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Efavirenz is one of the most widely used nonnucleoside reverse transcriptase inhibitors (NNRTIs) in first-line antiretroviral therapy (ART) and is recommended as a preferred option in adult treatment guidelines. However, data from primate studies and some human case reports have raised concern regarding a association of first-trimester efavirenz exposure with central nervous system congenital anomalies. These data resulted in a recommendation by the United States Food and Drug Administration (FDA) in 2005 and the European Medicines Agency (EMEA) to avoid using efavirenz-based regimens in the first trimester of pregnancy.