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Analysis Shows Efavirenz Teratogenicity Very Low in Pregnant Women With HIV: Presented at AIDS 2010 By Evelyn Harvey VIENNA -- July 23, 2010 -- Efavirenz is a component of first-line highly active antiretroviral therapy (HAART) regimens globally, but there are concerns over potential teratogenic effects if taken during pregnancy. Advice on the use of efavirenz in pregnant women with HIV is unclear and conflicting, from national and international guidelines to drug labels, and clinicians have limited data on which to base their treatment decisions. A new meta-analysis of published studies and unpublished cohort and registry data suggests that any risk is likely to be very low, and must be balanced against the adverse effects of discontinuing HAART or terminating the pregnancy. The results were presented on July 21 here at the 18th International AIDS Conference by Nathan Ford, MD, Medecins Sans Frontieres, and the University of Cape Town, Cape Town, South Africa. Dr. Ford and colleagues conducted a systematic review of publication databases and conference abstracts. The Antiretroviral Pregnancy Registry and several large ongoing cohort studies of antiretrovirals were approached for data relating to efavirenz use. Data from 16 studies, involving over 10,000 pregnancies overall, were examined. Birth defects of any kind, in efavirenz versus non-efavirenz treated women, were the study's primary endpoint. Secondary endpoints included spontaneous abortions, terminations of pregnancy, stillbirths, and premature delivery. Analyses of first trimester versus second or third trimester use of efavirenz were also undertaken. A pooled risk ratio for birth defects with efavirenz use of 0.85 (P = .47) was calculated, which rules out a high risk of birth defects associated with efavirenz. Out of 1,301 births, 1 neural tube abnormality occurred, in an efavirenz-treated case, giving an overall prevalence of 0.08%, which is within normal population levels. Stillbirth, premature delivery, and spontaneous abortion rates were similar to background rates in efavirenz-treated women. There was also no difference in the occurrence of birth rates with the timing of efavirenz treatment. In some studies, the rates of termination were very high (up to 33%), which Dr. Ford attributed to fears over efavirenz use in pregnancy and a lack of counselling. "We can't rule out any risk associated with efavirenz use in pregnancy," concluded Dr. Ford. "But we know that the absolute risk of neural tube defects would be very small, compared with valproate -- where a 10-fold risk is proven." Attendees welcomed the findings, but some took issue with Dr. Ford's suggestion of a link between efavirenz use and higher rates of selective terminations. [Presentation title: Safety of Efavirenz in First-Trimester of Pregnancy: A Systematic Review and Meta-Analysis of Outcomes From Observational Cohorts. Abstract WEAX0102] E-mail this page to a friend or colleague! To print, use this version