Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date. 
Elizabeth Glaser Pediatric AIDS Foundation - February 23, 2005
Recent data and media coverage have prompted concern regarding resistance surrounding the use of single-dose nevirapine to prevent mother-to-child transmission (PMTCT) of HIV/AIDS. Earlier this week, the Elizabeth Glaser Pediatric AIDS Foundation convened a think tank meeting of nearly 40 of the world's leading HIV/AIDS experts to discuss this issue and the future of PMTCT. We strongly believe that PMTCT programs must be guided by the best science available so that 1) we prevent as many infections as possible; 2) safeguard the health of HIV-positive mothers, children and their families; and 3) protect their ability to respond successfully to antiretroviral therapy.
It is important to understand that clinical studies have demonstrated that all antiretroviral drugs are associated with some level of resistance. This is frequently what necessitates change in treatment strategies. A number of studies have raised concerns about resistance from single-dose nevirapine that might preclude the use of nevirapine for later treatment of the mother. The clinical significance of these findings is still unclear, and therefore, this data warrants further study, and the Foundation and others are actively pursuing this question. Preliminary data demonstrates that a post-partum regimen of Combivir (AZT + 3TC) substantially reduces nevirapine resistance. Some sites with appropriate infrastructure and training, and where national policies permit, are considering implementing this regimen to reduce resistance.
In the meantime, we need to provide pregnant women with a range of choices to prevent HIV infections in their infants. At an absolute minimum, all women should have access to single-dose nevirapine, which has been proven safe and effective in numerous clinical trials and in practice at sites around the world. It is essential to preserve single-dose nevirapine as an option when more complex regimens are unavailable. Due to cost and infrastructure limitations, UNAIDS estimates that simple interventions like nevirapine are still available to less than 10 percent of the women who need them worldwide. Therefore, we must continue to aggressively expand access to PMTCT services and improve our ability to offer the most effective drug regimens in all instances.
We must also offer other effective PMTCT regimens to pregnant women, from regimens that supplement single-dose nevirapine to expanded availability of HAART for pregnant women who qualify. More effective drug regimens, including a combination of AZT and single-dose nevirapine and long-term combination therapy for the mother, exist and are already being used at some of our sites and in other parts of the developing world. There are additional healthcare sites that have the infrastructure and wish to offer more complex regimens, but they require additional financial support and/or training to accomplish this. In accordance with the host government's national HIV policies, we must move more rapidly to making more efficacious options available for women.
HAART for mothers who qualify is the most effective PMTCT method of all and has resulted in the virtual elimination of mother-to-child transmission of HIV in the United States and other developed nations. HAART therapy is also well-known to limit resistance, and its availability is expanding rapidly in the developing world with support from the U.S. government, the Global Fund, and other providers. Of course, HAART is also critically important to keep HIV-infected mothers alive.
The Foundation strongly believes that it is essential to save the lives of children and their families. With the proper support and investment, it is absolutely clear that we can do both. The Foundation has proven this point this year by rapidly placing thousands of mothers, children and families on HAART in four African nations. This Thursday, we will report data from our Project HEART program in Lusaka, Zambia, demonstrating rapid scale-up of full care and treatment programs in a challenging developing world setting.
Other EGPAF-funded sites are also moving to implement more effective PMTCT regimens. For example, the EGPAF-funded site at McCordHospital in Durban, South Africa, has implemented a regimen of AZT plus nevirapine for pregnant women who do not qualify for treatment of their own infection based on CD4 count. This site also makes it a priority to place pregnant women who qualify for care on combination therapy.
The participants in the Foundation's scientific Think Tank agreed that we are at a critical moment for PMTCT and care and treatment of mothers and families. Our founder and namesake, Elizabeth Glaser, always insisted that we do as much as possible, as quickly as possible, to eradicate pediatric AIDS and improve care and treatment. At this moment, we have the tools and believe the world can do more to provide pregnant women with the means to prevent infection of their infants and to safeguard their own health and the health of their entire family. Today, we are committing as an organization to do our share to further that critical goal, and we urge all other funders and service providers throughout the world to join us in this vital mission. In order to spark more aggressive action to expand women's options, the Foundation will take the following steps:
1. Expand Access to a Range of PMTCT Programs: The Foundation will support programs to expand women's access to more sophisticated PMTCT regimens, when that is technically feasible from a cost and infrastructure standpoint, and when it is supported by science and host governments. This includes support for swifter movement towards the following regimens:
In addition, as data continue to emerge, some sites will consider adding a post-partum regimen of Combivir (AZT + 3TC) to limit resistance. The Foundation will seek to advance access to all levels of PMTCT services simultaneously.
2. Better Linkages Between PMTCT and Care and Treatment
Pregnant women in need of PMTCT services deserve access to the very best regimens available, including treatment for their own health if indicated. In support of this critical goal, the Foundation will more formally link its PMTCT services, now available in 19 nations and more than 600 sites around the world under the Call to Action Project, to care and treatment programs. We will act to ensure that pregnant women who qualify for treatment are among the priority candidates for HAART and that a full continuum of care is being provided whenever possible.
3. Advocacy for Critical Policy Goals
Advocacy has long been a critical part of the Foundation's mission. The Foundation will engage in stepped-up advocacy efforts aimed at gaining universal access for all pregnant women to PMTCT services. The Foundation will also advocate for infrastructure improvements and education and training of health care workers that will facilitate more effective PMTCT and care and treatment regimens in the field. Finally, advocacy efforts will also focus on lower drug costs, including access to non-brand drugs, and for swift progress on pediatric formulations and drug testing.
4. Support for Additional Research
The Foundation will seek additional funds from public and private donors to fund further research on critical PMTCT-related issues. This includes vital studies on resistance, prevention of transmission through breastfeeding, feasibility of more effective regimens, early diagnosis of infants, and operational research to increase the availability and acceptance of the full range of PMTCT services.
See Also: http://www.pedaids.org/fs_latest_news_nevirapine_croi_2.23.htm
For more information, please call or e-mail: Lisa Guiterman (lisa@pedaids.org) or Ashley Wolfington (ashley@pedaids.org) of the Elizabeth Glaser Pediatric AIDS Foundation, Sheraton: 617/236-2000 Room 2835 or Cell: 202/246-1079
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