Introduction Significant progress of ART in HIV infection has led to a remarkable decline in mother-to-child transmission (MTCT) of HIV. However, the use of complex regimens can cause side effects to women and exposed children.The objective of this study was to evaluate side effects in pregnant women and their neonates exposed to ART at an universitary hospital in Brazil between 2000 and 2016.

Methods Cohort study of 793 pregnant women and 787 newborns selected from clinical records and epidemiologic surveillance system. Analysis was performed through proportions and medians. The specific effect of different ART regimens was analysed through risk ratios (RR), qui-square test, Fisher’s exact test, student t test, Mann-Whitney test, 95% confidence interval and level of significance of 0.05.

Results MTCT rate was 2.3%. Mean age was 28 years, more than 60% were White and diagnosed before pregnancy. HAART use: 17.4% with nevirapine (NVP), 16.9% with nelfinavir (NFV), 53.2% with lopinavir/ritonavir (LPV/R), 4.3% with other PI (26 with atazanavir/ritonavir). Only 1.9% women did not use ART by late diagnosis. There were: 56% cases of maternal anaemia,14.1% of thrombocytopenia, 54.5% of hepatic abnormalities, 2.7% of allergic reactions, 82% of dyslipidemia, 6.2% of diabetes. NVP use was associated to hepatotoxicity, allergic reactions and anaemia. NFV was associated to hepatic impairment and allergic reaction, ATV/R use was associated to bilirrubin increase, and LPV/R to dyslipidemia.Prematurity rate was 21.7% and low birth weight rate 22.5%. In the newborns: 25.7% of anaemia, 3.6% of thrombocytopenia, 36% of hepatic impairment. Congenital anomalies were presented in 10%. NVP use associated to anaemia and hepatic impairment. NFV was associated to hepatic abnormalities. ATV/R was associated to thrombocytopenia.

Conclusion Although growing evidence indicates that antiretroviral treatment in pregnancy has overall a very favourable risk-benefit profile, it is important to maintain monitoring of the safety and efficacy of drug classes in order to optimise treatment recommendations.