Drug updated on 3/28/2024
| 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 | Antivirals |
| 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 history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
Summary
- Bictegravir, embitcitabine, and tenofovir alafenamide (Biktarvy) is 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.
- Three systematic reviews/meta-analyses were reviewed which provided insights into Biktarvy's efficacy, safety, tolerability and comparison with other regimens.
- The real-world efficacy of Biktarvy was found to be comparable to phase III trials but adverse effects and discontinuation rates were higher according to one study.
- A review comparing clinical trials of dolutegravir-based therapies with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) suggested that results may not be directly comparable due to methodological differences between studies; however BIC/FTC/TAF had high quality scores on average compared to medium quality for dolutegravir-based therapies.
- Another meta-analysis involving seven randomized controlled trials including 3547 participants concluded that BIC/FTC/TAF has similar safety profiles as control regimens containing non-nucleoside reverse transcriptase inhibitor, protease inhibitor or integrase strand transfer inhibitors plus two nucleos(t)ide reverse transcriptase inhibitors at week 48 post-treatment initiation.
- There is a need for further prospective studies on under-represented groups such as women, pregnant people, ethnic minorities and older adults using Biktarvy given the demographic diversity observed in real-world cohorts compared with drug approval trial populations according to one scoping review included here.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Biktarvy (bictegravir, embitcitabine, and tenofovir alafenamide) Prescribing Information. | 2022 | Gilead Sciences, Inc. Foster City, CA |