Antiretroviral pregnancy registry: dolutegravir update
Antiretroviral pregnancy registry (APR) data do not demonstrate an increased risk of overall birth defects with dolutegravir (DTG) use above the expected population rate. [1, 2]
And, although one neural tube defect (NTD) is reported in this data set, the denominator is too small to draw any conclusions about an association between periconception DTG and NTDs.
These findings were presented at EACS 2019 and are also described in the most recent version of the APR interim report.
By 31 July 2019, 667 pregnancies with exposure to DTG were prospectively reported to APR: 357 periconception (2 weeks before through 28 days after conception) exposures, 67 later during the first trimester, and 243 during the second/third trimesters.
Median maternal age at conception was 29 years; just over 60% of women were black and approximately 80% were from the United States. At enrollment over 80% had CD4 count greater than 200 cells/mm3.
Among the 667 DTG exposed pregnancies there were 614 live singleton births: 312 with periconception exposure, 63later during the first trimester, and 239 during the second/third trimesters.
There were 21/614 defects overall: prevalence 3.4% (95% CI 2.1 to 5.2). With periconception exposure there were 10/312 defects: prevalence 3.2% (95% CI 1.6 to 5.8). Defect prevalence for later first trimester and second/third trimester were both similar.
These data do not show a risk of overall defects above the population expected rate of defects: 2.72 and 4.17/100 live births from Metropolitan Atlanta Congenital Defects Program (MACDP)and Texas Birth Defects Registry (TBDR) respectively.
There was 1/312 neural tube defect (NTD) case of anencephaly with periconception DTG exposure.
The next interim APR report will include data through 31 January 2020.
Although 1/312 gives an NTD prevalence of 0.3%, similar to data from the Tsepamo study in Botswana, the number of periconception outcomes is not sufficient (2000 needed to rule out a 3-fold increase) to refute or confirm an association between DTG and NTD.
- et al. – Dolutegravir (DTG) use during pregnancy and birth outcomes: data from the Antiretroviral Pregnancy Registry (APR). 17th European AIDS Conference (EACS). Basel, Switzerland. 6–9 November, 2019. Oral abstract PS1/2.
- Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry Interim Report for 1 January 1989 through 31 July 2019.