Sofosbuvir/GS-5816 Fixed-Dose Combination in Adults with Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20142995

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