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

PHASE4UnknownINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

July 21, 2020

Study Completion Date

June 22, 2021

Conditions
HIV-1-infectionHepatitis C, ChronicMethadone DependenceOpioid DependenceBone Diseases, MetabolicHIV/AIDSCo-infectionBuprenorphine DependenceHCV Coinfection
Interventions
DRUG

Genvoya

"Switching to Genvoya for 48 weeks in patients with HIV/HCV co-infection and stably suppressed HIV RNA, prior to starting HCV treatment, while receiving methadone or buprenorphine/naloxone as opioid substitution therapy.~Plasma HIV-1 RNA \< 50 copies/mL at weeks 4, 12, 24, 36 and 48."

DRUG

Epclusa

"HCV therapy with direct-acting-antiviral therapy with Epclusa in HIV-HCV co-infected patients with suppressed HIV RNA, receiving methadone as opioid substitution therapy.~Plasma HCV RNA viral load at weeks 12, 24, 36, 48, 72 and 96."

DRUG

Biktarvy

"Switching to Biktarvy for 48 weeks in patients with HIV previously treated with Genvoya, stably supressed HIV RNA, while receiving methadone or buprenorphine/naloxone as opioid substitution therapy.~Plasma HIV-1 RNA \< 50 copies/mL at weeks 52, 60, 72, 84 and 96."

Trial Locations (1)

S4P 0W5

RECRUITING

Saskatchewan Health Authority, Regina

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Saskatchewan Health Authority - Regina Area

OTHER

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 | Biotech Hunter | Biotech Hunter