Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy … (NCT03549312) | Clinical Trial Compass
UnknownPhase 4
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
Canada25 participantsStarted 2018-02-01
Plain-language 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, Genvoyaâ„¢) followed by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusaâ„¢), followed then by switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvyâ„¢) for an additional 48 weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and Females, 18 years or older
✓. HIV infected (ELISA with western blot confirmation)
✓. HCV RNA positive for minimum of 6 months / Genotype 1-6
✓. Prescribed a combination ART regimen (cART) that may include any DHHS recommended or alternative regimens, which the treating physician considers is appropriate for their patient, except E/C/F/TAF or B/F/TAF at any point previously.
✓. HIV RNA ≤ 50 c/mL at screening and ≤ 200 c/mL for at least 3 months prior to screening.
✓. CD4 ≥ 200 cells/uL at screening.
✓. Stage 0 to 4 fibrosis.
✓. On methadone or buprenorphine/naloxone as OST for at least 3 months prior to screening and deemed stable on OST by the investigator.
Exclusion criteria
✕. Have received any anti-HCV therapy previously with NS5A inhibitors. Previous treatment regimens allowed may include pegylated interferon, ribavirin, 1st generation NS3/NS4 protease inhibitors (telaprevir or boceprevir), and sofosbuvir.
What they're measuring
1
Feasibility assessment: participants approached, screened and enrolled in the study along with completed study visits
Timeframe: Up to 48 weeks on Genvoya and 12 weeks of Epclusa and 48 weeks of Biktarvy
2
Assessment of incidence of screen failures
Timeframe: Week 96
3
Adherence
Timeframe: Week 96
Trial details
NCT IDNCT03549312
SponsorSaskatchewan Health Authority - Regina Area
✕. Have any evidence of decompensated liver disease including ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other symptoms suggestive of advanced liver disease. For cirrhotic patients with Child-Pugh Class B or C or with Pugh-Turcotte (CPT) score greater than 6 must be excluded.
✕. Co-infection with hepatitis B.
✕. Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC), or is under evaluation for HCC.
✕. Concomitant use of drugs with contraindication or drug-interactions with E/C/F/TAF on Day 1 visit or B/F/TAF on Week 48/0E visit. However, the use of any concomitant drugs with contraindication with SOF/VEL are to be stopped during the weeks of treatment (i.e. week 12-24), and only after the Principal Investigator's permission, may the use of these drugs may be continued or restarted after week 24 visit (i.e. end of SOF/VEL therapy).
✕. Have any active contraindication to the use of methadone, as listed in the product monograph for methadone and listed below, unless deemed acceptable based on the Principal Investigator's judgement:
✕. Patients who are hypersensitive to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation.
✕. Patients with a known or suspected mechanical gastrointestinal obstruction.