Dolutegravir Recommendations for Treatment and PEP

Following data indicating increased risks of neural tube defects among infants whose mothers became pregnant while taking dolutegravir-based regimens, the Department of Health and Human Services Antiretroviral Guidelines Panels on May 30 issued recommendations for treatment of adults and adolescents with HIV who are pregnant or of child-bearing potential. The recommendations, with clinical scenarios and alternatives to treatment with dolutegravir, elaborate on the panels’ May 18 statement.

In addition, the U.S. Centers for Disease Control and Prevention released an Interim Statement Regarding Potential Fetal Harm from Exposure to Dolutegravir – Implications for HIV Post-Exposure Prophylaxis. Health care providers seeking additional advice can call the National Clinical Consultations Center’s PEPline at 1-888-448-4911, a public service supported by HRSA and CDC.  

The U.S. President’s Emergency Plan for AIDS Relief, the World Health Organization, and the European Medicines Agency have joined the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services antiretroviral treatment guidelines panels in releasing public statements about the potential safety of dolutegravir use at the time of conception.