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PEPFAR Implementation: Progress and Promise (2007)

Chapter: 5 PEPFAR's Treatment Category

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Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
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5

PEPFAR’s Treatment Category

Summary of Key Findings

  • PEPFAR narrowly defines treatment as antiretroviral therapy (ART) and includes in this category only activities that directly support the provision of ART. PEPFAR has supported rapid expansion of the availability of ART to people living with HIV infection. By September 2006, PEPFAR was supporting ART for 822,000 women, men, and children in the focus countries.

  • PEPFAR is supporting ART within national treatment plans that are consistent with the World Health Organization’s guidelines for ART in resource-constrained settings. However, PEPFAR has not always been able to support national plans for purchases of antiretroviral medications.

  • PEPFAR is supporting ART programs in addressing the critical issue of adherence to therapy, and limited observational studies show that adherence in the focus countries compares favorably with that observed earlier in Western Europe and North America. PEPFAR is also supporting sentinel surveillance to monitor for resistance.

  • Among people receiving ART supported by PEPFAR, 61 percent are women and 9 percent children. PEPFAR’s Pediatric Treatment Initiative is attempting to address real and perceived barriers to pediatric treatment.

  • The observed rapid clinical response to ART has, in a number of the programs the Committee visited, reportedly resulted in increased interest by people in obtaining HIV testing, followed by ART when indicated.

  • PEPFAR is supporting programs in addressing the rapid resurgence of tuberculosis in both child and adult populations throughout sub-Saharan Africa. This resurgence has been fueled by HIV-associated immunodeficiency. In some communities, as many as 80 percent of people newly diagnosed with active tuberculosis have concomitant HIV infection.

  • While the success of PEPFAR-supported roll-out of ART has been gratifying, many obstacles remain and will require continued concerted attention at all levels. These obstacles include shortages of trained medical and paramedical personnel, insufficient quantities of antiretroviral medications, difficulties in delivering ART in many rural districts, weak supply chains for antiretroviral medications and other commodities, and inadequate laboratory capacity.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
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Recommendations Discussed in This Chapter


Recommendation 5-1: The U.S. Global AIDS Coordinator should ensure that adequate medications are available to place 2 million people on sustained antiretroviral therapy to achieve PEPFAR’s stated 5-year treatment target. To achieve this target, the Coordinator should also ensure that adequate linkages are established among prevention, treatment, and care programs and rapidly expand the availability of antiretroviral therapy to both children and adults.


Recommendation 5-2: To support countries’ ownership of their responses to their HIV/AIDS epidemics, the U.S. Global AIDS Initiative should maintain its commitment to harmonization and participate fully in the development of harmonized procedures. To this end, the U.S. Global AIDS Coordinator should work to support World Health Organization (WHO) prequalification as the accepted global standard for assuring the quality of generic medications. Specifically, the Coordinator should provide an analysis of WHO prequalification that determines whether it can adequately assure the quality of generic antiretroviral medications for purchase under PEPFAR. If the analysis shows that WHO prequalification needs strengthening to provide a sufficient guarantee of quality for PEPFAR, the U.S. Global AIDS Initiative should work with other donors to support strengthening of the process, and work to transition from U.S. Food and Drug Administration approval to WHO prequalification as rapidly as feasible.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

5
PEPFAR’s Treatment Category

CATEGORY, TARGET, AND RESULTS

The Treatment Category

The President’s Emergency Plan for AIDS Relief (PEPFAR) defines treatment narrowly as antiretroviral therapy (ART), and for purposes of budgeting and performance targets, ART is categorized separately from all other related care services. PEPFAR’s treatment category includes only activities that directly or indirectly support the provision of ART, including procurement of antiretroviral medications (ARVs), essential laboratory monitoring, equipment and training of personnel for the provision of ART and laboratory monitoring, development of adequate laboratory infrastructure, and support for supply chain management systems for ARVs and related commodities. For purposes of budgeting, complying with budget allocations, and counting progress toward targets, PEPFAR categorizes other services in the care continuum under its other categories. For example, PEPFAR includes most treatment for the prevention of mother-to-child transmission in its prevention category1 (see Chapter 4), and therapy for coinfections such as tuberculosis and malaria, as well as nonclinical care, in its care category (see Chapter 6). The consequences of this definition and categorization are discussed further in this chapter and in Chapter 8 in the section

1

Only services in which the mother is receiving ART (termed prevention of mother-to-child transmission plus) are included under the treatment category. Provision of ARVs solely to prevent transmission of HIV from mother to infant is included under the prevention category.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

on integration. Funding for PEPFAR-supported treatment activities includes ART and laboratory infrastructure and has roughly tripled from 2004 to 2006 (see Chapter 3).

Target

PEPFAR’s 5-year treatment target, as described in the program’s authorizing legislation, is to support the focus countries in providing ART to 2 million people. This target represents a count of the number of people receiving ART that is supported directly or indirectly by PEPFAR, and is a globally accepted and widely used early indicator of program implementation. This count provides limited information and does not indicate how well people receiving ART are doing or how the availability of ART affects a country and its HIV/AIDS epidemic. Challenges to obtaining this count are discussed in this chapter; measures of treatment success are addressed in the discussion of impact evaluation in Chapter 8.

Similar to other donor programs, PEPFAR has had to balance its need to be accountable to the U.S. Congress with its accountability to the people of the focus countries within the framework of harmonization. The program has faced the dilemma of needing information that is not readily or routinely available from clinics or ministries of health, and has imposed unprecedented reporting requirements on both urban and rural treatment centers that often have severe shortages of personnel at all levels.

At the global level, PEPFAR requirements for monitoring the number of people receiving ART are reasonably well harmonized with the recommended indicators of the World Health Organization (WHO) and their definitions. PEPFAR generally supports the WHO-recommended tools, including patient records and ART registers, for monitoring and evaluating ART.

Information systems in the focus countries are generally in need of substantial development and strengthening, and PEPFAR is supporting improved HIV-related information systems from the level of rural clinics to that of ministries of health. Although PEPFAR is supporting some innovative information system projects, paper-based records and limited computer access are still the prevailing norm in the focus countries. Provision of even basic monitoring data therefore remains a challenge in most of the countries.

PEPFAR has had to work closely with host countries and other donors to determine which people on ART it can fairly count as having received its support. Host countries are understandably sensitive to donors appearing to take credit for the country’s accomplishments, and it is important at both the country and global levels to avoid double-counting if an accurate accounting of the proportion of eligible patients who are receiving ART is to be obtained. Initially, PEPFAR did create ill will in a few focus countries

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

by appearing to take credit for the country’s accomplishments. The program has since endeavored to be clear in its reporting that it is claiming credit for having provided some measure of support for a person’s ART rather than exclusively and directly providing the treatment. PEPFAR has also been working closely with the Global Fund, as well as with each focus country, to avoid overlaps in attribution. The Committee encourages PEPFAR to continue in this vein, participating in joint attribution and enhancing coordination among all donors and with the host countries.

PEPFAR’s strategy for achieving its treatment target includes

  • Rapidly scaling up treatment availability using a network model.

  • Building capacity for long-term sustainability of quality HIV/AIDS treatment programs.

  • Collecting strategic information with which to monitor and evaluate progress and ensure compliance with PEPFAR and national policies and strategies (OGAC, 2004).

To achieve the treatment target, PEPFAR’s approach to implementation is to assist countries in the “development of appropriate treatment protocols and policies to ensure safe and effective treatment services, drug supply, and equitable distribution of health resources,” and to work with existing clinical programs and develop additional infrastructure, staff, and technical capacity, as needed, to provide “long-term, widespread, high-quality, safe, and essential services to the maximum number of people in need” (OGAC, 2004, p. 11).

Results

According to the Office of the U.S. Global AIDS Coordinator (OGAC), 822,000 people were receiving PEPFAR-supported ART in the focus countries by the end of September 2006, as compared with 155,000 in fiscal year 2004. Approximately 61 percent of this total were women and 9 percent children (OGAC, 2007). These proportions for women and children compare favorably with global averages (WHO and UNAIDS, 2006; UNAIDS, 2006), but may need to increase to reflect actual needs. Recent data indicate that women are disproportionately represented among people living with HIV/AIDS and among the newly infected, particularly in resource-constrained countries, and that children accounted for more than 13 percent of AIDS deaths in 2005 (GAA, 2006; UNAIDS, 2006; WHO and UNAIDS, 2006).

PEPFAR has also supported training in the provision of ART for more than 100,000 health workers and training for more than 17,000 laboratory personnel, as well as significant expansion in the number of ART delivery

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

TABLE 5-1 PEPFAR Treatment Results by Fiscal Year, 2004–2006

Subcategory

Fiscal Year 2004

Fiscal Year 2005

Fiscal Year 2006

ART

 

 

 

Number of people receiving ART supported by PEPFAR

155,000

401,000

822,000

Number of ART sites supported by PEPFAR*

300

800

1,912

Number of health workers trained with PEPFAR support in the provision of treatment according to national and/or international standards

12,200

36,500

52,000

Laboratory Infrastructure

 

 

 

Number of laboratories supported by PEPFAR with the capacity to perform (1) HIV tests and (2) CD4 tests and/or lymphocyte tests

Not available

900

958

Number of people trained with PEPFAR support in the provision of laboratory-related services

3,100

5,700

8,300

*Includes both ART and prevention of mother-to-child transmission plus sites.

SOURCE: OGAC, 2005a, 2006a, 2007.

sites and laboratories that can provide the needed support (see Table 5-1). In addition, PEPFAR has provided funding and technical assistance to strengthen laboratory infrastructure and national procurement and supply chain systems.

REVIEW OF PROGRESS TO DATE

Support for National Programs to Follow the World Health Organization’s Guidelines

Nearly all of the focus countries have developed treatment targets and published plans for scaling up ART to meet those targets. While each focus country has a program tailored to its particular circumstances, all the programs are based on WHO’s recommendations for delivery of ART in resource-limited settings. PEPFAR has both supported the development of national treatment plans and endeavored to program its activities within the parameters of these national plans and the WHO guidelines. Although concerns have been expressed by several focus countries about the lack of consultation with local authorities during the initial development of PEPFAR treatment programs, and there has been widespread frustration with PEPFAR limits on the procurement of ARVs, PEPFAR’s support for ART appears to be generally consistent with national plans in the focus countries.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

The 2003 revision of the WHO guidelines is intended to support and facilitate the proper management and scale-up of ART by promoting a public health approach that includes the following elements:

  • Scaling up ART, with the objective of universal access.

  • Standardizing and simplifying antiretroviral regimens to support efficient implementation of treatment programs in resource-limited settings.

  • Ensuring a scientific evidence base for ART programs so as to avoid the use of subpar treatment protocols that could compromise the treatment outcomes of individual patients and create the potential for the emergence of widespread drug resistance.

The WHO guidelines emphasize consideration of the challenges to ART programs posed by working in resource-limited settings, including human resources, health system infrastructure, and socioeconomic conditions. The guidelines include recommendations for when to start ART and with which antiretroviral regimens, reasons for changing the treatment, and what regimens to use if such change is necessary. They also address how treatment should be monitored, with specific reference to the side effects of ART, and make recommendations for particular patient subgroups (WHO, 2006a).

PEPFAR recommends that ART include the following elements (OGAC, 2005a):

  • Uninterrupted supply of appropriate ARVs

  • General clinical support for patients, including other medications and diagnostics

  • Training and support for health care providers

  • Infrastructure (clinics, counseling rooms, laboratories, distribution and logistics systems)

  • Monitoring and reporting systems

  • Appropriate referrals

At the same time, PEPFAR officials have recognized that each nation’s needs are unique, and that each nation is therefore in the best position to tailor its plans to fit its particular circumstances. Thus the approach to ART varies considerably among the focus countries. One important factor in this variation is differences in the prevalence of HIV infection; the national HIV prevalence varies more than 20-fold among the 15 focus countries (see Chapter 2). A second salient factor is wide variation in the health care systems already in place. Several countries have well-established medical, nursing, and paramedical education programs, while a few have neither medical nor nursing schools. Access to basic medical services is also highly variable, although most of the focus countries have developed plans for

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

improving access to medical care as an essential element of national policy. In those nations with strong publicly financed health systems, government-supported hospitals were generally able to assume major responsibilities for the initial roll-out of ART, while in others, the process was more dependent on nongovernmental organizations, often faith-based organizations, which provide the majority of health care services in many of the focus countries (GHC, 2005). Integration of those organizations into the national system also varies considerably from country to country.

Diagnosis and Evaluation

As seen among the ART programs the Committee visited, patients diagnosed as HIV-positive are usually scheduled to receive clinical and laboratory evaluation by a health care worker to determine whether they require initiation of ART. Clinical evaluation is uniformly based on the WHO clinical criteria; availability of appropriate laboratory evaluation is variable, however.

Eligibility for ART

Eligibility for ART is determined by country treatment guidelines, which are generally based on the WHO 2006 Recommendations for Antiretroviral Therapy in Adults and Adolescents in Resource-Limited Settings. As recommended by WHO, focus country guidelines utilize WHO clinical staging and, when available, CD4 cell count to determine eligibility for ART. Patients with severe HIV-associated clinical disease (WHO clinical stage 4) and those with WHO clinical stage 3 disease with associated tuberculosis or severe bacterial infections are eligible for ART, as are all patients with CD4 counts below 200 cells/mm3, regardless of WHO clinical stage. In all focus countries visited, the great majority of patients receiving ART have WHO clinical stage 4 disease or clinical stage 3 complicated by major opportunistic infections (usually tuberculosis or severe bacterial disease) or unexplained severe malnutrition. Eligibility criteria for infants and young children are different and are discussed in the section below on treatment of HIV/AIDS in children.

Preparation for ART

Most of the focus countries have developed readiness programs to enhance adherence of eligible patients to ART. Although these programs vary, many are based on the “buddy” concept, by which each patient is required to bring a friend (a family member if possible) to one or more meetings with an adherence counselor prior to the initiation of ART. An essential part of such programs is discussing with the patient and buddy what side

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

effects may be experienced with ART, which of those side effects may be self-limited, and which dictate prompt discontinuation of ART (Nachega et al., 2006). Overall, this approach appears to be working well, but is difficult to accomplish in instances in which access to ART is limited to centers at considerable distances from where patients live.

ART Initiation

Following diagnosis, evaluation, and readiness training, the patient begins ART, usually involving one of the three-drug, first-line regimens recommended by WHO (Gilks et al., 2006). None of the WHO-recommended first-line regimens for adults require refrigeration, and all are now produced in generic form by one or more pharmaceutical companies (FDA, 2006). Although the ART guidelines in all the focus countries are based on the ARV regimens recommended by WHO, other three-drug regimens may be used at the discretion of the supervising physician in some tertiary treatment sites.

Follow-up of Patients Receiving ART

Follow-up is arranged at intervals recommended by WHO and is often reinforced by providing ARVs sufficient to last until the next essential follow-up visit. Most programs visited by the Committee use additional techniques to support adherence during the first few weeks of ART. In some sites, weekly visits to patients’ dwellings by an outreach worker are arranged for 4 to 6 weeks after initiation of treatment. In other cases, assigned “buddies,” who have received adherence training along with the patients, provide similar support. Although not universal, such techniques for enhancing adherence are employed in the majority of treatment sites. At follow-up visits, the patient is asked about side effects and difficulties with adherence. Continued close adherence to the prescribed regimen is emphasized by the health care worker. If stated adherence is good but improved strength and well-being have not been achieved, potential underlying problems (for example, inadequate caloric intake or concomitant tuberculosis infection, both discussed below) are investigated, and appropriate adjuvant therapy, insofar as possible, is arranged.

Adherence to Therapy

Based on limited observational studies, short-term adherence to ARV regimens in the focus countries appears to be as good as or better than that observed earlier in Western Europe and North America (Farmer et al., 2001; Mills et al., 2006; Nachega et al., 2006; Stringer et al., 2006). As PEPFAR progresses with rapid scale-up and outreach to previously

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

neglected communities, a continued strong emphasis on adherence to therapy is essential. Substantial lack of adherence would not only result in treatment failure, but also would contribute to widespread resistance of the virus to therapy. Failure to adhere would thus not only be harmful to individual patients, but would also necessitate even greater investments of human and financial resources to overcome the resulting resistance problems (IOM, 2005).

PEPFAR does not routinely report on adherence as part of its ongoing program monitoring. However, some relevant data have been obtained from independent observational cohort studies in the focus countries, several of which have reported encouraging levels of adherence (Spacek et al., 2005; Calmy et al., 2006; Stringer et al., 2006; Wools-Kaloustian et al., 2006). Continued support for such evaluations will be critical for determining program effectiveness. Relatively short breaks in adherence (2 to 4 weeks) or repeated breaks for shorter intervals can result in viral resistance to two of the three components of recommended first-line ARV regimens. And a single resistance mutation (K103N) to the non-nucleoside component (either nevirapine or efavirenz) renders the virus resistant to the entire class of non-nucleoside reverse transcriptase inhibitor drugs. The consequence of such resistance patterns is that patients require drugs of a different class—protease inhibitors (Hirsch et al., 2003). The protease inhibitors not only cause more frequent undesirable side effects, but are several-fold more expensive than the WHO-recommended first-line drugs. Few protease inhibitors are now available as generics, and the complexity of their production may cause them to remain relatively expensive for the indefinite future.

Stigma Reduction

Clinicians visited by the Committee reported that the excellent clinical response to ART has in many areas led people in the surrounding communities to be more receptive to obtaining HIV testing and, when appropriate, therapy. This same phenomenon has been reported in other settings as well, including South Africa and Haiti (Castro and Farmer, 2005; Nachega et al., 2006). It appears that a benefit of the response to therapy may be a reduction in stigma associated with HIV testing. Recognition that people receiving effective ART rapidly gain weight and strength and do not suffer from recurrent opportunistic infections reportedly has greatly enhanced the perceived value of the PEPFAR program in the focus countries.

Resistance Monitoring

A previous Institute of Medicine report concluded that general screening for resistance to ARVs was not recommended because the prevalence

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

of resistance in HIV-infected individuals not previously exposed to ART was expected to be very low. However, the report did recommend that coordinated, systematic testing for resistance to ARVs should be conducted among a subset of patients failing treatment (IOM, 2005). The results of testing such patients would aid in determining whether and when routine population-based resistance testing might prove effective. PEPFAR provides support for resistance monitoring; selected examples of such activities in are presented in Box 5-1.

Women as a Proportion of Those Receiving PEPFAR-Supported ART

To ensure that women benefit from equitable access to ARVs and other HIV-related treatments, PEPFAR is working to support treatment programs in addressing the many barriers faced disproportionately by women and girls in accessing health care. Approaches to this end include efforts to shorten waiting times, to provide appropriate appointment schedules and increased numbers of female health workers, and to ensure privacy and confidentiality. These efforts appear to be yielding positive results, and OGAC reported that 61 percent of those receiving PEPFAR-supported ART are women and girls.

BOX 5-1

Selected Examples of PEPFAR-Supported Resistance Monitoring Activities

In Mozambique, PEPFAR is supporting a combined tuberculosis/HIV prevalence and drug resistance study.

In Namibia, PEPFAR is providing technical assistance and funding for resistance testing for surveillance purposes, and is planning to gradually build local capacity to perform resistance testing in the country over the next 3 to 4 years.

In Rwanda, PEPFAR is providing technical assistance and training to laboratory professionals in molecular virology techniques, as well as the development of a quality assurance/quality control program for the HIV drug resistance surveillance program.

In South Africa, PEPFAR is supporting surveillance to detect resistant virus in pregnant women.

In Vietnam, PEPFAR supported the establishment of a surveillance system for ARV resistance focused on strengthening national collaboration and partnerships for ARV resistance monitoring and assisting in the development of national guidelines for such efforts.


SOURCE: OGAC, 2005b.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×
Treatment of HIV/AIDS in Children

The Country Operational Plans for fiscal years 2005 and 2006 describe a wide range of PEPFAR-supported pediatric treatment activities. Selected examples of these activities are presented in Box 5-2.

According to the Global AIDS Alliance (GAA, 2006), although PEPFAR has increased funding available for pediatric HIV services, country-level stakeholders still are not mobilizing sufficiently to take advantage of opportunities offered by the Global Fund and PEPFAR to scale up pediatric treatment. Even though the number of countries offering infant testing programs increased in 2005, the laboratory infrastructure for widespread infant testing has not been established (GAA, 2006). PEPFAR’s 2007 guidance for Country Operational Plans requests that when setting 2007 targets, Country Teams take into account that pediatric formulations may be limited and that the cost of such formulations may be up to three times that of adult formulations. The guidance suggests that 15 percent of people receiving PEPFAR-supported ART should be children, but recognizes that while some countries may be able to meet this target for 2007, others may be just initiating their pediatric programs and may feasibly be able to target

BOX 5-2

Selected Examples of PEPFAR-Supported Pediatric Treatment Activities

PEPFAR is providing technical assistance to support a number of countries in adapting and implementing international pediatric treatment guidelines.

In Côte D’Ivoire, PEPFAR supports a National Pediatric ART Reference Center.

In Namibia, PEPFAR is supporting efforts to help make nonpediatricians more comfortable with pediatric HIV/AIDS. These efforts include adapting training materials to the country context as the basis for a new training program in pediatric HIV/AIDS. This training is targeted to medical officers and nurses assigned to pediatric outpatient departments, pediatric wards, and communicable disease clinics.

In Tanzania, PEPFAR supports a collaborative aimed at improving quality of care for children with severe illness and HIV/AIDS in three district hospitals. The effort includes strengthening the pediatric components of the national HIV/AIDS care and treatment guidelines and facilitating the training of physicians, nurses, and other caregivers so they can provide higher-quality pediatric services in the context of the collaborative approach to quality improvement.


SOURCE: OGAC, 2005b, 2006d.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

the 5–10 percent range, with the goal of increasing to 15 percent (OGAC, 2006e).

To help address the universal challenges involved in pediatric treatment (discussed below in the section on issues and opportunities for improvement), in early 2006 PEPFAR announced a public–private partnership that would be devoted to scientific and technical discussions of solutions for pediatric HIV treatment, formulations, and access. This partnership includes innovator and generic pharmaceutical companies, multilateral organizations such as the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the United Nations Children’s Fund (UNICEF), and agencies across the U.S. government. The partners are expected to contribute their diverse expertise to accelerate children’s access to treatment. The partnership met twice in 2006. Its initial plans include the following: (1) identify scientific obstacles to pediatric treatment that the partnership could address; (2) take practical steps and share best practices on the scientific issues surrounding dosing of ARVs for pediatric patients; and (3) develop systems for clinical and technical support to facilitate rapid regulatory review, approval, manufacture, and availability of pediatric ARV formulations (OGAC, 2006c).

ISSUES AND OPPORTUNITIES FOR IMPROVEMENT

Limited Availability of ART

Virtually every treatment program that the committee visited in the focus countries was crowded to the point of overflowing, and many programs reported long waiting lists. Many people lamented the lack of availability of ART for large numbers of those identified as eligible and expressed the hope that scale-up of treatment could proceed even more rapidly.

In all focus countries, ART roll-out to rural areas has been slow and challenging. In these areas, transportation is often poor, and trained health care workers and laboratory facilities are either minimal or nonexistent. The inability to reach some health care facilities during the rainy season in several countries is a major challenge. A challenge to PEPFAR is the need to collaborate with host governments to develop means of overcoming these obstacles and to demonstrate to all countries how rural treatment can best be achieved.

Recommendation 5-1: The U.S. Global AIDS Coordinator should ensure that adequate medications are available to place 2 million people on sustained antiretroviral therapy to achieve PEPFAR’s stated 5-year treatment target. To achieve this target, the Coordinator should also ensure that adequate linkages are established among prevention, treatment, and care programs and rapidly expand the availability of antiretroviral therapy to both children and adults.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×
Areas for Improvement in ART Programs
Eligibility for ART

The WHO guidelines state emphatically that “treatment of patients with WHO clinical stage 4 disease should not depend on a CD4 cell count determination; all such patients should initiate ART” (WHO, 2006c, p. 14). In several of the sites visited by the Committee, symptomatic stage 4 patients were required to await a CD4 cell count before initiation of treatment, a sometimes lethal delay. Since CD4 cell count determinations are not available in the majority of treatment sites, PEPFAR can effectively address this issue by supporting countries in ensuring that medical and paramedical personnel at ART sites understand that no CD4 cell count is needed prior to initiation of ART in people with WHO clinical stage 4 and symptomatic clinical stage 3 disease.

Preparation for ART

A practice observed in a few treatment sites was a rigid requirement for a fixed number of readiness or adherence training sessions. Such practices are problematic in areas in which patients must travel long distances and/or have no means of transportation to treatment sites, and thus can pose an insurmountable burden, especially for people with advanced AIDS. PEPFAR can address this problem by supporting treatment sites in building reasonable flexibility into such preparatory programs.

Resistance Monitoring

Although results from the current limited surveillance will be helpful in determining the loci for more extensive resistance testing, the Coordinator has determined that it is now time to establish a more effective, systematic means of resistance monitoring in carefully selected sentinel populations more broadly representative of the focus countries. Both the high cost and the requirement for relatively sophisticated laboratory equipment make it impractical to establish widespread resistance testing at all treatment sites. The Committee supports PEPFAR’s plans to address the problem by establishing sentinel systems that monitor specific representative populations on a continuing basis to determine what resistance mutations are emerging and how rapidly, and by supporting the development of simple, inexpensive techniques for resistance monitoring with the potential for utilization at secondary and tertiary treatment sites.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×
Integration of Treatment with Prevention and Care Programs

Although PEPFAR promotes integration of ART with other needed prevention, treatment, and care services, primarily through referral, PEPFAR’s programmatic division into discrete prevention, treatment, and care categories does not facilitate integrated services. The Committee observed and was told about many needed improvements in the integration of ART, for example, with counseling and testing; with treatment programs for other sexually transmitted infections, tuberculosis, and malaria; with reproductive health clinics; with home-based care programs; and with community-based programs. A particular problem resulting from the lack of integration is a disconnect between HIV testing and ART availability. The Committee visited a number of sites where large numbers of people who had been identified as HIV-positive and in need of treatment could not access it. This lack of access was due in part to the rapid scale-up of testing programs not linked to treatment sites and ARV availability. Some of the clinicians with whom the Committee met reported that knowledge of HIV infection in large numbers of people for whom no treatment was available was profoundly demoralizing to they themselves, as well as to those eligible but untreated and those already in treatment in the same areas. The need for evaluations aimed at understanding the appropriate balance between testing and treatment specifically and how to achieve better integration of programs generally is discussed in Chapter 8.

Need for Data on the Effectiveness of ART

Overall, 12- to 18-month follow-up results for ART appear to have exceeded expectations in focus countries for which adequate follow-up data are available (Stringer et al., 2006; Wools-Kaloustian et al., 2006). This, however, is an area to which more attention will need to be directed, with specific information being gathered on such critical issues as ability to return to the workforce and presence or absence of long-term side effects of ART. The effectiveness and sustainability of the PEPFAR program will be dependent on the improved quality of life and return to normal daily activities of a large proportion of patients receiving ART. Data on the effectiveness of ART exist for some cohorts of patients in the focus countries, but are not yet uniformly available. PEPFAR will need to support the focus country ART programs in making such data routinely available.

Challenges for Treatment of Children

Globally, the roll-out of ART to pediatric populations has lagged considerably behind that to adults (GAA, 2006; UNAIDS, 2006). The reasons

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

for this are multiple, and most are currently being addressed by PEPFAR (OGAC, 2005b, 2006d). All elements of treatment have been more difficult in young children than adults. Diagnosis of HIV/AIDS in children has been limited in part because most counseling and testing programs in the focus countries have targeted primarily young adults. The general lack of linkage of prevention of mother-to-child transmission to testing of infants and small children has lessened the likelihood of identifying those who are HIV-positive at that level. Many children who are found to be HIV-positive are orphans or living with orphan heads of households, further complicating adherence to treatment regimens and follow-up clinical visits (GAA, 2006). Treatment has frequently been compromised by initial extreme shortages or absence of U.S. Food and Drug Administration (FDA)-approved generic pediatric formulations of ARVs, especially oral suspensions, which are most helpful for infants and small children, and by the fact that one of the initially utilized pediatric formulations required refrigeration (WHO, 2006a). There still are no available FDA-approved combination preparations in dosages appropriate for small children and infants. This problem is exacerbated by the fact that several focus countries have few if any pediatricians, and general practitioners are often reluctant to assume responsibility for treatment of small children with HIV/AIDS. Even experienced clinicians with whom the Committee visited reported some hesitation in initiating treatment of children because of the complexity of dosing and the need to vary doses over time as the child grows.

A further complicating factor is the very high rate of HIV/tuberculosis coinfection in small children. Such coinfection has been even more common in small children than in adults in the few regions for which relevant data are available (GAA, 2006; UNAIDS, 2006). This has added to the complexity of already difficult dosing schedules. (Tuberculosis/HIV coinfection is discussed further below.)

Despite the many ongoing obstacles to treatment for children, PEPFAR has supported the initiation of pediatric ART programs in all focus countries (OGAC, 2006a,c,d,f,g).

Need for Continued Attention to Marginalized Populations

There is little data available with which to determine how successful PEPFAR-supported ART programs have been in providing access to treatment by especially vulnerable populations in whom HIV prevalence usually exceeds that of the general population. These populations include, but are not limited to, incarcerated people, people who engage in commercial sex work, men who have sex with men, and people who use injection drugs. PEPFAR reported that it is supporting a variety of ART programs that focus on these populations. However, there is a need to further develop and

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

document such programs (see Chapter 3 for discussion of the Committee’s recommendation).

Need to Address Tuberculosis/HIV Coinfection

Another large group of people who are benefiting greatly from PEPFAR programs are those coinfected with tuberculosis and HIV. The immunodeficiency associated with HIV/AIDS has fueled a rapid resurgence of tuberculosis in both children and adults throughout sub-Saharan Africa. In several focus countries, the most frequent cause of death in people with HIV/AIDS is rapidly progressive tuberculosis (Elliott et al., 1993; Harries et al., 2001). In some communities, up to 75 percent of people newly diagnosed with active tuberculosis have concomitant HIV/AIDS infection (Lawn et al., 2006), and an effective response to therapy for tuberculosis depends on concomitant treatment of HIV/AIDS. This poses a challenge, since rifampicin, one of the most effective anti-tuberculosis medications, decreases the plasma levels of several first- and second-line ARVs (Aaron et al., 2004). The Committee learned that effective dosing schedules to overcome this problem are now being introduced at PEPFAR-supported treatment sites.

PEPFAR categorizes tuberculosis/HIV coinfection and other opportunistic infections under its care category. Therefore, these issues are discussed more fully in Chapter 6.

Limited Direct Support for Nutrition

Inadequate caloric intake is a major problem in some regions of all the focus countries and has been clearly identified as a principal reason for failure of clinical response to ART in several regions (Wools-Kaloustian et al., 2006). PEPFAR has recognized this problem and supported many programs in undertaking initiatives to address it. Many patients identified as having HIV infection in the focus countries have lost considerable amounts of weight, and are severely malnourished by the time the diagnosis has been established and ART initiated. Several focus country programs are using PEPFAR funds to develop and implement innovative nutritional support programs for patients receiving ARVs, and additional sites have requested that PEPFAR provide funds to increase nutritional support.

OGAC reported that when possible, PEPFAR has been coordinating with other U.S. government partners such as the U.S. Department of Agriculture and with United Nations agencies, private volunteer organizations, and other international and local partners to ensure that nutritional support is being provided to people living with HIV/AIDS. Additionally, in cases where no other food support resources are available, PEPFAR directly funds the provision of nutritional support both to patients receiving ART and

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

to pregnant and lactating women living with HIV/AIDS (OGAC, 2006b). Both the 2005 and 2006 Country Operational Plans describe ongoing and planned nutritional support activities, including collaborations with other, non-PEPFAR U.S. government food funding sources (see Box 5-3).

Need to Harmonize PEPFAR’s ARV Purchase Requirements with National Plans

PEPFAR has a stated goal of supporting rapid scale-up of ART and is “committed to funding the purchase of the lowest-cost ARVs from any source, regardless of origin, whether copies, generic, or branded, as long as those drugs are proven safe, effective, and of high quality, and their purchase is consistent with international law” (OGAC, 2006a, p. 47). However, PEPFAR’s quality assurance requirement has prevented the program from being fully harmonized with the ART programs of the focus countries and thus has limited PEPFAR’s ability to support the purchase of the focus countries’ first-choice ARVs.

When PEPFAR was initiated, the U.S. Global AIDS Coordinator determined that FDA approval would be the standard for assuring the quality of PEPFAR-provided ARVs. This standard differs from that of other donors—the Global Fund, the World Bank, and the agencies of the United Nations—as well as that of national HIV/AIDS programs, including those

BOX 5-3

Selected Examples of PEPFAR-Supported Nutritional Support Activities

In Kenya, PEPFAR is supporting a demonstration/training farm that fills food prescriptions for eligible patients. The initiative is a public–private partnership between U.S. and Kenyan organizations that involves several comprehensive HIV care clinics in urban and rural centers in western Kenya with close to 4,000 patients on ART.

In Ethiopia, PEPFAR coordinates with the U.S. Department of Agriculture food aid program. Funding is managed by USAID and is used to complement care programs for orphans and vulnerable children and people living with HIV/AIDS.

In Haiti, PEPFAR coordinates with other U.S. food assistance programs for the nutritional support of orphans.

In Mozambique, PEPFAR is supporting HIV-specific nutritional training for improved immune system response in people who are HIV-positive, as well as training on home garden food production specifically for resource-poor households to improve food security for those on ART.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

in the focus countries, all of which rely on the WHO Prequalification of Medicines Project to assure the quality of ARVs for purchase under their programs (see Box 5-4).

The majority of the focus countries have chosen to use generic versions of ARVs in their national programs, and a number of generic ARVs have been prequalified by WHO. When PEPFAR started, however, no generic ARVs had FDA approval, and thus the focus countries were unable to use PEPFAR funds to support their purchase—particularly first-line ARVs and medications that combine two or three ARVs into one pill, known as fixed-dose combinations. Consequently, focus countries whose plans called for generic ARVs made arrangements, whenever possible, to use other sources of funding to purchase the desired generics, and used PEPFAR funds for the purchase of ARVs for which no generic version was available—primarily second-line and pediatric formulations.

Subsequently, the Coordinator supported an expedited FDA review process for generic ARVs (DHHS, 2004; DHHS et al., 2006), and since December 2004 when the first such drug was approved, more than 30 generic versions of first-line ARVs have been FDA-approved for purchase by PEPFAR, including several of the two- and three-drug fixed-dosed combinations suitable for adults as well as several pediatric formulations (FDA, 2006; OGAC, 2007). However, some of the fixed-dose combination ARVs most desired by the focus countries were approved by the FDA only within the past year (FDA, 2006). Moreover, because some focus countries rely on WHO prequalification, they require it in addition to FDA approval. To partly address this problem, the FDA has agreed to share its drug files

BOX 5-4

The WHO Prequalification of Medicines Project

The WHO Prequalification of Medicines Project started in 2001 with the mission of facilitating access to medicines that meet unified standards of quality, safety, and efficacy for HIV/AIDS, malaria, and tuberculosis. The United Nations and the World Bank support WHO prequalification as a key contribution to the United Nations’ priority goal of addressing widespread diseases in countries with limited access to quality medicines. Prequalification evaluates products submitted by companies around the world according to WHO standards of quality, safety, and efficacy. When products are found to meet those standards, they are added to a list accessible to United Nations organizations, countries, and procurement agencies.


SOURCE: WHO, 2006b.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

with WHO to expedite the drugs’ addition to WHO’s list of prequalified medicines. Nonetheless, PEPFAR’s requirement for FDA approval rather than the globally accepted WHO prequalification was the most often-cited impediment to coordination and harmonization during the Committee’s visits to the focus countries, and continues to limit harmonization and rapid availability of PEPFAR-supported first-line ARVs. OGAC reported that only 10 percent of all PEPFAR-supported ARV purchases were for FDA-approved generics in fiscal year 2005, increasing to 27 percent in 2006 (OGAC, 2006f, 2007). Across the focus countries in 2006, the proportion of PEPFAR-supported ARV purchases for FDA-approved generics ranged from 0 to 87 percent (OGAC, 2007).

A previous IOM Committee strongly endorsed “a rigorous, standardized international mechanism to support national quality assurance programs for antiretroviral drugs” (IOM, 2005, p. 8). The Coordinator has not yet determined whether WHO prequalification provides such a mechanism and can adequately assure the quality of generic ARVs for purchase under PEPFAR. U.S. participation in such a mechanism would improve both coordination at the global level and harmonization at the country level, and facilitate more rapid availability of ARVs.

Recommendation 5-2: To support countries’ ownership of their responses to their HIV/AIDS epidemics, the U.S. Global AIDS Initiative should maintain its commitment to harmonization and participate fully in the development of harmonized procedures. To this end, the U.S. Global AIDS Coordinator should work to support World Health Organization (WHO) prequalification as the accepted global standard for assuring the quality of generic medications. Specifically, the Coordinator should provide an analysis of WHO prequalification that determines whether it can adequately assure the quality of generic antiretroviral medications for purchase under PEPFAR. If the analysis shows that WHO prequalification needs strengthening to provide a sufficient guarantee of quality for PEPFAR, the U.S. Global AIDS Initiative should work with other donors to support strengthening of the process, and work to transition from U.S. Food and Drug Administration approval to WHO prequalification as rapidly as feasible.

Human Resource Limitations

Although PEPFAR has supported the training of large numbers of health and laboratory workers, the human resource limitations facing treatment facilities are increasingly felt as treatment expands. A full discussion of human resource issues and the Committee’s related recommendation can be found in Chapter 8.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×
Limited Laboratory Services

The focus countries have generally accepted the WHO guidelines on minimal basic laboratory requirements for initiating and monitoring ART (Gilks et al., 2006; WHO, 2006d). All focus countries have at least one functioning laboratory that can provide these essential services in a tertiary site. However, these services are not uniformly available in secondary treatment sites (provincial medical centers), are seldom available in primary sites (district medical centers), and are generally lacking in outlying rural areas in every focus country. This situation further limits the achievement of PEPFAR’s treatment goals.

PEPFAR’s stated goal for laboratory activities and infrastructure is to establish and support national quality-assured networks of tiered laboratory services that provide clear lines of authority and organization for the development of national laboratory policies, quality assurance programs, and standardized training and testing. PEPFAR’s approach is to promote the early establishment and regular reinforcement of local referral networks both within and among implementing partners. According to 2007 PEPFAR planning direction (OGAC, 2006e), the laboratory components of Country Operational Plans should emphasize implementing partner efforts to

  • Standardize laboratory best practices and provide related training.

  • Provide for uniform quality assurance measures among laboratories.

  • Provide for common equipment and supportive maintenance testing.

  • Support a unified approach to procurement and distribution of laboratory commodities.

A previous Institute of Medicine committee recommended that donors and program managers plan and budget for laboratory activities that can foster more accurate and effective HIV diagnosis and management, using WHO’s 2003 guidelines as the initial template (IOM, 2005). PEPFAR’s Adult Treatment Technical Working Group advised that the focus of PEPFAR-funded laboratory services should be to support ART, and that funding and activities for laboratory services should therefore be related primarily to supporting patients at sites where they are treated. In addition, the working group advised that laboratory services should demonstrate the adequacy of physical infrastructure, trained staff, equipment, supplies, reagents, and quality assurance for diagnosing and treating HIV and opportunistic infections and evaluating drug toxicities. The working group recommended that PEPFAR promote and support a tiered, public health–focused laboratory network as part of the national laboratory strategy (OGAC, 2006h).

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×
Strengthening the Supply Chain

Both the Leadership Act and the PEPFAR strategy recognized the life-threatening consequences of any interruption to the supply of ARVs, as well as the need to avoid waste and to address such issues as diversion and counterfeiting. During the Committee’s visits, the many challenges to securing a reliable supply of ARVs and other HIV/AIDS commodities were evident across all of the focus countries, as were considerable efforts to overcome those challenges, many supported by PEPFAR. Officials in most of the countries visited reported that their ability to predict and maintain supplies had improved, often with assistance from PEPFAR. Some reported past examples of dangerous stock-outs, and all cited the difficulty of obtaining certain drugs or formulations and ongoing concern about maintaining adequate supplies.

PEPFAR has supported the strengthening of supply chain systems and initially planned to support a central supply chain management system (OGAC, 2004, 2005b, 2006b). In late 2005, PEPFAR established the Partnership for Supply Chain Management, a consortium of 17 companies (including those that had previously been providing procurement and logistical support in the focus countries) that is managed under a contract with the U.S. Agency for International Development (USAID) (see Box 5-5). The stated goal of the partnership is to support the provision of an uninterrupted supply of HIV/AIDS commodities flowing through an accountable system.

OGAC funds the central operations of the Partnership for Supply Chain Management from its budget ($15 million for the first year, which includes funds to provide technical assistance to the focus countries in planning for their supply chain needs). The rest of the partnership’s funding comes from country budgets and depends on which services the Country Teams opt to purchase. OGAC reported that at the end of 2006, funding from focus country prevention, treatment, and care budgets totaled $94 million (OGAC, 2007). The contract for the Partnership for Supply Chain Management began in October 2005—too late for the 2006 planning cycle; thus its activities would, at the earliest, be part of the 2007 Country Operational Plans. However, Partnership for Supply Chain Management officials told the Committee that all 15 focus countries had opted to work with the partnership to some degree, ranging from procurement of a limited range of ARVs or laboratory supplies to procurement of almost all PEPFAR-funded commodities. Further, officials of the partnership have made initial visits to all focus countries and opened 10 country offices (OGAC, 2007). Also, as part of its effort to collaborate with other global procurement and distribution systems, the Partnership for Supply Chain Management is serving as the technical secretariat of a World Bank, Global Fund, and PEPFAR working group for joint procurement planning.

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

BOX 5-5

Institutions Comprising the Partnership for Supply Chain Management

  • Affordable Medicines for Africa (AMFA)—Johannesburg, South Africa

  • AMFA Foundation—St. Charles, Illinois, USA

  • Booz Allen Hamilton—McLean, Virginia, USA

  • Crown Agents Consultancy, Inc.—Washington, DC, USA

  • Fuel Logistics Group (Pty) Ltd.—Sandton, South Africa

  • International Dispensary Association—Amsterdam, Nether lands

  • JSI Research & Training Institute, Inc.—Boston, Massachusetts, USA

  • Management Sciences for Health, Inc.—Boston, Massachusetts, USA

  • The Manoff Group, Inc.—Washington, DC, USA

  • MAP Inter national—Brunswick, Georgia, USA

  • Net1 UEPS Technologies, Inc.—Rosebank, South Africa

  • The North-West University—Potchefstroom, South Africa

  • Northrop Grumman Information Technology—McLean, Virginia, USA

  • Program for Appropriate Technology in Health (PATH)—Seattle, Washington, USA

  • UPS Supply Chain SolutionsSM—Atlanta, Georgia, USA

  • Voxiva, Inc.—Washington, DC, USA

  • 3i Infotech, Inc.—Edison, New Jersey, USA

SOURCE: OGAC, 2007.

The Partnership for Supply Chain Management was established too recently for the Committee to be able to judge its performance fairly. However, the Committee shares a number of concerns that have been raised by various stakeholders and urges OGAC to monitor the partnership’s implementation carefully to ensure that any problems that develop are addressed immediately. One concern relates to PEPFAR’s requirement for FDA approval of medications purchased under the program, discussed elsewhere in this chapter. The Partnership for Supply Chain Management is subject to this requirement, which will likely limit its usefulness to many of the focus countries, its efficiency, and its ability to offer medications at the lowest possible cost.

The Committee also shares the concern expressed by stakeholders such as the advocacy group Health GAP and the Ecumenical Pharmaceutical Network—a broadly based international organization that includes many of the faith-based organizations supported by PEPFAR—that the Partnership for Supply Chain Management could undermine country capacity by creating a parallel system, and thus destabilizing rather than strengthening existing systems; having a brain drain effect by taking personnel from

Suggested Citation:"5 PEPFAR's Treatment Category." Institute of Medicine. 2007. PEPFAR Implementation: Progress and Promise. Washington, DC: The National Academies Press. doi: 10.17226/11905.
×

existing systems to work for the partnership; lacking adequate transparency in sharing plans for an exit strategy; and lacking long-term plans for sustainability (Health GAP, 2005; EPN, 2004, 2006). The Partnership for Supply Chain Management has articulated plans to address each of these concerns (Partnership for Supply Chain Management, 2006; OGAC, 2007), but it is too soon to determine how effectively it is carrying out these plans.

The Committee believes it is critical that the Partnership for Supply Chain Management not create a parallel, U.S.-controlled system, but rather strengthen existing local, national, and regional systems, as well as facilitate technology transfer and regional harmonization to ensure sustainability well beyond the life of PEPFAR. To this end, the partnership requires the ability to respond genuinely to local priorities and needs rather than imposing a uniform solution. Evaluating the effectiveness of the partnership in these terms would encourage it to operate in this manner (see Chapter 8).

CONCLUSION

PEPFAR has supported a rapid and substantial expansion of the availability of ART to men, women, and children in the focus countries and has provided support to strengthen the associated workforce, laboratory, procurement, and supply chain systems. The primary early accomplishment of the U.S. Global AIDS Initiative has been to demonstrate that HIV/AIDS services, particularly treatment, can be rapidly scaled up in resource-constrained and otherwise severely challenged environments such as those existing in the focus countries—something many had doubted could be done (UNAIDS, 2001; WHO, 2003a,b; IOM, 2005). But the impact of the expanded availability of ART on the countries’ epidemics remains to be demonstrated, and further expansion of treatment and strengthening of related systems are needed. Meeting these needs will continue to be challenging, and continued support from the U.S. Global AIDS Initiative, with the improvements suggested by the Committee, will be necessary to assist the focus countries in sustaining and expanding the gains made against their HIV/AIDS epidemics.

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In 2003, Congress passed the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act, which established a 5-year, $15 billion initiative to help countries around the world respond to their AIDS epidemics. The initiative is generally referred to by the title of the 5-year strategy required by the act--PEPFAR, or the President's Emergency Plan for AIDS Relief.

PEPFAR Implementation evaluates this initiative's progress and concludes that although PEPFAR has made a promising start, U.S. leadership is still needed in the effort to respond to the HIV/AIDS pandemic. The book recommends that the program transition from its focus on emergency relief to an emphasis on the long-term strategic planning and capacity building necessary for a sustainable response. PEPFAR Implementation will be of interest to policy makers, health care professionals, special interest groups, and others interested in global AIDS relief.

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