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Antiviral

Switch to Genvoya Followed By HCV Therapy Then Start Biktarvy for Coinfection

Phase 4
Waitlist Available
Led By Alexander Wong, MD
Research Sponsored by Saskatchewan Health Authority - Regina Area
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 12, 24, 36, 48, 52, 60, 72, 84 and 96
Awards & highlights

Study Summary

This trial will test the feasibility of switching HIV-HCV co-infected patients who are receiving methadone or buprenorphine/naloxone as opioid substitution therapy, have a 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™),

Eligible Conditions
  • Coinfection
  • Methadone Addiction
  • Opioid Addiction
  • Metabolic Bone Diseases
  • Chronic Hepatitis C
  • HIV
  • Buprenorphine Dependence
  • Hepatitis C Virus Infection
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 12, 24, 36, 48, 52, 60, 72, 84 and 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 12, 24, 36, 48, 52, 60, 72, 84 and 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence
Assessment of incidence of screen failures
Feasibility assessment: participants approached, screened and enrolled in the study along with completed study visits
Secondary outcome measures
Adjustments to methadone or buprenorphine/naloxone dosing over study duration
Discontinuation of study medication due to adverse events
HCV clearance post Epclusa therapy
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Switch to Genvoya Followed By HCV Therapy Then Start BiktarvyExperimental Treatment3 Interventions
Oral Genvoya 150/150/200/10 mg & Epclusa 400/100 mg once daily. Once completed HCV therapy, switch anti-retroviral treatment to Oral Biktarvy 50/200/25 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emtricitabine
FDA approved
Sofosbuvir
FDA approved
Tenofovir alafenamide
FDA approved

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaLead Sponsor
27 Previous Clinical Trials
5,493 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,816 Total Patients Enrolled
15 Trials studying Coinfection
3,896 Patients Enrolled for Coinfection
Alexander Wong, MDPrincipal InvestigatorSaskatchewan Health Authority - Regina Area

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
Alexander Wong, MD 2018. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03549312.
All > Opiate Addiction > Genvoya
~3 spots leftby Apr 2025
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