CCC Response to FDA Notice: Dolutegravir and Post-Exposure Prophylaxis (PEP)

The U.S. Food and Drug Administration (FDA) alerted the public on 5/18/18 that serious cases of neural tube birth defects have been reported in babies born to women living with HIV who were treated with dolutegravir at the time of becoming pregnant or early in the first trimester (https://fda.gov/Drugs/DrugSafety/ucm608112.htm).  Until more information is available, we recommend against using dolutegravir in women of childbearing potential who are not using an effective form of contraception.  At this time, there are no data to suggest similar concern regarding raltegravir use.  Guidelines recommend providers have individualized conversations with patients about the implications of antiretroviral medication exposure during pregnancy, as well as HIV transmission risk if a patient becomes (or is) pregnant.  Providers are welcome to call our PEPline with questions.  If you need additional support or have questions, please call our PEPline at (888) 448-4911.