Project Paper on Risk of Birth Defects Associated with in Utero Exposure to Antiretroviral Drugs

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Addis Ababa University


Antiretroviral compounds differ from most other new pharmaceutical agents in that they havebecome widely prescribed in pregnancy in the absence of proof of safety. In this paperantiretroviralagents used in pregnant women infected with humanimmunodeficiency virus and their effects on theinfantsare reviewed.This review gives an overview aboutinvivoandinvitrodevelopmental toxicityand teratogenicity of the anti-AIDS drugs (antiretrovirals),inexperimental animalsandhumans. Animal embryos exposed in vivo to antiretrovirals exhibited significantly increased pregnancylosses, drugs incorporation into the DNA of fetal organs, external abnormalities, skeletal defects,developmental toxicity, carcinogenicity, reduced weight, anemia, deaths and significantmitochondrial damage. The invitroantiretrovirals exposure of animal cells or organs resulted incytotoxicity, growth retardation, chromosomal aberrations, mutations, sister chromatid exchange andother genotoxic effects. Inearlier human studies, management of AIDS positive pregnant womenwith antiretrovirals revealed exposure of their infants to such drugs with evidence of adverse events.However, recent publications present conflicting data about the associations between antiretroviralsand adverse pregnancy outcomes. Because of the increasingly frequent use of highly active antiretroviral therapy during pregnancy,ongoing efforts are needed to monitor any long-term effects of in uteroexposure to themultipleantiretroviral agentsused.



Birth defects, ARV Drugs, HIV, Pregnancy.