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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member the American Foundation for AIDS Research has issued a brief analyzing the human impact that widespread budget cuts, or sequestration, would have on US-funded global health programs. The brief concludes that a “proportionate cut in US Global Health Initiative funding through sequestration would have minimal impact on deficit reduction … The human impact of such cuts in US investments, however, would be devastating.” The director of the National Institutes of Health (NIH), Francis Collins, also discussed the effect of sequestration on biomedical research. He testified before the Health Subcommittee of the Energy and Commerce Committee, saying that sequestration “could do serious damage to the progress that we now see in medical research [at the NIH].” The European Medicines Agency has issued a recommendation that the Hexaxim childhood vaccine is safe for use outside of the European Union. Developed by Sanofi, the vaccine offers protection against six World Health Organization priority diseases. A recent article in USA Today looks at the potential of a widely used HIV/AIDS drug, Truvada, as a possible tool to prevent HIV transmission. In an effort to make foreign assistance more transparent, the US Agency for International Development has made its foreign assistance obligation and expenditure data available online on the Foreign Assistance Dashboard. An experimental four-in-one HIV and AIDS drug called Quad is found to be safe and effective after going through a three-phase clinical process. The Lancet published the research following a recommendation in May by a US Food and Drug Administration (FDA) advisory panel to approve Quad for previously untreated adults infected with HIV-1. A final decision is expected from the FDA by August.

This post originally appeared on the ONE blog. As the International AIDS Conference descends on DC later this month — the first time this conference has been held in the United States in over 20 years — there couldn’t be a better time to reflect on the scientific gains that have emerged over the past several months, and how a wide range of dedicated Americans are pushing this HIV and AIDS research forward. Just last month, one of GHTC’s member organizations, the Maryland-based International Partnership for Microbicides, launched a new study to determine whether a monthly antiretroviral (ARV)-containing vaginal ring can safely and effectively help prevent HIV infection in women. Advocates have long called for more female-initiated HIV prevention options, like a microbicide gel or ring. If proven to be efficacious, the ring would provide women with a discreet and easy-to-use form of protection and could provide new power by putting HIV prevention in the hands of women. The US government has historically played a major role in pushing forward a research and development (R&D) agenda for HIV and AIDS, and the past few months are no exception. For example, the US Food and Drug Administration (FDA) has been particularly active in reviewing new HIV and AIDS tools that have successfully emerged from the research pipeline. The US government and partners worldwide have long supported research for new tools to prevent, test, and treat HIV and AIDS. At this Kenya AIDS Vaccine Institute lab in Nairobi, US support is helping to advance research for an HIV and AIDS vaccine. Photo credit: PATH/Evelyn Hockstein Earlier this summer, an FDA advisory council recommended that the agency approve the use of the ARV Truvada, made by Gilead Sciences, by certain high-risk, HIV-negative people as a preventive measure against HIV in a method known as pre-exposure prophylaxis (PrEP). Although the FDA will not make a final decision until mid-September, an approval by the FDA would signify a new way forward in preventing HIV infection in the US and across the globe. And just a few days ago, the first-ever take home HIV test was approved by the FDA. Although some questions remain around the implementation of the home test, it is an important step forward in providing greater testing access to the many individuals in the US who are unaware of their HIV status. In addition to the FDA, a host of US federal agencies have long been committed to advancing HIV and AIDS R&D. A new report released earlier this year by the GHTC and Policy Cures illustrates the impact of US government support for new HIV tools, like an HIV vaccine and the woman’s condom. Both the woman’s condom and many HIV vaccine candidates have been developed in partnerships with the US government alongside philanthropic organizations and industry. Without the critical support from the US government and partners around the world, we would not be as close to creating these and other breakthrough technologies in the fight against HIV and AIDS. For instance, new modeling data released by the New York-based International AIDS Vaccine Initiative shows that a safe, preventive HIV vaccine that is accessible and affordable can help us end the AIDS pandemic. IAVI’s data shows that even a 50 percent effective HIV vaccine could prevent over five million new HIV infections over a decade, once introduced to a segment of the population in low- and middle-income countries. This is a critical moment in the fight against AIDS, and the first International AIDS Conference to be held in the US in more than two decades provides a tremendous opportunity for US policymakers to recommit the US government to advancing new tools for HIV prevention, diagnosis, and treatment. It’s my hope that US policymakers -– both members of Congress, particularly as they continue to move forward with the annual appropriations process, and the Administration — listen to the thousands of researchers, advocates, people living with HIV, and others who will be calling for new tools to help curb and eventually end this epidemic at the International AIDS Conference later this month. Kaitlin Christenson is the GHTC's coalition director.

George Fistonich is a recent graduate of the University of Southern California with a Master of Public Health degree, and currently serves as a research and policy fellow at amfAR, The Foundation for AIDS Research. He wrote this guest post about a new amfAR analysis that details the human impact of possible federal budget cuts on global health programs. amfAR recently released a new analysis that outlines the potential effects of budget sequestration on global health programs, using updated figures to reflect recent and accurate estimates. As our analysis illustrates, cutting funding for global health programs—including those that support access to lifesaving HIV and AIDS, tuberculosis (TB), and malaria tools and programs that fund research for the next generation of global health products—would barely make a dent in reducing the US federal deficit. However, cuts to global health and health research programs would have a crippling impact on people around the world. “Sequestration” is a fiscal process by which automatic, indiscriminate, across-the-board cuts would be made to most budget line-items at a certain set percentage. This process was included as a provision in the Budget Control Act of 2011, which would trigger sequestration at the start of the 113th Congress in January, unless Congress is able to pass $1.2 trillion in deficit reductions by the end of this year. The Center on Budget and Policy Priorities estimates that sequestration would lead to an 8.4 percent reduction in funding for non-entitlement federal programs, including all global health and health research and development programs. Under the rules of sequestration, a total of $109.4 billion would be cut for fiscal year 2013, of which nearly $690 million would be taken from global health programs. This cut to global health represents a negligible 0.6 percent of the total deficit reductions for that year, but would lead to devastating human impact worldwide. Secretary of State Hillary Clinton and President Obama both set an ambitious goal last year by announcing the United States’ intent to create an AIDS-free generation. Sequestration would not only undermine this achievable goal, but would undermine the progress we have made so far in providing treatment and care for millions of people worldwide, restrict funding for groundbreaking AIDS research, and ultimately result in thousands of unnecessary deaths in the next year alone. amfAR’s analysis estimates that an 8.4 percent cut to bilateral funding through the President’s Emergency Plan for AIDS Relief (PEPFAR), the President’s Malaria Initiative (PMI), and TB programs would lead to the following in 2013: 273,000 fewer people receiving AIDS treatment. 62,000 more AIDS-related deaths. 122,500 more children becoming orphans. 111,000 fewer HIV-positive pregnant women receiving services to prevent mother-to-child transmission. 21,000 more infants being infected with HIV. 354,000 fewer children receiving food, education, and livelihood assistance. 2.2 million fewer insecticide-treated nets procured. 3.7 million fewer people receiving malaria treatment. 6,000 more malaria-related deaths. 65,000 fewer people receiving TB treatment. 8,000 more TB-related deaths. Sequestration would also lead to the following in 2013 alone due to cuts in multilateral investments: 1.2 million fewer pentavalent vaccines procured through the GAVI Alliance, leading to 13,000 child deaths due to diphtheria, tetanus, pertussis, Haemophilus influenza type B, and hepatitis B. 2.8 million fewer insecticide-treated nets procured; 7,500 more malaria deaths; 102,000 fewer people receiving TB treatment; 12,000 more TB deaths; and 114,000 fewer people receiving AIDS treatment through the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Sequestration would not only limit access to currently available treatment and prevention tools, leading to an increase in HIV and AIDS, TB, malaria, and childhood deaths—it would also hinder research into new tools that are critically needed to fight these diseases. Cutting these programs would do nothing to reduce the federal deficit, and Congress must therefore work to prevent sequestration and protect funding for global health and research and development. Full text of the analysis, including methods for determining these estimates, can be found here.

Yesterday, the International AIDS Society (IAS) and the University of California-San Francisco released the Washington, DC Declaration ahead of this month’s XIX International AIDS Conference. The declaration aims to build support for efforts to end the HIV and AIDS pandemic, and lists nine priorities that are needed to achieve this goal. Accelerated research for new HIV and AIDS prevention and treatment tools is included among the priorities listed in the declaration as necessary to finally end the pandemic. Recent years have seen game-changing research results for new treatment and prevention products—from microbicides to vaccines to using treatment as prevention—that are leading many to believe that research is contributing to a watershed moment in HIV and AIDS. "We want to make sure we don't overpromise," Anthony Fauci—head of the National Institute of Allergy and Infectious Diseases—said in a recent Associated Press article. But, he added, "I think we are at a turning point." It seems that the conference organizers couldn’t agree more about the role of science and research in this metamorphosis in the pandemic. “In a scenario unthinkable just a few years ago, we now have the knowledge to begin to end AIDS in our lifetimes,” said Elly Katabira, president of IAS and international chair of AIDS 2012, when releasing the declaration. And as we recently noted, research is shaping up to be a central theme of the conference overall. Accelerated research for new HIV and AIDS prevention and treatment tools is included among the priorities listed in the Washington, DC Declaration as necessary to finally end the pandemic. Photo credit: PATH/Evelyn Hockstein At the same time that science is leading to hope that the end of HIV and AIDS is within reach, countries around the world are dealing with budget constraints and the effect of a global economic crisis. “Yet, at this moment of extraordinary scientific progress and potential, the global response to AIDS faces crippling financial challenges that threaten past success and future progress,” Katabira said. “Through this declaration, we stand together to call on world leaders across all sectors to provide increased resources, visionary leadership, and a full-fledged commitment to seize the opportunity before us.” It’s heartening that this year’s International AIDS Conference will be held in the United States for the first time in more than 20 years. When the conference last took place in the United States (in San Francisco in 1990), an HIV diagnosis was still equitable with a death sentence. But research soon led to life-saving antiretroviral drugs that, for many, have made HIV and AIDS a chronic and manageable condition. It’s almost overwhelming to think about what the next generation of HIV tools will bring. As Congress and other US policymakers continue the federal appropriations process and the country heads into a presidential election, we hope that US leaders listen to the 25,000 researchers, advocates, people living with HIV, and others attending the conference and calling for much-needed new ways to prevent and treat the disease.