drugset
drugset / Trial / NCT03549312

Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy

NCT03549312 ↗

Phase 4 Unknown 25 enrolled Saskatchewan Health Authority - Regina Area Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

Summary

The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current antiretroviral therapy to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya™) followed by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusa™), followed then by switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvy™) for an additional 48 weeks.

Timeline

Start
2018-02-01
Primary completion
2020-07-21
Completion
2021-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Biktarvy Other / unclassified 25 mg Oral
Subject Biktarvy Other / unclassified 50 mg Oral
Subject Biktarvy Other / unclassified 200 mg Oral
Subject Epclusa Unknown 100 mg Oral
Subject Epclusa Unknown 400 mg Oral
Subject Genvoya Unknown 10 mg Oral
Subject Genvoya Unknown 150 mg Oral
Subject Genvoya Unknown 200 mg Oral

Indications

HIV infectious disease chronic hepatitis C virus infection coinfection metabolic bone disorder opiate dependence