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
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|ClinicalTrials.gov Identifier: NCT03549312|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection Hepatitis C, Chronic Methadone Dependence Opioid Dependence Bone Diseases, Metabolic HIV/AIDS Co-infection Buprenorphine Dependence HCV Coinfection||Drug: Genvoya Drug: Epclusa Drug: Biktarvy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Switch Followed by Sofosbuvir/Velpatasvir (SOF/VEL) Antiviral HCV Therapy Followed by Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Simplification in HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy - A Pilot Feasibility Study|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||July 21, 2020|
|Estimated Study Completion Date :||June 22, 2021|
Experimental: Switch to Genvoya Followed By HCV Therapy Then Start Biktarvy
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.
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.
Other Name: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide
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.
Other Name: Sofosbuvir and Velpatasvir
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.
Other Name: Bictegravir, Emtricitabine and Tenofovir Alafenamide
- Feasibility assessment: participants approached, screened and enrolled in the study along with completed study visits [ Time Frame: Up to 48 weeks on Genvoya and 12 weeks of Epclusa and 48 weeks of Biktarvy ]Feasibility will be measured by collecting data on the number of participants approached, screened and enrolled. In addition, feasibility will be assessed by proportion of completed study visits as outlined in the protocol.
- Assessment of incidence of screen failures [ Time Frame: Week 96 ]Screen failures will be assessed by drug-drug interactions, prior documented resistance to any component of Genvoya or Biktarvy, non-adherence to opioid substitution therapy or antiretroviral therapy.
- Adherence [ Time Frame: Week 96 ]Adherence will be assessed at key time points of the study and will be determined by patient self-report and pill count at each study visit and by reviewing the accountability logs provided to the pharmacists to keep track of dispensed and returned pills or bottles for subjects receiving their study medication from their pharmacy with their OST.
- HCV clearance post Epclusa therapy [ Time Frame: Weeks 24 and 48 ]Proportion of participants with HCV RNA <12 copies/mL (c/mL) at Week 24 and Week 48
- Sustained HIV Viral Load Suppression [ Time Frame: Weeks 4, 12, 24, 36, 48, 52, 60, 72, 84 and 96 ]Proportion of participants who maintain suppressed HIV Viral Load (i.e. plasma HIV-1 RNA <= 50 copies/mL)
- Discontinuation of study medication due to adverse events [ Time Frame: 96 weeks ]Proportion of participants discontinuing study medications due to adverse events (overall and liver enzyme abnormalities
- Adjustments to methadone or buprenorphine/naloxone dosing over study duration [ Time Frame: 96 weeks ]Proportion of participants who required any changes in the methadone or buprenorphine/naloxone dosing deemed secondary to the use of Genvoya, Epclusa or Biktarvy
- Opioid withdrawal or overdose symptoms over study duration [ Time Frame: 96 weeks ]Proportion of participants who experience opioid withdrawal or overdose symptoms while receiving Genvoya, Epclusa or Biktarvy and methadone or buprenorphine/naloxone as OST through 96 weeks of study, as per standardized survey measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549312
|Contact: Alexander Wong, MDemail@example.com|
|Contact: Dennaye Fuchs, RNfirstname.lastname@example.org|
|Saskatchewan Health Authority||Recruiting|
|Regina, Saskatchewan, Canada, S4P 0W5|
|Contact: Alexander Wong, MD 306-766-3915 email@example.com|
|Contact: Dennaye Fuchs, RN 306-766-4521 firstname.lastname@example.org|
|Principal Investigator: Alexander Wong, MD|
|Sub-Investigator: Stuart Skinner, MD|
|Sub-Investigator: Kumudhini Karunakaran, MD|
|Principal Investigator:||Alexander Wong, MD||Saskatchewan Health Authority - Regina Area|