Prevalence of Congenital Anomalies in Infants With In Utero Exposure to Antiretrovirals

Abstract

Background While use of efficacious interventions, including antiretrovirals (ARVs), has reduced dramatically the rate of mother-to-child transmission (MTCT) of HIV, the safety of in utero ARV exposure remains of concern. Methods Data regarding 1112 infants enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) protocol P1025 born between 2002 and 2007 were analyzed for this study. Congenital anomalies were classified based on the Metropolitan Atlanta Congenital Defects Program (MACDP) guidelines. Associations between congenital anomalies and timing of first in utero exposure to ARVs were evaluated by logistic regression analysis. Results 61 of the 1112 infants had congenital anomalies identified and confirmed, resulting in a prevalence of 5.49/100 live births (95%CI: 4.22–6.99). Among the 80 anomalies identified, the organ systems involved included: cardiovascular (n=33), musculoskeletal (n=15), renal (n=9), genitourinary (n=6), craniofacial (n=4), and central nervous system (n=2). First trimester exposure to efavirenz was associated with a significantly increased risk of congenital anomalies (OR 2.84, 95%CI: 1.13–7.16). No significant associations were observed between exposure to other individual ARVs or classes of ARVs started at any time during pregnancy and infant congenital anomalies. Conclusions The observed rate of congenital anomalies in this cohort is higher than previously reported for the general population, but is consistent with rates observed in other recent studies of children born to HIV-infected women. Cardiovascular anomalies occurred most frequently. With the exception of a known teratogen (efavirenz), no statistically significant associations between in utero exposure to ARVs and congenital anomalies were identified.

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

“…[5][6][7][8][9][17][18][19] The reasons underlying this variability may include the variable definition of birth defects, underreporting, the selective reporting of cases with defects, differential use of diagnostic techniques in the ascertainment of defects, and variable concomitant medication and substance exposure. 19 We also evaluated other potential predictors of birth defects, such as age, recent substance use, time since HIV diagnosis, CD4 cell count, body mass index, and coinfections. Overall, as for other studies in HIV infection, no maternal risk factors for birth defects were identified.…”

Suspectable Risk Factors of Congenital Anomaly in Dr. Hasan Sadikin General Hospital Bandung, Indonesia

“…But, it was also found several medications which might cause congenital anomaly in other studies such as NSAID. 6 NSAID might cause cleft lip, spine anomaly, and others. 6 Antiretroviral consumption might also cause congenital anomaly.…”

“…6 NSAID might cause cleft lip, spine anomaly, and others. 6 Antiretroviral consumption might also cause congenital anomaly. 7 However, there are several medications which might prevent congenital anomaly prevalence, for example, folic acid consumption in pre-conception time.…”

Tolérance pour l’enfant des antirétroviraux durant la grossesse

“…Chez la femme, les données sont encore discordantes : après la description de quelques cas cliniques d'anomalies neurologiques, la méta-analyse d'une série de cohortes et d'un registre déclaratif américain suggère l'absence de risque [10]. Plus récemment, deux cohortes -dont la cohorte EPF-ANRS -démentent toutefois cette analyse et retrouvent un risque significatif [11,12]. Ces doutes doivent être levés rapidement.…”