"While we should proceed with caution and care given the many challenges that lie ahead, we should not delay; we must act now to rein in the global AIDS catastrophe," said committee co-chair James Curran, dean and professor of epidemiology; and director, Center for AIDS Research, Rollins School of Public Health, Emory University, Atlanta.
"Solving the AIDS crisis will take more than just inexpensive drugs, however," added co-chair Haile Debas, director, global health sciences, and professor of surgery, University of California, San Francisco. "Success now hinges more on having adequate infrastructures to distribute therapies and sufficient numbers of trained health care workers in developing countries. Even if we had enough money right now to buy all the necessary drugs to treat every infected individual, global expansion of treatment and prevention could fail just because of the scarcity of trained personnel."
Approximately 40 million people worldwide are infected with HIV, and 6 million need antiretroviral therapy now. Only about 400,000 people in developing nations have access to treatment. With 5 million additional people infected by HIV each year, the number of people needing treatment will only increase. The committee's report offers an independent, expert assessment of existing and proposed initiatives to scale up HIV treatment in developing countries, and it provides a framework and key principles to guide the rollout and expansion of these programs.
WORK-FORCE CRISIS
Significant expansion of HIV/AIDS treatment and prevention will require tens of thousands of health care workers with the experience and training to treat millions of people who have a disease that requires a complicated and long-term regimen of care. In addition, workers with other types of technical expertise are needed to run the daily operations and manage the complex process of reliably delivering therapies to their intended destinations. The lack of an adequate work force in poor nations reflects the underlying crisis of inadequate access to high-quality education throughout the developing world, the report says. Furthermore, most of these nations are experiencing a "brain drain," as many of the limited pool of educated and trained individuals migrate to other areas or countries that offer a better quality of life. Not only are there not enough skilled workers to conduct and manage HIV/AIDS treatment expansion now, but the numbers also are shrinking, the committee found.
A variety of innovative government and private-sector programs should be developed or expanded to bring a corps of volunteer medical and other professionals from resource-rich nations into developing countries to train their citizens in HIV/AIDS treatment and prevention and provide technical assistance, the committee said. This "HIV/AIDS corps" initiative would strengthen long-term ties among health professionals and others working to fight the disease in all countries, the report says.
Donors financing the global fight against HIV/AIDS should encourage partnerships among clinics, hospitals, and other medical institutions within and across national borders. Expertise developed through the AIDS education and training networks sponsored by the U.S. government, as well as similar initiatives in other countries, should be used to shape new training programs. Technology transfer and knowledge sharing also are needed among academic institutions, industry, public health agencies, and nongovernmental organizations to strengthen the work forces in developing nations.
LEARNING BY DOING
Tackling AIDS on a global scale should be based as much as possible on established public health practices, but it also will necessarily involve much learning by doing, the committee said. Several experts have expressed concerns that problems with organization and patient adherence to the therapy regimen in large-scale HIV/AIDS initiatives could lead to faster development of drug resistance, which ultimately could result in widespread treatment failure.
The committee urged that in addition to building on successes, program managers use mistakes and setbacks as learning opportunities. Efforts to control the epidemic in developing nations are still too new to have produced much evidence of which tools and methods work best in these nations, and most existing knowledge comes from research and treatment in the United States and other resource-rich countries. While some of the knowledge gleaned from these industrialized countries is applicable to developing nations, much will need to be reassessed.
About 5 percent to 10 percent of donor funding should be earmarked upfront to go toward monitoring and evaluation, the report says. These activities are important because the data gleaned from them will be critical for improving HIV/AIDS programs, identifying best practices that can be shared with others, and assuring donors that the programs are working, the committee said. The standards and methods for monitoring and evaluation need to be harmonized across all initiatives to minimize inefficiencies and maximize the ability to make comparisons among programs.
Although they have some limitations, the World Health Organization's guidelines for the treatment and monitoring of HIV-infected individuals should serve as an initial template that program managers and governments can use to tailor programs for their countries, the report says. The WHO guidelines acknowledge some uncertainties and will require modification as experience and research findings accumulate. However, they provide a useful starting point by outlining simple criteria and steps that can be used in even the most resource-poor settings, thus standardizing and simplifying treatment.
FIXED-DOSE COMBINATIONS
Fixed-dose combinations (FDCs) -- single pills that contain multiple drugs -- should be used, but only if they are shown to be safe, effective, and of high quality, the committee said. Many experts tout the ability of FDCs to improve adherence to treatment by reducing the number of pills that people have to take each day, and they usually are less costly. However, concerns have been raised about developing nations' abilities to ensure that FDCs -- as well as single-medication pills -- are of consistent quality and effectiveness, especially as less-experienced manufacturers enter the market and compete to produce drugs. A standardized, rigorous, international quality-assurance process for drug production must be developed, the report says.
"While costs are a factor, what is most important is that any drugs used are of proven quality and efficacy," Curran said. "Having less-effective drugs in these environments could do more harm than having no drugs at all."
LONG-TERM FUNDING COMMITMENT
Ensuring the best chances of success will require commitments from donors to provide continuous funding for decades, the report noted. Although WHO has set the ambitious goal of placing 3 million individuals on antiretroviral treatment by the end of 2005, tens of millions more infected people will reach the point at which they need therapy over the next decade. UNAIDS estimates the total annual need for HIV/AIDS funding to be $10.7 billion for 2005 and $14.9 billion by 2007. The total estimated funding provided in 2003 was $4.2 billion.
ADDITIONAL TREATMENT NEEDS
Programs to control tuberculosis should continue to operate in parallel with initiatives to scale up HIV/AIDS treatment, the report urged. Nearly one-third of HIV-infected individuals also have tuberculosis, which is one of the leading causes of AIDS-related death. Tuberculosis treatment programs already established in many developing countries should be supported as an important point for entry into HIV testing and treatment.
In addition, HIV/AIDS program planners should develop and enact stronger, more effective efforts to prevent HIV infection at the same time that they expand treatment, the report says. Prevention efforts should focus on those at risk for becoming infected, not just those receiving treatment.
The study was sponsored by the Fogarty International Center and the Office of AIDS Research at the National Institutes of Health; and the Bill & Melinda Gates Foundation. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.
A pre-publication version of SCALING UP TREATMENT FOR THE GLOBAL AIDS PANDEMIC: CHALLENGES AND OPPORTUNITIES is available on the Internet at HTTP://WWW.NAP.EDU. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
[This news release and report are available at HTTP://NATIONAL-ACADEMIES.ORG].
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INSTITUTE OF MEDICINE
Board on Global Health
COMMITTEE ON ANTIRETROVIRAL DRUG USE IN RESOURCE-CONSTRAINED SETTINGS
JAMES W. CURRAN, M.D., M.P.H. (CO-CHAIR)
Dean and Professor of Epidemiology
Rollins School of Public Health
Emory University
Atlanta
HAILE T. DEBAS, M.D. (CO-CHAIR)
Dean, School of Medicine, and
Vice Chancellor, Medical Affairs
University of California
San Francisco
SOLOMON R. BENATAR, M.D.
Professor of Medicine
Department of Medicine; and
Director
Bioethics Centre
Faculty of Health Sciences
University of Cape Town
Cape Town, South Africa
SALLY BLOWER, PH.D.
Professor
Department of Biomathematics
School of Medicine
University of California
Los Angeles
J. BROOKS JACKSON, M.D., M.B.A.
Baxley Professor, and
Director of Pathology
Johns Hopkins University School of Medicine
Baltimore
GILBERT KOMBE, M.D., M.P.H.
Senior HIV/AIDS Technical Adviser
Partnership for Health ReformPLUS Project
Abt Associates nc.
Bethesda, Md.
PETER MUGYENYI, M.B., CHB. Director Joint Clinical Research Center Kampala, Uganda
NICKY PADAYACHEE, M.D.
Dean
Faculty of Health Sciences
University of Cape Town
Cape Town, South Africa
NANCY S. PADIAN, PH.D.
Professor
Department of Obstetrics, Gynecology, and
Reproductive Sciences; and
Director of International Research
AIDS Research Institute
University of California
San Francisco
PRISCILLA REDDY, PH.D, M.P.H.
Director
Health Promotion Research and Development Group
Medical Research Council of South Africa
Tygerberg
DOUGLAS RICHMAN, M.D.
Professor of Pathology and Medicine, and
Director
AIDS Research Institute
Departments of Pathology and Medicine
University of California
La Jolla
BRUCE D. WALKER, M.D.
Professor of Medicine, and
Director
Division of AIDS
Harvard University Medical School
Boston
INSTITUTE STAFF
STACEY KNOBLER
Study Director
Contacts: Christine Stencel, Media Relations Officer Heather McDonald, Media Relations Assistant Office of News and Public Information 202-334-2138; e-mail news@nas.edu.