As stated, the manufacturer of nevirapine has requested the Food and Drug Administration to withdraw the NDA status for the mother-to-child transmission (MTCT) indication of nevirapine.
The World Health Organization and UNAIDS continue to support use of nevirapine for prevention of mother-to child HIV transmission. They consider that a statement released on 22 March 2002 by the United States National Institutes of Health (NIH), concerning some reporting and documentation irregularities in clinical trial HIVNET 012, does not warrant any change in the recommendations issued by a WHO technical consultation on mother-to-child HIV transmission in October 2000.
This expert group, convened by WHO on behalf of UNICEF, UNFPA, and the UNAIDS Secretariat, concluded 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 mother-to-child HIV transmission. The simplest regimen requires a single dose of nevirapine to the mother at delivery and a single dose to the newborn within 72 hours of birth.
The NIH statement (set out below) emphasized that, according to available information, there is no evidence that the scientific data from the HIVNET 012 study demonstrating the safety and effectiveness of nevirapine is invalid. Each year, more than 600 000 infants become infected with HIV, mainly through mother-to-child transmission. WHO and UNAIDS recommend that the prevention of mother-to-child transmission of HIV, including antiretroviral regimens such as nevirapine, should be included in the minimum standard package of care for HIV-positive women and their children.
Reference: Press Release, WHO, Geneva and UNAIDS, Geneva.