According to results of an observational surveillance study, the combination of tenofovir disoproxil fumarate, emtricitabine, and efavirenz (TDF-FTC-EFV) was associated with the lowest risk of adverse birth outcomes compared to other antiretroviral treatment (ART) options in infants exposed to ART from conception.
To determine the risk of adverse birth outcomes associated with maternal use of different ART therapies, data was collected between August 2014 and August 2016 from 8 government hospitals throughout Botswana. Both live birth and stillbirth (gestational age of ≥24 weeks) data were included in the study. The study authors noted that births were considered “ART exposed” if maternal use of the 3-drug regimen was initiated before the patient’s last menstrual period and was not discontinued or switched to another therapy during pregnancy.
The primary endpoint of the study was any adverse birth outcome, which included “stillbirth, preterm birth (<37 weeks), small size for gestational age (SGA; <10th percentile of weight for gestational age) or neonatal death (<28 days from delivery), and any severe adverse outcome, including very preterm birth (<32 weeks), very SGA (<3rd percentile of weight for gestational age), stillbirth, and neonatal death.”
The study authors reported that of the 11,932 infants exposed to HIV, 5780 (48.4%) of them were considered ART exposed from conception. Additionally, 39.6% of HIV-exposed infants experienced adverse birth outcomes compared to 28.9% of HIV-unexposed infants (adjusted relative risk [ARR]: 1.40; 95% CI: 1.36, 1.44).
Results of the study found that the risk for any adverse birth outcome was 36.4% in infants exposed to TDF-FTC-EFV (901/2472) compared to 41.7% for TDF-FTC and nevirapine (NVP) (317/760; ARR: 1.15; 95% CI: 1.04, 1.27), 48.5% for TDF-FTC and lopinavir-ritonavir (TDF-FTC–LPV-R) (112/231; ARR: 1.31; 95% CI: 1.13, 1.52), 47.4% for zidovudine, lamivudine, and NPV (ZDV-3TC-NVP) (647/1365; ARR: 1.30; 95% CI: 1.20, 1.41), and 44.9% for ZDV-3TC–LPV-R (75/167; ARR: 1.21; 95% CI: 1.01, 1.45).
Additionally, it was found that the risk for any severe adverse outcome was 12.3% for infants exposed to TDF-FTC-EFV (303/2472) from conception compared to 17.9% for infants exposed to TDF-FTC-NVP (136/760; ARR: 1.44; 95% CI: 1.19, 1.74), 19.5% for TDF-FTC–LPV-R (45/231; ARR: 1.58; 95% CI: 1.19, 2.11), 20.7% for ZDV-3TC-NVP (283/1365; ARR: 1.68; 95% CI: 1.44, 1.96), and 23.4% for ZDV-3TC–LPV-R (39/167; ARR: 1.93; 95% CI: 1.43, 2.60).
The study authors added, “compared with TDF-FTC-EFV, all other regimens were associated with higher risk for SGA; ZDV-3TC-NVP was associated with higher risk of stillbirth, very preterm birth, and neonatal death; and ZDV-3TC-LPV-R was associated with higher risk for preterm birth, very preterm birth, and neonatal death.”
In infants exposed to different ART regimens from conception, TDF-FTC-EFV was found to be associated with the lowest risk of adverse birth outcomes.
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