European Regulator Renews Birth Defect Warning for Dolutegravir-Containing HIV Drugs

Published on October 9, 2018 by Sandy Liebhard

European regulators have renewed warnings for dolutegravir, an HIV medication that has been linked to neural tube birth defects when taken in the earliest days of a pregnancy.

 Dolutegravir and Neural Tube Birth Defects

Dolutegravir is currently sold in the United States under the brand name Tivicay. It is also one of the active ingredients in two HIV combination drugs, Juluca and Triumeq.

Regulatory authorities the United States, Canada, and Europe issued initial dolutegravir warnings in May, after preliminary findings from a study being conducted in Botswana suggested that women who were taking dolutegravir-containing HIV drugs at conception were 9-times more likely to give birth to a child with a neural tube abnormality.

In July, the study authors reported that 170 additional women treated with dolutegravir at conception had given birth since May 2018. While all of the babies born to these mothers were free of birth defects, the rate of dolutegravir-associated neural tube defects remained 6-times higher in comparison to other HIV medications, even after data on the additional births was included in the analysis.

Regulatory Advice Regarding Dolutegravir HIV Drugs and Pregnancy

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) confirmed its previous advice regarding dolutegravir and pregnancy during a regular monthly meeting convened from October 1^st through October 4, 2018.

As a precaution, the Committee advised health care providers in the European Union to:

• Avoid prescribing dolutegravir to any woman of child-bearing potential who is trying to become pregnant.
• Conduct a pregnancy test before prescribing dolutegravir to any woman of child-bearing potential.
• Advise women of child bearing potential to use effective contraception while undergoing treatment with dolutegravir.
• Switch patients to an alternative HIV medication (unless there is no suitable alternative) if a pregnancy is confirmed during their 1st trimester.

Final Results of Dolutegravir Birth Defect Study Expected in 2019

The U.S. Food & Drug Administration and Health Canada have each issued dolutegravir recommendations similar to the European Union’s.

Women taking dolutegravir have been warned not to stop treatment without first talking to their doctor, as doing so could cause their HIV infection to worsen.

The Botswana study is continuing. As such, dolutegravir pregnancy recommendations could be revised once final findings are published in 2019.