Breakthroughs Blog: Contraceptives

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. According to clinical trial results recently published in the New England Journal of Medicine, tafenoquine—a new single-dose oral antimalarial drug developed by Medicines for Malaria Venture and GlaxoSmithKline—significantly lowered the risk of the recurrence of malaria caused by the Plasmodium vivax (P. vivax) species of the parasite. P. vivax malaria affects approximately 7.5 million people annually and often lies dormant in the liver even after initial treatment, causing debilitating recurring malaria episodes. This single-dose treatment could significantly boost cure rates, as adherence to the standard two-week drug course is difficult in low-resource regions in Southeast Asia, Latin America, and parts of North Africa where this form of malaria is endemic. Based on the results of this clinical trial, the US Food and Drug Administration has already approved tafenoquine for use in July 2018, followed by the Australian Therapeutic Goods Administration in September 2018. A new, long-acting contraceptive designed to be self-administered by women using microneedle skin patch technology could provide a valuable new family planning option, particularly for women in low-resource settings where access to healthcare can be limited. When the patch is applied to the skin, microscopic needles break off and remain under the surface of the skin where biodegradable polymers slowly release the contraceptive drug, levonorgestrel. In animal testing, an experimental microneedle patch provided a therapeutic level of contraceptive hormone for more than a month with a single application. Experimental patches designed for humans have been developed but not yet tested. If the microneedle contraceptive patch does eventually reach the market, it could become the first self-administered, long-acting contraceptive that does not require a conventional needle injection.A new rapid DNA and RNA sequencing device could offer potential to instantly diagnose viruses such as Ebola or Zika at the point of care during an outbreak. Researchers at the French agricultural research institute CIRAD have found a way to use a device known as the Oxford Nanopore MinION device, which can sequence DNA and RNA in real time, to identify plant viruses—and potentially animal and human viruses too. The CIRAD team was able to test and validate the use of this portable device to identify plant viruses quickly and early in the infection process—avoiding the time-consuming and potentially dangerous task of transferring contaminated samples to a lab. The device’s ability to rapidly and accurately detect a virus in plants is a step forward in providing real-time detection of viruses with a mobile device, which would be especially useful in low-resource settings and remote areas. This device has the potential to help public health officials manage outbreaks by reducing the time between taking a sample and diagnosing it as carrying a particular virus—enabling the detection of potential outbreaks at an earlier stage than was previously possible.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. The Population Council and its partners announced the launch of the first clinical trial to test the safety and efficacy of a male contraceptive gel—an innovation that could advance contraception and bring more equality to the burden of family planning, which is largely borne by women. The gel, known as NES/T, is a novel, reversible contraceptive composed of a progestin hormone used for female contraception and testosterone. The gel is designed to be applied daily and absorbed through the skin on the upper arms and shoulders. The phase 2b trial, sponsored by the National Institutes of Health, will test the product for pregnancy prevention among more than 400 couples. Should NES/T prove effective, it would be the first user-controlled method for contraception for men since the condom. Last Monday, South African drug maker Aspen Pharmacare launched a triple-antiretroviral (ARV) combination tablet for the treatment of HIV in South Africa—a country which accounts for 19 percent of the global burden of people living with HIV and 15 percent of new infections. The new medicine, known as Emdolten, is taken once daily and contains dolutegravir, an antiretroviral medication that counters the drug resistance that often develops with older HIV treatments, along with lamivudine and tenofovir disoproxil fumarate. In May, the South Africa Regulatory Authority and the European Medicines Agency issued a warning advising doctors not to prescribe dolutegravir to women seeking to becoming pregnant following cases of birth defects in a study; however, Aspen Pharmacare stated that using dolutegravir is safe for men, women not of child-bearing age, and child-bearing women using contraceptives, which account for approximately 70 percent of HIV patients. Researchers have developed a way to freeze-dry an inactivated poliovirus vaccine (IPV) so that it can be stored at elevated temperatures, up to 40°C, for four weeks and then dissolved for use without losing its potency—potentially offering a new tool to eradicate the disease. While existing oral vaccines have led to polio’s elimination in many countries, these oral vaccines contain a weakened live virus, which can cause paralysis in rare cases. Thus, there has been push to use IPVs, which contain dead strains of the virus. Although IPVs have already been introduced in many countries, their widespread use is inhibited by their sensitivity to temperatures above and below approximately 4°C (39.2°F).

There is no doubt that the past decade has brought transformative breakthroughs in global health innovation, from new medicines, to combatting leading child killers like malaria and tuberculosis (TB), to interventions that are making an AIDS-free generation possible. These game changers have saved millions of lives and helped unlock better health and opportunity for people around the world. The Global Health Technologies Coalition (GHTC) spent this past decade standing side-by-side in partnership with scientists and innovators, working to ensure they have the resources and supportive policies needed to advance innovation that truly drives impact. As we close out our tenth anniversary year and mark our first decade of advocacy, we wanted to take a moment to reflect on our shared progress and celebrate the headlines and moments that shaped global health research and development (R&D) over the past decade. Here are ten highlights: Could pills taken daily prevent HIV infection? That was a key question on researchers and activists minds in the early 2000s.By the end of the decade, the evidence pointed to yes. In 2012, the US Food and Drug Administration (FDA) approved the use of the antiretroviral drug Truvada as pre-exposure prophylaxis (PrEP) to prevent HIV infection. While it took several more years for PrEP to begin to be approved and introduced in low- and middle-income countries (LMICs), it has proved a powerful new tool in the global fight against HIV and AIDS. Revolutionary. Simple. Empowering. These are words that have been used to describe Sayana Press, an all-in-one injectable contraceptive developed by GHTC member PATH. Sayana Press combines a long-acting contraceptive with the easy-to-use Uniject injection system that involves minimal training, making it an especially suitable tool for low-resource settings and for women to self-administer. Since its introduction in 2014, more than 1 million doses of Sayana Press have been delivered to women worldwide, giving them greater power and autonomy over their reproductive health. Despite the fact that over 70 percent of all malaria deaths are children, before 2009 there was not a single high-quality malaria drug designed for kids. Instead, parents would crush adult tablets in what amounted to a daily struggle to provide an accurate dose as well as convince their kids to swallow these bitter tasting pills. This changed with the introduction of Coartem Dispersible, the first malaria medicine designed for children. Developed by GHTC member Medicines for Malaria Ventures, the medicine is affordable, easy-to-administer, sweet-tasting, and dosed for children. As of 2016, over 300 million treatments have been distributed worldwide, saving an estimated 750,000 lives. For more than a century, meningitis has ravaged a swath of the African continent known as the “meningitis belt,” killing one in ten people it sickened. But thanks to the efforts of a coalition of partners, including GHTC member PATH, we’ve stopped deadly meningitis A epidemics in their tracks. In 2010, MenAfriVac—a low-cost vaccine against mengingitis A—was introduced in Africa. Since then, more than 270 million people in 26 countries have been vaccinated, and thankfully, meningitis A is becoming a disease of the past. HIV and AIDS remains one of the greatest threats to women’s health globally, yet women and girls still lack the range of tools they need to protect themselves. Thanks to over a decade of effort by a unique partnership led by GHTC member the International Partnership for Microbicides, the future looks different. The partnership has advanced a new woman-center HIV prevention tool: a monthly, vaginal microbicide ring that deliver antiretroviral drugs. The groundbreaking new tool was found to reduce HIV risk in women in late-stage clinical trials in 2016, and it is now under regulatory review and poised for potential introduction worldwide. For parents with kids suffering from TB, getting their child to take multiple pills a day for months was a serious struggle, from trying to split up pills, to achieving the right dosage, to convincing children to swallow bitter tasting medicine. In 2016, this process became easier with the introduction of the first kid-friendly TB drugs. Developed by GHTC member TB Alliance, the drugs are appropriately dosed for children, dissolvable in water, and fruit-flavored to appeal to children. Already close to 80 countries, have adopted this improved treatment, with 700,000 courses ordered. Malaria has plagued humanity for tens of thousands of years. Fortunately, this past decade has brought a number of new and improved tools and approaches to tackle this age-old scourge, including the world’s first approved malaria vaccine, Mosquirix. In 2017, the World Health Organization announced plans to pilot the vaccine—developed by GHTC member PATH—in sub-Saharan Africa. While developing a high-efficacy vaccine against malaria has proved challenging due to the parasite’s complexity, Mosquirix, which reduced the rate of infection in children by 39 percent in clinical trials, is an important scientific breakthrough, and health officials hope it will prove a valuable addition in fighting malaria used alongside existing interventions. In 2014, the world’s deadliest Ebola outbreak caught the global community unaware and unprepared, devastating nations in Western Africa. While health workers went to work in the field to contain the immediate crisis, scientists went to work in their labs to develop a vaccine to prevent future epidemics. Thanks to research on Ebola vaccines that had been undertaken in the early 2000s, researchers were able to accelerate the leading Ebola vaccine candidate—RVSV-ZEBOV—from preclinical testing to phase III trials in less than two years. In 2016, it was announced that the vaccine was found nearly 100 percent effective in these trials. The vaccine could be approved by the FDA as early as 2019. More than two billion people worldwide suffer from hidden hunger—a condition characterized by deficiencies in micronutrients such as zinc, iron, and Vitamin A, which can cause stunted growth, blindness, and learning disabilities. In the 1990s, a young economist Howarth Bouis had a kernel of an idea: What if we could create better crops to provide better nutrition? His answer was biofortification, a process of naturally breeding sustenance crops so they are rich in micronutrients. After years of proof of concept research, in 2009, the nonprofit he founded—GHTC member HarvestPlus—introduced its first wave of crops in LMICs, providing nutrient-rich food for people in need. For decades, diagnosing multi-drug resistant TB (MDR-B) meant using older testing methods that took weeks to deliver results and required expensive laboratory equipment. In 2010, this began to change with the introduction of the Xpert MTB/RIF test, an automated diagnostic test developed by GHTC member FIND, which does not require microscopes or a laboratory, involves very little training to operate, and can deliver results in less than two hours, start to finish. FIND and partners will soon introduce a next-generation version—the Genexpert Omni—that is smaller, more portable, and battery-operated, which should further expand access to improved TB diagnosis. View a slideshow of more moments and milestones in global health R&D over the past decade. Here’s to ten more years of progress! At GHTC, we are proud to work with so many believers, innovators, and changemakers who are driving progress in global health. As we embark on 2018 and beyond, we recommit to continuing this momentum and look forward to another decade of advancing innovation to save lives.

It’s that time of year when Americans join together with family and friends and give thanks for the many things in life for which they are most grateful. In the spirit of the Thanksgiving holiday, GHTC asked our members and staff to share what they are most thankful for in global health. Here’s what they had to say: “I am thankful for all patients who take part in clinical trials so that the world will have more effective regimens to end TB, in all its forms.” Willo Brock, Senior Vice President of External Affairs, TB Alliance “I’m thankful there is increasing global interest in the development and production of vaccines for diseases of poverty, like hookworm, schistosomiasis, and Chagas.” Tara Bracken, Communications Associate, Sabin Vaccine Institute “I am thankful that 2016 was a turning point for women’s HIV prevention research—one that brought us hope for one day soon expanding women’s options with a long-acting vaginal ring. I am also grateful for the amazing partners who believe women’s health and empowerment matter!” Zeda Rosenberg, Founder and CEO, International Partnership for Microbicides “I’m thankful for the new generation of emerging R&D leaders who are both generating new knowledge and achieving global health impact.” Dr. Timothy Mastro, Chief Science Officer, FHI 360 “I’m thankful for sustained US government funding to fight emerging epidemics, like Ebola and Zika, through R&D and scientific advancement.” Lindsay Litwin, Jhpiego Innovations “I’m thankful that elimination of sleeping sickness is now a real possibility thanks to new tests being strategically implemented alongside new vector control technologies and improved treatment regimens.” Dr. Joseph Ndung’u, Head of Neglected Tropical Diseases Programme, FIND “I’m thankful that the six antimalarials MMV and partners have brought forward are saving young lives today!” Andrea Lucard, Executive Vice President of External Relations, Medicines for Malaria Venture “I’m thankful for research that has shown promise for an effective six-month regimen to cure XDR-TB [extensively drug-resistant TB].” Rabita Aziz, Policy Research Coordinator, ISDA Global Health “I’m thankful for the inspirational dedication and continued participation of all HIV vaccine clinical trial volunteers. Without you, the important work of finding a safe and effective HIV vaccine would not be possible.” Dr. Fran Priddy, Chief Medical Officer, International AIDS Vaccine Initiative “I’m thankful for the over 200 members of Congress who have co-sponsored the Reach Act to accelerate efforts to end preventable deaths of mothers and children around the world.” Brandon Ball, Policy and Advocacy Officer, PATH "I'm thankful for low-cost interventions like chlorhexidine gel for umbilical cord care being made more accessible to Sub-Saharan Africa to reduce newborn mortality." Assumpta Nantume, Communications Associate/Global Health Corps Fellow, Global Health Council “I'm thankful a new generation of Middle Eastern scientists are advancing the development, production, and characterization of new vaccines to help endemic countries better respond to the threat of infectious diseases like MERS, schistosomiasis, and leishmaniasis.” Chris Bennett, Senior Program Officer, Sabin Vaccine Institute “I’m thankful for pioneering donors such as UNITAID for funding development of new hepatitis C tests for countries where fewer than 1 percent of people living with hepatitis C have been diagnosed.” Catharina Boehme, Chief Executive Officer, FIND “I’m thankful for scientists and researchers who devote their lives to important global infectious disease work to help people around the world and to protect Americans here at home and the funding the US government provides for such important work.” Karen Goraleski, Executive Director, American Society for Tropical Medicine and Hygiene “I’m thankful for the tremendous progress we’ve made in advancing child and maternal survival and excited for the prospect of saving the lives of more than 6 million mothers and children by 2030 if we work together to advance and scale-up 11 promising innovations.” Heather Ignatius, Multilateral, US, and Europe Policy & Advocacy Team Lead, PATH “I’m thankful for researchers across the globe whose efforts have, with unprecedented speed, deepened our scientific understanding of and advanced new tools to prevent, detect, and treat Zika.” Kat Kelley, Senior Program Assistant, GHTC “I'm thankful so many good dengue vaccine candidates are in development that could help curb the growing global dengue epidemic.” Tara Bracken, Communications Associate, Sabin Vaccine Institute "I'm thankful for increased awareness on global antibiotic resistance and WHO's new evidence-based Infection Prevention and Control Guidelines." Danielle Heiberg, Advocacy Manager, Global Health Council “I'm thankful for the lives of mothers and babies that have been saved, sustained, and supported by midwives across the globe.” Shannon Egan, Jhpiego Innovations “I’m thankful that malaria rapid tests have contributed to better malaria control, which in turn has helped fuel a massive decline in childhood mortality over the past decade—and that partners around the world are working together to find innovative new solutions for identifying non-malarial causes of fever. Diagnosis matters!” Dr. Iveth J. González, Head of Malaria and Acute Febrile Syndrome programme, FIND “I’m thankful for the support of MMV’s committed donors and partners that make our work to develop new antimalarials for vulnerable populations possible.” Andrea Lucard, Executive Vice President of External Relations, Medicines for Malaria Venture “I’m thankful to be a part of the #StartStayAIDSFree initiative which aims to end AIDS in children by 2020.” Catherine Connor, Senior Director of Public Policy and Advocacy, Elizabeth Glaser Pediatric AIDS Foundation “I’m thankful that members of both major US political parties have continued to demonstrate strong, bipartisan support for global health research and development and US efforts to save lives around the world.” Marissa Chmiola, Communications Officer, GHTC