English Medical Medical: Pharmaceuticals

The United States Food and Drug Administration and European Medicines Agency advise against using EFV in the first trimester and in women of childbearing potential unless the potential benefits outweigh the potential risks; however, the British HIV Association recently changed its recommendation to allow EFV to be used in the first trimester (143). Because the risk of neural tube defects is limited to the first five to six weeks of pregnancy and because pregnancy is rarely recognized this early, especially in resource-limited settings, any potential risk of neural tube defects with the use of EFV would be primarily in women who become pregnant while already receiving EFV. Evaluation of prospectively collected data in humans is reassuring ; an updated systematic review and meta-analysis, including the Antiretroviral Pregnancy Registry (47,134), reported outcomes for 1502 live births to women receiving EFV in the first trimester and found no increase in overall birth defects and no elevated signal for EFV compared with other ARV exposure in pregnancy (140). With one identified neural tube defect, the estimated prevalence from the systematic review continues to be about 7 per 10 000 population (0.07%), which is comparable to the estimates of 0.02–0.2% in the general population in the USA (138).

http://www.who.int/hiv/pub/guidelines/arv2013/art/artpregnan...

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