NCT02533934

Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

A Retrospective/Prospective Cohort Study to Assess Safety, Tolerability, and Efficacy of Sofosbuvir Based Direct Acting Antiviral (DAA) Therapy for Hepatitis C Treatment in HIV/HCV Coinfected Subjects Pre or Post Liver Transplant

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants

Detailed description

Approximately fifty HIV/HCV coinfected patients with decompensated liver disease will be enrolled in the study. Ten (up to twenty) subjects will be treated with FDC SOF/LDV pre or post liver transplant and followed prospectively. Forty + subjects will be enrolled retrospectively with the intent to capture all patients who have been exposed to sofosbuvir based DAA therapies at participating sites since 1/2014, and to mirror the population being enrolled prospectively. In addition, participants in the retrospective arm will be contacted to consent to one prospective study visit for liver staging to determine rates of reversal of decompensation, reversal of cirrhosis and improvements in graft survival post treatment, and for future contact by the NIH Clinical Center to assess longer term outcomes when this study ends.

Conditions

• HIV
• Hepatitis C
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Harvoni	Treatment of Hepatitis C with sofosbuvir based HCC therapy

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2015-08-27
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

8 sites across 1 country: United States