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A child in Delhi holds new appropriate, child-friendly TB medicine in the correct doses. Photo: TB Alliance Early this month, GHTC member TB Alliance and its partners announced the creation of the first-ever appropriate, child-friendly tuberculosis (TB) medicine in the correct doses. These treatments, which will be available in early 2016, are simple to administer, affordable, and the first to meet childhood TB dosage treatment guidelines set by the World Health Organization (WHO) in 2010. GHTC’s Breakthroughs blog is joined by TB Alliance’s Cherise Scott, Director of the Pediatric Programs and Willo Brock, Senior Vice President, to learn more about this exciting development that could dramatically improve treatment for the one million children with TB each year. Q: Why do we need TB medicines designed specifically for children? And how are these new treatments more child-friendly than what’s in use today? Children need different dosing of their TB treatment than their parents. Until now, this meant that parents needed to split or crush pills to get to the right dosage, which is difficult. The current pills also taste bad, which can lead to children refusing to take their medicine and thus poor adherence and growth in drug resistance. The new formulations that are available are appropriately dosed, dissolvable, and fruit-flavored, which will improve adherence. This should simplify and improve treatment for children everywhere. For more information on what these medicines mean for children with TB and their families, see this video. Infographic: TB Alliance Q: According to WHO, 140,000 children die each year from TB. Given this tremendous need, why did it take so long for appropriately dosed, child-friendly TB medicines to be developed? Not only do 140,000 children die, at least one million children get sick every year from TB. However, children with TB have been neglected for too long. Children with TB often live in poverty, and companies therefore do not have a commercial incentive to invest in research and development for improved TB treatments. After WHO created specific dosage guidelines for children in 2010, TB Alliance, with WHO and a range of other partners, worked together with funding from UNITAID, the US Agency for International Development, and others to advance product development and introduce important medicines that fulfill this critical gap. Q: In product development we know that successfully developing a new product is only half the battle; it needs to actually reach patients to have an impact. What’s next for these treatments in terms of regulatory approval, introduction, and product roll-out? These new treatments for the one million people with TB each year. Photo: TB Alliance In early December 2015, TB Alliance announced the availability of the products under WHO’s “ERP” [Expert Review Panel] mechanism, which is an interim step to expedite access to lifesaving drugs. That means the products are now available for procurement through the Stop TB Partnership’s Global Drug Facility. Full WHO Prequalification is expected in 2016, which will enable even greater access. However, various countries require additional steps to register the treatments. We are asking everyone to help accelerate access to appropriate TB treatments for children by signing our call to action and asking governments to speed up approval and adoption of the new child-friendly treatment. Please sign it and spread the word!

In this guest post, Mike Frick, TB/HIV project officer at the Treatment Action Group (TAG), reflects on activist calls for greater investment in tuberculosis (TB) research and development (R&D) at the 46th Union World Conference on Lung Health and the stagnation of global TB R&D funding at a time of growing drug resistance. Activists march at the 46th Union World Conference on Lung Health in Capetown, South Africa to call for more funding for TB R&D. Photo: David Harrison One city, host to two TB conferences, opened by two marches, held eight years apart. In certain moments at the 46th Union World Conference on Lung Health in Cape Town, South Africa, the present echoed the past. On Friday, December 4, 1,000 people organized by Treatment Action Campaign (TAC) and SECTION 27 marched to the site of the conference to call on governments of the BRICS countries [Brazil, Russia, India, China, and South Africa] plus Indonesia to triple their funding for TB R&D. The sight of so many people demonstrating in support of TB R&D called to mind a moment at the 38th Union World Conference in 2007 when thousands took to the streets of Cape Town demanding greater global investments in TB research and programs. TAC march to demand more funding for research into & the treatment of TB. Photo: David Harrison Seasoned TB activists present at last week’s march likely experienced a feeling of déjà vu. Both marches pointed to the grave lack of investment in TB research. And each occurred at moments their participants described as emergencies. In 2006, an outbreak of extensively drug-resistant TB in Tugela Ferry, South Africa, captured headlines around the world and crystallized how decades of inattention had allowed TB to become more deadly. This year, marchers carried banners reading “We die of TB,” “Invest in TB research,” and “Invest so we can live” (see photos). According to the protest’s organizers, these messages were in response to ten years of data on global funding for TB research collected and analyzed by TAG in a report released on November 29. TAG’s tenth annual Report on Tuberculosis Research Funding Trends shows that after increasing modestly from 2005–2009, funding for TB research has stagnated in the five years since. Over this ten-year period, total funding for TB research has never exceeded more than US$700 million per year (see figure 1). In 2015, worldwide funding for TB R&D totaled $674 million, falling $1.3 billion short of the $2 billion experts estimate the world must spend on TB research each year to eliminate TB. Funding shortfalls have persisted in each category of research tracked by TAG—basic science, diagnostics, drugs, vaccines, and operational research—each of the last ten years, making the last decade one of missed targets and forestalled potential. Credit: TAG Members of TAC and those who marched with them understand that the pace of research to develop new drugs, diagnostics, and vaccines to fight TB is falling behind the spread of drug-resistant TB (DR-TB). The need for better ways to prevent, diagnose, and treat TB has never been greater. TB is now the leading cause of death from an infectious disease, responsible for more deaths each year than HIV and AIDS. In 2014, 400,000 people newly developed DR-TB. TAG’s research suggests that filling the funding gap and accelerating TB research will depend on increasing support from endemic country governments, which is why TAC directed the message of its march to the BRICS countries and Indonesia. Sixty-two percent of money spent on TB research comes from public institutions, a proportion that has grown in the wake of an exodus of pharmaceutical companies from TB research since 2012. Photo:David Harrison Throughout the week, activist voices compelling greater attention to TB research reverberated throughout the conference center. Speaking at the conference’s closing ceremony, Anele Yawa, TAC general secretary, pointed out that 40 percent of TB deaths occur in the BRICS countries, yet these nations give only 3.6 percent of the available funding for TB research. Calling out leaders of the BRICS countries by name, Anele urged them to triple their support for research to overcome a disease that kills so many of their people. “We can’t just tinker and settle for incremental change while our brothers and sisters are dying,” said Anele. “We demand a revolution in funding for TB research.” This call appears to be gaining traction in South Africa. At the end of the march, South Africa’s Minister of Health, Aaron Motsoaledi, accepted a memo endorsed by TAC, TAG, Médecins Sans Frontières, the Global TB Community Advisory Board, HIV i-base, TB Proof, SECTION 27, and the People’s Health Movement. The memo called on governments to declare TB and DR-TB public health emergencies and close the TB research funding gap. In some ways, Minister Motsoaledi’s very presence at the march was a sign of how things have changed since the first march for TB research in Cape Town eight years ago. In 2007, no parliamentarians or ministers of health received the protestors’ list of demands, and the stagnation of TB research funding in the years that followed suggests these earlier cries fell on deaf ears. Political will to support TB research is also gaining traction at the global level. A week before TAG released its report on TB R&D funding, the World Health Organization (WHO) launched the Global Action Framework for TB Research and announced the creation of a TB research focal point within the WHO’s Global TB Programme. Intensified research and innovation is the third pillar of the WHO’s End TB strategy, which aims to eliminate TB by 2035. Through the Action Framework, the WHO aims to advance TB research by building support for TB R&D at the country level, with a focus on low- and middle-income countries that bear the greatest burden of TB but that have traditionally given less than 5 percent of global funding for TB R&D. As part of this initiative, the WHO will work with a group of “pathfinder” countries to develop national strategic plans for TB research backed by concrete milestones over the next five to ten years. It is imperative that these plans are backed by financial commitments that increase TB R&D funding above its current level. Those who marched alongside TAC in Cape Town on December 4 took just the initial steps to build the public pressure and accountability that will be required to make the Action Framework a success and enable the research required to end the TB epidemic—in South Africa and across the world.  

Virginia Commonwealth University (VCU) received a grant from the Global Alliance to Prevent Prematurity and Stillbirth, a member of the GHTC, to study the human microbiome in search of biomarkers to predict preterm birth. The human microbiome is comprised of all the microorganisms (i.e., bacteria) normally found in the human body and the genetic material of those microorganisms. The team at VCU will study the microbiome of women throughout pregnancy, assessing the impact of changes in the microbiome on pregnancy outcomes. Existing research has demonstrated a correlation between an imbalance in the vaginal microbiome of pregnant women and preterm birth, specifically for African Americans. A recent study out of The Rockefeller University in New York could pave the way for a new treatment against human African trypanosomiasis (sleeping sickness), a disease caused by the Trypanosoma brucei parasite and transmitted by the tsetse fly. Once in the human bloodstream, the parasite evolves, and constantly changes the proteins on its surface so that the immune system can’t recognize it. The team at The Rockefeller University determined that by blocking bromodomains—a particular type of protein—through either genetic modification of the parasite or the use of a molecule known as I-BET151, they could trick the parasite into thinking it was still in the tsetse fly. Thus, the parasite would revert to the form it takes within the fly, making it much easier for the immune system to detect and attack it. The method was tested in sleeping sickness–infected mice, and those treated with I-BET151 survived much longer than their counterparts. Child receiving a vaccine. Photo: PATH/Robin Biellik The world’s first vaccine against dengue fever—a mosquito-borne disease that causes fever, headache, and, muscle and joint pain—has been approved for use in people aged 9 to 45 by the national regulatory authority of Mexico. Nearly half the world’s population lives in dengue-endemic countries, and an estimated 390 million infections occur each year. The vaccine, which cost US$1.65 billion to develop over 20 years, is projected to generate $1.4 billion in sales by 2020. Sanofi, the pharmaceutical company that developed “Dengvaxia,” is currently pursuing regulatory approval in 19 other countries and has stated that the vaccine will be sold at a “fair, affordable, equitable, and sustainable price.”

In this guest post Tom Harmon, senior policy analyst at the International AIDS Vaccine Initiative (IAVI), and Anna Forbes, a globally recognized advocate for women’s HIV prevention needs, discuss a new piece proposing how HIV prevention research and development (R&D) for women and girls can better align with programs to improve their health and well-being. Photo: PATH/Doune Porter Around the time a girl in sub-Saharan Africa reaches the age of fifteen her risk of HIV infection skyrockets from two to five times that of boys her age. This high incidence stands in contrast to the increasing success of the global HIV and AIDS response, which has seen global infections reduced year after year and millions more people living with HIV and AIDS able to access lifesaving antiretroviral treatment (ART). It’s not news that HIV and AIDS has increasingly impacted young women and girls in sub-Saharan Africa. Fortunately, this past year may be remembered as a year the world stepped up to the challenge. The 2015 launch of the US$500 billion dollar DREAMS program (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe women) by the US President’s Emergency Plan for AIDS Relief (PEPFAR), the Bill & Melinda Gates Foundation, and Girl Effect aims to leverage high-impact interventions to reduce new HIV infections by 40 percent in girls and women in ten countries in Africa by 2017. Even as this program was scaling up, the World Health Organization expanded HIV treatment guidelines to cover all individuals living with HIV and AIDS regardless of the extent to which the virus has impacted their immune system status. This expansion will include many women and girls not previously covered. These near-term efforts should make a substantial difference in women’s lives. It’s also encouraging that pre-exposure prophylaxis (PrEP)—just a few years after formal approval as an HIV prevention tool—is incorporated in DREAMS. We know that the optimal HIV prevention toolbox for women and girls is one that can be customized to meet each person’s individual needs. Continuing to expand that toolbox with other new HIV prevention options, including HIV-blocking microbicides and a preventive HIV vaccine, can ultimately break the back of the rising epidemic among women and girls and the global epidemic in the long-term. Research to develop and deliver effective new prevention options doesn’t take place in a vacuum—it must take into consideration the wider needs of the women and girls it seeks to ultimately protect. To that end, IAVI recently published a new policy brief “Research and Development of New Biomedical HIV Prevention Tools for Women and Girls: Combating the global AIDS epidemic through a more empowered response in sub-Saharan Africa” that summarizes findings and recommendations for improved HIV prevention research with and for women and girls. Our work highlights challenges to better align HIV prevention research for women and girls with the needs and realities of their lives. For instance, a recent issue of the Journal of Acquired Immune Deficiency Syndromes highlighted the relatively low participation of women in HIV vaccine trials (38 percent) and AIDS treatment trials (19 percent), which limits our understanding of how effective an intervention is for women and girls. And, we know that if research taking place in a community doesn’t ensure some ongoing community benefit once a trial is completed, it can discourage participation by women in future trials. Fortunately, some of these essential elements are already being addressed. Positive results in microbicides research have correlated to excellent efforts to incorporate end user perspectives in product profiles. The Ragon Institute’s FRESH study links girls and young women highly vulnerable to HIV with programs that build job skills, attacking one of the drivers of poverty while also identifying early HIV infection and quickly enrolling women living with HIV and AIDS in ART programs. Keeping HIV prevention R&D in touch with the renewed focus on fighting HIV and AIDS among women and girls in sub-Saharan Africa is critical to the long-term goal of ending AIDS. We’re proud to be part of an HIV prevention research community that is already making strides to improve the lives of women and girls while building the scientific knowledge necessary to bring new tools to the fight. Doing right BY communities will ensure that the fruits of our work will be more effective IN those communities. Pockets of high incidence are devastating in any population and put overall progress at risk. Infectious diseases spread in the wider world when they are not stopped where they hit the hardest. This further underscores the importance of a sustained commitment to improving and expanding programs that reduce HIV incidence in women and girls and adding new interventions that women and girls can use to protect themselves. None of this is possible if we can’t assure women and girls with a strong HIV response that engages them, listens to them, and then implements the programs and research necessary to make this feminized epidemic yesterday’s news.