A recent study has provided further evidence that infants exposed to the antiretroviral drug dolutegravir around the time of conception do not have an increased risk of neural tube defects, such as spina bifida. The study, conducted by researchers from the US Centers for Disease Control and Prevention, analyzed data from over 18 million pregnancies recorded in two large healthcare databases in the United States between January 2008 and December 2020.
While the study did find a slightly increased risk of pregnancy loss in all women with HIV who were taking antiretroviral treatment around the time of conception, it did not find a significant increase in the risk of neural tube defects for infants exposed to dolutegravir. This finding supports previous studies conducted in Brazil and Canada, which also found no increased risk of neural tube defects associated with dolutegravir.
The researchers defined periconception exposure to antiretroviral drugs as lasting from the date of a prescription issued at least eight weeks before the last premenstrual period until the end of the first trimester of pregnancy. They identified a total of 1,463 pregnancies with periconception exposure to dolutegravir in the Medicaid database and 69 pregnancies in the MarketScan database.
In the Medicaid cohort, there were three cases of neural tube defects in pregnancies with periconceptional exposure to antiretrovirals other than dolutegravir and one case in pregnancies with periconceptional exposure to dolutegravir. However, the rate of neural tube defects in pregnancies of women with HIV exposed to any antiretroviral drugs around conception in the MarketScan cohort was not significantly different from those without HIV.
These findings have important implications for the use of dolutegravir in pregnancy. The World Health Organization and national guidelines in Europe and North America now recommend the use of dolutegravir in pregnancy or by women of childbearing potential, as long as food is supplemented with folic acid. This study further supports the safety of dolutegravir use in pregnancy when adequate folic acid supplementation is provided.
Source: US Centers for Disease Control and Prevention
Glossary:
– Medicaid: A program in the United States that provides health insurance to people on low incomes.
– Multivariable analysis: A statistical technique used to identify the association between a factor of interest and an outcome, while controlling for confounding factors.
– Prospective study: A type of longitudinal study in which people join the study and information is collected on them over a period of time.
– Comorbidity: The presence of one or more additional health conditions alongside a primary condition, such as HIV.
