1. In an observational study across hospitals in Botswana, women with HIV infection had higher rates of adverse birth outcomes than uninfected women. Women who were on antiretroviral therapy (ART) from conception onward had worse birth outcomes than those that started ART after conception.
2. The tenofovir disoproxil fumarate, emtricitabine, and efavirenz (TDF-FTC-EFV) regimen was linked to the lowest rate of adverse birth outcomes than any other ART regimen.
Evidence Rating Level: 2 (Good)
Study Rundown: All people with HIV infection are recommended to be on three-drug ART therapy according to World Health Organization guidelines. Women with HIV infection who become pregnant are recommended to continue ART due to concerns of vertical transmission to the fetus. There are concerns that certain agents may have adverse effects on the placenta or developing fetus. The comparative safety of different 3 drug regimens has not been examined. The current study examined all births from 8 government hospitals in Botswana to examine the correlation between different ART regimens and adverse birth outcomes including small for gestational age, preterm delivery, and neonatal death. The study found that HIV infected women had greater rates of adverse outcomes and these were more common for women on ART at time of conception. Of all the drug regimens studied, the TDF-FTC-EFV combination had the lowest rate of adverse birth outcomes.
The study brings attention to the issue of iatrogenic birth complications from ART, and offers some insight into what agents in particular may be more harmful. The study was large in size and offered complete data on adverse birth outcomes at these hospitals. The observational nature of the study can be a source of bias due to the lower numbers of women on certain drug regimens, and lack of data on CD4 counts and other important clinical variables.
In-Depth [retrospective cohort]: This study included all women who delivered at one of 8 government hospitals in Botswana from August 15, 2014 to August 15, 2016. Women were excluded if data on birth outcomes or HIV status were unavailable. Only those that were on ART from the time of conception were included in the final analysis. Primary outcome was combined endpoint of stillbirth, neonatal death (within 28 days of birth), preterm birth (<37 weeks), and small for gestational age (SGA, below 10th percentile).
Of the 47 124 births during this time period, 11 932 were HIV exposed with 5,780 on ART from conception. Adverse birth outcomes were more common in the HIV exposed population (39.6%vs 28.9%; ARR, 1.40; 95%CI, 1.36-1.44), and those on ART from conception had higher rates of SGA (22.6% vs. 18.8%), and neonatal deaths (1.7% vs. 1.3%). Compared to those on TDF-FTC-EFV, adverse birth events were higher for women on TDF-FTC-NVP (ARR, 1.15; 95%CI, 1.04-1.27), TDF-FTC–LPV-R (ARR, 1.31; 95%CI, 1.13-1.52), ZDV-3TC-NVP (ARR, 1.30; 95%CI, 1.20-1.41), or ZDV-3TC–LPV-R (ARR, 1.21; 95%CI, 1.01-1.45).
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