FDA expands approval of Biktarvy to include younger children with HIV
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Gilead Sciences said the FDA has approved a new low-dose tablet form of its HIV drug Biktarvy for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to ART.
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; BIC/FTC/TAF) was originally approved in 2018 for use in adults. In 2019, it was approved for use in children weighing at least 25 kg.
Carina Rodriguez, MD, professor and chief of the division of pediatric infectious diseases at the University of South Florida Morsani College of Medicine, said the approval means more options for pediatric patients with HIV.
“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” Rodriguez, who was an investigator on the trial that led to the expanded approval, said in a news release.
“Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success,” Rodriguez said. “With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”
The approval was based on data from a phase 2/3 open-label, single-arm study that found low-dose BIC/FTC/TAF tablets to be effective and generally well tolerated through 24 weeks among virologically suppressed children with HIV-1. The study cohort included 22 participants weighing between 14 and 25 kg who continued the treatment for 48 weeks and could then continue to receive the study drug through an extension phase.
After switching to BIC/FTC/TAF, 91% (20/22) of participants remained virologically suppressed at Week 24, and the mean change in CD4 from baseline was 0.2%. In the pediatric studies, no new adverse reactions or laboratory abnormalities were identified compared with those observed in adults, Gilead said.
“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, said in the release. “To address this unmet need, innovations in pediatric formulations must strive toward expanding treatment options for children. The [supplemental new drug application] approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world.”
References:
B/F/TAF FDC in HIV-1 infected adolescents and children. https://clinicaltrials.gov/ct2/show/study/NCT02881320. Published Aug. 26, 2016. Accessed Oct. 18, 2021.
Guidelines for the use of antiretroviral agents in pediatric HIV infection. https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/bictegravir#:~:text=BIC%2C%20which%20is%20available%20only,adolescents%20weighing%20%E2%89%A525%20kg. Published April 7, 2021. Accessed Oct. 18, 2021.
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U.S. Food and Drug Administration approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in pediatric populations. https://www.gilead.com/news-and-press/press-room/press-releases/2021/10/us-food-and-drug-administration-approves-expanded-indication-of-gileads-biktarvy-for-treatment-of-hiv1-in-pediatric-populations. Published Oct. 18, 2021. Accessed Oct. 18, 2021.
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