Breakthroughs Blog: HIV/AIDS

Science expands our understanding, makes the impossible possible, and helps us build the future we want for all people. Science drives the work of our Global Health Technologies Coalition, so we wanted to take a step back to reflect on five ways science is transforming global health:1. Science is generating treatments, cures, and vaccines to tackle the world’s most devastating diseases.  From a vaccine that has put us at the brink of eradicating polio to antiretroviral treatments that have dramatically extended the lives of people living with HIV and AIDS, science has generated new health technologies that have driven tremendous progress in global health. Thanks to investments in science and research, 82 new vaccines, drugs, diagnostics, and other lifesaving global health tools have been developed and introduced since 2000. These tools include a new meningitis A vaccine—which has already saved 378,000 lives and prevented 673,000 new infections since 2010—and new child-friendly malaria drugs that have helped cut childhood malaria deaths by 65 percent since 2000. Science has also fueled a robust pipeline of over 670 global health technologies now in development poised to further build upon these gains.2. Science is helping us understand the unique needs of users and communities so we can design the right tools for impact. A scientist assembles a point-of-care diagnostic test. Photo: PATH/Dan ChangDriving progress in global health is not just about developing tools that work; it’s about developing tools that work for the communities and contexts in which they are used. A diagnostic test won’t help us identify and control an emerging epidemic unless it can be administered on the spot in remote communities and deliver results quickly. Likewise, a woman is not likely to adopt a new contraceptive or HIV and AIDS prevention method unless it’s easy-to-use, comfortable, affordable, and fits in with her lifestyle and culture. Through surveys, data analysis, diagnostics, and user testing, science is enabling us to study end users and the environments and social systems in which they operate. This helps us better understand the complexity of their unique needs and design and refine technologies to deliver the most effective solutions for impact.3. Science is helping us predict, detect, and track emerging health risks so we can be better prepared to confront tomorrow's challenges. From using weather patterns to forecast the risk of insect-borne disease outbreaks, to employing genomics and evolutionary theory to predict how bacteria will become resistant to antibiotics, to advancing new hybrid systems that combine crowdsourced data with traditional disease surveillance, science is helping us better predict, detect, and track infectious disease outbreaks and other emerging health challenges. Early detection can make the difference between an outbreak becoming an epidemic and is critical to mounting an effective response.4. Science is helping us understand what works and what doesn't so we can better target interventions and design health programs for maximum impact.  How often does an insecticide-treated bed net need to be replaced, and how many tears can it sustain before its stops working? In an era of limited resources, can we predict which technologies and interventions are likely to save the most lives in a country if brought to scale? How do we get people to change their handwashing habits to reduce diarrheal disease and childhood deaths? These are the questions big and small that scientists, data analysts, and other health researchers are working to answer in labs, offices, and program sites across the United States and world. The answers they get are helping us better target health solutions and refine health programming to more save lives and more dollars.5. Science is putting information and data at our fingertips to help us fight global diseases and health challenges in new and unusual ways. The revolution in mobile technology, digital health, and big data is transforming our approach to fighting global diseases and health challenges. Health care workers are using mobile devices to track immunization coverage door-to-door and monitor vaccine supplies to prevent stockouts, doctors are using SMS to remind patients to take their tuberculosis drugs and treatment adherence, and health ministries are deploying new data visualization toolsto turn a mountain of data into accessible and actionable information to guide decision on to best deploy and target resources.Science creates a foundation upon which improvements in global health are built. It unlocks discoveries and fuels innovation, informs policies and programs, breaks down barriers, and ultimately advances better, healthier lives for all people. At this moment in time, it is more vital than ever that we build a convincing case of the benefits that flow from science and the importance of strong investment in science and research.In global health, science matters because #scienceserves and science saves.

Scientists at the University of Oklahoma are looking for the next breakthrough drug in an unusual place: roadkill. Every animal hosts a unique microbiome—a community of microorganisms, including bacteria, fungi, and molecules with antibacterial and antifungal properties. The research team is collecting swabs from dead animals found along a state highway and has already discovered two compounds (taken from an opossum’s ear) that could prevent the spread of yeast infections. Hypothermia is a significant driver of morbidity and mortality among babies born prematurely, even though the condition is easy to detect and treat. Detection relies on temperature monitoring, and current standard of treatment is Kangaroo Mother Care (skin-to-skin contact). Now, an electronic alert bracelet is being used to prevent hypothermia among preemies in India. If the infant is healthy, the bracelet flashes a blue light every ten seconds; if the infant’s temperature drops, the light turns to red and an alarm goes off. The single-use device is safe and can be used for a month straight—even at home. Though a daily dose of pre-exposure prophylaxis (PrEP) can prevent HIV infection, stigma, cost, and frequent stockouts can impede adherence to the regimen. While only four doses per week is sufficient to protect men from infection, if women miss a single daily dose, they risk infection. To mitigate these barriers, researchers at Intarcia Therapeutics Inc. are developing an implant that would release PrEP over time, meaning just one visit to the doctor’s office would protect patients for an entire year. The device has already undergone advanced testing and is currently under review by the US Food and Drug Administration for the delivery of diabetes drugs. Researchers at the Center for Infectious Disease Research (CIDR) in Seattle are using mosquitoes, rather than syringes, to deliver an experimental malaria vaccine. The vaccine uses live, but weakened malaria parasites, which can only grow inside living mosquitoes. In an initial trial, ten volunteers were vaccinated, none of whom developed malaria and all of whom produced antibodies that could confer immunity against malaria. The antibodies were extracted from volunteers and successfully used to protect mice against malaria, however, additional trials are needed to determine their efficacy in humans. CIDR is partnering with the Maryland-based biotech company Sanaria to develop a more standard and sustainable vaccine delivery system, producing the weakened parasites and extracting them from the mosquitoes, and attempting to grow the parasites outside of the mosquitoes.

2016 was a year that ushered in significant shifts in the global health landscape. We witnessed the waning of the Ebola epidemic and the waxing of the Zika outbreak; important leadership changes among the biggest institutional players in global health; and the development and introduction of new innovations that could turn the tide against leading infectious disease killers. As the year comes to an end, GHTC is reflecting on the top stories in global health innovation that made news in 2016. Here are seven of those top moments: 1. Scientists mobilize against Zika A vial of the National Institute of Allergy and Infectious Diseases (NIAID) Zika Virus Investigational DNA Vaccine (Photo: NIAID).Once considered an obscure virus responsible for a mild illness, Zika took the world by storm in 2016. As the virus gained a foothold in more than 60 countries, its association with devastating birth defects and neurological conditions was firmly established. Prior to Zika’s emergence in the Americas, only 25 research papers had been published on the virus. As the epidemic grew, scientists around the world joined the fight against Zika, often sharing their data and research in real time to speed progress. Thanks to the efforts of these researchers, over the past year our scientific understanding of Zika has grown exponentially, and we have advanced a robust pipeline of new tools to prevent, detect, and treat Zika. Today, there are more than 35 Zika vaccine candidates under development; 13 Zika diagnostics have been authorized for use by the US Food and Drug Administration; and researchers are screening novel compounds and evaluating existing drugs to advance treatments for the disease. 2. The world commits to the fight against antimicrobial resistance United Nations General Assembly (Photo: GHTC/Matthew Robinson). 2016 marked the year the world finally got serious about tackling antimicrobial resistance. On the heels of several major analyses examining the potentially devastating health and economic impact of antimicrobial resistance, the United Nations (UN) General Assembly convened global leaders for a high-level summit on antimicrobial resistance—the fourth time such a meeting has been held on a health-related topic during the UN’s 71-year history. At the close of the summit, UN member states unanimously endorsed and adopted a political declaration committing to developing action plans and policies; mobilizing resources; and supporting public awareness, surveillance, and R&D efforts to combat antimicrobial resistance. It is our hope that 2017 will mark the year political commitment translates to concrete action to advance the development of new antibiotics. 3. New strategies deployed to stymie mosquito-borne diseases Mosquito-borne diseases remain an age-old scourge, but 2016 saw the advancement of several novel strategies to combat these tiny foes. Efforts to combat mosquito-borne diseases with the transmission blocking–bacteria Wolbachia took an important leap forward this year. Past studies have shown that when the Wolbachia bacteria is introduced to Aedes aegypti mosquitos—which carry viruses like Zika and yellow fever—it prevents the viruses from replicating and blocks further transmission. Because the bacteria can be passed from one generation of mosquitoes to the next, the bacteria offers hope for eliminating a virus’s presence within a local mosquito population. After several years of conducting small-scale tests of this method, the Eliminate Dengue Program announced in 2016 it would begin conducting two large-scale trials in South America to determine whether this approach is effective in halting the spread of mosquito-borne diseases in large urban settings. This year the biotech company Oxitec also advanced efforts to test the use of genetically modified mosquitoes to reduce mosquito populations and disease transmission. The company has engineered mosquitoes that mate with A. aegypti mosquitoes, producing offspring that are unable to mature to adulthood. Early last year, Oxitec introduced the mosquitoes into the Brazilian city of Piracicaba, resulting in an 82 percent decrease in the population of A. aegypti mosquitoes in just nine months. Now, Oxitec has expanded the trial to a larger geographical area and is also initiating trials in the Florida Keys and the Cayman Islands. 4. World’s first kid-friendly TB medicine launches Children who receive tuberculosis (TB) medicines require a different dose than adults, yet until this year, there were no TB medicines designed specifically for children, so parents were forced to split or crush adult pills in an attempt to administer the right dose to their child. This year, that all changed with the launch of the world’s first kid-friendly TB medication. Developed by TB Alliance, the medicine is designed with the unique needs of children in mind: It is fruit-flavored, dissolvable in water, easy to administer, and appropriately-dosed. Already, more than 30 countries have adopted the new medicines, and enough orders have been placed to treat half of childhood TB cases worldwide. 5. Unique HIV prevention option for women reaches important development milestone Image captionMonthly vaginal dapivirine ring helps protect women against HIV (Photo: International Partnership for Microbicides). Women may soon have a powerful new tool at their disposal to prevent HIV infection. Earlier this year, the International Partnership for Microbicides (IPM) announced the results of two large phase 3 clinical trials demonstrating that a monthly vaginal ring containing the antiretroviral drug dapivirine can help protect women from HIV. While initial results indicated that the dapivirine ring reduced HIV risk by approximately 30 percent, further analysis revealed that the ring reduced infection rates by 75 percent in women who used the ring consistently. Now, IPM is seeking regulatory approval for the dapivirine ring and is conducting open-label studies, enabling trial participants to continue using the ring as IPM collects additional data. The dapivirine ring is the only long-acting, female-initiated HIV prevention tool to have proven successful in phase 3 clinical trials. Young women in sub-Saharan Africa are more than twice as likely to be infected with HIV than their male counterparts, and thus female-centered prevention tools are needed stem the epidemic. 6. Roll out begins of world’s first malaria vaccine candidate After decades of development and testing, the world’s first malaria vaccine candidate will soon be introduced in several communities in sub-Saharan Africa. The vaccine—RTS,S—was developed by PATH and GlaxoSmithKline and received a positive opinion from the European Medicines Agency last year following completion of phase 3 clinical trials. In November, the World Health Organization (WHO) announced it would pilot and evaluate the vaccine in real-life settings, thanks to funding from The Global Fund; UNITAID; and Gavi, the Vaccine Alliance. Pending results of these pilot tests, WHO will determine whether to deploy the vaccine on a wider scale. 7. New global health technologies advance through the pipeline PATH launches an easy-to-use, rapid diagnostic for onchocerciasis (Photo: PATH/Dunia Faulx) Over the past year, several other promising new health innovations have moved through the development pipeline and one step closer to reaching the hands of patients: Two important health tools—a novel, affordable oral cholera vaccine developed by the International Vaccine Institute, and the Woman’s Condom developed by PATH and partners—received WHO prequalification this year, paving the way for their procurement by UN agencies and other international procurement organizations. Two new rapid diagnostic tests for the neglected tropical diseases onchocerciasis (river blindness) and lymphatic filariasis were launched this year. Developed by PATH, these tests provide results in just 30 minutes and can be stored at a wide range of temperatures. Development has begun for an affordable therapy for hepatitis C. In 2013, the world’s first cures for hepatitis C hit the US market, however, treatment remains out of reach for many patients due to the high price tag. This year, the Drugs for Neglected Diseases initiative announced it would begin testing an alternative therapy in phase 2 and 3 clinical trials, with a guarantee from the manufacturer that, if successful, the entire regimen will be sold for no more than US$294.  As 2016 draws to a close and 2017 begins, it is time for the global health community to redouble our efforts to make sure this vital progress in global health innovation continues to ensure that people around the world will have access to lifesaving and life-improving health technologies.

The HIV virus is rapidly developing resistance to common antiretroviral drugs. In low- and middle-income countries (LMICs), 10 percent of patients starting antiretroviral therapy (ART) and 40 percent of patients restarting treatment are infected with drug-resistant strains. The leading contributor to drug resistance is failure to adhere to treatment—a problem that plagues nearly three-fourths of patients in LMICs. In low-resource settings, many patients only have access to older, more toxic drugs, and more than one third of clinics report stock outs of HIV medicines. If action is not taken to improve treatment for these patients, drug-resistant strains of HIV-1 could result in 300,000 new infections and 425,000 deaths over the next five years. Last week, the US Congress overwhelmingly approved the nearly 1000-page 21st Century Cures Act, a massive initiative that channels new funding into the US National Institutes of Health and alters the way the US Food and Drug Administration (FDA) regulates certain medicines and devices. While some advocates argue that it weakens the FDA’s regulatory review process, others have applauded the legislation for its potential impact on the development and approval of new antibiotics. One provision—the limited population approval pathway—would allow the FDA to approve antimicrobials and other drugs for serious or life-threatening infections based on smaller clinical trials, addressing the challenge of identifying an adequate number of clinical trial participants (i.e., patients who are infected with drug-resistant pathogens). Another component addresses the FDA’s approach to updating antimicrobial susceptibility interpretative criteria, which informs the development of diagnostics that help physicians prescribe the best antibiotics for a given infection. The provision enables the agency to rely on other organizations’ research and update its criteria accordingly, rather than reviewing the research in house—a time consuming and costly process. While the legislation will likely be signed into law by President Obama, it could take years to fully implement. Scientists have long known that the tuberculosis vaccine offers protection against a number of pathogens and even treats certain conditions (i.e., bladder cancer and asthma), and a recent study in Cell Reports may explain why. Studies in mice and humans revealed that the Bacillus Calmette-Guerin vaccine increased glycolysis—the process of breaking down glucose—in monocytes, a type of immune cell. The effect, which lasts long after vaccination, enhances monocytes’ immunological memory—their ability to remember pathogens they have previously encountered—improving their disease detection and response capabilities. These findings could help scientists devise new strategies for boosting the immune system or its response to certain diseases. The European Medicines Agency (EMA) released a statement last week indicating that patients treated with certain hepatitis C medicines may experience a resurgence of previously latent hepatitis B. The phenomenon applies to a new class of drugs known as direct-acting antivirals and includes Daklinza, Exviera, Harvoni, Olysio, Sovaldi, and Viekirax. While there have only been 30 reported cases, the EMA is recommending patients be tested for hepatitis B before starting treatment.