Birth defects in a national cohort of pregnant women with HIV infection in Italy, 2001–2011

Abstract

Objective We used data from a national study of pregnant women with HIV to evaluate the prevalence of congenital abnormalities in newborns from women with HIV infection.Design Observational study.Setting University and hospital clinics.Population Pregnant women with HIV exposed to antiretroviral treatment at any time during pregnancy.Methods The total prevalence of birth defects was assessed on live births, stillbirths, and elective terminations for fetal anomaly. The associations between potentially predictive variables and the occurrence of birth defects were expressed as odds ratios (ORs) with 95% confidence intervals (95% CIs) for exposed versus unexposed cases, calculated in univariate and multivariate logistic regression analyses.Main outcome measures Birth defects, defined according to the Antiretroviral Pregnancy Registry criteria.Results A total of 1257 pregnancies with exposure at any time to antiretroviral therapy were evaluated. Forty-two cases with major defects were observed. The total prevalence was 3.2% (95% CI 1.9-4.5) for exposure to any antiretroviral drug during the first trimester (23 cases with defects) and 3.4% (95% CI 1.9-4.9) for no antiretroviral exposure during the first trimester (19 cases). No associations were found between major birth defects and firsttrimester exposure to any antiretroviral treatment (OR 0.94, 95% CI 0.51-1.75), main drug classes (nucleoside reverse transcriptase inhibitors, OR 0.95, 95% CI 0.51-1.76; non-nucleoside reverse transcriptase inhibitors, OR 1.20, 95% CI 0.56-2.55; protease inhibitors, OR 0.92, 95% CI 0.43-1.95), and individual drugs, including efavirenz (prevalence for efavirenz, 2.5%).Conclusions This study adds further support to the assumption that first-trimester exposure to antiretroviral treatment does not increase the risk of congenital abnormalities.

Congenital Anomalies and In Utero Antiretroviral Exposure in Human Immunodeficiency Virus–Exposed Uninfected Infants

“…We observed an overall prevalence of 6.78 CAs for every 100 live births, which is considerably higher than many prior studies of HIV-exposed infants in the U.S. and the U.K, with reported prevalences ranging from 2.8% to 5.5% 4–7, 12,13 and higher than the rate of 3.2% in a recent Italian cohort, 10 but is similar to the 6.2% rate reported by a Latin American study. 27 We observed an increasing trend in the rate of CAs from prior to 2002 through 2010, followed by a slight decline through 2012.…”

Prevalence of non-HIV cancer risk factors in persons living with HIV/AIDS

“…Twenty-six publications reported HBV infection prevalence [63, 65, 69, 71, 79-81, 89, 102, 106, 110, 123, 141, 144, 147, 150, 151, 154, 157, 159, 162, 165, 170, 172, 174, 175]. HBV infection was defined in 72% of individual studies as positive by HBV surface antigen test (see Supplemental Table S7 for all definitions).…”

The global burden of oral diseases in pediatric HIV‐infected populations: a workshop report

“…Congenital defects were slightly higher in children born from mothers who started ARVs in the first trimester (1.7–4.5%) (Watts et al , ; APR, ) compared to those who were exposed only in the second/third trimester (1.2–3.8%) (Patel et al , ; Watts et al , ). Moreover, the results of a 10‐year Italian study showed that ARV drug first‐trimester exposure did not increase the risk of congenital abnormalities (Floridia et al , ). One of the best tools currently available to register child outcomes of ARVs during pregnancy is the Antiretroviral Pregnancy Registry (APR) (APR, ), a prospective exposure‐registration cohort study.…”