Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

Summary

Background: \- Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why. Objective: \- To learn why new hepatitis C drugs sometimes do not work. Also, to learn if these drugs are safe and how well they work in people with different virus strains. Eligibility: \- Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have either never been treated or treated previously with an interferon regimen (with or without ribavirin) that failed to clear the virus. Design: * Participants will be screened with medical history and physical exam. They will have blood and urine tests and complete questionnaires. * Participants will have a Fibroscan, an ultrasound that measures liver stiffness and other liver scans. They will have an electrocardiogram. * Eligible participants will have a liver biopsy. * Participants will be admitted to the Clinical Center. They will have a physical exam and blood tests, and complete questionnaires. * They will take the first study drug dose as a tablet taken once daily. * Participants will take the drug at home for 12 weeks. * Participants will have 6 study visits. They will have blood and vital signs taken, and complete questionnaires. * At week 4, participants will have another liver biopsy. * After their last drug dose, participants will have 5 follow-up visits. They will have blood and vital signs taken, and complete questionnaires. They will discuss their medications and side effects. They may have another Fibroscan.

Timeline

Start

2015-06-09

Primary completion

2018-09-14

Completion

2018-09-14

Publications

• Sarrafan-Chaharsoughi Z, Takyar V, Auh S, Nee G, Alawad A, Abel BS, Kapuria D, Byrnes C, Wolska A, Kleiner DE, Shamburek R, Remaley AT, Ghany MG. Clearance of Hepatitis C Viremia During Direct-Acting Antiviral Therapy Leads to Rapid Changes in Lipid and Lipoprotein Metabolism. Aliment Pharmacol Ther. 2025 Jul;62(2):146-158. doi: 10.1111/apt.70130. Epub 2025 May 13.

Drugs

Indications