1. Aschenbrenner, Diane S. MS, RN


* The Food and Drug Administration is investigating early reports from an ongoing clinical trial in Botswana that the HIV drug dolutegravir may increase the risk of neural tube birth defects if used from the time of conception through the first trimester of pregnancy.


* A pregnancy test is now recommended for women of childbearing age prior to starting HIV treatment with dolutegravir.



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Preliminary results from an ongoing observational study in the country of Botswana indicate that use of the HIV drug dolutegravir during the first trimester of pregnancy can increase the risk of neural tube birth defects involving the brain, spine, and spinal cord. The Food and Drug Administration (FDA) has issued an alert regarding this risk and will issue additional advice when more information is available.


Dolutegravir is an integrase inhibitor that prevents a complete cycle of HIV replication. It is available as a single entity drug, Tivicay, and in combination with other antiretroviral drugs, as Juluca (with rilpivirine) or Triumeq (with abacavir and lamivudine).


The FDA has added information to the labeling of all forms of dolutegravir suggesting that patients take a pregnancy test prior to starting treatment with dolutegravir. To monitor the outcomes of fetal development in women taking dolutegravir during pregnancy, health care providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at (800) 258-4263. Updated information about the ongoing trial in Botswana has also been added to the drug's labeling in the section titled "Use in Specific Populations."


Nurses, NPs, and nurse midwives should educate women of childbearing age on the potential risk of neural tube defects from dolutegravir. The risk is highest if the drug is used from the time of conception through the first six weeks of pregnancy. Alternative antiretroviral drugs should be considered. Patients taking dolutegravir should understand the need for consistent effective use of birth control. To read the FDA Drug Safety Communication, go to