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History of Medicine: PEPFAR — 15 Years and Counting the Lives Saved

Drotumdi O

In the long history of successful public health initiatives, such as those leading to the eradication of smallpox, the elimination of polio throughout most of the world, and the marked reduction globally in vaccine-preventable childhood diseases, few programs have matched the impact of one that began in 2003, the President’s Emergency Plan for AIDS Relief, or PEPFAR. This innovative program has had an unprecedented impact on the pandemic of HIV and AIDS.

The major scientific and clinical advances that made PEPFAR possible were the development and approval of highly effective combinations of antiretroviral medications that suppressed the replication of HIV. These drugs, generally administered in combinations of three or more, have transformed the lives of people living with HIV/AIDS, providing them with the possibility of a near-normal life expectancy and, in most cases, the ability to return to normal daily activities. Although HIV-infected people in resource-rich countries almost immediately benefited from these medications when they were licensed in the mid-1990s, a dramatic discrepancy in access to these drugs soon became apparent. More than 90% of all HIV infections were occurring in resource-limited countries, particularly in sub-Saharan Africa, where patients had little or no access to antiretroviral medications. Millions of people who could have been saved were needlessly dying.

PEPFAR was created by President George W. Bush, who felt strongly that as a resource-rich and privileged country, the United States was morally obligated to help people in low-income countries with diseases for which there were effective interventions that were unavailable to them. HIV/AIDS in the resource-limited world, particularly in southern and eastern Africa, was a stark example of such a disease. Early in his administration, Bush articulated his belief that the United States could and should design and implement a transformational and accountable program to address the HIV/AIDS pandemic in low-income countries. At that time, an estimated 30 million people were living with HIV/AIDS in Africa, where more than one third of adults in some countries were infected.1

After consulting scientific advisors, faith-based organizations, and others from both inside and outside his administration, Bush tasked trusted officials, including one of us (A.S.F.) and an inner circle of White House staff, with determining the feasibility of developing a program for the prevention, treatment, and care of people living with or at risk for HIV/AIDS in Africa and other low-income regions. The proposed goal would be to supply lifesaving drugs to HIV-infected people and provide the means of preventing new infections, such as the distribution of condoms to at-risk individuals.

In 2002, Bush sent members of his administration and federal officials, including one of us (A.S.F.), on a fact-finding mission to several of the hardest-hit African countries to determine whether such a program was feasible. In those countries, philanthropic and other organizations were efficiently and effectively providing antiretroviral drugs to small numbers of patients, and it was clear that patients there understood and embraced the critical need for treatment and adherence to treatment regimens. The firsthand observation of what was attainable in sub-Saharan Africa directly contradicted the notion expressed by some that HIV-infected people in southern Africa were incapable of adhering to a daily treatment regimen for a potentially lethal disease. When the delegation returned, the President, through his immediate staff, gave the go-ahead (to A.S.F. and Dr. Mark Dybul) to begin designing the program.

The challenge was to provide HIV prevention, treatment, and care for as many people as possible. Multiple versions and iterations of the proposed program were labored over by White House and other government officials, with the encouragement of the President and his senior staff. There were intense discussions concerning the size and magnitude of the program; which countries would be included; and how best to allocate effort and resources among prevention, treatment, and care; as well as several other considerations. After months of discussion and debate, Bush announced the formation of PEPFAR in his State of the Union Address on January 28, 2003. The original proposal for PEPFAR, authorized with strong bipartisan support from Congress under the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, was for a program costing $15 billion over 5 years and aiming for ambitious goals, including preventing 7 million new HIV infections, treating 2 million HIV-infected persons, and providing care — including basic medical services, education, and social support — for 10 million HIV-infected people, including children who have lost one or both parents to AIDS.

Shortly after President Bush signed the legislation in May 2003, PEPFAR was officially launched in 14 countries in Africa and the Caribbean that were severely affected by HIV/AIDS: Botswana, Ethiopia, Guyana, Haiti, Ivory Coast, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zambia. These countries collectively accounted for nearly 20 million HIV-infected men, women, and children.1 With the addition of Vietnam in July 2004, the PEPFAR partner countries were home to more than 50% of all HIV-infected people in the world.2 The program was an interagency effort spanning the administration and the U.S. government, coordinated by the Department of State.

PEPFAR has received continuous bipartisan support from Congress since 2003 and is the largest global health initiative for a single infectious disease that has ever been implemented. The amount of funds appropriated for PEPFAR in fiscal year 2017 totaled $6.8 billion to provide HIV/AIDS treatment, prevention, and support programs in more than 50 countries. Four PEPFAR directors — Ambassadors Randall Tobias (2003–2006), Mark Dybul (2006–2009), Eric Goosby (2009–2013), and Deborah Birx (2014–present) — reporting directly to the U.S. Secretary of State, have guided and shaped PEPFAR into a remarkable global health success. As of September 2017, PEPFAR-funded programs have provided 13.3 million HIV-infected men, women, and children with antiretroviral therapy; supported 15.2 million voluntary medical male circumcisions in eastern and southern African countries to reduce the risk of HIV transmission; averted nearly 2.2 million perinatal HIV infections; and provided care for more than 6.4 million orphans and vulnerable children.3

Major hurdles of lack of health systems, pervasive stigma and discrimination, and limited access to and uptake of treatment and prevention programs, as well as socioeconomic, cultural, and demographic barriers at the local, regional, and national levels, had to be overcome in order to realize these achievements. Recent PEPFAR data indicate that five African countries — Lesotho, Malawi, Swaziland, Zambia, and Zimbabwe — are on track to achieve the Joint United Nations Program on HIV/AIDS (UNAIDS) targets for treatment implementation by 2020.4

PEPFAR has also provided some of the critical workforce, organizational, and physical infrastructure to address other concerns — such as malaria, tuberculosis, maternal and child health, immunizations, and unanticipated infectious disease outbreaks — that affect the geographic areas where patients with HIV are treated. Specifically, the program has contributed to building sustainable health system capacity in host countries by investing in the critical infrastructure of laboratories and training more than 220,000 health care workers.5 With regard to international public relations, PEPFAR has done as much as or more than any other program in enhancing the humanitarian image of the United States and has firmly established it as a key player in the response to a historic global public health crisis.

Over the past 15 years, PEPFAR has demonstrated the transforming results that can be realized by strong government leadership in the global health arena. It is entirely possible to bring the HIV/AIDS pandemic to an end, and PEPFAR will undoubtedly play an essential role in this endeavor. However, it is vital that support for this transformative program continue both to meet the immediate challenge of HIV/AIDS and to serve as the model for the control and elimination of other globally devastating infectious diseases.