Phase 3
Completed N=25
Effects of Biktarvy on CFR in Stable HIV Patients
Source: ClinicalTrials.gov NCT03656783 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Change in Global CFR — -.05 ratio
◆ Published Evidence
Emerging
9citations · ~3 / year
Coronary Microcirculatory Dysfunction in People With HIV and Its Association With Antiretroviral Therapy.
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.
Linked Publications
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Coronary Microcirculatory Dysfunction in People With HIV and Its Association With Antiretroviral Therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global CFR |
-.05 | — |
| SECONDARY Change in Peak Stress Global MBF |
0.09 | — |
| SECONDARY Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L)) |
-0.40 | — |
| SECONDARY Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) |
-0.04 | — |
| SECONDARY Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) |
-14.2 | — |
Eligibility Criteria
Inclusion Criteria
Patients with HIV on abacavir/lamivudine/dolutegravir STR regimens for at least 1 year fulfilling the following inclusion criteria:
- age ≥ 45 years for men and ≥ 55 years for women;
- at least one coronary risk factor including smoking, dyslipidemia, hypertension, obesity (BMI >30) or diabetes, or a calculated 10-year risk of heart attack of 7.5% or higher;
- HIV RNA 200;
- Screening HIV RNA 200 or DBP >110);
- pregnancy;
- Patients requiring medications contraindicated with the components of B/F/TAF;
- Patients on active treatment for severe asthma or severe COPD.
Data sourced from ClinicalTrials.gov (NCT03656783) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.