A historic aspect of President Bush's Emergency Plan for AIDS Relief (PEPFAR/Emergency Plan) is the focus on scaling up quality antiretroviral treatment (ART) in 15 focus countries in Africa, Asia, and the Caribbean. Quality ART requires a host of essential activities and services, including assessments of current capacity and resources for efficient and effective roll-out; training and support for care providers; adherence training and monitoring; infrastructure enhancement, including clinics, laboratories, and medical records systems; routine laboratory monitoring tests; antiretroviral (ARV) drugs and other medications; hospitalization capability when necessary; the development and maintenance of secure distribution, logistics, and management systems; and much more. In the resource-limited settings of the focus countries, few of these essential activities and services were available prior to the Emergency Plan. Although it is critical to move as quickly as possible to save as many lives as possible, moving too quickly without ensuring the provision of the highest-quality ART could do more harm than good for the generations that will live or die with decisions made now. The emergence of widespread drug resistance from suboptimal therapy could severely curtail the fight against the global pandemic. President Bush's Emergency Plan is committed to supporting national strategies to guarantee the full spectrum of quality treatment through both public and private providers, ensuring that HIV-infected adults and children receive the greatest benefit from therapy and that the risks of developing resistance are limited.
A fundamental means of rapidly expanding services while developing sustainable capacity is to support national strategies to build HIV/AIDS care and treatment networks. Network systems ensure comprehensive reach of high-quality services by building capacity to support centers of excellence at referral hospitals, with health professionals trained in all aspects of HIV/AIDS care and treatment, adequate physical infrastructure, and laboratory capability. These core institutions link to regional hospitals and district facilities down to community-level satellite clinics, mobile units, and community-based services. These linkages provide clinical support for laboratory tests, training, logistical and distribution systems, monitoring and reporting systems, and other aspects of quality care and treatment. By working with host governments to support the development of comprehensive indigenous network systems, the Emergency Plan will ensure that capacity and services are sound, sustainable, and prepared to respond to the long-term challenge of turning the tide of the HIV/AIDS pandemic.
Results: Rapid Scale-Up
The Emergency Plan has moved rapidly to support national strategies for treatment in partnership with the public and private sectors, committing more than $231.9 million for ART, or 40.8 percent of the total resources committed to prevention, treatment and care in the 15 focus countries. The results of these joint U.S./hostcountry efforts are impressive. In the first eight months of the Emergency Plan, the United States has supported ART for 155,000 HIV-infected adults and children in the 15 focus countries, achieving 78 percent of its target for June 2005. As a reference point for this rapid progress, in December 2002, one month before President Bush announced the Emergency Plan, only 50,000 people were reported to be receiving ART in all of sub-Saharan Africa. Eight months into the Emergency Plan, three times that number were receiving treatment. The Emergency Plan is well on track to meet the goal of supporting ART for 2 million adults and children in five years.
Of the 155,000 people receiving support for ART from the Emergency Plan, 67,000 were treated at U.S. Government-supported health centers, and 88,000 benefited from upstream support provided by the Emergency Plan to strengthen national health care networks and systems for ART provision. Of the 67,000 adults and children treated at specific sites, 40,000 began therapy during the reporting period, with the remainder taken up by the Emergency Plan at its launch to ensure continuing treatment. Reporting systems for upstream support do not currently provide an accurate count of those patients who began ART during the reporting period.
The Emergency Plan is dedicated to expanding care and ART to HIV-infected children, supporting ART for at least 4,800 children during the first reporting period. Few sites are currently able to disaggregate data by adults and children, so the number of children receiving ART is likely under-reported. Women (who are disproportionately infected with HIV, particularly in Africa) must be ensured access to quality ART. During the first reporting period, not all sites captured the numbers of women and girls receiving ART; however, among the sites reporting such numbers, 56 percent of new clients receiving ART were female. Reporting on women and children receiving ART will improve significantly in the coming years.
In addition to support for ART in focus countries, in fiscal year 2004 the President's Emergency Plan supported ART for 17,000 HIV-positive people through bilateral programs in other countries, for a total of 172,000 women, men, and children in focus countries and other countries combined. A fundamental component of the Emergency Plan is the commitment of resources to the Global Fund to Fight AIDS, Tuberculosis and Malaria. In January 2005, the Global Fund reported that it had supported ART for 130,000 HIV-positive people globally through December 2004. Of those, 63,000 received support from both the bilateral and multilateral resources of the Emergency Plan, as shown in figure 2.1 below.
Sustainability: Building Capacity
A key aspect of the Emergency Plan is to rapidly build capacity as services are being scaled up to provide the foundation for sustainable high-quality services. Human resource capacity is a fundamental limitation to quality ART in many settings; because ART is new in many places, there is limited number of trained providers. The Emergency Plan coordinates with host-country national strategies to support significant training for health care providers to ensure the quality of ART services and the success of national plans in both public and private sectors. In the first eight months of the Emergency Plan, the United States supported training for 12,200 service providers. In addition to training, sites must be prepared for quality ART, including the strengthening of physical infrastructure, laboratories, procurement and distribution of essential supplies, and other key areas. In the reporting period, the Emergency Plan supported 300 sites for ART in the 15 focus countries.
Antiretroviral drugs as a component of antiretroviral treatment. Safe, effective, high-quality ARV drugs are a critical component of quality ART. ARV drugs are a significant component of the cost of ART. There are various sources of ARV drugs, including host governments and other donors. The Emergency Plan often provides other essential components of ART (see Defining Support for Antiretroviral Treatment above). In addition, no one regimen is adequate for the needs of all patients. Drug interactions, such as those between ARVs and anti-TB drugs, can alter the preferred first-line therapy in many patients.
In certain settings, more than 30 percent of patients who begin ART cannot use the preferred national first-line regimen because of the need to simultaneously treat HIV and TB. In addition, as access to ART expands, drug toxicities and drug resistance will increase, thus requiring a sufficiently broad formulary to sustain quality ART. The United States is committed to providing the necessary elements of a formulary to ensure safe, effective, highquality ARVs for sustainable ART. In the reporting period, the Emergency Plan provided nearly $12 million for the purchase of ARV drugs in the focus countries.
The Emergency Plan is fully committed to providing funding for the lowest-cost ARV drugs from any source, regardless of origin, be they copies, generic, or branded, as long as those drugs are proven safe, effective, and of high quality, and purchase is consistent with international law. In May 2004, then U.S. Secretary of Health and Human Services Tommy Thompson and U.S. Global AIDS Coordinator Randall L. Tobias jointly announced an expedited process for review of ARVs through the U.S. Food and Drug Administration (FDA). This process establishes an eight-week review from the time a completed application is received. Since May, the FDA has worked with multiple companies from Africa, Asia, and the Caribbean to ensure the success of the expedited review process, providing technical support and guidance for the preparation of applications.
In December 2004, the FDA approved a generic form of didanosine (Barr Pharmaceuticals, U.S.), a drug commonly used in second-line regimens. In January 2005, the FDA approved a generic copackaged ARV "blister pack" (Aspen Pharmcare, South Africa). The three-drug combination contained in the blister pack (the fixed-dose combination of zidovudine/lamivudine and the single drug nevirapine) is one of the most commonly used regimens in resource-limited settings and provides patients with an easy-to-use package of two tablets twice per day. This approval took two weeks from the time a complete application was received by the FDA. Other companies have also announced their intention to enter the FDA expedited review process in fiscal year 2005.
Key Challenges and Future Directions
Human capacity. There are insufficient numbers of health care providers in both the public and private sectors trained in the many aspects of quality ART. This is due in part to the fact that ART is relatively new in most settings so there has been little need for training to date. However, there is also a significant shortage of health professionals. For example, in Mozambique there are 500 to 600 physicians for 18 million people. Some focus countries do not have their own medical schools. There is a chronic shortage of nurses, exacerbated by "brain drain" of trained personnel to developed countries and by the fact that many personnel are themselves at risk for HIV infection. Many national strategies, and the Emergency Plan, recognize these key challenges and are working to provide the upstream support necessary to provide sustainable solutions. Progress has been made in innovative training programs that provide preservice training for health workers in school and on-the-job training (which prevents depletion of an already limited worker pool during training sessions). The "network system" of health care is essential in resource-limited settings; limited human capacity requires that different levels of care and ART be provided by those with the necessary training to perform tasks well, while limiting the use of highly specialized professionals when their expertise is not required. In certain circumstances, changes in national government policy or legislation are required to bring greater flexibility to health care delivery. In Uganda and Haiti, home health aides perform routine follow-up and patient adherence counseling in the home setting. Innovative approaches to fully integrate a network ART system will be necessary to achieve a rapid scale-up of quality ART.
Expanding ART in rural areas. In many areas where the Emergency Plan is working, a significant segment of the population resides in rural communities. To achieve the treatment goals of supporting ART for 2 million people in five years, it will be necessary to expand services from the urban centers in which they are often concentrated to rural areas. Again, the network system favored by national strategies and the Emergency Plan is essential to maximize the reach of quality ART. Community- and faith-based organizations and private sector providers are a key component of the strategy to extend the reach of care and treatment to the community level. Ensuring that women have access to treatment as it expands is a focus of the Emergency Plan. In addition, novel approaches to place health care professionals in rural settings are needed. In 2004, the Emergency Plan supported a pilot project in Namibia to provide incentives to physicians and other health care professionals to move to underserved rural areas. As a result of this program, physicians, pharmacists, and nurses relocated to these areas and began providing services to thousands of HIV positive people. In 2005, the Emergency Plan will expand the Namibian program and other countries, such as Mozambique, will employ a similar strategy.
Secure and reliable ARV drug supply. A secure and reliable drug and commodity supply chain is a key component of safe and effective ART and quality HIV prevention and care. An interruption in drug supply poses significant risks of patients developing resistance to ARV drugs and to patient and community confidence in national strategies. Accurate forecasting is essential to ensure proper levels of ARV production. Currently, the partners of the Emergency Plan are utilizing existing supply chain systems to expand programs. While this is an appropriate emergency response to rapidly expand services, for the long term a more robust approach is needed. The Office of the U.S. Global AIDS Coordinator (OGAC) has overseen the release of a request for applications to develop a secure, reliable supply chain management system (see chapter 5, "Building Capacity for Sustainability"). This performance-based contract will be awarded in fiscal year 2005. The fundamental intent of the contract, and of current U.S. efforts, is to provide technical assistance to develop national supply chain systems for drugs and commodities.
Accountability: Reporting on the Components of Treatment
The Emergency Plan supports national HIV/AIDS treatment strategies, leveraging resources in coordination with host-country multisectoral organizations and other donors to ensure a comprehensive response. Host nations must lead a multisectoral national strategy for HIV/AIDS for an effective and sustainable response. Donors must ensure that interventions are in concert with host government national strategies, responsive to host country needs, and coordinated with both host governments and other partners. Stand-alone service sites managed by individual donors are not desirable or sustainable. In such an environment, attribution is complex, including both "upstream" (system strengthening) and "downstream" (site-specific) activities (see Defining Support for Antiretroviral Treatment above), often with multiple partners supporting the same sites to maximize comparative advantages. OGAC is conducting audits of its current reporting system to refine methodologies for the future, and in the coming fiscal year will further assess attribution and reporting methodologies in collaboration with other donors.
During this reporting period, to account for Emergency Plan treatment programming, in-country teams counted those activities that supported ART provision, including training, the provision of ARV drugs, clinical monitoring of ART for people with advanced HIV infection, related laboratory services, infrastructure support, and other activities described above. Where downstream service delivery sites were directly supported by U.S. Government funding, distinct individuals receiving services at those sites were counted. Support to a specific site may or may not be in partnership with other funders of HIV prevention, care, and treatment. For example, the U.S. Government may fund the clinical staff delivering ARV treatment, while Global Fund monies support the pharmaceuticals used in the clinic. For support to national treatment programs provided upstream (for which funding is not directly given to a specific service delivery site or program), the Emergency Plan estimated, in conjunction with other partners and national governments, the number of individuals receiving care or treatment as a result of the U.S. Government's contribution to national, regional, or local activities.