BackgroundAntiretroviral therapy (ART) in pregnancy was associated with a drastic reduction in HIV mother-to-child transmission (MTCT), although it was associated with neonatal adverse effects. The aim of this study was to evaluate the neonatal effects to maternal ART.MethodsThis study was a cohort of newborns from HIV pregnant women followed at the CAISM/UNICAMP Obstetric Clinic from 2000 to 2015. The following adverse effects were evaluated: anemia, thrombocytopenia, liver function tests abnormalities, preterm birth, low birth weight and congenital malformation. Data collected from patients’ files was added to a specific database. Descriptive analysis was shown in terms of absolute (n) and relative (%) frequencies and mean, median and standard deviation calculations. The association between variables was tested through Chi-square or Fisher exact test (n < 5) and relative risk (RR) with its respective p values for the categorical ones and t-Student (parametric data) or Mann-Whitney (non-parametric data) for the quantitative ones. The significant level used was 0.05. A multivariate Cox Logistic Regression was done. Statistical analysis was performed using SAS version 9.4.ResultsData from 787 newborns was analyzed. MTCT rate was 2.3%, with 0.8% in the last 5 years. Observed neonatal adverse effects were: liver function tests abnormalities (36%), anemia (25.7%), low birth weight (22.5%), preterm birth (21.7%), children small for gestational age (SGA) (18%), birth defects (10%) and thrombocytopenia (3.6%). In the multivariate analysis, peripartum CD4 higher than 200 cells/mm3 was protective for low birth weight and preterm birth, and C-section was associated with low birth weight, but not with preterm birth. Neonatal anemia was associated with preterm birth and exposure to maternal AZT. Liver function tests abnormalities were associated with detectable peripartum maternal viral load and exposure to nevirapine. No association was found between different ART regimens or timing of exposure with preterm birth, low birth weight or congenital malformation.ConclusionHighly active antiretroviral treatment in pregnant women and viral load control were the main factors associated with MTCT reduction. Antiretroviral use is associated with a high frequency but mainly low severity adverse effects in newborns.

BackgroundAntiretroviral therapy (ART) use in pregnancy presents unquestionable benefits in preventing mother-to-child transmission (MTCT) of HIV although it is associated with maternal adverse effects. The aim of this study was to evaluate the adverse effects of antiretroviral therapy in pregnant women infected with HIV.MethodsCohort study of pregnant women infected with HIV followed at the CAISM/UNICAMP Obstetric Clinic from 2000 to 2015. The following maternal adverse effects were observed: anemia, thrombocytopenia, allergy, liver function test abnormalities, dyslipidemia and diabetes. Data collected from patients’ files was added to a specific database. Descriptive analysis was shown in terms of absolute (n) and relative (%) frequencies and mean, median and standard deviation calculations. Chi-square or Fisher exact test (n < 5) and relative risk (RR) with its respective p values were used for categorical variables and Student t-test (parametric data) or Mann-Whitney (non-parametric data) for the quantitative ones. A 95% confidence interval (CI) and a significant level of 0.05 were used. A multivariate Cox Logistic Regression was also done. Data analysis was conducted using SAS version 9.4.ResultsData from 793 pregnancies were included. MTCT rate was 2.3%, with 0.8% in the last 5 years. Maternal adverse effects were: dyslipidemia (82%), anemia (56%), liver function test abnormalities (54.5%), including hyperbilirubinemia (11.6%), fasting glycemia alteration (19.2%), thrombocytopenia (14.1%), and allergic reaction (2.7%). The majority of adverse effects deemed related to ART in this study were mild according to DAIDS scale. In the multivariate analysis, co-infections and starting ART during pregnancy were risk factors for maternal anemia, while CD4 count higher than 200 cells/mm3 was protective. Nevirapine, nelfinavir and atazanavir regimens increased the risk for liver function tests abnormalities. Lopinavir use during pregnancy increased the risk for fasting glycemia alteration.ConclusionThe evolution of the national guidelines of antiretroviral therapy for pregnant women improved adherence to the treatment and resulted in a significant reduction of MTCT. Despite the high frequency of maternal adverse effects, they are mostly of low severity. Newer ART medications with improved efficacy and significantly more favorable tolerability profiles should reduce the incidence of ART-related adverse effects.

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IntroductionSignificant 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.MethodsCohort 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.ResultsMTCT 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.ConclusionAlthough 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.

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