WHO, UNAIDS Release Joint Statement Supporting Use of Nevirapine to Prevent Vertical HIV Transmission

The World Health Organization and UNAIDS yesterday released a joint statement supporting the continued use of nevirapine to prevent vertical HIV transmission, despite concerns raised by the U.S. FDA and National Institutes of Health over a study involving the drug, the Associated Press reports (Higgins, Associated Press, 3/26). Drug maker Boehringer-Ingelheim announced Friday that it was withdrawing its FDA application for the right to market nevirapine in the United States after FDA regulators said they uncovered problems with a 1999 study performed in Uganda by Johns Hopkins University researchers. The questions relate to procedure and not the validity of the study, which found that use of the drug during childbirth can reduce HIV transmission (Kaiser Daily HIV/AIDS Report, 3/25). The National Institute of Allergy and Infectious Diseases on Friday also issued a statement citing concerns with the trial, but these concerns also stemmed from data collection methods (NIAID statement, 3/22). In their joint statement, WHO and UNAIDS said that the concerns raised by NIAID and NIH "do not warrant any change in the recommendations issued [by WHO] ... in October 2000" (Associated Press, 3/26). These recommendations, which were drafted by an "expert group," stated that the "safety and effectiveness of antiretroviral regimens, including nevirapine, in preventing mother-to-child HIV transmission has been clearly documented and that the use of these regimens is thus warranted for preventing" vertical transmission. The statement also stressed that "there has been no evidence" that the safety and effectiveness data from the Ugandan study of nevirapine is "invalid" (WHO/UNAIDS statement, 3/22). The statement released by NIAID also said that there has been no evidence to suggest that the Ugandan study conclusions are invalid or that any trial participants were "placed at an increased risk of harm." In its statement, NIAID said that nevirapine represents a "major public health advance in resource-poor settings and ... there is no reason for programs implementing this life-saving regimen to change their practices" (NIAID statement, 3/22).