The Food and Drug Administration has approved the supplemental New Drug Application for a new low-dose tablet formulation of Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection in pediatric patients weighing at least 14kg to less than 25kg who are virologically suppressed or new to antiretroviral therapy. Previously, Biktarvy was only approved for patients weighing at least 25kg.
Biktarvy combines bictegravir, an integrase strand transfer inhibitor, and emtricitabine and tenofovir alafenamide, both nucleoside analogue reverse transcriptase inhibitors. The new approval was based on data from an open-label, single-arm phase 2/3 study (ClinicalTrials.gov Identifier: NCT02881320) that evaluated the efficacy, safety and pharmacokinetics of Biktarvy in 22 virologically suppressed pediatric patients 2 years of age and older weighing at least 14kg to less than 25kg.
Results showed that after switching to Biktarvy, 91% (n=20/22) of patients remained virologically suppressed at week 24; HIV-1 RNA was not collected for 2 patients due to COVID-19 pandemic-related study disruption. The mean change in CD4% from baseline to week 24 was 0.2%. No new adverse reactions or laboratory abnormalities were identified in this patient population.
Biktarvy is currently supplied as 50mg/200mg/25mg tablets. The new 30mg/120mg/15mg fixed-dose tablet formulation is expected to be available November 2021. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
- US Food and Drug Administration approves expanded indication of Gilead’s Biktarvy® for treatment of HIV-1 in pediatric populations. News release. Gilead Sciences, Inc. Accessed October 18, 2021. https://www.businesswire.com/news/home/20211018005505/en/U.S.-Food-and-Drug-Administration-Approves-Expanded-Indication-of-Gilead%E2%80%99s-Biktarvy%C2%AE-for-Treatment-of-HIV-1-in-Pediatric-Populations.
- Biktarvy. Package insert. Gilead Sciences, Inc.; 2021. Accessed October 18, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf.