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HIV drug linked to birth defects :

June 6, 2018

An HIV drug has been linked to neural tube birth defects, according to a warning from the Food and Drug Administration (FDA).

Among 426 women in Africa who were taking antiretroviral medicine dolutegravir when they conceived, four infants were born with these defects, preliminary study results found.

Dolutegravir is an FDA-approved drug and is available under the brand names Tivicay, Juluca and Triumeq. Preliminary findings from the same study have not found increased risk of neural tube defects among 116 mothers who initiated a dolutegravir-based regimen during the first trimester. More results from hundreds of births are expected in the coming months.

The FDA is recommending women of childbearing age get tested to ensure they are not pregnant before starting dolutegravir and that health care providers counsel them on the risks, benefits and alternatives. Women who take the drug should use effective birth control. The U.S. Department of Health and Human Services Antiretroviral Guidelines Panels recently released detailed guidance, which is available at

The FDA also recently warned PREZCOBIX (darunavir and cobicistat) should not be used to treat pregnant women with HIV due to "substantially lower exposures of darunavir and cobicistat during pregnancy."

Providers can prospectively report pregnancy exposures of women with HIV receiving antiretroviral therapy to the Antiretroviral Pregnancy Registry at For additional guidance, contact the Perinatal HIV/AIDS hotline at 888-448-8765.

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