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HIV infection continues to be a worldwide public health problem. After the introduction of effective preventive measures, perinatal transmission dramatically decreased. Our aim was to assess the sociodemographic changes in pregnant women living with HIV infection and trends in perinatal transmission rates over time.The Madrid cohort of HIV-infected mother-infant pairs is a multicenter, prospective, observational, and cohort study that collects information on HIV-infected pregnant women and their children.Information on clinical-epidemiological characteristics of HIV-infected pregnant women until delivery and their children from 9 public hospitals was included. Data were collected from a standardized questionnaire from medical records. The results were classified in 3 periods: period 1 (P1) 2000-2006, period 2 (P2) 2007-2013, and period 3 (P3) 2014-2020.A total of 1521 women living with HIV and 1548 newborns were included. In P1, most mothers (75.8%) were Spanish, whereas in P2 and P3 there was a predominance of foreign origin [62.8% and 70.5% respectively ( P0.01)]. The percentage of women with antiretroviral treatment before pregnancy increased significantly in P3 ( P0.01). The proportion of Caesarean sections decreased over time ( P0.01): 66.2% (n = 472) in P1, 54.9% (n = 245) in P2, and 46.7% (n = 141) in P3. The percentage of preterm and low birth weight newborns showed a statistically significant decrease. Even though there were no statistically significant differences ( P = 0.154), a decrease in cases of perinatal infection was observed (1.6% in P1, 1.3% in P2 and 0.3% in P3).The epidemiologic characteristics of pregnant women with HIV infection have changed over time in our setting, with an increase of non-Caucasian, heterosexual, and perinatally infected mothers. Although there are still perinatal infections, especially in vulnerable populations such as immigrant women, transmission rate has markedly decreased in recent years and is still of major concern. Prevention measures should be reinforced in the most socially disadvantaged groups.

Perinatal transmission of HIV has dramatically decreased in high-income countries in the last few years with current rates below 1%, but it still occurs in high-risk situations, mainly pregnant women with late diagnosis of infection, poor antiretroviral adherence and a high viral load (VL). In these high-risk situations, many providers recommend combined neonatal prophylaxis (CNP). Our aim was to evaluate the safety and toxicity of CNP in infants deemed at high-risk of HIV infection among mother-infant pairs in the Madrid Cohort.Prospective, multicenter, observational cohort study between years 2000 and 2019. The subgroup of newborns on CNP and their mothers were retrospectively selected (cohort A) and compared with those who received monotherapy with zidovudine (cohort B). Infants with monotherapy were classified according to treatment regimes in long (6 weeks) and short (4 weeks) course.We identified 227 newborns (33.3% preterm and 7 sets of twins) with CNP. A maternal diagnosis of HIV-1 infection was established during the current pregnancy in 72 cases (36.4%) and intrapartum or postpartum in 31 cases (15.7%). Most infants received triple combination antiretroviral therapy (65.6%; n = 149). The perinatal transmission rate in cohort A was 3.5% (95% confidence interval: 1.13%-5.92%). Infants from cohort A developed anemia (26.1% vs. 19.4%, P = 0.14) and neutropenia more frequently at 50-120 days (21.4% vs. 10.9%, P0.01), without significant differences in grade 3 and 4 anemia or neutropenia between the two cohorts. There were no differences in increased alanine aminotransferase. Neutropenia was more common in the long zidovudine regimes.Our findings provide further evidence of the safety of CNP in infants with high-risk of HIV-1 perinatal transmission.

Background: Minimizing the time to achieve complete suppression of HIV replication, is critical in pregnancy to decrease the risk of mother-to-child transmission (MTCT). Integrase inhibitors(INSTIs) are characterized by a rapid drop in viral load (VL) and a good transplacental penetration. Our objective was to determine the effectiveness of INSTIs in MTCT and present the experience in the Madrid Cohort of HIV infected mothers-infant pairs. Methods: Paired cohorts, multicentric and observational study, that includes retrospectively the cohort of pregnant women exposed to INSTIs during pregnancy and their infants (Cohort A) from 2000 to 2017, and another cohort of mothers without INSTIs treatment and their children matched by year of birth +/- one year (Cohort B). Maternal demographic, clinical and analytical characteristics were recorded. The follow-up of children was included. Results: 67 pregnant women exposed to INSTIs from Madrid cohort (n:1423) and their children were identified. Another group of 67 pregnant women without INSTI treatment were selected. Both groups were similar in maternal age, ethnicity and route of transmission. The percentage of pregnant women with detectable VL at the first trimester was statistically higher (p

Background The risk of HIV-1 mother-to-child transmission (MTCT) is associated mainly with the gestational age at which antiretroviral therapy (AT) begins and HIV-1-RNA viral load (VL) at delivery. The importance of achieving virological supression during pregnancy, has led to an increased use of integrase inhibitors (INIs) in risky conditions. Our objective was to assess the safety and effectiveness in Madrid-Cohort of mothers-children exposed to INIs during pregnancy. Methods Retrospective, multicentric, observational, cohort study, of HIV-1-infected pregnant women exposed to INIs during pregnancy and their infants, from 2000 to 2017, from the nine public hospitals belonging to the Madrid Cohort. Maternal demographic characteristics, clinical data, HIV-1 infection features, AT regimens and changes of treatment during pregnancy were recorded. Blood count, biochemistry panel, HIV-1 VL and CD4+ lymphocyte counts/percentage at first trimester and at the last one near delivery were also collected. Results Sixty seven pregnant women exposed to INIs from the Madrid cohort (n: 1423) and their 68 children were identified (17.6% premature). Neonatal prophylaxis consited mostly on zidovudine (AZT) monotherapy, followed by combined prophylaxis with ‘triple therapy’. There were no cases of MTCT. Twenty women were diagnosed with HIV-1 in the current pregnancy. Of 43 women with AT before pregnancy, 65% received INI before conception. Raltegravir was the most commonly used (80.5%). The median lenght with INI at delivery was 148 days [interquartile rang (IR): 29-251]. Median CD4+ lymphocyte count increased from 428 cells/mL (IR: 310-642) in first trimester to 636 cells/mL (IR: 408-818) in the third. There was a statistically significant increase (p=0.02) of mothers with undetectable VL at delivery compared with first trimester. INIs were well tolerated, without any relevant adverse effect notification. There was no case of discontinued medication due to intolerance or toxicity. 11,7% of children had minor birth defects and one patient had ventricular septal defect without hemodynamic compromise. All of them evolved favourably. Conclusions INI seems safe and effective in prevention of MTCT. Antiretroviral regimens during pregnancy that include INI are increasingly being used. Our findings support the use of INI as intensification in pregnant women at high risk of MTCT.