Breakthroughs Blog: PEPFAR

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. On Thursday, the US Senate confirmed Dr. John Nkengasong as US global AIDS coordinator to head the President's Emergency Plan for AIDS Relief, or PEPFAR. Dr. Nkengasong, a Cameroonian virologist who currently serves as director of the Africa Centres for Disease Control and Prevention (CDC), is the first person born on the African continent to take on the global AIDS coordinator role. President Joe Biden nominated him for the position last September, following a gap in permanent leadership since Dr. Deborah Birx departed in 2020. Prior to his position at Africa CDC, Dr. Nkengasong worked at PEPFAR on strengthening laboratory capacity across Africa. Africa CDC Deputy Director Dr. Ahmed Ogwell Ouma will head the agency in the interim while the African Union Commission selects a new director.The World Health Organization (WHO) last week released a rapid communication stating that patients 15 and older with multidrug-resistant tuberculosis (TB) or rifampicin-resistant TB can take a six-month, all-oral treatment regimen—comprising the drugs bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM)—instead of a regimen lasting nine months or longer. The guidance also indicates that patients with multidrug-resistant TB or rifampicin-resistant TB who have developed resistance to fluoroquinolones can subscribe to the same six-month treatment regimen, but without moxifloxacin—known as BPaL. WHO has previously recommended the BPaL and BPaLM treatment regimens, but only under operational research conditions; the new recommendation will allow programmatic implementation of treating almost all forms of drug-resistant TB with either of the shorter regimens.Two novel COVID-19 vaccine platforms—a plant-based coronavirus-like particle vaccine and a receptor-binding domain (RBD)–dimer-based vaccine—showed promising results, according to studies published last week based on phase 3 clinical trials. The two-dose, plant-based particle vaccine, developed by Medicago and GlaxoSmithKline, showed 69.5 percent efficacy against symptomatic COVID-19 caused by five variants identified in sequencing, and no severe cases or deaths were recorded. The RBD-dimer-based vaccine, developed by Anhui Zhifei Longcom, is a three-dose shot that showed 75.7 percent efficacy against infection and 87.6 percent efficacy against severe to critical disease. Neither vaccine requires extreme cold chain storage, which makes them appealing candidates for global COVID-19 vaccination efforts.

The Trump administration’s budget request for fiscal year 2020 (FY20) includes cuts that—if enacted—would hamstring the research and development (R&D) of new global health technologies funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), US Agency for International Development (USAID), and Department of Defense (DoD). Since the release of the budget request in early March, however, lawmakers from both parties have expressed their commitment to shielding these critical funding strings from the president’s scissors.Among the proposed cuts is a 12 percent reduction for NIH. On April 11, the Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee (LHHS) held a hearing to review the budget request for NIH. From the beginning, it was clear the administration’s proposal would face bipartisan pushback. Subcommittee Chairman Roy Blunt (R-MO), in his opening remarks, said, “I'm disappointed, of course, that the 2020 budget request would cut the agency by 13 percent. I'm confident that this committee will not do that, but we'll talk to you today about the reasons that we should continue in the direction we're in rather than head in another way.”Chairman Blunt was followed by Ranking Member Patty Murray (D-WA), who delivered an even stronger rebuke: “At a time of remarkable possibility in medical research, a time where we can and should continue leading the world in medical discovery, the Trump administration wants to cut funding for NIH… President Trump's damage -- damaging budget is wildly out of step with the sentiments of Congress, thankfully, and the American people. And I feel confident, working with our Chairman, that we will once again reject it.”Later in the hearing, Senator Richard Shelby (R-AL), who serves as Chairman of the full Senate Appropriations Committee, also voiced his support for an NIH funding increase:“What you do is more important than most [of] what we do in America. I'm not interested in cutting your budget. I'm interested in increasing it…I think this is a great investment for America, for the world, for humanity, what you do… it's not only a financial investment, which is good for the economy. It is the leading scientists, the cutting edge of scientific research that you add. And we all benefit from it immensely.”The week prior, the House Appropriations LHHS Subcommittee had held their hearing on the NIH budget. Subcommittee Chairwoman Rosa DeLauro (D-CT) said that Congress would reject proposed funding cuts to the NIH. In her opening statement she emphasized the value of scientists’ work: "Funding [biomedical] research has the power to do more good for more people than almost anything else within the purview of this subcommittee.”Referring to the administration’s newly launched effort to end the transission of HIV and AIDS in the United States, Chairwoman DeLauro continued: “Decades of research supported by NIH led to the development of the very treatment and prevention approaches that have put achieving this goal within reach, specifically antiretroviral therapy and PrEP. The NIH must be involved, if we are to continue to make progress in reducing HIV and AIDS, domestically and abroad.”In other budget hearings, lawmakers focused on important funding sources for global health R&D outside of NIH—including the DoD. In the House Appropriations Defense Subcommittee hearing on the US Army budget on April 9, Rep. Betty McCollum (D-MN), Vice Chair of the Subcommittee and Co-chair of the House Global Health Caucus, pressed the Secretary of the Army and Army Chief of Staff about proposals to divert funding from malaria vaccine research funded by the US Army: “Given that malaria remains the number one infectious disease threat for troops deployed in these regions, and we know that we have issues with [treatment] compliance, whether it’s State Department, military, even Peace Corps volunteers because of the side of effects from these diseases, it remains critically important that the Army’s research on malaria vaccines continue. I’m concerned in the FY20 budget that the justification appears that the funding for the project that conducts malaria vaccine research is being realigned into other projects. Given nearly all the most effective widely-used anti-malarials were developed in part by the US military research team, I find the possibility of losing momentum in research extremely alarming.” With the ongoing outbreak in the Democratic Republic of the Congo (DRC), Ebola is another infectious disease high on lawmakers’ radar. On March 14, the Senate Appropriations LHHS Subcommittee held a hearing on the Ebola outbreak in DRC and other emerging health threats. Subcommittee Chairman Blunt’s (R-MO) opening statement emphasized, “It is clear that our investments to improve global health have a direct impact on the wellbeing of every American.” He highlighted recent funding increases he has championed for the NIH National Institute for Allergy and Infectious Diseases, the CDC, and the Global Health Security Agenda. Senator Richard Durbin (D-IL) also expressed his support for global health research: “If you wanted to look at the most important room in Washington, DC, when it comes to medical research over the last few years, it would be this room, this subcommittee. Under the leadership of Chairman Blunt and Senator Murray, we have seen for four straight years a 5 percent increase and real growth at the NIH. I think an overall 30 percent over that period of time, the 5 percent real growth each year. Increases to the CDC I wish were equal, but they had been good. We hope they'll get better in the future. I reject the President's budget out of hand. This notion of 12 percent cut to the NIH is just unacceptable and I think most Democrats and Republicans would agree.”In addition to defending investments in biomedical R&D, lawmakers have expressed support for funding for international aid and development—which would be cut by 24 percent under the President’s budget proposal. On February 27, the House Appropriations State and Foreign Operations Subcommittee held an oversight hearing on USAID Programs and Policies. In her opening statement, Appropriations Committee Chairwoman Nita Lowey (D-NY) emphasized the value of USAID, stating, “Failing to maintain our position as the leader in global development and humanitarian assistance will cost lives, risk the spread of infectious diseases, and reduce American influence around the world.” Included in the budget proposal is a US$1.35 billion reduction to the President’s Emergency Plan for AIDS Relief (PEPFAR). In response, several lawmakers vigorously defended the United States’ role in addressing the international HIV and AIDS epidemic. On March 6, Rep. Eliot Engel (D-NY), Chairman of the House Foreign Affairs Committee, said, “I'm particularly opposed to cuts in funding for global AIDS programs. There's a 22 percent cut in PEPFAR used to treat millions internationally, mostly in Africa.” Later that month, Rep. Karen Bass (D-CA) also defended PEPFAR: “The administration has maintained most Africa focused aid initiatives launched by previous Congresses, and in some cases have sought to fund them, however at far lower levels. These include the global President's Emergency Plan for AIDS or PEPFAR…and I'm glad that those initiatives have continued but concerned about the cuts in funding. I will conclude by stressing…that US relations with Africa has always enjoyed bipartisan support here in Congress, and we expect to continue to work together. Each time the administration has sought to reduce funding, the State Department or USAID, especially those that would impact African countries, we have worked together in a bipartisan manner to restore that funding.”In early April, Rep. Eliot Engel (D-NY) again affirmed his belief “in development as a way to advance American interest and security that’s rooted firmly in our values.” In reaction to the President’s budget proposal, he noted that, “Tuberculosis and malaria and AIDS patients all around the world” would be pushed aside by the “heartless and harmful approach to foreign policy.” The Trump administration’s budget request, if enacted, would slash funding for lifesaving research, development, and implementation of new global health technologies. Fortunately, lawmakers, with support from advocates, have diligently opposed these cuts. It’s our job to ensure this continues.

On February 15, President Trump signed into law a bipartisan spending bill—averting another partial government shutdown and ensuring full-year funding for the government for the remainder of fiscal year (FY) 2019. The move followed several days of speculation about whether discord between Congress and the President on funding for a border wall would imperil the spending measure passed by Congress to fund the remaining one-quarter of the federal government.The months-long saga ended with some great news for global health and research and development (R&D)—a roughly US$150 million funding increase for global health programs in the State and Foreign Operations (SFOPs) bill, as well as a significant boost to the Food and Drug Administration (FDA) under the Agriculture bill included in the package.The bill included some welcome increases to global health accounts which have been flat-funded for five years running, including a $50 million (1.16 percent) increase to the President’s Emergency Plan for AIDS Relief (PEPFAR) and a $2.5 million (2.5 percent) increase to the US Agency for International Development’s (USAID) Neglected Tropical Disease Program compared to FY 2018. Nutrition saw a $20 million (16 percent) increase and Maternal and Child Health got a $5.5 million (0.66 percent) boost. But perhaps the most notable win in the bill was a long-sought increase to USAID’s tuberculosis (TB) program. After TB was in the spotlight at the United Nations High-Level Meeting on TB in September, the United States backed up its pledge of additional support for the global fight against TB by including a $41 million (15.71 percent) increase to the program in the final spending package for FY 2019—the largest increase to the program in more than five years. All other global health accounts were level-funded compared to FY 2018, resulting in an overall increase of 3.23 percent for USAID Global Health—a stark difference from the 36 percent cut proposed in the President’s budget.While most accounts of relevance to global health R&D within the Department of Health and Human Services were funded for the entire fiscal year in a spending package passed in September, the FDA was one agency whose funding was still in limbo. The FDA’s unique funding structure—divided between budget authority, or discretionary funding (appropriated by Congress), and fees (paid by FDA users) —shielded the agency from some of the worst impacts of the partial government shutdown in December and January as it drew down on user fees to continue most operations. But the final FY 2019 funding package included a welcome $460 million (9 percent) increase for the agency, including a $269 million (9 percent) increase in budget authority.As the FY 2019 appropriations process lurched across the finish line, advocates were already gearing up for another budget battle for FY 2020. Check back for regular updates as appropriations hearings begin and GHTC continues monitoring the prospects for global health R&D accounts in the coming year.  For reference, the text of the Conference Report to accompany H.J. Res. 31, the Consolidated Appropriations Act, 2019, is available here, the text of the Joint Explanatory Statement is here (with the Global Health Program breakdown on page 454 of the PDF), and a division-by-division summary is available here.

On February 5, President Trump delivered his second State of the Union address. Among the long list of policy proposals and pledges in the speech was one of great interest to the global health research community—an announcement of a new whole-of-government plan to eliminate HIV transmission in the United States by 2030. Though just a few sentences long, this announcement hinted at a much-anticipated budget increase for HIV and AIDS efforts and linked the feasibility of this goal to “scientific breakthroughs”—many driven directly by US government investments in research for new tools to diagnose, treat, and prevent HIV and AIDS. As the President put it, “In recent years we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach. My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years. We have made incredible strides. Incredible. Together, we will defeat AIDS in America. And beyond.”Though the announcement and the associated plan released shortly thereafter by the Department of Health and Human Services (HHS) is squarely focused on eliminating HIV transmission within the US, the wording of the statement and a subsequent editorial published in the Journal of the American Medical Association penned by key agency officials both connect to international efforts and reference advances in HIV research and product development supported by the US government.At this moment of excitement—a “once-in-a-generation opportunity,” as Alex Azar, HHS Secretary, put it in the release of the plan—it is worth noting how our “chance to end the HIV epidemic for the next generation” is based on decades of patient, bipartisan commitment by the US government to advancing our understanding of HIV and AIDS and our ability to diagnose, treat, and prevent it through the development of cutting-edge tools.As the AIDS crisis was growing in the 1980s, NIH research led to the development of the first screening tests to detect the virus in the blood supply and the first antiretroviral treatment, AZT. Later, NIH research led to strategies to prevent maternal-to-child transmission, improved combination therapies, and the discovery that antiretroviral therapies could be used to prevent and treat the disease—research that was foundational to the development of pre-exposure prophylaxis (PrEP). CDC research has expanded our understanding of the epidemiology of the disease, improved prevention and treatment programs, and supported the development of a novel diagnostic that can, for the first time, identify whether an infection is recent or longstanding to improve contact tracing.While many don’t associate the Defense Department with health research, the US Military HIV Research Program has been on the forefront of the battle against HIV to both protect US troops and reduce the global impact of the disease. The program supported a large-scale HIV and AIDS vaccine trial in Thailand that was the first to show that a safe and effective HIV vaccine is possible and continues to advance HIV vaccine research. The US Agency for International Development (USAID), in addition to funding the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR) programs in nearly 100 countries, has also supported HIV vaccine research, as well as the development of microbicides to reduce transmission among women—including a microbicide-based vaginal ring. The US Food and Drug Administration has also played a crucial role in ensuring the availability of HIV treatment and prevention tools for those in need globally. The agency operates a program to facilitate the “tentative approval” of antiretroviral drugs for purchase by PEFPAR programs and recently launched a pilot program with the World Health Organization (WHO) to expedite the review of HIV drug applications through WHO’s prequalification program.The progress we have achieved through sustained whole-of-government investment in HIV research is astounding, but a need for new and improved HIV and AIDS prevention and treatment tools, including a vaccine, remains. As President Trump said, we can end the HIV epidemic—through both the scale-up of existing interventions and continued investment in the development of new tools. Even a cursory glance at the history of HIV and AIDS shows that every new product developed for treatment or prevention has both increased our ambition to end the epidemic and fundamentally altered our approach. We cannot know for certain that the tools we have in hand today are the most effective we will ever have, so our continued commitment to discover the next game-changer must ramp up in tandem with our efforts to expand access to existing interventions.While the President’s pledge to end HIV and AIDS in the US and his acknowledgement of the importance of scientific breakthroughs is encouraging, his past actions have failed to match this rhetoric. In 2017 and 2018, the administration proposed the elimination of HIV and AIDS vaccine and microbicides funding at USAID and deep cuts to NIH and CDC programs that fund HIV research. As the President prepares to release his fiscal year 2020 budget request, we hope it will include the resources necessary to realize the goals of this welcome pledge, including strong funding for the programs which develop and deliver the tools needed to end AIDS domestically and globally. This is an area of historically bipartisan consensus that offers a rare but important chance at this moment of divided government for Congress and the administration to work together to achieve a bold vision: defeating AIDS in America—and beyond.