*EPF211 04/02/2002
Text: USAID Reaffirms Nevirapine Use to Prevent HIV transmission
(Aid agency will continue to provide drug to pregnant mothers) (570)

The U.S. Agency for International Development (USAID) announced April 1 that it will continue to provide the drug nevirapine to prevent transmission of the HIV virus from infected pregnant mothers to their infants. The agency is providing support for programs in which pregnant women are receiving the drug in six nations.

The USAID statement follows a March 22 announcement from the U.S. National Institute of Allergies and Infectious Diseases (NIAID) that reaffirms earlier findings that the drug is safe and effective for prevention of mother-to-child transmission (MTCT), especially in situations where resources and prenatal care are limited. NIAID conducted a successful trial of nevirapine for this use in Uganda in 1997-1999, a trial identified as HIVNET 012.

A NIAID fact sheet issued March 29 summarizes the findings:

"Reduction of MTCT by a safe and effective regimen that is both easy to use and affordable represents a major public health advance for regions in which most people do not have access to expensive antiretroviral drugs or continuous medical care. The simple dosage schedule and low cost of nevirapine may make it suitable for use in a variety of countries and health care settings. NIH supports the use of single-dose nevirapine as a component of MTCT prevention programs."

A complete explanation of the NIAID findings is available at
http://usinfo.state.gov/topical/global/hiv/02032901.htm

Following is the text of the USAID press release:

(begin text)

THE UNITED STATES AGENCY FOR INTERNATIONAL DEVELOPMENT

Statement on the National Institutes for Allergies and Infectious Diseases (NIAID) Review of HIVNET 012

PRESS RELEASE

WASHINGTON, DC 20523

April 1, 2002

Washington, DC -- On Friday, March 22, the National Institutes for Allergies and Infectious Diseases (NIAID) released information regarding the clinical trial HIVNET 012. This trial, conducted in Uganda, demonstrated the safety and effectiveness of single-dose Nevirapine for the prevention of mother-to-child transmission of HIV. During a review of the study, NIAID found that some of the study's data collection did not conform to Food and Drug Administration reporting requirements.

The U.S. Agency for International Development supports the National Institutes for Allergies and Infectious Diseases' (NIAID) conclusion that this in no way negates the scientific findings of HIVNET 012. In this and other trials, Nevirapine has been shown to be safe and effective in preventing the transmission of HIV from mother to infant. Therefore, USAID reaffirms its support for the use of Nevirapine to prevent mother to child transmission of HIV and is pleased that the manufacturer, Boehringer Ingelheim, will continue to donate Nevirapine for this purpose.

USAID provides direct support to ten programs to prevent mother to child transmission of HIV in Kenya, Zambia, Rwanda, and Ukraine; and provides indirect support to other sites in Uganda and South Africa. Many of these sites use Nevirapine and will continue to do so.

Last year, 800,000 infants were born with HIV infection, making this the second most common cause of all new HIV infections. The use of Nevirapine is a simple and effective method to prevent these infections has brought hope to millions of people around the world. USAID remains committed to providing access to this intervention in developing countries.

USAID has spent more than $2 billion in the fight against the pandemic. For more information on USAID's HIV/AIDS programs see: http://www.usaid.gov/pop_health/aids/index.html.

(end text)

(Distributed by the Office of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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