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In countries like Kenya, some of the most incredible global health research is taking place to develop new drugs, vaccines, diagnostics and other health products. In addition, previous research has lead to the roll-out of lifesaving health tools such as HIV and AIDS drugs, vaccines to protect children from pneumonia, and insecticide-treated bednets to prevent malaria. Last week, the GHTC hosted a photo reception that represented the people, both Kenyan and American, who are making new lifesaving health tools a reality, as well as the families benefitting from ongoing research and past research successes. The reception centered around two stories. One showed how lifesaving tools are making a difference in communities across Kenya. The second showed how current research is on the cusp of developing some of the most exciting new tools in global public health in recent years. Lifesaving tools are making a difference A historical commitment to research from the US government has led to the development of innovative health tools that are saving lives around the world. People worldwide have benefited from the development of critical medicines like antiretrovirals to treat HIV and AIDS and drugs to treat childhood killers like diarrhea, vaccines to protect infants from pneumonia and polio, and insecticide-treated bednets to prevent malaria. In Kenya, many individuals and families credit these valuable health tools with saving their lives and ensuring their children can have healthy and long futures. Researchers at agencies like the Centers for Disease Control and Prevention, the Department of Defense, and the US Agency for International Development are making a difference on the ground in Kenya by leading the development and delivery of drugs, vaccines, diagnostics, and other health products. With sustained support from the United States, countries like Kenya will continue to see the impact of these lifesaving health tools that are helping people abroad and right here at home. Kisumu, Kenya: Calvin Lang'at, a nurse at Vihiga District Hospital, gives an infant an oral polio vaccine. Immunization campaigns have reduced polio rates by more than 99 percent worldwide, and the disease is now near eradication. Photo credit: PATH/Evelyn Hockstein Kibera, Kenya: The Centers for Disease Control and Prevention use technologies to control the spread of infectious disease and to act as a warning system for the emergence of possible epidemics. Handheld PDAs—like the one health worker Joseph Thomas is using above—help officials conduct disease surveillance among 28,500 residents in Kibera. Disease surveillance can also help drive research for new health products, by alerting officials to large disease burdens and the need for new prevention and treatment options. Photo credit: PATH/Evelyn Hockstein Kombewa, Kenya: Martha Omondi puts her daughter Mercy Gloria, who is three years old, under a mosquito net to take a nap. Insecticide-treated nets have prevented millions of children from contracting malaria in Africa. Photo credit: PATH/Evelyn Hockstein Siaya, Kenya: Faith Oduor holds her daughter Brittany’s hand while she receives treatment for malaria at the Siaya District Hospital in western Kenya. Malaria treatments, including pediatric artemisinin therapies such as Coartem, help to save the lives of children like Brittany across Africa. Photo credit: PATH/Evelyn Hockstein Elwesero, Kenya: Peter Lumumba, a father of six, was first diagnosed with HIV in 1987 and started antiretroviral treatment in 2006 through the Aids, Population, and Health Integrated Assistance (APHIA II) program. He said of his treatment, “I am now well. People are totally astonished … when we are telling people we are (HIV) positive, they will say, ‘No, you are lying.’ Without the research that led to this lifesaving medicine, I would have already died.” Photo credit: PATH/Evelyn Hockstein Elwesero, Kenya: Peter Lumumba, pictured above with his son, was first diagnosed with HIV in 1987 and started antiretroviral treatment in 2006. Peter is open with his family about the fact that he is HIV-positive and is taking antiretroviral drugs. In the year 2000, Kenya had just a handful of HIV-positive people taking antiretroviral drugs. Today, the country has a half-million people on these drugs, which have saved many from an early death. Photo credit: PATH/Evelyn Hockstein Vihiga, Kenya: Rister Kageha holds her daughter Sylvia Mboga, who is 14 months old, at the Vihiga District Hospital. Rister learned she was HIV-positive and was put on antiretrovirals one month before she gave birth to her daughter. Sylvia was given the antiretroviral nevirapine after birth and is HIV negative. Rister accessed drugs through the Aids, Population, and Health Integrated Assistance (APHIA II) program, which provides comprehensive health care and prevention services. APHIA II is supported by the US Agency for International Development and run by GHTC member PATH. Photo credit: PATH/Evelyn Hockstein On the cusp of new global health tools The world is on the cusp of some of the most exciting new global health tools in recent years, thanks in large part to groundbreaking research supported by the US government through agencies such as the Centers for Disease Control and Prevention, the Department of Defense, and the US Agency for International Development. Clinical trials are showing promising results for the first-ever malaria vaccine, as well as a host of new interventions to prevent HIV infections. Researchers are on the verge of developing new drugs to treat neglected diseases that affect the poorest of the poor. This incredible health research is producing breakthroughs that could save countless lives, and Kenya is among the countries at the forefront of these efforts. Several global health research projects in Kenya are on the verge of producing new lifesaving health tools, and the US government continues to be a key player in supporting these groundbreaking research efforts. In Kenya, researchers confirmed how critical continued support from the US will be in reaching the finish line to defeat malaria, tuberculosis, HIV and AIDS, pneumonia, and other neglected diseases. It is imperative that the United States continues to drive the momentum around these new tools, from discovery to delivery, so that this research can produce the results that will help communities across the globe. Siaya, Kenya: At the Kaminogeldo Primary School, two miles from Lake Victoria in western Kenya, a mother enrolls her child in a study that will provide new information about co-infection of malaria and schistosomiasis, which is a major problem in the area. Fishermen and children often contract schistosomiasis from snails that live in and around the lake. The study is being run by the Kenya Medical Research Institute/Centers for Disease Control and Prevention partnership. Photo credit: PATH/Evelyn Hockstein Nairobi, Kenya: Lucas Agura, a medical laboratory technologist who works with the Kenya Medical Research Institute on neglected tropical diseases, conducts research at the KEMRI headquarters laboratory. KEMRI works with GHTC member the Drugs for Neglected Diseases initiative on its efforts to create new treatments for visceral leishmaniasis, a painful and deadly disease that affects half a million people worldwide each year. Photo credit: PATH/Evelyn Hockstein Kisian, Kenya: Mosquito DNA samples are prepared for testing at the Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Field Research Station. KEMRI and the CDC have been partnering together for more than 30 years in Kenya. Dr. Pauline Mwinzi, a principal research officer who works with KEMRI/CDC said, “Without the US funding…we wouldn’t be able to move the sophisticated research that we do now.” Photo credit: PATH/Evelyn Hockstein Siaya, Kenya: Mothers sign consent forms to enroll their children in a study to examine co-infection with malaria and schistosomiasis in the region, run by the Kenya Medical Research Institute/Centers for Disease Control and Prevention partnership. Local residents said they appreciated the study. "One in five children in this area do not survive to their fifth birthday," said Jack Oloo Otieno, the school board chair. "We don't really know the full extent of the problem of schistosomiasis. If all our kids have it—and that's what we suspect—it is doing such harm to them. So we want as much information as possible, and this study will help." Photo credit: PATH/Evelyn Hockstein Kisian, Kenya: Wilfred Murithi, assistant research officer at the Kenya Medical Research Institute/Centers for Disease Control and Prevention facility in Kisian, prepares a sample to detect tuberculosis (TB) resistance to ritampicin, a TB drug. Resistance to TB drugs has become a severe problem in parts of the world and is increasing. There are an estimated 440,000 cases of multi-drug resistant TB globally, and at least 58 countries have reported cases of extensively drug resistant TB, which can be incurable. New TB drugs are desperately needed. Photo credit: PATH/Evelyn Hockstein Rawa, Kenya: Sharon Akinyi Ouma holds her daughter Winfrey Juma, who is 16 months old, outside their rural home in western Kenya. Sharon said she was happy to join a tuberculosis vaccine trial run by GHTC member Aeras in collaboration with the Kenya Medical Research Institute/Centers for Disease Control and Prevention. “I think of so many babies, so many children in Africa and around the world, have been helped by vaccines,” she said. “If this vaccine works, that means all those children will be helped by my baby’s participation. That makes me feel very good.” Photo credit: PATH/Evelyn Hockstein Nairobi, Kenya: Robert Langat, a lab technologist at the Kenya AIDS Vaccine Initiative (KAVI) in Nairobi, checks on vaccine samples stored in deep freeze at the laboratory. The US Agency for International Development supports a partnership KAVI maintains with GHTC member the International AIDS Vaccine Initiative to identify prevention strategies and a response to HIV and AIDS. In 1999, the partnership helped discover broadly neutralizing HIV antibodies—a critical piece of progress developing an AIDS vaccine. Photo credit: PATH/Evelyn Hockstein Nairobi, Kenya: Irene Anne Wangari and Agatha Nyawira work with blood samples at the Kenya AIDS Vaccine Initiative (KAVI) lab in Nairobi. Through its partnership with the International AIDS Vaccine Initiative, KAVI has facilitated significant breakthroughs in the research and trained world-class scientists and technicians who will continue to build on the research progress in Kenya. Photo credit: PATH/Evelyn Hockstein

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.