Breakthroughs Blog: HIV/AIDS

Recently, a US Food and Drug Administration (FDA) panel recommended that the HIV and AIDS drug Truvada be approved for HIV prevention among certain groups at risk of infection. Known as pre-exposure prophylaxis (PrEP), this prevention method involves HIV-negative individuals taking antiretroviral drugs to prevent HIV infection. This recommendation from the FDA panel does not oblige the agency to follow suit; however, it often does. The Truvada hearing is illustrative of the important role that the FDA plays in the research, review, regulation, and licensure of global health technologies—both those that are brand new, as well as reviewing new uses for current tools. Indeed, the FDA has a vast amount of expertise that it can leverage to help address regulatory issues in the developing world, where countries often lack the expertise or resources to appropriately review new health tools. In addition to the regulation and review of health products, the FDA also plays a small but important role in research and development (R&D) for global health. Starting in 2010, the FDA engaged in R&D funding for new drugs to combat tuberculosis (TB) though its work with the Critical Path Institute. The Critical Path to TB Drug Regimens brings together leading pharmaceutical companies and other drug developers, global regulatory agencies, and nongovernmental organizations—like GHTC member the Global Alliance for TB Drug Development—to facilitate the development and availability of new TB treatments. In addition to the regulation and review of health products, the FDA also plays a small but important role in research and development (R&D) for global health. Photo credit: PATH/Evelyn Hockstein FDA clearly recognizes the importance of its position in the global regulatory world, as evidenced by its recent Pathway to Global Product Safety and Quality report. It’s equally important that Congress recognize the FDA’s increasing role in global health, and that it works with the agency to provide the funding needed to sustain and expand these activities. This week, the House Agriculture, FDA, and Related Agencies Appropriations Subcommittee will debate its version of fiscal year (FY) 2013 appropriations legislation. And recently both the House and the Senate approved very similar versions of the Food and Drug Administration Safety and Innovation Act (FDASI), including reauthorizations of the Prescription Drug User Fee and Medical Device User Fee programs – which provide a large chunk of FDA’s operating expenses, and must be reauthorized by September 30th. Included in FDASI is the Generating Antibiotic Incentives Now (GAIN) Act, a provision which would extend data exclusivity for new antibiotics to combat drug resistant bacteria—including multi-drug resistant TB—by five years. While incentives that engage the private sector in product development are urgently needed, data exclusivity alone may not solve the gap in antibiotics R&D, and should be combined with several other incentive mechanisms in order to truly leverage the knowledge and resources of the industry. The legislation does request a study be conducted outlining the use and effectiveness of such incentives, a positive step in the right direction. The next few months are a critical time for all of FDA’s programs—and also an excellent opportunity for Congress to make smart reforms that enhance the best of what FDA does, including its work to support global health research and development. Ashley Bennett is the GHTC’s senior policy associate.

Margaret McGlynn is the president and CEO of the International AIDS Vaccine Initiative (IAVI). In this guest post to mark HIV Vaccine Awareness Day, she writes about the potential impact of a safe and effective HIV vaccine around the world. The post originally appeared on the US Agency for International Development’s (USAID) Impact blog. Throughout my career, I have witnessed the tremendous power of vaccines to prevent sickness and save lives—delivering incredible victories for humanity against diseases such as polio, smallpox, and measles. These vaccines would not have been possible without the inspiration, persistence, and courage of researchers, volunteers, and health workers around the world. And so today, on HIV Vaccine Awareness Day, I join countless others around the world in reflecting on what it would mean to see AIDS consigned to a list of former pandemics. To achieve that goal, it is essential that we enlist the participation of researchers around the world in the design and development of HIV vaccines. Young researchers such as Gladys Njeri Macharia in Kenya—who has dedicated her career to exploring immune responses to HIV—will play an especially important role in that effort. And one day, critical scientific questions addressed by this research might help lead to an effective vaccine. Thanks to a USAID-supported program, Gladys Njeri Macharia is studying how rare individuals might be blocking HIV infection. Photo credit: IAVI New modeling data available today from IAVI and the Futures Institute, with support from USAID, illustrates how a safe, preventive HIV vaccine that is accessible and affordable can help us end the AIDS pandemic. This information is available in a series of publications and an interactive web tool. The potential impact of a vaccine is striking. Because HIV is so extraordinarily resistant to the immune response, it is highly unlikely that any single vaccine will be able to prevent infection by all variants of the virus. Still, our modeling shows that if an AIDS vaccine that is only 50 percent effective is introduced in 2020 to 30 percent of the population in low- and middle-income countries, 5.2 million new HIV infections could be averted over the first decade. Higher efficacy and more coverage would have an even greater impact on the pandemic. The world must continue to scale up and improve the response to HIV by using powerful prevention tools that are currently at our disposal. These include condoms, treatment, and voluntary medical male circumcision. Our new models show that a vaccine can build on these existing tools and take us down the last mile to the end of the AIDS pandemic. A 50 percent effective vaccine combined with greater use of current HIV-prevention tools could prevent nearly 20 million new HIV infections by 2030—20 million people that would not need to face the physical, emotional, and social hardships caused by the disease and could avoid lifelong, daily antiretroviral treatment to stave off AIDS-related illness or death. This HIV Vaccine Awareness Day, IAVI and our partners remember those we have lost to AIDS, gain inspiration from those living with and combating the disease today, and look forward to building on the incredible momentum of recent discoveries and study results to deliver on the tremendous potential of an AIDS vaccine. To access IAVI and the Futures Institute’s impact modeling publications and interactive modeling tool, visit www.iavi.org/

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. On HIV Vaccine Awareness Day, GHTC members the International AIDS Vaccine Initiative and AVAC have released new materials and data on the search for and potential impact of this new prevention tool. The House Appropriations Committee voted on its fiscal year 2013 State and Foreign Operations Appropriations bill and released a report that clarifies its funding intentions for global health programs. The GHTC and Policy Cures stress that all stages of research—from early science to the later stages of product development—are critical to the successful creation of new global health tools. A Food and Drug Administration advisory panel has recommended that the agency approve the first over-the-counter HIV test, a kit that could return results for consumers in the privacy of their homes.

Late last week, USAID Administrator Rajiv Shah released his second annual letter, outlining major issues and initiatives that have shaped the agency since its inception 50 years ago. Shah also charts a course forward for USAID, detailing areas that the agency should focus on in the coming years in order to make inroads in international development. One major area of focus is, of course, global health, and Shah rightly emphasizes the role of science, technology, and innovation in meeting USAID’s international health goals. The health component of the annual letter largely aligns with a recent effort at USAID to improve child survival. “[P]erhaps the most important choice is helping all children live to see their fifth birthday,” Shah writes, adding, “The good news is we have remarkably effective and cheap ways to help children survive.” Many of these methods—from insecticide-treated bednets to prevent malaria, antiretroviral drugs to prevent mother-to-child HIV transmission, and vaccines to prevent childhood killers like pneumonia and diarrhea—are available today because scientists and funders like the US Government made a commitment many years ago to develop new tools to fight these diseases. The new tools of yesterday have now become the standard tools to help children survive. Late last week, USAID Administrator Rajiv Shah released his second annual letter, which emphasizes science and innovation. Shah also highlighted how USAID continues to harness science and research to develop the next generation of new drugs, vaccines, and other technologies to save children’s lives. For instance, USAID’s Savings Lives at Birth initiative provides grants to foster innovative prevention and treatment options for pregnant women and newborns in rural, low-resource settings. USAID also supports research and development (R&D) for new health tools to benefit not just children, but a wide range of populations. “We’re also increasing our investments in core scientific research and technological innovation at USAID,” the letter reads. “Last year, our support of AIDS vaccine research led to the isolation of 17 novel antibodies that could each hold the key to ending the pandemic.” And just last month, the agency launched a new partnership with US colleges and universities to promote research for global development challenges, including health. It’s exciting to see that Shah continues, time and again, to recognize how science and innovation can overcome some of the world’s long-standing global health problems. We at the GHTC heard just two weeks ago at our annual Congressional briefing that health R&D produces real results for people at home and abroad. It’s heartening to have a leader at USAID who is so committed to the power of research, and who continues to provide such critical leadership.