Effects of Biktarvy on CFR in Stable HIV Patients
Condition: HIV
Study type: Interventional
Phase: Phase 3

Summary: 
      Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was
      approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is
      Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was
      found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes.
      B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result,
      B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on
      coronary flow reserve.
    

Detailed description: 
      Positron emission tomography (PET) imaging allows precise and reproducible quantification of
      myocardial blood flow, thereby providing a direct assessment of coronary vascular health.
      Coronary flow reserve (CFR, calculated as the ratio of peak hyperemic myocardial blood flow
      over that at rest) is emerging as a powerful quantitative prognostic imaging marker of
      clinical cardiovascular risk. CFR provides a robust and reproducible clinical measure of the
      integrated hemodynamic effects of epicardial coronary artery disease (CAD), diffuse
      atherosclerosis, vessel remodeling, and microvascular dysfunction resulting from endothelial
      cell dysfunction on myocardial tissue perfusion across the entire coronary circulation. These
      processes have direct relevance to the underlying vascular pathobiology in patients with HIV
      infection. Consequently, quantitative CFR provides a unique opportunity to examine the
      potential impact of novel therapies on the biology of the disease and its association with
      cardiovascular outcomes. By testing the fundamental concept of whether novel ART therapies in
      HIV can lead to improved coronary blood flow and myocardial tissue perfusion, TAF-CFR would
      provide important mechanistic insights of the capabilities of TAF therapy to improve key
      determinants of clinical risk.

      This is an open label, multicenter, uncontrolled, single arm pilot study. Patients with
      stable HIV currently treated with abacavir/lamivudine/dolutegravir STR regimens will be
      eligible for the B/F/TAF-CFR study. PET scans will be performed after enrollment while on the
      abacavir/lamivudine/dolutegravir STR regimen and at 24 weeks after the switch to B/F/TAF
      regimen. Patients will be encouraged to remain on stable medical therapy throughout the
      enrollment period.
    

Intervention name(s): Biktarvy
Intervention type(s): Drug
Intervention description(s): Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Other intervention name(s): Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment