Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA > 10^4 IU/mL at screening

- Chronic HCV infection (≥ 6 months)

- Confirmed CPT class B (7-9) at screening

Exclusion Criteria:

- Current or prior history of solid organ transplantation, significant pulmonary
disease, significant cardiac disease, or porphyria

- Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of
baseline/Day 1

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

- Screening ECG with clinically significant abnormalities

- Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B
(NS5B) inhibitor or any HCV NS5A inhibitor

- Laboratory results outside of acceptable ranges at screening