Last updated on June 2018

Switch to Genvoya Followed by HCV Therapy With Epclusa in Patients With HIV/HCV Co-Infection on Methadone

Brief description of study

The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone who are stably suppressed on current antiretroviral therapy to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya) for 12 weeks followed immediately by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusa).

Detailed Study Description

This clinical study is a phase IV, prospective, open-label, single arm multi-center study designed to assess the feasibility of the switch from a participant's current antiretroviral therapy regimen to Genvoya, followed shortly thereafter by initiation of Epclusa for treatment of HCV co-infection. A total of 25 participants over the age of 18 on stable antiretroviral therapy with documented HIV viral suppression who are on stable opioid substitution therapy at least three months will be enrolled. Participants will be recruited from two different clinical sites across Saskatchewan, all of which care for large numbers of participants living with HIV-HCV co-infection. Approximately 15 participants will be recruited at the Infectious diseases clinic in Regina (IDC), and 10 participants at Access Place in Prince Albert.

Eligible participants will have baseline investigations performed, including measures of renal parameters and bone mineral densitometry. Based on investigator preference, eligible participants will be switched from their current antiretroviral regimen to Genvoya for the first 12 weeks of the study. Various reasons for switching may play a role in clinician decision-making, including simplification, improved tolerability, an improved metabolic risk profile, etc. The primary drawbacks to Genvoya in clinical practice include the potential for drug-drug interactions due to the presence of cobicistat, and the relatively low so-called "genetic barrier" of resistance, meaning that sub-optimal adherence may be more likely to result in antiretroviral resistance. Participants must already be fully suppressed at the time of screening to be enrolled in the study, as well as having been stable on methadone for at least three months, in order to reduce the risk of poor adherence.

After the switch to Genvoya occurs, participants will be seen at weeks 1 and 4 to assess for adverse events, including any changes in methadone dosing. Laboratory testing will be performed as per standard of care with CD4 counts and HIV viral loads checked at weeks 4 and 12 to ensure stable virologic suppression. At each visit, validated questionnaires will be performed to determine whether the participant is having any symptoms or signs of opioid withdrawal and to determine treatment satisfaction with their new antiretroviral regimen.

After 12 weeks of Genvoya, provided that participants remain stably suppressed in terms of their HIV, they will then proceed to receive 12 weeks of Epclusa to treat their chronic HCV infection while continuing to take Genvoya. Participants are allowed to have any HCV genotype and may have stage 0-4 liver fibrosis as assessed by transient elastography / Fibroscan, but may not have decompensated cirrhosis or hepatocellular carcinoma. Participants will be followed at weeks 13/16/24 with questionnaires and clinical assessments performed, with repeat HCV viral loads performed at weeks 16 and 24 as per standard of care. Participants will be seen at weeks 36 and 48 and have their HCV viral loads performed to determine whether they have achieved a sustained virologic response 12 and 24 weeks following end of HCV therapy, which defines HCV cure. Bone mineral densitometry will be performed at week 48 to determine any interval change in bone mineral density has occurred between study initiation and study end. At each visit, participants will see a study coordinator and have vital signs performed, a review of their concurrent medications including any changes in their methadone dosing, review for any adverse events, and weight and height measurements. Laboratory investigations will be performed as per current standards of care. Urine drug screens will be performed as per current standards of care. Questionnaires will be administered to study participants at each visit. Each visit is anticipated to take approximately 60-90 minutes, and the appointment for bone mineral density testing will take no longer than 2 hours to complete with waiting time included. All study medication will be provided during study period but not after study completion.

At the study conclusion, demographic and other baseline variables will be summarized using percentage, mean, median, standard deviation and interquartile range as appropriate. The proportion of subjects achieving the various endpoints and the associated 95% confident interval will be calculated. Adverse events will be summarized by grade and relationship to treatment in addition to presenting the data in a listing format.

Clinical Study Identifier: NCT03549312

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Recruitment Status: Open

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