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Luann Tia Blount is the Clinical Communications Officer for GHTC member the International Partnership for Microbicides (IPM), a nonprofit product development partnership dedicated to developing new HIV prevention technologies and making them available to women in developing countries. This post discusses novel approaches to HIV prevention, namely an adapted medical technology used to deliver hormones to women—the vaginal ring. Last week, in honor of World AIDS Day, the International Partnership for Microbicides (IPM) renewed its commitment to finding innovative ways to fight the spread of the epidemic. At the International Conference on Family Planning in Dakar, Senegal, IPM announced a five-year award with a $2 million ceiling from the US Agency for International Development (USAID) to support the development of a 60-day dual-purpose vaginal ring that would combine the antiretroviral (ARV) drug dapivirine with a contraceptive to offer women around the world both HIV protection and contraception in a single product. Research has consistently shown that a woman’s risk of HIV and her reproductive health are inherently linked, demonstrating a clear need for tools that women can use that address these issues in tandem. Filling the gap in maternal health services for women who want to delay or prevent pregnancy could decrease the number of women who die during pregnancy or childbirth by about one-third. Expanding women’s options with a discreet and affordable product that could safely meet both women’s contraceptive and HIV prevention needs could therefore help reduce maternal mortality and empower women to protect their own health. The USAID funding will support IPM as it integrates a contraceptive into IPM’s existing dapivirine-only HIV prevention ring, also in development. The dapivirine ring adapts a medical technology commonly used to deliver hormones to women—the vaginal ring—to the fight against HIV. Expanding women’s options with a discreet and affordable product that could safely meet both women’s contraceptive and HIV prevention needs could therefore help reduce maternal mortality and empower women to protect their own health. Photo: Andrew Loxely The dual-purpose dapivirine-contraceptive ring could one day offer a convenient and affordable option for women who cannot negotiate the use of condoms or for whom condoms are not always a realistic choice. In addition, because the ring offers sustained protection, it may help women use it consistently and could help ensure its effectiveness. Dapivirine is IPM’s most clinically advanced microbicide candidate. It belongs to a class of ARVs known as non-nucleoside reverse transcriptase inhibitors, or NNRTIs, which work by preventing HIV from replicating its genetic material after the virus enters a healthy cell. ARVs have long been used successfully to treat HIV and to prevent mother-to-child transmission, and research in the past year has shown their potential to prevent HIV. IPM is developing the drug for use as a microbicide through a royalty-free license granted by Tibotec Pharmaceuticals, one of the Janssen pharmaceutical companies. Since 2004, 15 clinical safety studies of dapivirine, formulated as either a vaginal gel or a vaginal ring, have been conducted by IPM and its partners showing that it is safe and well-tolerated by women. Early next year, IPM will advance a different product, the dapivirine-only HIV prevention ring, into a product licensure program with its partner, the National Institutes of Health-funded Microbicide Trials Network (MTN). The monthly dapivirine ring may also help expand women’s HIV prevention options with a long-acting and easy-to-use product women can use to protect themselves. As part of the program, IPM will conduct the Ring Study, also known as IPM 027, which will collect long-term safety and efficacy data and involve 1,650, healthy, HIV-negative women ages 18 to 60 at several research centers across Africa. The Ring Study will also assess women’s adherence to and acceptability of the vaginal ring. MTN will conduct a second efficacy study of the dapivirine ring next year. Called ASPIRE—A Study to Prevent Infection with a Ring for Extended Use, also known as MTN-020—the trial will enroll approximately 3,475 HIV-negative women between ages 18 and 45 in five African countries. Collectively, these two studies will provide the data necessary to determine dapivirine’s suitability for licensure, should the product prove effective. IPM is also exploring other novel approaches and combinations products such as a maraviroc ring and a maraviroc-dapivirine combination HIV prevention ring, also in partnership with MTN. Maraviroc is a CCR5 blocker that works by obstructing a receptor (CCR5) on the surface of cells that is used by the most commonly transmitted strains of HIV-1 to attach to and enter healthy cells. When that receptor is blocked, HIV cannot enter healthy cells. IPM is developing maraviroc for use as a microbicide through a royalty-free license with ViiV Healthcare. This is the first time maraviroc is being studied for use as a microbicide. As we know from the contraceptive field, a variety of product choices greatly increases the chances that one of them will be used. So our best weapon against the epidemic is a range of daily and long-acting options that meet women’s unique needs and preferences.

Earlier today, the fourth annual G-FINDER report was released. This resource, developed by Policy Cures, is the only one of its kind that maps the global level of investment in developing new vaccines, drugs, diagnostics, and other tools that address 31 neglected diseases. This year’s report studies funding levels and trends in 2010. The G-FINDER report illustrates the first real evidence that the global financial crisis is impacting funders’ ability to support global health research and development (R&D). The report shows a drop of 3.5% among donors who were surveyed—including public donors in high- and low-income countries, private foundations, and the pharmaceutical industry. It is important to note that these findings merely report trends from one year to the next, and that it is essential to look at trends across multiple years to understand true patterns of change. In 2010 there were many reasons for decreased funding from some donors. For example, the Gates Foundation’s decreased funding can be largely attributed to a lower disbursement in 2010 for clinical trials of the RTS,S malaria vaccine because much of the significant funding for this research was provided up front, thus not disbursed in 2010. On the whole, funding levels in 2012 for global health R&D are higher than when the G-FINDER began tracking these numbers in 2007, which is a positive signal. That said, it is striking that in a year when the financial crisis hit its peak, public funding for global health research took an equally significant hit. The G-FINDER report also shows that globally, the public sector plays an important role in funding research and development for neglected diseases, providing nearly two-thirds of global funding. And in 2010, contributions from public funders fell by a stark 6%, or $125 million. At the GHTC, we’re paying special attention to trends related to the US government’s expenditures: The US remains the largest government funder of global health research, but even its funding for global health R&D dropped significantly: down by 5%, or $74.5 million. Drops in overall US funding are largely attributed to a decrease in funding from the National Institutes of Health (NIH) (down $44.8 million, or by 3.6%), as well as a significant decrease in funding by the Department of Defense (DoD) (down by $28.3 million, or nearly 30%). It is of interest to note that this drop in funding from the NIH came during a year when the agency received funding through the American Recovery and Reinvestment Act (ARRA). Even a modest increase in funding from the US Agency for International Development (USAID) (up $1.5 million, or roughly 1.8%) doesn’t come close to accounting for the drops by NIH and DoD. This decline in US government funding has real and significant consequences in the near- and long-term. Without sufficient funding, groups like product development partnerships, which are leading the development of global health products, are left without the immediate resources needed to complete the final phases of clinical research. And without the tools we need to combat the most severe global health challenges, people living around the world will continue to suffer and succumb to diseases that might have been otherwise prevented or treated. The scientific community is on the cusp of groundbreaking research that will yield powerful new tools to address global health, and now is not the time to turn back. An investment in science means an investment in the future, and policymakers in the US must keep their gaze forward as they make funding decisions today. Note: all funding amounts included in the G-FINDER report are adjusted for inflation and reported as 2007 dollars so that they may be compared to previous G-FINDER reports, which date back to 2007.

Kevin Fisher is the Policy Director for GHTC member AVAC: Global Advocacy for HIV Prevention, an organization that focuses on accelerating the development and delivery of critical AIDS vaccines and HIV treatment and prevention tools. AVAC and partners are hosting a congressional briefing this week to discuss promising results from a Military HIV Research Program’s (MHRP)-sponsored trial to develop a safe and effective HIV vaccine. Although further research is needed, a safe and effective HIV preventive vaccine has now been shown to be possible. In 2009, the Military HIV Research Program’s (MHRP)-sponsored RV144 trial became the first HIV vaccine trial ever to demonstrate effectiveness in preventing HIV infection, lowering the rate of HIV infection by 31.2 percent. MHRP, along with the study partners, announced another significant discovery in September 2011. Aiming to better understand how RV144 protects against HIV infection, the research team found two important molecular clues—two antibodies whose presence either increases or decreases the risk of HIV infection. With these findings, we are the closest we have come to discovering a scientific pathway to an HIV vaccine after three decades of research. The MHRP plans to evaluate the clues they discovered with follow-up studies. However, lack of funding for the MHRP may prohibit the researchers from advancing as planned. New findings show that we are the closest we have come to discovering a scientific pathway to an HIV vaccine after three decades of research. Photo: Satvir Malhotra/PATH Since 1986, the MHRP has worked to develop a safe, globally effective HIV vaccine and began providing critical support for the President’s Emergency Plan for AIDS Relief (PEPFAR) programs in Africa in 2004. Vaccines are one of the most powerful tools for preventing infectious diseases and should be one of the highest priorities of the research and scientific community to prevent the spread of HIV. While the unique properties of the HIV virus make finding a safe and effective vaccine one of the greatest challenges in science today, the MHRP has made extraordinary strides in meeting this challenge. MHRP is also a critical PEPFAR partner. While its primary focus is developing a globally effective HIV vaccine, the program provides prevention, care, and treatment through PEFFAR. With five sites in Africa and Asia, MHRP leverages existing in-country technical expertise and administrative infrastructure to expand partnerships with local researchers, health care services and NGOs to implement PEPFAR activities. Just as we are on the brink of a major breakthrough in HIV prevention the world is facing a global AIDS funding crisis. HIV treatment funding shortages and continued infection rates threaten to overtake progress made in the previous decade. The US has a critical role to play in stopping the spread of the epidemic, and through such programs as the MHRP the US can dramatically advance science and move forward the development of a safe and efficacious vaccine to control and halt the spread of HIV. As Secretary of State Hillary Clinton recently said, “An AIDS-free generation would be one of the greatest gifts the United States could give to our collective future.” On December 9th AVAC: Global Advocacy for HIV Prevention, amfAR, the Foundation for AIDS Research and the Infectious Disease Society of America, in cooperation with Sen. Barbara Mikulski, will be holding a congressional briefing focused on the work of MHRP. Join us to discuss the recent exciting and promising results from the MHRP scientific team and critical efforts to increase the impact of the PEPFAR program by delivering lifesaving drugs and prevention tools more effectively. Speakers will include: Dr. Debbi Birx (Centers for Disease Control and Prevention), Dr. Alan Fix (National Institute for Allergy and Infectious Diseases), Col. Nelson Michaels (MHRP) and Dr. Fred Sawe (Walter Reed Army Institute of Research–PEPFAR program, Kenya). Innovations in HIV Vaccine Development and PEPFAR Implementation through the Military HIV Research Program Friday, December 9, 2011 12:00-1:30 p.m. 385 Russell Senate Office Building SR-385 Lunch will be provided For more information or to RSVP, please contact Emily Donaldson at AVAC at edonaldson@avac.org.