Breakthroughs Blog: HIV/AIDS

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Agency for International Development announced the launch of its second request for applications for its ‘Saving Lives at Birth: A Grand Challenge for Development’ program, which calls for innovation prevention and treatment approaches for pregnant woman and children in developing countries. The Centers for Disease Control and Prevention discusses its role in global HIV and tuberculosis research and development (R&D) with Science Speaks. Medicines for Malaria Venture announced more than 100 million child-friendly malaria treatments have been delivered to 30 malaria-endemic countries since 2009. The announcement represents a key success story in global health R&D OneWorld Health’s treatment for leishmaniasis is now registered for use in Nepal.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. President Obama releases his fiscal year 2013 budget with mixed reviews for global health research and development. The Centers for Disease Control and Prevention is making headway in tuberculosis research in Kenya. New ways of preserving vaccines are about to enter field trails in Vietnam. This technology could be used around the world. Data sharing can be the catalyst to more research and development for neglected tropical diseases. Scientists show how some cells in the body can repel attacks from HIV.

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.

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.