Labeling Updated for Bictegravir, Emtricitabine, Tenofovir Combination to Include Info on Neural Tube Defect Risk

The FDA has approved updated labeling for Biktarvy to include information regarding the risk of neural tube defects.

The Food and Drug Administration (FDA) has approved updated labeling for Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide; Gilead) to include information regarding the risk of neural tube defects.

The updated labeling is based on data from an observational study in Botswana that showed dolutegravir, an integrase inhibitor, was associated with an increased risk of neural tube defects when administered at the time of conception and in early pregnancy. Currently, there is insufficient evidence to correlate this risk with Biktarvy. Healthcare providers are advised to weigh the benefits and risks of using Biktarvy in women of child-bearing age.

Biktarvy combines bictegravir, an integrase strand transfer inhibitor, and emtricitabine and tenofovir alafenamide, 2 nucleoside reverse transcriptase inhibitors (NRTIs). It is approved as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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There is a pregnancy exposure registry that monitors outcomes in women exposed to Biktarvy during pregnancy. Clinicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at (800) 258­-4263. 

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This article originally appeared on MPR