December 14, 2004

STATEMENT

The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV

In 1997, a clinical trial known as HIVNET 012 was begun in Uganda to address the developing world’s urgent need for safe, effective and affordable regimens to prevent mother-to-infant transmission of HIV. The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and conducted by co-investigators from The Johns Hopkins University and Makerere University in Kampala, Uganda.

The purpose of HIVNET 012 was to examine whether a simple, inexpensive regimen of the drug nevirapine could effectively block mother-to-infant HIV transmission. In the study, both mother and baby were treated with a single dose of nevirapine, a drug licensed for the treatment of HIV-infected adults and children in the United States.

The researchers found that this intervention reduced the risk of mother-to-infant HIV transmission by approximately 50 percent.  The results of this landmark study were published in The Lancet in 1999. The HIVNET 012 nevirapine regimen subsequently has been endorsed by the World Health Organization (WHO), the Joint United Nations Programme on AIDS (UNAIDS) and other international organizations. NIAID stands by the accuracy of the results of HIVNET 012.

The simple and cost-effective nevirapine regimen has been used in developing countries to prevent HIV infection in thousands of infants; it represents a major public health advance and is one of the true success stories in HIV prevention.

The results of HIVNET 012, including the safety and effectiveness of the nevirapine regimen, have been subjected to multiple reviews. In every instance, the initial conclusions of the HIVNET 012 investigators have been found to be correct. In addition, findings of other studies conducted in the United States and internationally have consistently supported the results of HIVNET 012.

Because of the striking results of HIVNET 012, in 2001 the manufacturer of nevirapine decided to apply to the U.S. Food and Drug Administration (FDA) for an expanded indication for nevirapine in the United States to include use of the drug to prevent mother-to-infant transmission of HIV. As part of the evaluation of the HIVNET 012 trial for this new indication, the conclusions of HIVNET 012 were re-affirmed as valid. Certain aspects of the collection of some of the primary data, however, did not strictly conform to FDA regulatory requirements.  For this reason, the study could not serve as a single pivotal trial leading to an expanded indication.

As noted above, NIAID and NIH initiated several reviews and re-reviews of HIVNET 012. These reviews identified procedural flaws in the study that led NIAID to implement improvements in the conduct of clinical research it supports both in the United States and abroad. We understand that certain previously recognized criticisms of the conduct of HIVNET 012 have re-emerged, but stress strongly that throughout multiple reviews, the overall conclusions regarding the safety and efficacy of single-dose nevirapine in this setting have remained intact.

Moreover, NIH has contracted the Institute of Medicine (IOM), part of the National Academy of Sciences, to conduct an additional independent review of HIVNET 012. The results of the IOM review are anticipated in March 2005. NIAID is confident that the previous conclusions regarding the integrity of the HIVNET 012 data will be upheld.

The reduction of perinatal HIV transmission by the use of the readily accessible, inexpensive nevirapine regimen studied by the HIVNET 012 investigators represents a major public health advance for developing countries. No new data exist to suggest that current recommendations regarding use of this regimen should be changed, and we urge clinicians and policymakers to continue to heed the current WHO and UNAIDS guidance on single-dose nevirapine.

Please see Questions and Answers: The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV for more information.

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Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Media inquires can be directed to the NIAID OCPL media group at 301-402-1663.

Prepared by:
Office of Communications and Public Liaison
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892

U.S. Department of Health and Human Services

NIAID is a component of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.

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