The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial identified potential safety concerns for using tenofovir disoproxil fumarate, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r) in pregnant women. Infants were more than twice as likely to be born prematurely and were more likely to die within 14 days after delivery.
Using data from the Surveillance Monitoring for ART Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study (PHACS) and the P1025 study of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, an analysis was performed to further examine these potential risks.
According to the primary analysis:
“There were 10 recorded fetal losses: 2 (1.6%) among women who received TDF–FTC–LPV/r as their first regimen during pregnancy, 2 (0.4%) among those receiving TDF–FTC–ATV/r, and 6 (0.6%) among those receiving ZDV–3TC–LPV/r. One infant each in the TDF–FTC–ATV/r and ZDV–3TC–LPV/r groups died within 14 days after delivery (0.2% and 0.1%, respectively); in both cases, the cause of death was extreme prematurity. Across the regimens, the risk of preterm birth ranged from 16.1 to 21.4%, the risk of low birth weight ranged from 16.2 to 23.8%, and the risk of any adverse outcome ranged from 23.7 to 28.1.”
The study found the risk of adverse birth outcomes was not higher with TDF-FTC-LPV/r than with ZDV-3TC-LPV/r or TDF-FTC-ATV/r.