News

New tools are needed to prevent HIV and AIDS, particularly among at-risk women. Photo: PATH/Gabe Bienczycki Sitting halfway around the world from my office in Washington, DC, looking out my Durban hotel window at the Indian Ocean, I am reminded just how small and interconnected our world really is. While home is a 24-hour journey from here, international travel is easy now. Like people, infectious diseases also move easily around the globe. As advocates gathered from across geographies, we are here in Durban to discuss research and development for new tools in the fight against HIV and AIDS. The excitement in our discussions is palpable as we think about where we have come in the HIV and AIDS epidemic to date, but also guarded as we look ahead to the daunting task of ending the epidemic forever. I traveled to Durban to participate in a partners meeting with the International Partnership for Microbicides (IPM). IPM, a GHTC member, is leading an exciting Phase III clinical trial program to determine if a new monthly vaginal ring it developed can prevent women from becoming infected with HIV and is safe for long-term use. The ring contains the antiretroviral (ARV) drug dapivirine, which is a new drug but part of the same class of ARVs currently in use for HIV and AIDS treatment. Initial efficacy results are expected as early next year. Dapivirine ring. Photo: IPM Throughout the meeting one thing became clear to me: we need new tools to combat the HIV and AIDS epidemic in South Africa, in Washington, DC, and everywhere in between. ARV treatment has helped save millions of lives. For the most part, people on treatment can live healthy and productive lives. That is, of course, if they have access to the medications they need, if they can take these medications daily, if they can keep regularly scheduled appointments with a health care provider, and perhaps most importantly, if they know they are infected in the first place. That’s a lot of ifs. What if we could prevent more infections in the first place? The new post-2015 development agenda about to be solidified by the United Nations later this month sets out to end the HIV and AIDS epidemic by 2030. This is a lofty goal that has policymakers and funders excited, but it should be regarded with caution as we look to the work that needs to be done. Truvada. Photo: CDC In the United States, the US Food and Drug Administration has approved the use of the ARV drug Truvada as a pre-exposure prophylaxis (known as PrEP) to prevent HIV infection among individuals who are determined to be at high risk for contracting HIV. PrEP is not yet approved for use in South Africa despite Truvada being an approved—and commonly used—drug for HIV and AIDS treatment. Why PrEP hasn’t been approved for use yet in South Africa is a complicated story, but unfortunately one that seems to haunt us in the global health advocacy community. All too often, we know what needs to be done to treat or prevent an infection, to save a mother’s life during childbirth, to keep a child alive during the most vulnerable early years of life, but politics keeps us from making progress. The stigma associated with HIV and AIDS is still real for women and men around the world. In the United States, it doesn’t help when we hear politicians talk about cutting funding for HIV and AIDS research because it doesn’t affect enough Americans anymore. Yes, we know how to treat people living with the disease, and yes, we know how to prevent mother-to-child HIV transmission, and yes, we even know how to prevent HIV infection in adults, but the reality is that politics are getting in the way. If we know how to save lives, it should not matter how policymakers personally feel about the way a disease is transmitted or the lifestyle of the populations most at risk for contracting a disease. Logic says that science should win this debate, but unfortunately, that is not the reality. To combat both the disease itself and a challenging global political environment, we need to keep our options open as we think about the tools we have and the tools that are needed to fight HIV and AIDS. We need to have an arsenal of tools that can be used safely and sometimes discretely by the people most at risk. IPM's monthly dapivirine ring has the potential to help women take more control over their health and reduce their risk. Too many women cannot negotiate the use of condoms (male or female) with their partners and therefore cannot be in control of their own HIV prevention. Developing and providing new options—like the dapivirine ring—that women could use as personal protection is essential. Further, we don’t just need to develop tools for the sake of new tools—we need to ensure that women and men have access to the most effective, affordable, and appropriate tools to address their health needs. I was fortunate to be able to accompany IPM and other partners on a visit to Qhakaza Mbokodo in Lady Smith, South Africa—one of the research clinics conducting IPM's Ring Study, which is one of two Phase III trials evaluating the ring. While there, I met an engaged and dedicated staff who have integrated themselves into a local community and really gotten to know the women who are participating in the trial. Women joined the trial voluntarily, many of them expressing an interest in helping to end a disease that is devastating their community or has killed a family member. They understand the potential risks associated with testing a new tool, and they know it might not be effective. But like me, as an advocate dedicated to preventing HIV, ending infectious disease epidemics, and empowering women to take control of their own health, they are all hopeful that the ring can be an effective tool to help us in the fight. We cannot end the HIV and AIDS epidemic with the current tools we have, and no one tool used alone—not PrEP, not the dapivirine ring, not condoms, not male circumcision—will get us to this goal. We need to have a comprehensive approach to the fight that involves both prevention and treatment. IPM's dapivirine ring program, regardless of the results, will teach us a lot about what works and what doesn’t. This is the way we must combat global health threats: with scientific rigor, with international partnership, and with robust investment in new tools. Erin Will Morton is GHTC’s Director

A new study suggests that with basic training, individuals can learn to accurately and safely test themselves for HIV and AIDS. Nearly 17,000 adult and adolescent citizens of urban Malawi were provided with testing kits, and within a year, more than three-fourths had self-tested. Across sub-Saharan Africa, only one-fourth of adults have recently been tested for HIV and AIDS, and only half of people living with HIV and AIDS know their status. The research team conducted repeat HIV and AIDS tests on 1,649 participants, and in 99.4 percent of cases, the results of self-testing proved accurate. The results also suggest that HIV and AIDS self-testing is culturally acceptable in urban Malawi and that pre- and post-test counselling was adequate, as no testing-related partner violence or suicides were reported. As the stigma surrounding HIV and AIDS remains a significant barrier to both testing and treatment, HIV and AIDS self-testing could be a game changer in curbing the epidemic. Photo: CDC/ James Stewart Researchers at the University of Queensland in Australia and the University of California, Berkeley have identified a protein—nonstructural protein 1 (NS1)—that may be the key to the dengue virus’ virulence. The virus infects nearly 400 million people each year, resulting in 22,000 deaths, primarily from fluid loss and damage to the blood vessels. The discovery dates back to the early 2000s, when a study in Thailand revealed a correlation between NS1 levels and the severity of the disease in patients. Further research demonstrated that NS1 attaches itself to another molecule which enables it to bind to blood vessel walls; NS1 also prompts the immune system to produce cytokines—proteins that weaken the blood vessels. Essentially, NS1 causes the immune system to react as it does to bacterial infections. These findings could pave the way for both a vaccine and a treatment against dengue fever. The team at Berkeley has demonstrated that NS1 could be used in a dengue vaccine, as the immune system readily detects NS1, rather than the dengue virus itself. In mice, NS1 provided protection against all four strains of the dengue virus, at rates of 60 to 100 percent efficacy. Furthermore, Dr. Paul Young of the University of Queensland believes that a drug for sepsis that is currently in clinical trials could be an effective treatment for dengue. The Drugs for Neglected Diseases initiative (DNDi) has completed phase I human clinical trials for SCYX-7158 (AN5568), a drug candidate with the “potential of becoming the first ever, oral-only, single-dose treatment” for human African trypanosomiasis (sleeping sickness), according to DNDi’s Dr. Antoine Tarral. The compound was identified by Anacor Pharmaceuticals, Inc. as part of DNDi’s lead optimization program, through which partners screened compounds from Anacor’s chemical library to identify those that combat sleeping sickness in a laboratory setting. The candidate was tested for safety and tolerability, as well as its effect on and interaction with the body, in 128 healthy volunteers. Due to the trials’ successful results, DNDi and partners will initiate phase 2 and 3 studies in 2016 in the Democratic Republic of the Congo. The leading treatment for sleeping sickness—also developed by DNDi—requires injections, and consequently skilled personnel; prior to the 2009 introduction of this therapy, the best option was an arsenic-based drug with extreme side effects.

As global leaders are set to adopt the Sustainable Development Goals (SDGs) later this month, a new report calls for the United Nations (UN) and its Member States to strengthen the SDG health targets by including indicators to measure global health research and development (R&D) progress in the SDG monitoring framework. The report—Measuring global health R&D for the post-2015 development agenda—which was prepared by the think tank Policy Cures and commissioned by a group of leading global health nonprofits, includes a short list of recommended global health R&D indicators for inclusion in the global and national SDG monitoring frameworks. The report underscores the critical link between global health R&D and achieving the SDGs. It notes that the SDGs include ambitious targets for reducing child and maternal deaths and ending the epidemics of HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, but existing global strategies that align with these targets clearly acknowledge they cannot be achieved without the development and delivery of new and improved drugs, vaccines, diagnostics, and other health tools. While the SDGs include a means of implementation target (target 3.b) to support R&D for vaccines and medicines for diseases primarily impacting developing countries, none of the official UN indicator proposals include any indicators to measure progress on the global health R&D needed to meet this and other health targets. To fill this gap and ensure the SDGs generate the innovations needed to reach the health targets, the report proposes three indicators to measure global health R&D for inclusion in the SDG global monitoring framework, as well as five additional indicators countries are encouraged to include in their national monitoring frameworks if appropriate for their circumstances. These indicators were recommended based on an extensive landscaping and consultative process to identify health R&D indicators and further analysis to refine this list based on feasibility, level of community endorsement, appropriateness, and cross-cutting potential. “Despite the importance of global health R&D to achieving the SDGs, it’s been largely ignored as part of the agenda,” said Erin Will Morton, director of the Global Health Technologies Coalition—one of the organizations that commissioned the paper. “If we want the SDGs to be successful, it is vital that Member States include robust global health R&D indicators in the monitoring framework. Without these indicators in place as we move toward 2030, we won’t be able to gauge whether we are on track to develop and deliver the next generation of health technologies needed to reach the SDGs.” In the interest of balancing the importance of advancing global health R&D with the need to achieve a manageable global monitoring framework, the report recommends three indicators for inclusion in the global framework—the first two of which can be monitored by specialized agencies through existing mechanisms at the global level, while the third can be monitored by national statistical offices: Public, private, and not-for-profit investment in R&D for the health needs that disproportionately affect people living in LMICs Number of new registered health technologies targeting the health needs that disproportionately affect people living in LMICs R&D expenditure as a percentage of gross domestic product To more comprehensively monitor global health R&D progress, the report recommends countries also adopt the following five complementary national indicators if appropriate for their circumstances: Number of new health technologies registered by the National Regulatory Authority and/or recommended by national guidelines National Regulatory Authorities participating in harmonized registration initiatives based on internationally recognized policies and standards; and sharing regulatory policies, legislation, guidelines, and information on registered products Number of formal coordination and collaboration initiatives aimed at increasing and facilitating transfer of health-related technology, including between public and private entities Number of registered clinical trials that meet international quality and safety standards Number of clinical trial sites that meet international quality and safety standards “While it is important to keep the list of global indicators manageable, it’s equally important to make sure we have the right indicators in place to effectively measure our progress toward the SDGs,” said Nick Chapman, Policy Cures’ director of research and the report’s lead author. “Inclusion of the indicators proposed in this paper would help us monitor progress in global health R&D and mobilize increased resources and political commitment to advance the health innovations needed to reach the SDGs, while creating very little or no additional burden on statistical offices.” The report was prepared by Policy Cures and commissioned by the Council on Health Research for Development (COHRED), the Foundation for Innovative New Diagnostics (FIND), the GHTC, the International AIDS Vaccine Initiative (IAVI), the Medicines for Malaria Venture (MMV), PATH, and the TB Alliance to inform stakeholders of the importance of including robust indicators for global health R&D and advise on the most suitable indicators for inclusion.

Health R&D is critically important to achieving the SDGs. Photo: PATH/Aaron Joel Santos Later this month global leaders are poised to approve the Sustainable Development Goals (SDGs), but a new report commissioned by a leading group of health nonprofits including GHTC warns that the SDG targets will not be achieved without the development and introduction of new and improved health technologies to address the health needs of the world’s poorest people. The report calls for the United Nations (UN) and its Member States to acknowledge the importance of global health research and development (R&D) in the SDGs and to include robust indicators in the monitoring framework to measure progress in advancing the development and accessibility of urgently needed new health technologies. The report includes a short list of recommended global health R&D indicators for inclusion in the global and national SDG monitoring frameworks. For the SDGs to be a success, it is vital they recognize the importance of R&D for global health There is no doubt the world has achieved enormous gains in health over the past few years—since 1990, we’ve halved child deaths, reduced maternal deaths by 45 percent, and achieved significant progress in fighting leading killers like HIV and AIDS, tuberculosis (TB), and malaria. The tools we have today are not sufficient to reach the SDG health targets. Photo credit: PATH/Evelyn Hockstein. Yet significant health challenges continue to weigh on the global economy and stand as barriers to poverty reduction and economic prosperity—particularly in low- and middle-income countries (LMICs) where their burden is most severe. Without addressing these challenges, we won’t achieve the ambitious goals of poverty reduction and economic prosperity envisioned in the SDGs. Recognizing the link between health and economic prosperity, global leaders included within the SDGs ambitious targets for reducing maternal and child mortality; ending the epidemics of HIV and AIDS, malaria, TB, and neglected tropical diseases; and addressing other health challenges. The problem? We can’t reach those targets using only the health tools we have today. The major disease-specific global strategies whose targets align with those in the SDGs clearly acknowledge this reality. For example, meeting the target of ending the epidemic of TB by 2030 will require new, effective drugs to treat the growing problem of multidrug-resistant TB. Likewise, without new tools to treat and prevent HIV transmission, the scale-up of existing tools will prove insufficient to achieve the end to HIV and AIDS by 2030 as envisioned in the SDGs. Despite its importance, global health R&D is largely missing from the SDG agenda Six essential elements of the SDGs. Credit: UN Despite the importance of global health R&D to achieving the SDGs, it’s largely missing from the current agenda. Only one of the 169 targets—target 3.b—is specifically aimed at advancing R&D to meet the health needs of LMICs, and, unfortunately, it excludes several important categories of health interventions including diagnostics, microbicides, devices, and other health tools, and it conflates two distinct problems—the need to support R&D to develop new tools and the need for those new tools to be affordable and accessible. Furthermore, none of the UN proposals for SDG indicators include any that can adequately measure progress on global health R&D. Delivering the next generation of lifesaving health technologies will require strong political commitment and the mobilization of resources from all nations to support health innovation. To make that happen, it’s critical that the SDGs explicitly acknowledge the importance of global health R&D and measure progress toward it. An opportunity to incorporate global health R&D in the SDG monitoring framework A new report recommends global health R&D indicators for inclusion in SDG monitoring framework. Photo: Policy Cures While the SDG goals and targets are now set, the indicators will not be finalized until later next year. Given the marginalization of R&D in the goals and targets, it will be vital that effective indicators to measure global health R&D are included in the SDG monitoring framework. Based on an extensive landscaping and consultative process to identify potential indicators and further analysis of their feasibility, data availability, level of community endorsement, appropriateness, and cross-cutting potential, the report recommends three indicators to measure health R&D for inclusion in the global monitoring framework: Public, private, and non-for-profit investment in R&D for the health needs that disproportionately affect people living in LMICs Number of new registered health technologies targeting the health needs that disproportionately affect people living in LMICs R&D expenditure as a percentage of gross domestic product The report also calls on Member States to voluntarily adopt national indicators to monitor progress on global health R&D if appropriate for their circumstances, recommending five additional indicators for this purpose: Number of new health technologies registered by the National Regulatory Authority and/or recommended by national guidelines National Regulatory Authorities participating in harmonized registration initiatives based on internationally recognized policies and standards; and sharing regulatory policies, legislation, guidelines, and information on registered products Number of formal coordination and collaboration initiatives aimed at increasing and facilitating transfer of health-related technology, including between public and private entities Number of registered clinical trials that meet international quality and safety standards Number of clinical trial sites that meet international quality and safety standards These indicators will help the global community monitor progress on advancing global health R&D, while creating very little additional burden on statistical offices. A win-win all around. With the right health tools, the world can achieve the SDGs. But to develop and deliver those tools, we need to mobilize greater resources and political commitment to support health R&D and put in place mechanisms–like indicators–to hold us accountable to make it happen. The SDGs present an opportunity to transform the future of global health through innovation. Will we grasp it? Learn more: Read the full report Read a fact sheet on the report’s findings and recommended indicators Read a press release about the report Express your support for the inclusion of global health R&D indicators in the SDG monitoring framework by adding your name or your organization's name to our call-to-action letter to the UN and its Member States