“Before the Emergency Plan for AIDS Relief, only 50,000 people of the more than 4 million people in sub-Saharan Africa needing immediate AIDS treatment were getting medicine – think about that, only 50,000 people. After two years of sustained effort, approximately 400,000 sub-Saharan Africans are receiving the treatment they need.”
-- President George W. Bush,
World AIDS Day December 1, 2005

Antiretroviral treatment (ART) is more than drugs – it represents hope. To people who have understood their HIV infection to be a death sentence, treatment promises a future.

Thanks to the urgent efforts of dedicated partners – both governmental and nongovernmental – in the field, and with support from the Emergency Plan, this hope is reaching a growing number of people.

Just two years into the initiative, the Emergency Plan is now partnering with host nations to support treatment for approximately 401,000 people in the 15 focus nations, and 70,000 people in the rest of the world, for a total of 471,000 people worldwide.

In achieving this success, the Emergency Plan has moved faster than any other bilateral or multilateral initiative to support the expansion of HIV/AIDS services using a network model of care to bring life-extending treatment to areas that are among the world’s most difficult to serve. This success is rapidly transforming the social landscape in many of the world’s hardest-hit nations, and it is an achievement to celebrate.

Yet it is not enough to scale up quickly. In the area of treatment, it is particularly essential that programs maintain the highest quality. Because treatment is complex, quality treatment has many elements. Antiretroviral drugs (ARVs) are one of these critical elements. The quality, safety and efficacy of formulations must be ensured, and ARVs and other needed commodities must travel to treatment sites via a secure and reliable supply chain.

Medical care must also be of high quality for treatment to be effective: those administering and monitoring treatment must be well-trained in the nuances of complex regimens. The unique dosing needs of children receiving ART must be considered on an individual basis. There must be effective integration of treatment with prevention and care services. Outreach to communities to support people on treatment and support adherence is also essential for quality programs.

The effects of poor quality treatment go beyond simple waste of scarce resources. Poor quality treatment means increased risk of morbidity and mortality for individual patients. Just as importantly, it can lead to widespread development of toxicity and transmission of viruses resistant to current treatment. The Emergency Plan is thus devoting intensive resources to strengthen the systems necessary to ensure that the treatment offered to HIV-positive people in the developing world is of high quality.

A second threat to the hope that ART scale-up brings is the threat that treatment will become unavailable in the future. When managed with ART, HIV is a chronic condition, and patients who begin therapy must maintain it for the rest of their lives. If people on ART lose their access to medications, they will die.

Sustainability for the indefinite future is thus also critical for ART efforts, and as with all HIV/AIDS responses, this can only be guaranteed by local leadership and ownership. For this reason, the Emergency Plan focuses support on helping host nations develop critical network systems. PEPFAR partners with these nations, supporting them as they harness the resources of their own societies to build capacity to treat their people for the long term.

Results: Rapid Scale-Up
ART – including ARV drugs and services, as well as laboratory support – received approximately $470 million in Emergency Plan funding in fiscal year 2005, or 46 percent of total focus country resources for prevention, treatment and care activities.

As a result of this unprecedented commitment to partnership with host nations, PEPFAR supported ART for approximately 401,000 people in the focus countries through September 2005. Of these people, approximately 249,000 benefited from site-specific “downstream” support, while approximately 152,000 benefited from “upstream” support for national health care networks and systems for ART provision. (These categories of support are explained in the Accountability section at the end of this chapter.) Of those receiving downstream support, approximately 171,000 began treatment during fiscal year 2005, while the remainder continued treatment previously begun.

The Emergency Plan features a growing commitment to pediatric AIDS treatment, and of those receiving ART at downstream sites for whom partners reported age, approximately 7 percent were children. This number is likely understated, as many partners are still developing systems – with PEPFAR support – to report adult or child status in all data. Further information on the challenges and early results in the area of pediatric AIDS treatment may be found in the chapter on Children.

The Emergency Plan is also committed to ensuring full participation of women in treatment activities, and is working with implementing partners toward the goal that all patients served be reported by gender. At downstream sites where implementing partners reported results by gender, 60 percent of those receiving PEPFAR-supported ART were women and 40 percent were men.

Graphic below shows the number of people receiving treatment, depicting those receiving treatment with support from Emergency Plan Bilateral Programs (471,000 people), which are 100 % funded by the Emergency Plan and/or those receiving treatment with support from the Global Fund To Fight AIDS, Tuberculosis, and Malaria (384,000 people), which is approximately 33% funded by the Emergency Plan. Of these two figures -- 471,000 and 384,000 -- 214,000 overlap, so the combined total is 641,000 people (471,000+384,000 less 214,0000).

Beyond the 15 focus countries, the Emergency Plan also supported ART for approximately 70,000 people through bilateral programs in 17 other nations, for a total of approximately 471,000 people worldwide receiving ART with PEPFAR support.

The Emergency Plan is working to support the implementation of effective monitoring and evaluation systems across USG implementing partners in support of national monitoring and evaluation systems. This is assisting incountry teams and implementing partners to monitor and improve delivery of services and, in particular, adherence to therapy. In Uganda, for example, PEPFAR has implemented a comprehensive monitoring and evaluation (M&E) system across some of its treatment partners, allowing the partners and USG to have a snapshot of partner-level data on key quality-specific indicators such as the retention of patients on ART and adherence to preventive care guidelines (such as the use of cotrimoxazole). This approach has yielded valuable information for both PEPFAR and its partners, and the USG is now planning to expand it to other partners in Uganda. Other innovative M&E programs are being developed in focus countries for use in them and beyond.

The U.S. is also the largest donor to the Global Fund. The Global Fund has reported that it supported ART for 384,000 people globally as of the end of 2005. Of those, 214,000 received support from both the bilateral and multilateral resources of the Emergency Plan, as shown in Figure 2.2.

Sustainability: Building Capacity
While helping host nations rapidly scale up high-quality treatment today, the Emergency Plan is also supporting them in building the capacity and instituting the systems to expand treatment in the future.

Training in ART services for health care workers is a major focus; in fiscal year 2005, the Emergency Plan supported training or retraining for approximately 36,500 service providers in the focus countries. These efforts range from lecture format to bedside mentoring and include on-the-job training and other strategies to support those trained in remaining at their posts.

Strengthening sites for quality ART provision is critical: this includes addressing deficits in infrastructure, laboratory capacity, and procurement and distribution of ARVs and other commodities. The Emergency Plan supported approximately 800 ART service sites in the focus countries in the reporting period, and the new Partnership for Supply Chain Management, described in the chapter on Building Capacity for Sustainability, will make a major contribution to meeting procurement and distribution challenges for ARVs and other commodities needed for quality treatment. PEPFAR support for laboratory capacity – including equipment, training, and quality control – is also helping nations improve their ability to monitor individuals’ response to care and treatment and make better informed clinical judgments.

Moving beyond a hospital- and clinic-based model for provision of ART will also help make services more widely available and sustainable, and PEPFAR is supporting development of a widening range of treatment settings. Strengthening linkages under the network model so that patients have access to seamless prevention, treatment and care services is also a priority. This is particularly important for persons with TB, OVCs, and mothers, among others.

Emergency Plan-supported activities involve networks of people living with HIV/AIDS (PLWHA) to support treatment literacy and adherence, fostering quality as well as sustainability.

Antiretroviral drugs as a component of antiretroviral treatment
Low-quality or inappropriately prescribed ARVs can do more harm than good in the fight against HIV/AIDS. Drug interactions often alter the preferred first-line therapy, as in the case of those treated for HIV and TB simultaneously, many of whom cannot use their nations’ preferred first-line regimens. Drug resistance and toxicity are already increasing in nations as ART becomes widely available, making it increasingly crucial that a broad formulary be available.

The Emergency Plan remains 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.

To meet the need for rapid identification of drugs proven to be safe, effective, and of high quality, the Food and Drug Administration of the Department of Health and Human Services (HHS/FDA) introduced in May 2004 an expedited process whereby drugs from anywhere in the world, produced by any manufacturer, could be rapidly assessed for purchase under PEPFAR.

Approved or tentatively approved drugs are determined to meet standards equal to those established for the U.S., ensuring that no drug purchased for use in PEPFAR programs abroad falls below standards for U.S. families. Through December 2005, 15 new generic formulations received approval or tentative approval from HHS/FDA under the expedited review established in May 2004, including four pediatric formulations. By late 2005, at least four focus countries had begun to import HHS/FDA approved generics. As a side benefit, the process developed for PEPFAR has also expedited availability of generic versions of ARVs whose U.S. patent protection has expired.

Some host nations, however, require additional review that can delay or prevent implementing partners from using ARVs that have been found safe and effective by HHS/FDA. HHS/FDA conducted a workshop for host governments on this issue in September 2005, and is engaging in additional outreach efforts to inform drug regulatory officials about the process that leads to approval or tentative approval of generic anti-retroviral agents, and to keep them informed about the current list of such drugs. This collaboration will hasten the incountry approval process.

The USG has also worked with multilateral partners. HHS/FDA has signed a confidentiality agreement with the World Health Organization (WHO) Secretariat to hasten the inclusion on the prequalification list at WHO of generic antiretroviral drugs approved or tentatively approved by HHS/FDA, and such ARVs have begun to be added to the drug list maintained by the WHO prequalification project. The Global Fund to Fight AIDS, Tuberculosis and Malaria now recognizes HHS/FDA tentative approval as approval by a “stringent regulatory authority,” which means Global Fund resources may go to purchase HHS/FDA tentatively approved generic antiretroviral drugs.

Key Challenges and Future Directions
Reaching HIV-positive children with ART is a major challenge, due in large part to the difficulty of infant diagnosis of HIV. The Emergency Plan has launched a major effort to meet and overcome this and other obstacles and is greatly expanding its pediatric treatment efforts. For more information, see the chapter on Children.

Ensuring adherence to ART is a critical challenge the Emergency Plan is working to confront. The Emergency Plan is expanding support for population-based testing for resistance and toxicities in order to adjust treatment, as well as laboratory support for testing to determine when a person needs to begin HIV treatment and to monitor that therapy.

Quality is also being addressed with a number of systemstrengthening approaches, including monitoring and evaluating programmatic indicators, on-site supervision, and district, national, and international ART program reviews. The Emergency Plan’s interagency ART Technical Working Group has guided such efforts, and the information is now being used to improve programs.

In Rwanda and other focus countries, PEPFAR provides the government with intensive technical assistance to ensure treatment quality, supporting such activities as equipment procurement, review and development of operating procedures, improvement of store management, and management and information systems.

One promising approach to meeting the challenge of reaching HIV-positive people with ART is public-private partnerships. Among these are workplace efforts, through which PEPFAR is partnering with employers to support ART for their employees and their families. In some cases, the Emergency Plan conducts training while the employer procures the ARVs. A number of U.S. Embassies have demonstrated leadership by instituting ART workplace programs for their own employees.

Human capacity constraints remain a serious impediment to ART scale-up, exacerbated by the “brain drain” of health workers from many focus nations to developed countries and the toll HIV/AIDS has taken on health workers. ART requires training, which the Emergency Plan is working to provide through innovative school and on-the-job methods.

Despite the shortage of health workers, some countries are reluctant to expand responsibility for ART administration and monitoring beyond physicians. The Emergency Plan has been working with governments to promote the “network system,” which seeks to allocate highly trained health workers – such as physicians with specialized training – to referral centers where their level of training is essential, while allowing non-physicians trained in ART to administer treatment at field sites. The soaring demand for ART in resource-poor nations requires a flexible health workforce, and PEPFAR supports policy initiatives to permit such flexibility. This topic is discussed further in the chapter on Building Capacity for Sustainability.

The geographic dispersal of PLWHA, with many in remote rural areas, provides a key challenge in making ART available to those who need it. PEPFAR efforts to reach rural populations include innovative models, as well as expansion of the network system and outreach to community- and faith-based providers. A home-based care (HBC) model for delivery of ARTs is also being used successfully in many settings; in Rwanda, the CHAMP program involves community-based organizations to provide HBC. There are training manuals on HBC and a network system that links HBC to services in the area, including pediatric services.

Quality ART programs depend on secure and reliable ARV supply chains, with risks of interruption a dangerous threat to ART programs. The new Partnership for Supply Chain Management, discussed in the chapter on Building Capacity for Sustainability, will do much to ensure that this is maintained even when local circumstances become difficult.

Another key challenge is coordination with other international partners. ARV supply challenges faced by Haiti in 2005 demonstrated the benefit of close cooperation among partners such as PEPFAR, the Global Fund, and the World Bank. The Emergency Plan has supported nations that have moved to country-level unified procurement and distribution systems, such as Rwanda.

Accountability: Reporting on the Components of Treatment
The First Annual Report to Congress of the Emergency Plan described the ways in which U.S. support is provided. Where partnership limitations or technical, material or financial constraints require it, the Emergency Plan, or another partner, may support every aspect of the complete package of prevention, treatment, or care services at a specific public or private delivery site, in coordination with host-country national strategies.

Downstream support
In many areas, the Emergency Plan coordinates with other partners to leverage resources at a specific site, providing those essential aspects of quality services that others cannot provide due to limited technical and/or financial circumstances. For example, in some settings components of services are provided to specific sites through the host-country government or other international partners such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, while the Emergency Plan may contribute other essential services, training, commodities, and infrastructure. “Downstream” site-specific support refers to these instances where the Emergency Plan is providing all or part of the necessary components for quality services at the point at which services are delivered.

Upstream support
Beyond the site-oriented downstream components of services, support is required to provide other critical elements, which may include the training of physicians, nurses, laboratory technicians, other health care providers, and counselors or outreach workers; laboratory systems; strategic information systems, including surveillance and monitoring and evaluation systems; logistics and distribution systems; and other support that is essential to the effective roll-out of quality services. This coordination and leveraging of resources optimizes results while limiting duplication of effort among partners, with roles determined within the context of each national strategy. Such support, however, often cannot easily be attributed to specific sites because it is national or regional in nature, and, in fact, many sites benefit from these strategic and comprehensive improvements. Therefore, this support is referred to as “upstream” support and is essential to developing network systems for prevention, treatment, and care.

Upstream support is vital to creating sustainable national systems. In Botswana, for example, the government has led an aggressive and highly successful multisectoral response with its own resources and significant downstream contributions from the private sector through the African Comprehensive HIV/AIDS Partnerships (funded by the Bill & Melinda Gates Foundation and the Merck Company Foundation). The USG has provided significant contributions to the development and implementation of national systems for training, quality assurance, and guidelines applied to clinical delivery of ART, HIV laboratory, and monitoring and evaluation of the ART program. These contributions strengthen the overall success of Botswana’s national strategy.

This report covers patients who are receiving upstream and downstream Emergency Plan support. The complexities of both forms of support highlight the vital importance of implementing the “Three Ones” agreement (see the chapter on Strengthening Multilateral Action). In working with major partners, including the Global Fund, WHO, and UNAIDS, the Emergency Plan is coordinating its monitoring and evaluation efforts and reporting criteria to develop consistent methodologies to determine the number and attribution of patients receiving treatment through upstream and downstream support from multiple organizations.

Attribution challenges due to country-level collaboration
The Emergency Plan supports national HIV/AIDS treatment strategies, leveraging resources in coordination with host-country organizations and other international partners to ensure a comprehensive response. Host nations must lead a multisectoral national strategy for HIV/AIDS for an effective and sustainable response. International partners 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 international partners are not desirable or sustainable. In such an environment, attribution is complex, including both upstream and downstream activities, often with multiple partners supporting the same sites to maximize comparative advantages. PEPFAR is conducting audits of its current reporting system to refine methodologies for the future, and continues to assess attribution and reporting methodologies in collaboration with other partners.

Treatment reporting conventions
During this reporting period, to account for Emergency Plan treatment programming, in-country partners 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 supported by the U.S. Government’s contribution to national, regional, or local activities.

Reporting by gender and age
The Emergency Plan requirement that ART service sites report on the gender and adult/child status of those served, in order to ensure that ART activities are reaching women and children, will become mandatory for all partners in fiscal year 2006.