FDA expands approval of Biktarvy to include younger children with HIV

October 18, 2021

2 minutes reading

Source/Revelations

disclosures:
Parsey is employed by Gilead Sciences. Healio was unable to confirm any relevant financial disclosures for Rodrigue at the time of publication.

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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’s Morsani College of Medicine, said the approval means more options for pediatric patients living with HIV.

“Since children with HIV will be in therapy for the foreseeable future and from such a young age, there are a number of factors that I, as a clinician, consider when prescribing the right HIV treatment option for my pediatric patients,” Rodriguez, who is a researcher about the trial that led to the expanded approval, said in a press release.

“Finding an effective treatment option is paramount, but tolerability and safety are the keys to treatment success,” Rodriguez said. “With this expanded approval, clinicians can add Biktarvy to their arsenal of options to ensure these children maintain virological suppression with a treatment option that makes sense to them.”

The approval was based on data from a Phase 2/3 open-label, single-arm study that showed that low-dose BIC/FTC/TAF tablets were effective and generally well tolerated for 24 weeks in children with HIV-1 with virological suppression. The study cohort included 22 participants weighing between 14 and 25 kg who continued treatment for 48 weeks and were then able to continue to receive 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%. No new side effects or laboratory abnormalities were identified in the pediatric studies compared to those seen in adults, Gilead said.

“Children living with HIV need effective and accessible formulations of antiretroviral therapy,” Merdad parsey, MD, PhDGilead Sciences chief medical officer said in the release. “To meet this unmet need, innovations in pediatric formulations should aim to expand treatment options for children. [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 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 August 26, 2016. Accessed October 18, 2021.

Guidelines for the use of antiretrovirals 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 October 18, 2021.

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