U.S. FDA approves Gilead's low-dose Biktarvy for use in young HIV-1 children

Gilead Sciences recently announced that the U.

Although effective treatment options available to pregnant women infected with HIV reduce the possibility of transmission of HIV infection during the perinatal period, pediatric HIV remains a global health problem

The FDA approved Biktarvy for HIV-1 infection in children weighing at least 14 kg, based on data from cohort 3 of the Phase 2/3 open-label single-arm study (NCT02881320)

Biktarvy is a single-tablet regimen (STR) taken orally once a day for the treatment of HIV-1 infection

In the United States, Biktarvy was approved for marketing in February 2018.

In China, Biktarvy was approved in Hong Kong in October 2018 and approved in the Mainland in August 2019

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Original source: US Food and Drug Administration Approves Expanded Indication of Gilead's Biktarvy® for Treatment of HIV-1 in Pediatric Populations