S52 Goosby et al J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, 2012

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1 SUPPLEMENT ARTICLE The United States President s Emergency Plan for AIDS Relief: A Story of Partnerships and Smart Investments to Turn the Tide of the Global AIDS Pandemic Eric Goosby, MD,* Mark Dybul, MD, Anthony A. Fauci, MD, Joe Fu, BS,* Thomas Walsh, JD, MPH,* Richard Needle, PhD, MPH,* and Paul Bouey, PhD, MPH* Abstract: The United States President s Emergency Plan for AIDS Relief (PEPFAR) has played a key leadership role in the global response to the HIV/AIDS pandemic. PEPFAR was inspired by the principles of the historic Monterrey Consensus (United Nations. Monterrey Consensus on Financing for Development, Monterrey, Mexico, March 18-22, New York: United Nations; Available at: Accessed April 21, 2012), which changed the underlying conceptual framework for international development, and therefore global health a shift from paternalism to partnership that begins with country ownership and requires good governance, a results-based approach, and engagement of all sectors of society. PEPFAR began with a focus on the growing emergency of the HIV/AIDS pandemic by rapidly expanding HIV services, building clinical capacity, implementing strategic information systems, and building a coalition of partners to lead the response. Within the first years of implementation, there was a shift to sustainability, including the advent of Partnership Frameworks. The PEP- FAR reauthorization in 2008 codified into law, the evolution in policies and programs for the next phase of implementation. In 2011 alone, PEPFAR supported nearly 4 million people on treatment, supported programs that provided more than 1.5 million HIVpositive pregnant women with antiretroviral drugs to prevent HIV transmission to their children, and supported HIV testing for more than 40 million people. This article provides an overview of how smart investments and partnerships across sectors and US agencies have helped achieve unprecedented results in increasing HIV/AIDS services and engaging partner countries and organizations in sharing the responsibility for an AIDS-free generation. Key Words: PEPFAR, HIV prevention, care, treatment (J Acquir Immune Defic Syndr 2012;60:S51 S56) From the *Office of the US Global AIDS Coordinator, Washington, DC; Georgetown University O Neill Institute for National and Global Health Law, Washington, DC; and National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Various authors have professional relationships with PEPFAR (either as employees of PEPFAR-supported US Government agencies or as grantees/ contractors) as outlined in the Copyright Transfer Agreement forms. The authors have no other funding or conflicts of interest to disclose. The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention, the US Government, or the World Health Organization. Correspondence to: Joe Fu, BS, Office of the US Global AIDS Coordinator, 301 4th Street SW, #700, Washington, DC ( fujkh@state.gov). Copyright 2012 by Lippincott Williams & Wilkins INTRODUCTION On June 5, 1981, the Centers for Disease Control and Prevention s Morbidity and Mortality Weekly Report reported the first cases of the syndrome that would become known as AIDS. 1 For the next 2 decades, the United States led a vigorous multidisciplinary response ranging from academicbased research sponsored by the National Institutes of Health and other US government agencies, to drug development efforts by the private sector, to community-based activism. One of the most notable developments was the introduction of highly active antiretroviral therapy (ART) in the mid-1990s, which helped HIV-infected patients effectively manage the disease. Despite the advent of ART and many other advances, the HIV/AIDS pandemic in low- and middle-income countries continued to spread at a frightening pace. By 1999, UNAIDS estimated that 34 million people worldwide were living with HIV, with more than 20 million in sub-saharan Africa. In some countries such as Botswana, 1 of 3 adults was HIV-positive. 2 HIV/AIDS was growing as a scourge that destroyed families, marginalized persons, and disproportionately harmed children and women. 3 The HIV/AIDS pandemic became so severe that in 2000, it became the first health issue ever addressed by the United Nations Security Council. 4 The United States argued to the United Nations that emerging infectious diseases such as HIV/AIDS, if left unchecked, could affect national security by destabilizing political and economic systems and weakening the military. 5 8 At the time, data from the US Defense Intelligence Agency and the US Armed Forces Medical Intelligence Center suggested that HIV prevalence in the military in African countries ranged from 10% to 60%. 8 A consensus developed, shared by the Administrations of both Presidents Bill Clinton and George W. Bush, that US leadership was necessary to halt the spread of HIV/AIDS. 8 Although US agencies were already working on global AIDS programs, it became clear that a much larger initiative would be necessary to turn the tide of the pandemic. The First 5 Years In response to the growing emergency, President George W. Bush assembled a team to develop a transformative program to fight HIV/AIDS globally. 9 In his January 28, 2003 State of the Union Address, he announced a proposal to devote $15 billion over 5 years to a US-led international J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, S51

2 Goosby et al J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, 2012 AIDS program the President s Emergency Plan for AIDS Relief or PEPFAR the largest international health initiative in history to combat a single disease. Congress provided strong bipartisan support for PEPFAR and authorized it from 2004 to 2008 through the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of Figure 1 provides a timeline of major PEPFAR milestones. During the first 5 years, congressional appropriations for PEPFAR, more than $18 billion, exceeded the authorization. As of 2012, more than $37 billion has been provided for PEPFAR bilateral programs. PEPFAR represented a continuum of services to combat a chronic infectious disease. In fact, it represented the first time the US Government had directly supported interventions for a chronic disease a historic and lasting legacy of the program. By focusing on (1) preventing new infections, (2) providing compassionate care for those who did not yet need treatment and for orphans and vulnerable children, and (3) scaling up treatment, PEPFAR set a new standard for a comprehensive approach to combat HIV/AIDS. Although it is appropriate that much is made of the emergency response, the chronic nature of the disease required an early and intensive focus on capacity building to support national scale-up of prevention, care, and treatment services. PEPFAR intentionally and controversially supported national scale-up to promote country leadership and ownership by focusing resources on 15 nations in Africa, Asia, and the Caribbean that accounted for more than 50% of the world s infections. During the course of the first 5 years, the countries of particular focus continued to expand, eventually reaching more than 30. Also of great importance was accountability. Before PEPFAR, global health and development programs were often judged largely on the amount of resources committed rather than on results achieved. President Bush set, and a bipartisan Congress adopted, specific goals to support the prevention of 7 million new infections, treatment of 2 million HIV-positive persons, and compassionate care for up to 10 million people, including orphans and vulnerable children. An important and unique aspect of PEPFAR was the all of government approach from the beginning. Through the Office of the US Global AIDS Coordinator at the Department of State, PEPFAR developed a unique interagency model that implemented these policies with the combined strengths of multiple US agencies, including the Departments of State, Health and Human Services, and Defense, the US Agency for International Development, and the Peace Corps. Reauthorization In 2007, the Bush Administration put forward a proposal for reauthorizing PEPFAR. On July 30, 2008, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 was signed into law by President Bush, authorizing up to $48 billion over the next 5 years to combat the 3 diseases globally. President Barack Obama, then a Senator from Illinois, and Secretary Hillary Rodham FIGURE 1. Major milestones in PEPFAR ( ), Source: Author s notes; Office of the US Global AIDS Coordinator. S52

3 J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, 2012 Role of PEPFAR in Global AIDS Pandemic Clinton, then a Senator from New York, cosponsored the bill, which passed with bipartisan support. Vice President Biden, then the Chairman of the Senate Foreign Relations Committee, shepherded the bill through his chamber. Although PEP- FAR has always underscored the importance of country ownership and leadership of its response to its own HIV/ AIDS epidemic, the second phase of PEPFAR has accelerated the transition from an emergency response to one of sustainability that was begun in the first phase. Legislative language in the 2008 reauthorization codified the evolution of PEPFAR that had already begun with an emphasis on strengthening health care systems, including expansion of trained health workforce, and development of Partnership Frameworks (PFs) with host countries to promote country ownership and sustainability of programs. In terms of prevention, the reauthorization allowed greater flexibility to fund programs tailored to specific country needs. The Global Health Initiative and the Second PEPFAR Strategy On May 5, 2009, less than a year after PEPFAR s reauthorization, President Obama announced the launch of the Global Health Initiative (GHI), a 6-year interagency effort to support partner countries in improving and expanding access to health services. As the largest US bilateral health program, PEPFAR serves as a central part of the GHI. GHI provides a forum for interface between PEPFAR and other US programs in strengthening health systems, improving monitoring and evaluation, adopting a woman and girl centered approach to health and gender equity, and integrating across health and development programs. Six months later, PEPFAR released its second 5-year strategy 10, which provided a roadmap for sustainability by incorporating the goals of both reauthorization and GHI. The concept of country ownership, seeking to advance health programs that are locally owned and responsive to the needs of host country nationals, is reflected in the document. The strategy addresses HIV/AIDS within a broader health and development context by strengthening health systems, integrating and coordinating health interventions across health programs, such as tuberculosis (TB) and malaria, and linking HIV/AIDS to women s and children s health. It also heightened attention to concentrated and mixed epidemics outside of the original focus countries. In addition, the United States has maintained strong support for the Global Fund throughout the evolution of PEPFAR and GHI (discussed further below). US contributions to the Global Fund support the delivery of significant and concrete health results; expand the geographic reach of and enhance bilateral efforts; catalyze international investment in AIDS, TB, and malaria; build capacity, country ownership, and sustainability; and demonstrate political commitment to international cooperation. LATEST RESULTS Under the Obama Administration, PEPFAR has made unprecedented progress, building on the strong foundation laid under the Bush Administration. Figure 2 shows the number of persons directly supported on ART and PEPFAR funding from 2004 to UNAIDS estimated at the end of 2002 that only 50,000 persons were receiving treatment for HIV in sub-saharan Africa. In its first 8 years, PEPFAR has increased the number of persons it directly supports on treatment from 67,100 in 2004 to nearly 4 million in Between 2008 and 2011, in the midst of the global economic recession, PEPFAR significantly increased the number of people supported on ART. A recently presented evaluation showed that African countries supported by PEPFAR experienced a nearly FIGURE 2. PEPFAR funding and number of persons directly supported on ART ( ). Source: Office of the US Global AIDS Coordinator, WHO Universal Access Progress Reports. S53

4 Goosby et al J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, % decline in all-cause adult mortality during the first 5 years alone. 11 Investments made in volume-based pricing and generic drugs, new shipment modes, prevention interventions such as voluntary medical male circumcision (VMMC), and infrastructure and human resources built early in the PEPFAR program continue to support the gains made. Continued and evolving alignment of funding and programs with bilateral and multilateral partners has also stretched the impact of every dollar invested. In 2011, PEPFAR issued guidance on preventing the sexual transmission of HIV, focusing on a combination prevention approach tailored to specific circumstances in each country, building on combination prevention guidance previously issued. 12 Although there has, appropriately, been much focus on the expansion of treatment, it is important to note the significant progress on HIV prevention. According to UNAIDS, from 2000 to 2010, 33 countries 22 of them in sub-saharan Africa 13 experienced a greater than 25% decline in HIV prevalence. Moreover, demographic health surveys in Botswana, Namibia, and South Africa have shown up to 60% declines in new cases of HIV infection among one of the highest risk groups, young adults. 13 Recent scientific advances indicate that even greater gains can be made. In addition to saving lives of those on treatment, treatment of infected individuals presents an opportunity to save many more lives by preventing HIV transmission. In 2011, a study published by Cohen and colleagues demonstrated that ART, which dramatically lowers HIV viral load in infected persons, reduced the risk of heterosexual HIV transmission to an uninfected partner by 96% if started relatively early in the course of HIV disease (CD4 + T-cell count of cells/mm 3 ), rather than waiting for the immune system to deteriorate. 14 In essence, implementation of treatment of HIV-infected individuals can have the dual benefit of saving lives of infected individuals at the same time as preventing transmission of HIV to uninfected sexual partners. Reflecting its role of translating new science into policy to inform programs, PEPFAR is expanding its commitment to treatment, consistent with input from its Scientific Advisory Board on how to achieve the greatest possible benefits from this breakthrough. 15 The long-term savings and broader benefits that result from providing treatment also make it a valuable investment. Studies suggest that increasing ART coverage can avert costly and detrimental outcomes that extend beyond the patient receiving treatment by extending productive lifeyears, preventing transmission and stopping children from becoming orphaned. 16 On World AIDS Day 2011, President Obama announced PEPFAR s plan to support 6 million persons on treatment by 2013, 2 million more than the previous treatment goal. PEPFAR has also accelerated scale-up of prevention of mother-to-child transmission (PMTCT) efforts. Not only do PMTCT interventions reduce pediatric infections, they also provide a platform to treat infected mothers and prevent their other children from becoming orphans. In 2011, PEPFAR directly supported HIV testing and counseling (HTC) for more than 9.8 million pregnant women (+88% since 2008) and antiretroviral drug prophylaxis to prevent mother-to-child S54 transmission for more than 660,000 (+72% since 2008) of these women who tested positive for HIV. These efforts allowed approximately 200,000 infants to be born HIV-free. PEPFAR also directly supported nearly 13 million people (+55% since 2008) with care and support in 2011, including more than 4.1 million orphans and vulnerable children (+40% since 2008). In addition to PMTCT, a significant component of the PEPFAR combination prevention portfolio is dedicated to VMMC and programs for key populations at high risk. VMMC reduces the risk of heterosexual acquisition of HIV by men, and some studies suggest VMMC can decrease the incidence of infection of circumcised men by more than 70%. 17 VMMC is also highly cost effective, as a 1-time investment with an average cost/vmmc as low as $20 results in future net savings because of averted treatment and care costs. Since 2007, PEPFAR has supported over 800,000 VMMCs for HIV prevention. For key populations at high risk, there is substantial evidence that a core set of interventions can drastically reduce HIV prevalence and that reduction will also carry over into the general population. These groups include sex workers, men who have sex with men, and people who inject drugs. The latter 2 populations are the focus of PEPFAR prevention guidance documents, which are guiding expansion of interventions adapted for different subgroups especially vulnerable to HIV. This emphasis is especially important in countries with epidemics driven by these groups, where the interventions will have the greatest epidemiologic impact. In clinical trials, preexposure prophylaxis with antiretroviral drugs has been shown to reduce infections in men who have sex with men by 44%. 18 When adherence is high, reductions in transmissions have exceeded 90%. 18 Although other clinical trials have been less encouraging, perhaps because of poor adherence of volunteers to study drugs, preexposure prophylaxis with further development likely will prove to be useful as a targeted intervention to selected high-risk populations. HTC is an often-overlooked critical success factor for the expansion of prevention programming. Knowledge of one s HIV status is a prerequisite to accessing treatment and taking appropriate prevention steps to stay safe or protect others. PEPFAR directly supported HTC for more than 40 million people in fiscal year 2011, providing a critical entry point to prevention, treatment, and care. Further efforts to expand HTC, including the use of rapid test kits, will enable more widespread and routine testing both within and outside of health facilities. The integration of related health programs in TB and gender-based issues, which enhance PEPFAR s response to HIV/AIDS, has played a key role in PEPFAR s strategy since authorization. TB is the leading cause of death among people living with HIV. In 2011, PEPFAR-supported programs screened 3.8 million people living with HIV for TB in HIV care or treatment settings. In line with GHI principles, PEPFAR s gender strategy recognizes that addressing gender norms and inequities is essential to reducing HIV risk and increasing access to HIV prevention, care, and treatment services for both women

5 J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, 2012 Role of PEPFAR in Global AIDS Pandemic and men. In low- and middle-income countries worldwide, HIV is the leading cause of death and disease in women in reproductive age; and in sub-saharan Africa, 60% of those living with HIV are women. Over the last 2 years, PEPFAR has invested a total of $155 million in gender-based violencerelated programming, making PEPFAR one of the largest investors worldwide. PEPFAR has also invested in special gender initiatives to pilot specific approaches, build our evidence base for investments, and expand programming at the country level. The drivers behind these exceptional results and the associated challenges and opportunities are thoroughly and thoughtfully examined in the articles throughout this supplement. A STORY OF PARTNERSHIPS PEPFAR s ability to scale-up HIV services has benefited from leveraging the core competencies of partners across multiple sectors and uniting them in the shared goal of saving lives. The idea of country ownership is a constant theme throughout PEPFAR, particularly in its second phase, as more attention is being paid to how we can better integrate country ownership into all aspects of program. Although always a complex process, the value of country ownership is essential to the long-term viability of a robust health system that is locally owned and led by a country s stakeholders in a sustained response to the epidemic. Bilaterally, Partnership Frameworks (PFs) have embodied this concept. These provide 5-year joint strategic frameworks for cooperation between the United States, the partner government, and other partners to combat HIV/AIDS in country through service delivery, policy reform, and coordinated financial commitments. As of 2011, 21 PFs have been signed with countries and regions around the world. In many cases, PFs build on and complement the work accomplished in the beginning years of PEPFAR, when the United States, United Kingdom, and UNAIDS supported the development of the 3 Ones strategy including a commitment to support one national AIDS strategy that brings together and aligns the efforts and contributions of many partners. 19 Global AIDS is a shared responsibility at the country level, a mix of resources from bilateral programs such as PEPFAR, host countries, and multilateral partners is required. The Global Fund represents the largest multilateral funding mechanism for responses to the 3 diseases. The United States is the largest contributor to the Global Fund, accounting for nearly one-third of total commitments. In addition, PEPFAR and the Global Fund are highly interdependent in support of country HIV programming. Figure 3 shows not only the combined global scale-up of treatment by PEPFAR and Global Fund (5.6 million persons in 2011) but also their coordinated support of more than 70% of all persons on ART worldwide in Within many countries, this combined support is so integrated that many individual patients depend on both PEPFAR and the Global Fund for support. More recently, US leadership has led to increased collaboration to improve grant management and implementation as part of an overall strategy to link US commitments to reforms, which will help ensure that every dollar invested is maximized to save lives helping in turn to convince donors that investments in the fund are sound ones. Faith-based organizations and civil society are critical elements of health systems in the developing world. An engaged and supported civil society is an essential part of the move toward country ownership of effective national HIV/AIDS responses, often serving as the only option for people who live in rural areas and for populations that are most at risk. Private public partnerships, which add the skills and core competencies of the private sector, have also played an essential role in strengthening PEPFAR s response. FIGURE 3. Persons directly supported by PEPFAR and the Global Fund on ART ( ). Source: The Global Fund, Office of the US Global AIDS Coordinator, World Health Organization. At the time of publication, data on the percentage of all persons on treatment in lowand middle-income countries supported by PEPFAR and the Global Fund in 2011 was unavailable. S55

6 Goosby et al J Acquir Immune Defic Syndr Volume 60, Supplement 3, August 15, 2012 Equally important is the thoughtful engagement of policy makers, implementers, advocates, and agency officials who work across disciplines and share expertise in making PEPFAR a stronger program. Ultimately, partnerships across sectors and US agencies have helped PEPFAR achieve unprecedented results in increasing HIV services and engaging partner countries and organizations in sharing the responsibility of easing the burden of HIV/AIDS. CONCLUSIONS With a large and continuing need for HIV services, in an era of constrained resources, PEPFAR will surely confront new challenges. PEPFAR s history of bringing together multiple sectors, countries, and administrations, and its commitment to scale-up of evidence-based, cost-efficient, and effective interventions offer encouragement for the road ahead. PEPFAR will continue to translate promising scientific discoveries and operations and implementation research into lifesaving public health programs and policies. This is an important juncture for the global AIDS response. Just as the second phase of PEPFAR built on and improved on the lessons learned in the first 5 years, the next phase of PEPFAR will grow from the strong foundation laid over the past decade. In the end, PEPFAR s success past and future is the success of the innovative, talented, and creative people in the countries that it supports and serves. It is a success of the American people acting on their deeply rooted belief in the dignity and worth of every person. It is, fundamentally, a story of the human spirit. REFERENCES 1. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Vol 50. Atlanta, GA: CDC; Available at: Accessed April 20, UNAIDS. Report on the Global AIDS Epidemic. Geneva, Switzerland: UNAIDS; Altman LK. More African women have AIDS than men. New York Times. November 24, Available at: world/more-african-women-have-aids-than-men.html. Accessed June 20, The White House, Office of the Vice President. Remarks Prepared for Delivery by Vice President Al Gore, United Nations Security Council Opening Session. Washington, DC: White House; Gordon DF. The Global Infectious Disease Threat and Its Implications for the United States. Washington, DC: National Intelligence Council (NIC), NIE 99 17D, Available at: globalinfectious.html. Accessed March 29, Singer PW. AIDS and international security. Survival. 2002;44: Sachs J. The best possible investment in Africa. New York Times. February 10, 2001:A Feldbaum H, Lee K, Patel P. The national security implications of HIV/AIDS. PLoS Med. 2006;3:e Fauci AS. A view from Washington through the eyes of an AAP physicianscientist. J Clin Invest. 2007;117: PEPFAR. Five-Year Strategy. Washington, DC: OGAC; Available at: Accessed April 20, Bendavid E, Holmes CB, Bhattacharya J, Miller G. HIV development assistance and adult mortality in Africa. JAMA. 2012;307(19): PEPFAR. PEPFAR Prevention Guidance. Washington, DC: OGAC; Available at: Accessed April 20, World Health Organization, UNAIDS, UNICEF. Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011 [Internet]. Geneva: WHO, UNAIDS, UNI- CEF; Available at: _eng.pdf. Accessed June 20, Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365: Available at: Accessed April 11, PEPFAR. PEPFAR Scientific Advisory Board Recommendations for the Office of the US Global AIDS Coordinator: Implications of HPTN 052 for PEPFAR s Treatment Programs. Washington, DC: OGAC; Available at: pdf. Accessed April 20, Blandford J. The Impact of Treatment as Prevention Models to Guide Ending the Epidemic. New York: AVAC Webinar; Available at: Accessed April 20, Gray R, Kigozi G, Kong X, Ssempiija V, Makumbi F, Wattya S, Serwadda D, Nalugoda F, Sewenkambo NK, Wawer MJ. The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow-up study. AIDS. 2012;26(5): Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010; 363: UNAIDS. The Three Ones in Action: Where We Are and Where We Go From Here. Geneva, Switzerland: UNAIDS; Available at: Accessed April 20, S56