Text: UN Health Agencies Reaffirm Value of Drug to Prevent HIV Transmission

26 March 2002

Text: UN Health Agencies Reaffirm Value of Drug to Prevent HIV Transmission

WHO, UNAIDS repeat endorsements of nevirapine for HIV mothers, infants

The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS (UNAIDS) are reaffirming their earlier endorsement of the drug nevirapine for prevention of transmission of the HIV/AIDS virus from pregnant mothers to their newborns.

Estimates indicate that 600,000 infants become infected by HIV-positive mothers each year. The WHO-UNAIDS statement says proper use of nevirapine is an effective way to prevent that transmission and keep the babies healthy.

The statement comes in the aftermath of an announcement from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) about a trial of the drug in Uganda. NIAID reports that some record-keeping irregularities occurred in that trial, but the effectiveness of the drug itself is still assured.

Following is the text of the WHO-UNAIDS statement:

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WORLD HEALTH ORGANIZATION
JOINT UNITED NATIONS PROGRAM ON HIV/AIDS

WHO AND UNAIDS CONTINUE TO SUPPORT USE OF NEVIRAPINE FOR PREVENTION OF MOTHER-TO-CHILD HIV TRANSMISSION

Geneva, 22 March 2002 - The statement released today by the United States National Institutes of Health (NIH), concerning some reporting and documentation irregularities in clinical trial HIVNET012, does not warrant any change in the recommendations issued following 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 emphasized that, according to available information, there has been no evidence the scientific data from the HIVNET012 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 the UNAIDS Secretariat 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. We are aware of no information that would cause the WHO and UNAIDS to change its recommendations.

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