A new investigation published by the US Centers for Disease Control and Prevention (CDC) in the Morbidity and Mortality Weekly Report
indicates that neutral tube defect (NTD) prevalence is similar between infants exposed to HIV during pregnancy and unexposed infants.
In 2018, a Botswana cohort study found an 8-fold increased risk association between dolutegravir use at the time of conception and NTDs among babies born to women living with HIV.
As a result, in December 2018 the World Health Organization (WHO) and the US Department of Health and Human Services issued interim guidance
that recommended against the initiation of dolutegravir during early pregnancy and in women of childbearing age.
However, several studies presented
following the release of the interim guidelines suggested that the risk of neural tube defects following exposure to dolutegravir is significantly lower than what was previously suggested. As such, the WHO issued follow-up recommendations,
which listed dolutegravir as the preferred first-line and second-line treatment for all populations, including pregnant women.
Now, for the first time, investigators with the CDC have linked data from HIV and birth defect surveillance programs in order to determine estimations of the prevalence of birth defects among infants born to women with HIV.
For the study, the investigators assessed data on NTD prevalence overall and in infants born to women living with HIV across 15 jurisdictions from 2013-17. This 5-year period was selected in order to gather data following dolutegravir’s approval in the United States in 2013.
The investigators divided the number of pregnancies with reported NTDs by the total number of live births during the study period to calculate total population prevalence estimates for NTDs. The team used the number of live births during the study period among women diagnosed with HIV.
Among more than 8 million live births from the 15 jurisdictions during the study period, the prevalence of NTDS was 5.8 per 10,000 live births. The investigators report that the prevalence of NTDs in pregnancies among women with diagnosed HIV infection was 7.0 per 10,000 live births, which was similar to that among the general population.
“Although no difference in NTD prevalence in HIV-exposed pregnancies was found, data on the sue of integrase strand transfer inhibitors in pregnancy are needed to understand the safety and risks of these drugs during pregnancy,” the authors write.
The authors of the report indicate that the findings are subject to several limitations. These limitations include that birth defect surveillance may be incomplete due to variety between methods used in respective jurisdictions. The team also notes that linking data from 2 separate surveillance programs is never 100% accurate and could have led to the underestimation of total births and NTDs. The authors also write that data limitations inhibited adjusting for confounders and that confidence intervals were used to determine statistical difference.
“Because data on pregnancy and ongoing antiretroviral medication use are not routinely collected in many state HIV surveillance programs, and HIV treatment options are evolving, continued efforts to collect information on pregnancies affected by maternal HIV infection are needed to understand the association between HIV treatment and birth defects and other pregnancy outcomes,” the authors write.
The study team also indicates that linking data from other surveillance programs could be beneficial to assess potential associations between use of medications at conception and pregnancy outcomes.
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