Ansley Kahn

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.Last Wednesday, GlaxoSmithKline (GSK) announced its two-drug HIV regimen, Dovato, was successful in suppressing the virus in patients over a 48-week period at the same level of a previous three-drug treatment in a late-stage trial. The study evaluated the effectiveness of Dovato in adults with HIV-1 virus, the most widespread strain, who switched to the regimen from at least a triple combination containing Gilead’s Vemlidy. GSK’s HIV drugs division, ViiV, noted that adults who used Dovato did not develop any resistance to the treatment. Dovato, a combination of dolutegravir and lamivudine, was approved in the United States in April for newly diagnosed patients. GSK already has a two-drug regimen, Juluca, on the market but only for HIV patients that have received prior treatment.Two experimental Ebola drugs, an antiviral called remdesivir and an antibody treatment called ZMapp, have been found to be effective in laboratory studies in treating the strain of the virus responsible for the deaths of more than 1,600 people in the current outbreak affecting the Democratic Republic of Congo (DRC). According to this new research performed by the Centers for Disease Control and Prevention, in laboratory studies both drugs inhibited the growth of the virus strain in human cells. These two treatments were developed based on strains from previous outbreaks, and this study was the first to test them on the strain causing the current outbreak, which researchers are calling the Ituri strain. According to the latest figures from the World Health Organization (WHO), the Ebola outbreak in DRC has killed 1,630 people with 2,418 total cases—making it the second biggest outbreak of the disease in history.On July 9, WHO published updates to two lists critical for global health: the twenty-first WHO Model List of Essential Medicines and the second WHO Model List of Essential Diagnostics (EDL). These lists help countries prioritize critical health products that should be available, accessible, and affordable in a health system. While the first EDL, developed in 2018, covered a limited number of priority diseases, the second list has expanded to include more noncommunicable and communicable diseases, consisting of 122 test categories. In this editorial piece, Dr. Madhukar Pai, Canada Research Chair of Epidemiology & Global Health at McGill University, explains what’s included in the EDL, what follow up is required by low-and middle-income countries (LMIC) to make the list work, and the LMIC investment required to develop the diagnostic tests and laboratories necessary to deliver on universal health coverage and to better detect outbreaks, antimicrobial resistance, and pandemics.

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. To help tackle antimicrobial resistance (AMR), the Global Antibiotic Research & Development Partnership (GARDP) announced its new “5 BY 25” strategy to mobilize global stakeholders to raise the €500 million needed to develop five new antibiotic treatments by 2025. According to a GARDP press release, drug-resistant infections cause at least 700,000 deaths per year globally and addressing the growing threat of AMR will be key to achieving universal health coverage and the Sustainable Development Goals. With this new strategy, GARDP aims to develop and make accessible five new treatments that will focus on the priority pathogens identified by the World Health Organization, along with current unmet needs for diseases and key populations. In a promising step towards an HIV and AIDS cure, researchers from Temple University and the University of Nebraska have successfully eliminated HIV from the DNA of infected mice using genome editing technology combined with a slow-release virus suppression drug. Researchers administered a treatment called LASER ART, or long-acting, slow-effective release antiretroviral therapy to suppress HIV cells from replicating in mice engineered to produce human T cells susceptible to the virus. The research team deployed the drug across several weeks to target tissue in the spleen, bone marrow, and brain where latent HIV reservoirs are likely to occur. The researchers then used CRISPR-Cas9, a gene-editing tool, to eliminate the remaining infective cells from the subject’s DNA. By the end of the study, researchers had successfully eliminated HIV from nine out of 23 mice. Researchers are now working on a version of the study with primates. If their methods continue to be successful, clinical trials could follow as soon as next summer. Heads of state from the world’s largest economies committed to advance global health priorities at this year’s G20 Summit in Osaka, Japan. In the G20 Osaka Leaders’ Declaration, they included commitments to move towards universal health coverage by bolstering primary health care and access to medicines, promote healthy aging by preventing noncommunicable diseases, improve emergency preparedness and response, provide support for the countries affected by the current Ebola outbreak, and identify better models for antimicrobial drug research and development. Participants in the summit, described as the “premier forum for international economic cooperation,” includes leaders from 19 countries and the European Union, as well as guest countries and international organizations.

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 National Institutes of Health has launched a large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB). The study is comparing the safety and efficacy of a newer TB drug delamanid—one of the first drugs available specifically to treat MDR-TB and the first to exist in a child-friendly formulation—with isoniazid, a decades-old drug for TB prevention, in preventing development of active MDR-TB among high-risk individuals exposed to household members with MDR-TB. Study participants are considered at high risk if if they have latent TB infection, suppressed immune systems from HIV or other factors, or are younger than five years old. Study investigators hypothesize that delamanid will be a better prophylactic treatment than isoniazid in reducing the likelihood that at-risk household members of individuals living with MDR-TB will develop active TB. Existing treatments for MDR-TB are often toxic, poorly tolerated, expensive, and aren’t always available. The World Health Organization (WHO) estimated 460,000 people worldwide developed MDR-TB in 2017. According the Access to Medicine Index issued last month, which ranks the world’s 20 largest pharmaceutical companies on their efforts to improve access to medications for the world’s poorest, the industry has made remarkable progress in increasing access to lifesaving medicines, through efforts like drug donation and licensing patents to generic producers. However, according to the report, most of the progress made by the industry is limited to a few companies with their efforts too reliant on donor dollars. GSK has ranked first every year since the rankings began, with its score steadily rising each year. Dr. Jayasree K. Iyer, executive director of the Access to Medicine Foundation which releases the index, stated that two billion people still lack access to the products they need, implying progress on access has just begun. A new, rapid diagnostic test that can detect yaws—a debilitating bacterial disease spread through skin-to-skin contact causing skin lesions and ulcers—may reinvigorate efforts to eradicate the disease which affects thousands of the world’s poorest children. The molecular diagnostic test costs just US$2 and can detect yaws within 30 minutes at point-of-care, eliminating the time-consuming need to transfer disease samples to expensive high-tech labs. Though WHO reported more than 80,000 suspected cases of yaws in 2018, the real number of infections is likely to be much higher. The rapid diagnostic test is one of 30 finalists of the WHO Innovation Challenge and was showcased at the Africa Health Forum earlier this year. The diagnostic has shown “impressive results” in small trials, according to its creator, who is looking to do larger scale testing.

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. A large new study confirms previous research suggesting that a vaccine against rotavirus—a highly contagious virus that can cause severe illness and death in infants and young children— may have an added benefit: lowering the risk for Type 1 diabetes, an autoimmune disease that usually develops in childhood. The study showed a 33 percent reduction in the incidence of Type 1 diabetes among children who completed the three-dose RotaTeq series compared with unvaccinated children. RotaTeq, which protects against five different strains of rotavirus, is one of two orally administered rotavirus vaccines. Among those children in the study who took only one or two of the required three RotaTeq doses, there was no reduction in incidence compared with unvaccinated children. The reductions in risk in those who took the other version of the rotavirus vaccine, Rotarix, were not statistically significant. Approximately one million treatment courses of new child-friendly, easy-to-administer tuberculosis (TB) medicines have been ordered by 93 countries since they were first introduced in 2016, according to developer TB Alliance. Prior to the development of these treatments, caregivers would approximate children’s dosing by crushing or splitting bitter-flavored adult pills, which created adherence challenges. The new treatments meet World Health Organization (WHO) guidelines for childhood TB treatment and are dissolvable in water and flavored for palatability, making it easier for caregivers to administer. The 93 countries in which these treatments have been introduced account for 75 percent of the estimated global childhood TB burden. According to WHO, one million children are diagnosed with TB every year. US President Donald Trump recently issued an executive order calling for all US federal agencies to cut at least one-third of their advisory committees by September—a move many previous agency heads and critics say would weaken science-based regulation processes and the use of evidence-based policymaking. When excluding agencies that are mandated by law, a total of 462 boards and advisory committees that advise on government regulations and provide scientific oversight on other agency decisions are potentially on the chopping block as a result of the executive order. Critics of the executive order said that the one-third number put forth by the Trump administration seemed completely arbitrary and also pushed back on the notion that cutting the committees would save taxpayer dollars.

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. A clinical trial in four African nations found no substantial difference in HIV risk among women using three different methods of contraception—an injectable, progestin-only contraceptive, a nonhormonal intrauterine device, or IUD, and a progestin-based implant. However, the study—conducted by a consortium led by FHI 360—revealed high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention and family planning services. The World Health Organization (WHO) will begin synthesizing and sharing findings from the Evidence for Contraceptive Options and HIV Outcomes, or ECHO trial, with WHO’s Guideline Development Group, which will convene at the end of July 2019. This group will consider the trial’s results, along with other research, to determine whether changes are needed to the global guidance on contraceptive use and issue recommendations at the end of August. A study performed by researchers at the University of Oxford, along with partners at five other institutions, has identified the human antibodies that prevent the malaria parasite from entering blood cells—potentially key to creating a highly effective malaria vaccine. The study was done as part of a clinical trial in Oxford of the first vaccine candidate that targets the RH5 malaria protein, a protein contained in the parasite which must bind to a human protein on red blood cells in order to infect them. This study demonstrated which human antibodies effectively block RH5 from binding, thus preventing the parasite from spreading through the blood. Another key finding of the study is the discovery of a new antibody which slows down the speed with which RH5 binds to red blood cells, giving antibodies that do block RH5 from binding more time to act. Researchers aim to use these findings to develop an improved RH5 vaccine that induces more of the effective antibodies. A new civil society group, the Drug Transparency Observatory, has formed in France to monitor the French government’s implementation of a resolution on the transparency of medicines markets adopted at the World Health Assembly last month. A statement released by the new group calls on the French government and all countries to not only implement the adopted resolution, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing to include disclosure of research and development costs. The statement noted that the Drug Transparency Observatory will monitor “the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting.”

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. Independent experts of a US Food and Drug Administration (FDA) advisory panel voted in favor of TB Alliance’s treatment for multi-drug resistant and extensively drug-resistant tuberculosis (TB)— pretomanid—as part of a three-drug combination regimen with Johnson & Johnson’s bedaquiline and linezolid. Although the FDA is not bound to follow the advice of its advisory panel, it usually does. The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants. Current treatments for TB involve a cocktail of drugs and multiple injections, making adherence difficult for patients. Thus, “having a three-drug oral regimen will be a benefit,” said Philip LoBue, a panel member who voted in favor of the treatment. The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of this year. A new affordable option for combating post-partum hemorrhage—the number one killer of women during childbirth—was announced last week at the Women Deliver conference. The new device, Ellavi, is a high-quality uterine balloon tamponade (UBT) designed for low-resources settings that can be manufactured for US$10, as opposed to a typical cost of $200-250 for a UBT in most industrialized countries. Ellavi, developed by PATH and its South African partner Sinapi Biomedical, has achieved CE marking in Europe, signifying it meets regulatory requirements—an important mark of confidence that eases a product’s path to market in many countries. Ellavi is expected to be on the shelf initially in Kenya and Ghana by 2020, with plans for further expansion. PATH also announced the Nigerian National Agency for Food and Drug Administration’s marketing approval of Caya®—an updated, one-size-fits most, easier to grip, silicone-based diaphragm developed by PATH. Caya® will be introduced in Nigeria within the next year by DKT International, the largest family planning products and services provider in the country. Oxford-based Enesi Pharma has developed a needle-free instrument, called ImplaVax, that can deliver vaccinations under the skin with practically no pain for the patient. Instead of being in liquid form, the vaccine is formed into a tiny, solid stick measuring 0.85mm in diameter and 3.5mm long, with a point at the end, which the ImplaVax device injects into the patient. In addition to being pain-free, this solid dose vaccination does not need to be kept cool—a particular benefit for countries with warmer climates and unreliable cold chains. With ImplaVax, there is also no risk of needle breakage and as a pre-measured solid dose, it is easy to administer, allowing the potential for lower-skilled health workers to administer rather than doctors or nurses. ImplaVax is still being tested in animals with the hope of beginning the first human studies next year.