Summary

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• Biktarvy (bictegravir, embitcitabine, and tenofovir alafenamide) 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 (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.
• This summary is based on the review of six systematic reviews/meta-analyses. ^[1-6]
• Real-world effectiveness of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is consistent with phase III trial outcomes, particularly in terms of virologic suppression (HIV-1 RNA < 50 copies/mL) and comparable CD4 + cell count changes at Week 144 to other regimens like DTG+3TC and DTG/ABC/3TC.
• Meta-analysis of 3,547 participants across seven randomized clinical trials found no statistically significant difference in efficacy between BIC/FTC/TAF and control regimens at Week 48, with an odds ratio of 1.01 (95% CI 0.79, 1.30).
• Indirect treatment comparison revealed similar long-term efficacy and durability between BIC/FTC/TAF, DTG+3TC, and DTG/ABC/3TC, with rates of virologic suppression and virologic failure remaining consistent across these regimens at Week 144.
• Adverse effects and discontinuation rates for Biktarvy were higher in real-world studies compared to phase III trials.
• Safety profiles of BIC/FTC/TAF were comparable to control regimens: OR for all adverse effects was 0.92 (95% CI 0.78, 1.09); OR for any grade 3 or grade 4 AEs was 0.96 (95% CI 0.66, 1.39); OR for treatment-related AEs was 1.31 (95% CI 0.68, 2.53).
• There is no population types or subgroups information available in the reviewed studies.