the exception of certain resolved skin cancers)

- Hepatitis B virus (HBV) infection

- Pregnant or nursing female

- Chronic use of systemically administered immunosuppressive agents