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

**PLEASE NOTE:  This statement is now outdated. We will provide updates when additional data is available. In the meantime, please reference the HHS Perinatal  Guidelines for more information on dolutegravir in pregnancy and pre-conception: https://aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0**

On May 30, 2018 the HHS Antiretroviral Guidelines Panels issued recommendations on the use of dolutegravir for treatment of adults and adolescents living with HIV who are pregnant or of child-bearing potential.  The purposes of these recommendations were to elaborate on their previous May 18, 2018 statement and to support the related FDA Drug Safety Communication.  The CCC continues to recommend against using dolutegravir as post-exposure prophylaxis for either of the following scenarios: (a) exposed persons who are pregnant at less than 8 weeks of gestation, and (b) exposed persons who desire pregnancy or are not using an effective method of contraception.  At this time it is not known if the potential effect of dolutegravir on neural tube development is specific to dolutegravir or whether it extends to other medications in the same class (i.e. raltegravir), and thus the CCC strongly recommends that this uncertainty be acknowledged and discussed with all patients when raltegravir is being considered as PEP.  We recommend providers have individualized conversations with patients about the implications of antiretroviral medication exposure, as well as HIV transmission risk, during pregnancy.  Providers are encouraged to call our PEPline with questions, including questions about alternative PEP options: (888) 448-4911.