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 Genvoya Unknown 10 mg Oral
Subject Genvoya Unknown 150 mg Oral
Subject Genvoya Unknown 200 mg Oral
Subject glecaprevir Other / unclassified 100 mg Oral
Subject glecaprevir Other / unclassified 400 mg Oral

Indications

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