Taking raltegravir around pregnancy is not associated with neural tube defects (NTDs) in the baby, an analysis of data from the manufacturer’s safety database that was published in Journal of Acquired Immune Deficiency Syndrome found.
Last year, a warning was issued for a similar integrase inhibitor, dolutegravir, raising concern that raltegravir may also cause NTDs. The current study’s authors analyzed data on 2,426 pregnancies, finding three infants with neural tube defects. In the general population, the estimated NTD rate is 19 per 10,000 births.
Most reports came from Europe and the U.S., while the initial concern was raised in Botswana, where folate supplementation, which is recommended to prevent NTDs, is uncommon. Study results were originally presented in March at the CROI 2019 conference in Seattle and are reiterated in the current report.
Meanwhile, at the IAS 2019 conference in Mexico City in late July, researchers retracted the dolutegravir warning, causing the World Health Organization to revise its recommendations. The upshot: Expert guidance is now that there is no reason to deny access to dolutegravir or raltegravir for women who are, or want to become, pregnant