Drug updated on 10/29/2024
| Dosage Form | Tablet (oral; bictegravir/emtricitabine/tenofovir alafenamide: 50 mg/ 200 mg/ 25 mg); Tablet (oral; bictegravir/emtricitabine/tenofovir alafenamide: 30 mg/ 120 mg/ 15 mg) |
| Drug Class | HIV integrase strand transfer inhibitors (INSTI), and HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
Latest News
Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Virologic suppression (HIV-1 RNA < 50 copies/mL) rates at Week 144 were similar across DTG + 3TC, BIC/FTC/TAF, and DTG/ABC/3TC regimens, with no significant differences in virologic failure (HIV-1 RNA ≥ 50 copies/mL) between the groups.
- In a pooled analysis of virologically suppressed Asian participants, 100% of those who switched to B/F/TAF maintained virologic suppression at Week 48, similar to those who remained on baseline regimens (95.9%, p = 0.2485).
- A meta-analysis of seven randomized clinical trials showed no statistically significant difference in efficacy between BIC/FTC/TAF and control regimens at Week 48 [OR 1.01 (95% CI)].
- There is no population type or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Prescribing Information. | 2024 | Gilead Sciences, Inc., Foster City, CA |