Therapy Areas: AIDS & HIV
US Food and Drug Administration Approves Expanded Indication of Gilead's Biktarvy for Treatment of HIV-1 in Pediatric Populations
19 October 2021 - - The US Food and Drug Administration approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy, US-based Gilead Sciences, Inc. (NASDAQ: GILD) said.

The approval of this supplemental New Drug Application expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children.

While effective available treatment options for pregnant women living with HIV lower the likelihood of perinatal HIV infection transmission, pediatric HIV remains a global health problem.

Each day in 2020, approximately 850 children worldwide became infected with HIV and approximately 330 children died from AIDS-related causes, mostly because of inadequate access to HIV care and treatment services.

The availability of a single-tablet antiretroviral regimen for children weighing at least 14 kg is a significant milestone with the potential to save many lives.

In the United States, 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 (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.

Biktarvy has a Boxed Warning for post treatment acute exacerbation of hepatitis B; please see below for additional Important Safety Information for Biktarvy.

The approval of Biktarvy for children weighing at least 14 kg is based on data from Cohort 3 of a Phase 2/3 open-label, single-arm study (NCT02881320), which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1.

Cohort 3 enrolled 22 participants weighing ≥14 to
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