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

• Status: Completed
• Trial end date: 2018-09-14

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.

• Phase: Phase 2

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Interferons; Sofosbuvir; Velpatasvir