FDA Issues Labeling Revisions for HIV-1 Treatment Biktarvy


The FDA has expanded the patient population and issued updated drug interactions, warnings, and precautions for Biktarvy.

The US Food and Drug Administration (FDA) has issued labeling revisions for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), a once-daily, single-tablet regimen for the treatment of HIV-1 infection, including an expanded patient population and updated drug interaction data, warnings, and precautions.

Approved by the FDA in February 2018, Gilead Sciences, Inc.’s Biktarvy was initially indicated for adults with HIV-1 with no history of antiretroviral therapy (ART) or as a replacement for a current antiretroviral regimen in adults who achieved virologic suppression (with HIV-1 RNA less than 50 copies per mL) who were on a stable ART regimen for at least 3 months without any history of treatment failure, and with no known substitutions associated with resistance to the individual components of Biktarvy.

The labeling revisions expand the patient population to include HIV-1 infected pediatric patients weighing at least 25 kg.

“The safety of BIKTARVY was evaluated in HIV-1 infected virologically-suppressed subjects between the ages of 12 to less than 18 years and weighing at least 35 kg (N=50) through Week 48 (cohort 1), and in virologically-suppressed subjects between the ages of 6 to less than 12 years and weighing at least 25 kg (N=50) through Week 24 (cohort 2) in an open label clinical trial (Trial 1474),” the FDA reported.

“No new adverse reactions or laboratory abnormalities were identified compared to those observed in adults. Adverse reactions were reported in 10% of pediatric subjects. The majority (85%) of adverse reactions were Grade 1. No Grade 3 or 4 adverse reactions were reported,” the FDA statement continued.

Additionally, the agency issued an update to the warnings and precautions for Biktarvy to include autoimmune hepatitis as one of the autoimmune disorders reported to occur in the setting of immune reconstitution.

Drug interactions were updated to include “revised clinical comments for medications or oral supplements containing polyvalent cations (eg, Mg, Al, Ca, Fe),” according to the FDA.

Providers are increasingly turning to Biktarvy as a regimen of choice because of its convenience as a single-tablet therapy option.

“Biktarvy requires no additional lab testing (eg, for HLA-B27), a limit of other first-line agent abacavir/dolutegravir/lamivudine. The high barrier of resistance and once-daily formulation, along with no restrictions on taking it with or without food, make it particularly attractive for many of our patients,” Brionna Matt, DO, a board-certified internal medicine physician in her second year of infectious disease fellowship at Temple University Hospital in Philadelphia, Pennsylvania, wrote in the June issue of Contagion®. “Additionally, Biktarvy remains a good alternative for virologically suppressed patients who are on more toxic regimens.”

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