PA-410 Adverse pregnancy and birth outcomes of DTG-based ART regimen roll-out in Ethiopia. A retrospective multicenter cohort study

Résumé fourni par la source

Background Dolutegravir (DTG) containing antiretroviral regimen (ART) has been rollout for pregnant and breastfeeding women in Ethiopia since April 2020. However, no data was reported on the new regimen’s pregnancy and birth outcome safety. Methods A retrospective cohort study was conducted in 14 hospitals across Ethiopia. Data were collected from the routine prevention of mother-to-child HIV transmission recording charts and participant medical charts. Eligible participants were HIV Positive pregnant women enrolled in the PMTCT care and later their infants. The primary outcomes were any adverse pregnancy outcome (abortion, intrauterine fetal death, preterm birth, and maternal death) and any adverse birth outcome (stillbirth, early neonatal death, low birth weight, infant death). Results A total of 2653 pregnant women enrolled in the PMTCT care. Among these, 38 (1.5%) of the pregnancies end up with abortion, 10 (0.4%) intrauterine fetal death and 20 (0.8%) gave birth to a dead fetus. Among the live births, 5 (0.2%) newborns died before one month of age, and 8 (0.4%) died after one month. There were two maternal deaths, one before and one after birth, due to obstetric complications. 87(4.9%) and 80(4.7%) of the women gave birth before 37 weeks of gestation and <2500 gm birth weight, respectively. 55.6% and 29.3% of the women used DTG and efavirenz-containing ART regimens for PMTCT, respectively. The remaining 15.1% used other ART regimens. The rate of adverse pregnancy outcome was significantly lower (p<0.002) among women who received a DTG-based ART regimen (2.2%) than efavirenz based (4.7%) or other ART regimens (9.4%). The rate of adverse birth outcome was lowest (p=0.059) for DTG (4.7%) compared to efavirenz- based (5.1%) or other ART regimens (6.5%). Conclusion DTG-containing ART regimens for pregnant women has a better pregnancy and birth outcome safety profile than efavirenz-based or other ART regimens.

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