A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection and Child-Pugh Class B Cirrhosis
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/GS-5816 FDC for 24 weeks in adults with hepatitis C virus (HCV) infection and Child-Pugh (CPT) class B cirrhosis.
Trial Website: https://clinicaltrials.gov/show/NCT02201901
Are you Eligible? (Inclusion Criteria)
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 NS5B inhibitor or any HCV NS5A inhibitor
- Laboratory results outside of acceptable ranges at Screening
Specialty Area(s)
Liver