*EPF306 12/15/2004
Text: Anti-AIDS Drug Nevirapine is Safe, Health Agency Says
(United States to pursue further reviews of side effects of AIDS drug) (1070)
The National Institute for Allergy and Infectious Diseases (NIAID) stands by previous findings that the drug nevirapine is safe and effective when administered to pregnant mothers with HIV/AIDS to protect their newborns from infection.
News reports have raised questions that safety concerns about the drug unveiled in a Uganda clinical trial did not receive proper consideration.
In a statement issued December 14, NIAID, part of the National Institutes of Health, acknowledges that there were certain concerns about the way the Uganda trial was conducted, but stood by the finding that the drug could reduce the risk of mother-to-infant HIV transmission by about 50 percent.
Even though new questions about these concerns have emerged, NIAID re-emphasized that "throughout multiple reviews, the overall conclusions regarding the safety and efficacy of single-dose nevirapine in the setting have remained intact."
The NIAID statement says the agency has contacted the Institute of Medicine, part of the National Academy of Sciences, to conduct another, independent review of the Uganda trial.
At the White House briefing December 14, spokesman Scott McClellan said the administration stands by its decision to support the use of nevirapine in U.S.-backed programs to reduce HIV transmission from mother to child.
"[W]e will always work to improve medicines and treatments on all diseases, and that includes HIV/AIDS," McClellan said. "In the meantime, though, we're pursuing the available treatments that have shown to be effective, and it is something that is approved for use here in the United States of America. And it can have very important, positive effects when it is used in the proper dosage."
The text of the NIH statement follows:
(begin text)
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
NATIONAL INSTITUTES OF HEALTH
[Bethesda, Maryland]
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 Makere 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.
NIAID is a component of the National Institutes of Health, 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.
Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
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
(end text)
(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)
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