Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).

Key Inclusion Criteria:

• All individuals:

  • Screening laboratory values within defined thresholds for group
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

• For individuals with moderate hepatic impairment:

  • Diagnosis of chronic (> 6 months) hepatic impairment
  • Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh Class B).

• For individuals with severe hepatic impairment:

  • Diagnosis of chronic (> 6 months) hepatic impairment
  • Score on the CPT scale of 10-15 at screening (Child Pugh Class C)

• For individuals with normal hepatic function:

  • Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

Key Exclusion Criteria:

• All individuals:

  • Pregnant or nursing female or male with pregnant female partner
  • HIV infection
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

• For individuals with moderate or severe hepatic impairment:

  • Active HCV infection
  • Current hepatic encephalopathy
  • Variceal bleeding in the last 6 months unless banded
  • Prior placement of a portosystemic shunt
  • History of hepatorenal or hepatopulmonary syndrome
  • Spontaneous bacterial peritonitis currently or within the last 6 months
  • Hospitalization within the last 2 months related to cirrhosis
  • Confirmed hypotension
  • Suspicion of hepatocellular carcinoma

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