News Article | May 15, 2017
"Door deze geneesmiddelenresistentie is TB zich aan het ontwikkelen tot een onbehandelbare ziekte voor een groeiend aantal mensen," zegt Michèle Boccoz, speciaal ambassadeur voor het bestrijden van HIV/AIDS en overdraagbare ziekten van het Franse ministerie van Buitenlandse Zaken en Internationale Ontwikkeling. "Onmiddellijke investeringen in onderzoek en ontwikkeling zullen ons in staat stellen de geneesmiddelen en vaccins te ontwikkelen, die de dreiging van TB als gezondheidsprobleem binnen Europa uiteindelijk zullen beëindigen." Hoewel de TB-cijfers in de Europese Unie (EU) relatief laag zijn, is de ziekte in elk land nog steeds aanwezig. Volgens de Wereldgezondheidsorganisatie (World Health Organization) heeft de Europese WHO-regio als geheel het hoogste aantal resistente TB-gevallen ter wereld. Negen van de wereldwijde top 30 van landen met de meeste gevallen van resistente TB zijn Oost-Europese en Centraal-Aziatische landen. De WHO zegt dat ongeveer 73.000 mensen in de regio jaarlijks ziek worden door TB die resistent is tegen meerdere geneesmiddelen. "Zonder hulpmiddelen zoals nieuwe geneesmiddelen en vaccins weten we zeker dat we onze doelstellingen voor het onder controle brengen van TB niet kunnen bereiken", aldus Marja Esveld, senior beleidsadviseur mondiale gezondheid van het Nederlandse Ministerie van Volksgezondheid. "Nu is het tijd om meer middelen beschikbaar te stellen om ervoor te zorgen dat we de epidemie effectief kunnen beëindigen en de opkomende bedreiging van resistente TB kunnen aanpakken". TB is nu de meest dodelijke infectieziekte ter wereld, met 1,8 miljoen doden in 2015. De wereldwijde economische investering in TB-onderzoek en -ontwikkeling is echter de afgelopen vijf jaar niet vergroot . De WHO schat dat jaarlijks meer dan 1 miljard dollar nodig is en dat er nog 1,7 miljard dollar nodig is voor preventie, diagnose en behandeling van TB. De ambitieuze strategie van de WHO om een einde te maken aan TB is gericht op het met 95 procent verminderen van TB als doodsoorzaak en een daling van het aantal nieuwe gevallen met 90 procent tussen 2015 en 2035. Under the TB Action Plan for the WHO European Region 2016-2020, an interim target is a 25 percent reduction in new TB cases and a 75 percent treatment success rate among patients with multidrug-resistant TB. De kortste behandeling voor vormen van geneesmiddelenresistente TB duurt minstens negen maanden en kan twee jaar of langer duren. De behandeling zelf bestaat uit een combinatie van zware geneesmiddelen, toegediend in de vorm van pillen en injecties. Minder dan de helft van alle mensen met TB die resistent is tegen meerdere geneesmiddelen wordt succesvol genezen. De topconferentie gaat vooraf aan de wereldwijde ministeriële conferentie over TB die in november 2017 in Moskou zal plaatsvinden en aan de VN-topconferentie over TB in september 2018. TB Alliance is een non-profitorganisatie die zich toelegt op het vinden van sneller werkende en meer betaalbare geneesmiddelenregimes voor het bestrijden van tuberculose (TB). Via innovatieve wetenschap en partners over de hele wereld, streven wij ernaar om eerlijke toegang tot snellere, betere TB-geneesmiddelen die de mondiale gezondheid en welvaart bevorderen te waarborgen. TB Alliance werkt met steun van het Ministerie van Buitenlandse Zaken en Handel van Australië, de Stichting Bill & Melinda Gates, het Federaal Ministerie van Onderwijs en Onderzoek van Duitsland via het KfW, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, het Nederlandse Ministerie van Buitenlandse Zaken, UNITAID, Department for International Development van het Verenigd Koninkrijk en Agency for International Development, en Food and Drug Administration in de Verenigde Staten. Voor meer informatie kunt u terecht op http://www.tballiance.org DSW richt zich op de behoeften en mogelijkheden van de grootste jeugdgeneratie in de geschiedenis. We richten ons op het creëren van vraag naar en toegang tot gezondheidsinformatie, diensten en benodigdheden en op het waarborgen van hun recht op een betere toekomst. We bereiken dit door ons bezig te houden met genderbewuste advocacy, capaciteitsontwikkeling en initiatieven voor gezinsplanning. DSW heeft een hoofdkantoor in Duitsland en daarnaast kantoren in Ethiopië, Kenia, Tanzania en Oeganda en verbindingsbureaus in Berlijn en Brussel. DSW pleit ook voor investeringen in onderzoek en innovatie om armoedegebonden en verwaarloosde tropische ziekten te bestrijden.
News Article | May 15, 2017
« En raison de sa résistance aux médicaments, la TB est en train de devenir une maladie incurable pour un nombre croissant de personnes », a déclaré Michèle Boccoz, Ambassadrice chargée de la lutte contre le VIH-sida et les maladies transmissibles au ministère français des Affaires étrangères et du Développement international. « Investir aujourd'hui dans la recherche et le développement nous permettra de disposer de médicaments et vaccins nécessaires pour mettre fin à la menace de la TB en tant que problème de santé en Europe. » Même si les taux de TB au sein de l'Union européenne (UE) sont relativement faibles, la maladie persiste dans chaque pays. Et d'après l'Organisation mondiale de la Santé, la Région européenne de l'OMS dans son ensemble présente les taux les plus élevés de TB résistante aux médicaments au monde. Neuf des 30 pays au monde affichant le fardeau le plus important de TB résistante aux médicaments sont des pays d'Europe de l'Est et d'Asie centrale. L'OMS estime qu'environ 73 000 personnes dans cette région contractent la TB résistante aux médicaments chaque année. La TB est aujourd'hui la maladie infectieuse la plus mortelle au monde, à l'origine de 1,8 million de décès en 2015. Cependant, le financement économique de la global recherche et du développement antituberculeux est resté inchangé au cours des cinq dernières années. D'après les estimations de l'OMS, plus de 1 milliard de dollars sont nécessaires chaque année, et 1,7 milliard de dollars supplémentaires doivent être dédiés aux services de prévention, de diagnostic et de traitement de la TB. L'ambitieuse Stratégie de l'OMS pour mettre fin à la tuberculose vise une réduction de 95 % des décès attribuables à la TB et de 90 % des nouveaux cas entre 2015 et 2035. Le Plan d'action contre la tuberculose pour la Région européenne de l'OMS 2016-2020 établit une cible intermédiaire visant à réduire de 25 % les nouveaux cas de TB et un taux de réussite du traitement de 75 % parmi les patients atteints de TB multirésistante aux médicaments. Le traitement le plus court pour les formes de TB résistante aux médicaments dure au moins neuf mois et peut prendre jusqu'à deux ans ou plus. Il s'agit d'une combinaison de médicaments agressifs, administrés sous forme de comprimés et d'injections. Moins de la moitié des personnes atteintes de TB multirésistante aux médicaments guérissent avec succès. « Pour les personnes souffrant déjà de TB multirésistante aux médicaments, des options de traitement plus efficaces, plus tolérables, agissant plus rapidement et moins coûteuses sont désespérément nécessaires », a ajouté le Dr Mel Spigelman, président et chef de la direction de TB Alliance, une organisation à but non lucratif basée aux États-Unis qui accélère le développement de nouveaux médicaments antituberculeux. « Afin de freiner la résistance aux médicaments, nous avons besoin d'une volonté politique et d'un engagement a' fournir considérablement plus de ressources à la recherche et au développement de nouveaux traitements médicamenteux. » Intitulée « TB and European Health Security: The critical role of TB R&D in the context of antimicrobial resistance » (Tuberculose et sécurité sanitaire européenne : le rôle crucial de la R&D dans le contexte de la résistance aux antimicrobiens), la réunion de haut niveau s'est tenue à Bruxelles à l'initiative du ministère de la Santé, du Bien-être et des Sports des Pays-Bas et du ministère français des Affaires étrangères et du Développement international. Elle a été organisée par la TBVI, la TB Alliance et la Deutsche Stiftung Weltbevölkerung (DSW), une ONG axée sur le développement mondial. La TB Alliance est une organisation à but non lucratif dont la mission est de trouver des schémas thérapeutiques peu coûteux et agissant rapidement contre la tuberculose (TB). Grâce à une science innovante et à des partenariats à travers le monde, notre objectif est d'assurer un accès équitable à des traitements plus rapides et améliorés de la TB qui exerceront un effet positif sur la santé et la prospérité dans le monde. La TB Alliance opère avec le soutien du ministère des Affaires étrangères et du Commerce australien, de la Bill & Melinda Gates Foundation, du ministère fédéral allemand de l'Éducation et de la Recherche par l'intermédiaire de KfW, du Global Health Innovative Technology Fund, d'Irish Aid, de l'Indonesia Health Fund, du National Institute of Allergy and Infectious Disease (Institut national des maladies allergiques et infectieuses), du ministère des Affaires étrangères néerlandais, d'UNITAID, du Département britannique pour le développement international, de l'Agence des États-Unis pour le développement international et de la Food and Drug Administration aux États-Unis. Pour en savoir plus, veuillez consulter le site : http://www.tballiance.org La TuBerculosis Vaccine Initiative (TBVI) est une fondation à but non lucratif qui facilite la découverte et le développement de nouveaux vaccins antituberculeux sûrs et efficaces qui soient accessibles et abordables pour tous. En tant que partenariat de développement de produits (PDP), la TBVI intègre, traduit et priorise les efforts de R&D visant à découvrir et développer de nouveaux vaccins et biomarqueurs contre la TB pour une utilisation mondiale. La TBVI fournit des services essentiels qui soutiennent les efforts de R&D de ses partenaires de consortium, 50 partenaires issus du monde universitaire, d'instituts de recherche et du secteur privé dans le domaine des vaccins antituberculeux. Pour tout complément d'information, rendez-vous à l'adresse : http://www.tbvi.eu La DSW se concentre sur les besoins et le potentiel de la jeune génération la plus vaste de l'histoire. Nous nous engageons à créer de la demande et un accès à des informations, services et produits de santé, ainsi qu'à garantir leur droit à un avenir meilleur. Nous faisons cela en participant à des initiatives de défense de l'égalité entre les sexes, de développement des capacités et de planification familiale. Notre siège est situé en Allemagne et DSW compte des bureaux en Éthiopie, au Kenya, en Tanzanie et en Ouganda, ainsi que des bureaux de liaison à Berlin et Bruxelles. DSW défend également l'investissement dans la recherche et l'innovation afin de lutter contre les maladies tropicales méconnues et liées à la pauvreté.
News Article | May 15, 2017
"Because of drug resistance, TB is evolving to become an untreatable disease for a growing number of people," said Michèle Boccoz, Special Ambassador for fighting against HIV/AIDS and communicable diseases at the French Ministry of Foreign Affairs and International Development. "Investment in research and development now will allow us to have the drugs and vaccines at hand to eventually end the threat of TB as a health problem in Europe." While TB rates in the European Union (EU) are relatively low, the disease persists in every country. And, according to the World Health Organization, the WHO European region as a whole has the highest rates of drug-resistant TB in the world. Nine of the world's top 30 countries with the highest burden of drug-resistant TB are in eastern European and central Asian countries. The WHO says around 73,000 people in the region are estimated to fall ill with multidrug-resistant TB every year. "Without tools such as new drugs and vaccines, we know we cannot reach our goals for controlling TB," said Marja Esveld, senior policy advisor, global health from the Dutch Ministry of Health. "Now is the time to step up the resources to ensure we have the means to effectively end the epidemic and address the emerging threat of drug-resistant TB." The AMR Review, a global study of antibiotic resistance data, estimated that, by 2050, drug-resistant TB will be responsible for an additional 2.1 million deaths in Europe at an economic cost of $1.1 trillion. Globally, drug-resistant TB now kills 200,000 people annually, but by 2050, that number could approach 2.5 million. TB is now the world's deadliest infectious disease, resulting in 1.8 million deaths in 2015. The economic funding for TB research and development globally, however, has remained flat for the past five years. The WHO estimates that more than $1 billion is needed annually, and an additional $1.7 billion is needed for TB prevention, diagnosis and treatment services. The WHO's ambitious End TB Strategy targets reduction in TB deaths by 95 percent and cutting new cases by 90 percent between 2015 and 2035. Under the TB Action Plan for the WHO European Region 2016-2020, an interim target is a 25 percent reduction in new TB cases and a 75 percent treatment success rate among patients with multidrug-resistant TB. "A major impetus for developing new vaccines against TB is to sidestep the problem of drug resistance. A vaccine would not be affected by whether the TB organism was resistant to drugs because vaccines have an entirely different mode of action in the body," said Dr. Nick Drager, executive director of TBVI, a European foundation supporting research and development activities for new TB vaccines. The shortest treatment for forms of drug-resistant TB takes at least nine months and can take up to two years or more. The treatment itself consists of a combination of harsh drugs, given as pills and injections. Fewer than half of all people with multidrug-resistant TB are successfully cured. "For those people already suffering from drug-resistant TB, more effective, more tolerable, shorter acting, and less expensive treatment options are desperately needed," said Dr. Mel Spigelman, president and CEO of TB Alliance, a U.S. based nonprofit accelerating development of new TB drug treatments. "To curb drug resistance, we need political will and a commitment of significantly more resources for research and development into new drug treatments." The high-level meeting in Brussels-"TB and European Health Security: The critical role of TB R&D in the context of antimicrobial resistance"-was hosted by the Ministry of Health, Welfare and Sport of the Netherlands and the Ministry of Foreign Affairs and International Development of France. It was organized by TBVI, TB Alliance, and Deutsche Stiftung Weltbevölkerung (DSW), a a global development NGO. The high-level meeting precedes the Global Ministerial Conference on TB to be held in Moscow in November 2017 and the UN high-level meeting on TB in September 2018. TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis (TB). Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, UNITAID, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration. For more information, please visit: http://www.tballiance.org The TuBerculosis Vaccine Initiative (TBVI) is a non-profit foundation that facilitates the discovery and development of new, safe and effective TB vaccines that are accessible and affordable for all people. As a Product Development Partnership (PDP), TBVI integrates, translates and prioritises R&D efforts to discover and develop new TB vaccines and biomarkers for global use. TBVI provides essential services that support the R&D efforts of its consortium partners - 50 partners from academia, research institutes and private industry in the TB vaccine field. For more information, please visit: http://www.tbvi.eu DSW focuses on the needs and potential of the largest youth generation in history. We are committed to creating demand for and access to health information, services and supplies, and to securing their right for a brighter future. We achieve this by engaging in gender sensitive advocacy, capacity development, and family planning initiatives. With our headquarters Germany, DSW maintains offices in Ethiopia, Kenya, Tanzania, and Uganda, as well as liaison offices in Berlin and Brussels. DSW also advocates for investment in research and innovation to fight poverty-related and neglected tropical diseases.
News Article | February 15, 2017
A new treatment strategy has had astonishing success against extensively drug-resistant tuberculosis (XDR TB), which kills more than 70% of patients. XDR and other drug-resistant forms of TB are burgeoning among people with HIV, and current treatments are so prolonged and toxic that many patients fail to adhere to them. But a small study now shows that a simpler, safer regimen can cure the disease. That “may represent an enormous breakthrough,” says Richard Chaisson, who directs the Johns Hopkins University Center for Tuberculosis Research in Baltimore, Maryland, and was not involved in the trial. Called Nix-TB, the trial has had 34 people in South Africa with XDR on three antibiotics that have never been combined before to treat TB: bedaquiline, pretomanid, and linezolid. Bedaquiline, which was designed for TB but has not been used much, came to market in 2012. Pretomanid is also designed for TB but is still experimental. Linezolid is mainly used for skin infections and pneumonia. After 6 months, the TB bacillus could not be cultured from anyone’s sputum, a sign that they had cleared the infection, Francesca Conradie of the University of the Witwatersrand in Johannesburg, South Africa, reported today at the Conference on Retroviruses and Opportunistic Infections in Seattle, Washington. More impressive, 20 people stopped taking the drugs at that point and just one relapsed. “I didn’t in my wildest dreams expect the results to be this successful,” Conradie says. In 2015, the World Health Organization estimates, there were 480,000 new cases of multidrug-resistant (MDR) TB, and 7234 people were treated for XDR TB, which is even more drug resistant. Standard treatment takes up to 2.5 years, often requires hospitalization, and includes painful injections. In addition, “The toxicities are almost worse than the disease,” says Melvin Spigelman, who heads the TB Alliance, a nonprofit in New York City that sponsored the Nix-TB study. The drugs in Nix-TB are all pills, and they have been used sparingly for TB before, which minimizes the chance that people will be resistant to the combination. Though they also have toxicities, no one withdrew from the study. Early on, however, four people died from advanced TB. The Nix-TB protocol is tailored for XDR TB, but it could be used for MDR TB if future studies show that lower, less toxic doses of linezolid can work, Spigelman says. “This really gives us a window on how to truly transform TB therapy.” Cost remains another big unknown. For example, Janssen Therapeutics of Titusville, New Jersey, which makes bedaquiline, has promised to donate 30,000 doses to poor countries, which also can buy it for $900 for a 6-month course. The same course sells for $30,000 in high-income countries. It’s unclear how quickly the treatment can be put into widespread use, as pretomanid has not yet been approved. “We’re discussing with regulatory authorities whether Nix-TB is sufficient for approval,” Spigelman says. Nesri Padayatchi, a TB doctor at the Centre for the AIDS Programme of Research in South Africa in Durban, is enthusiastic about the new findings. But she cautions that because many MDR and XDR TB patients are coinfected with HIV, studies must carefully evaluate interactions between antiretrovirals and the new TB drug combination.
News Article | October 26, 2016
TUCSON, Ariz., October 25, 2016 - The Critical Path Institute's Critical Path to TB Drug Regimens (CPTR) initiative and the Global TB Programme of the World Health Organization (WHO) have partnered with researchers from the University of California, San Francisco (UCSF), to develop leading-edge quantitative analyses of data from the TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS) database. This collaboration, called TB-ReFLECT, will extract from these analyses key lessons from the TB-PACTS platform, and then package such lessons as tools for future TB trial design. TB-PACTS, which is now available to researchers across the world, is an integrated and standardized patient-level database comprising data from three leading contemporary, Phase III studies (OFLOTUB, REMox, and RIFAQUIN trials) that were the first to evaluate the treatment-shortening potential of quinolone-containing regimens in a systematic and controlled way. TB-PACTS is hosted by C-Path, in partnership with the WHO Special Programme for Research and Training in Tropical Diseases (TDR), the TB Alliance, and St. George's, University of London. The database has been accessible since April 2016. So far, the TB-PACTS scientific committee has received 23 applications; 16 have been granted access within a mean of eight days. "TB-PACTS has already elicited a lot of interest; within the first six months of the database being available, 16 requests have been granted access to the data. And TB ReFLECT has already produced results, showing the value of data-sharing and maximizing the utility of shared trial data," says Piero Olliaro, head of Intervention and Implementation Research at TDR. TB-ReFLECT will evaluate endpoints of treatment outcome for the selection of new regimens to be tested in Phase III clinical trials, as well as optimizing statistical methods for comparing results between regimens. This will lead to an improved understanding of the factors responsible for the variability in a patient's response to treatment. As part of this effort, researchers will develop a framework with clinically relevant endpoints that links the response of the bacteria to treatment. "These Phase III trials represent over 4500 patients, decades of effort, and millions of dollars of investment," says Debra Hanna, PhD, Executive Director of CPTR. "The analysis of these aggregated data will provide critical new insights to the TB drug development community and help to shape increasingly informed TB clinical trial approaches." On October 27, CPTR and WHO will co-host a symposium at the 2016 Union World Conference on Lung Health in Liverpool, UK, to update the TB research community on the progress of the TB-ReFLECT partnership. Presentations and panel discussions will highlight initial results, publicly accessible tools, data standards, and the TB-PACTS data sharing platform. "The outcomes of this collaboration will provide vital guidance to the research and development community on their quest for shorter and optimal TB treatments," says Dr. Christian Lienhardt, Senior Research Adviser at the WHO Global TB Programme. "This will be crucial in saving lives, and easing the immense burden of suffering on the millions of people who combat TB each year." CPTR (Critical Path to TB Drug Regimens) is an initiative that aims to speed the development of new and markedly improved drug regimens for tuberculosis. This partnership brings together the world's leading pharmaceutical and other drug developers, global regulatory agencies, and civil society organizations to support advances in regulatory science, the development of infrastructure, and other progress needed to facilitate the development and availability of new TB drug treatments. Co-founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance, and launched in March 2010, CPTR is working with stakeholders around the world to advance a new paradigm that dramatically speeds new TB drug regimens to patients. C-Path (Critical Path Institute) is an independent, nonprofit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the US Food and Drug Administration (FDA). C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established 12 global, public-private partnerships that currently include over 1,450 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona. For more information, visit http://www. The World Health Organization (WHO) Global TB Programme guides global action for a world free of TB by advancing universal access to TB prevention, care and control; framing the response to threats through norms, standards and strategy; technically supporting Member States; monitoring the burden and response; and promoting innovation. WHO is the directing and coordinating authority for health within the United Nations system.
News Article | February 27, 2017
You may never have heard of Acinetobacter baumannii, Pseudomonas aeruginosa, or the Enterobacteriaceae—but these three killers top a new list, drawn up by the World Health Organization (WHO) in Geneva, Switzerland, of bacteria for which new drugs are desperately needed. Unveiled today, the list contains 12 bacteria and bacterial families, with the top three making up the category “critical.” The list “is not meant to scare people about new superbugs, but to signal to researchers and pharmaceutical companies what their priorities should be,” Marie-Paule Kieny, WHO’s assistant director-general for health systems and innovation, told a press conference today. The crucial drugs are unlikely to be big moneymakers for companies that develop them, she notes, so governments and health agencies need to cooperate to boost the chances that they will be developed in time. Doctors, researchers, and health officials have been sounding the alarm for years about the rise of antibiotic resistance. The list, developed by researchers at the University of Tübingen in Germany, took into account the level of resistance each class of pathogen has already acquired, how deadly it can be, how widespread, and the burden it causes to health systems. The top three are all gram-negative bacteria that are resistant to multiple drugs. They aren’t widespread yet, but they do cause severe, frequently deadly infections in hospitals, especially in people who are already immune compromised—including transplant recipients, chemotherapy patients, and elderly people. Just last month, for instance, a woman in Nevada died of an infection with a so-called CRE, or carbapenem-resistant Enterobacteriaceae. These bacteria can cause deadly infections if they take up residence in the respiratory system or bloodstream. The most dangerous strains have recently acquired resistance to a class of antibiotics called carbapenems, the only group that still killed them effectively. Nine more pathogens round out the agency’s dirty dozen: Six are listed as high priority, including drug-resistant strains of Neisseria gonorrhoeae, which causes gonorrhea, and food-borne agents like Salmonella and Campylobacter. Bacteria in this category cause infections that are less deadly than those caused by the three critical-level bugs, but they are much more widespread. Three “medium” priority organisms all are susceptible to some drugs, but are increasingly becoming resistant. The list “sets priorities in the right direction,” says Petra Gastmeier, head of the Institute for Hygiene and Environmental Medicine at Charité University of Medicine Berlin, who wasn’t involved in the development of the list. In the current market, antibiotics aren’t an attractive investment, Kieny says. When used properly, the drugs are taken only for a short time, so they don’t bring in the high returns that drugs for chronic diseases do. “And rather than trying to maximize sales, we need to restrict usage,” Kieny says, to delay the inevitable emergence of resistance. Part of the solution will be finding new ways to reward companies for developing antibiotics, Kieny says. One idea is to agree to pay companies a big up-front fee, or “prize” as soon as a new drug comes on the market, with guidelines in place so that it would be used sparingly. But governments or other donors would have to agree to pay for the prize money. One drug-resistant bacterial pathogen is notably absent from the list: Mycobacterium tuberculosis. The problem of drug-resistant tuberculosis (TB) is "already a globally established priority," the report says; the goal was to increase attention to threats not yet widely recognized. But the TB Alliance, a nonprofit research and advocacy group based in New York City, calls on WHO to reconsider. "The absence of TB from this list is shocking,” the alliance's President and CEO Mel Spigelman said in a statement yesterday. "Every global effort to address the burgeoning AMR [antimicrobial resistance] emergency must include TB." In a response , WHO Director-General Margaret Chan emphasized that "[a]ddressing drug-resistant TB research is a top priority for WHO and for the world." WHO released its list ahead of a meeting of G20 health experts this week in Berlin, where the topic of antibiotic resistance is high on the agenda. The focus is appropriate, Gastmeier says. “This is not a problem that we can solve at a national level, and it is one in which low- and middle-income countries are linked to high-income ones.” A prime example: The woman who died in Nevada had spent time in India, where she most likely acquired the resistant strain. *Update, 1 March, 10:35 a.m.: This item has been updated to include a statement from the TB Alliance and additional comments from WHO.
News Article | February 15, 2017
Tuberculosis, the world’s leading infectious killer, may have finally met its match. Two new drug therapies may be able to cure all forms of tuberculosis – even the ones most difficult to treat. “We will have something to offer every single patient,” says Mel Spigelman, president of the TB Alliance, the organisation coordinating trials of the two treatments. “We are on the brink of turning TB around.” It presently takes six months of drug treatment to cure ordinary TB, and two years to cure people whose infections are resistant to drugs. People may need to take up to 20 tablets a day, plus injections. Together, the new treatments, called BPaMZ and BPaL, could make treating TB much simpler and more effective. BPaMZ involves taking four drugs once a day. Trials carried out in 240 people across 10 countries in Africa suggest that it cures almost all cases of ordinary TB in four months, and most people with drug-resistant TB in about six months. In the majority of cases, the TB bacterium had disappeared from sputum within two months. “The alliance has never before seen such rapid action against TB bacteria,” says Spigelman. Meanwhile, BPaL, a therapy that involves taking three drugs once a day, has so far cured 40 of 69 patients with “extremely-drug-resistant TB” – the most difficult form to treat. What’s more, it achieved this within six months. The 29 remaining participants in this trial are still to be assessed. The TB Alliance says that BPaMZ has the potential to treat 99 per cent of people who catch TB each year, while BPaL could treat the remainder. Researchers presented results from both sets of trials at the Conference on Retroviruses and Opportunistic Infections in Seattle this week. The arrival of new drugs is long-awaited, says Spigelman, because the existing treatment for TB is now 50 years old. According to the latest figures from the World Health Organization, there were 10.4 million new cases of TB in 2015, but only 20 per cent of those with resistant TB were treated, and of those only half were cured. Once mass produced, BPaMZ could cost just a tenth of the $3000 it now costs to treat drug-resistant TB. Spigelman cautions, however, that larger trials are needed to confirm the effectiveness of both therapies and for them to be approved for global use. At best, this would take at least three years for BPaMZ, he says, although the therapy for extremely-drug-resistant TB may be available sooner. “The results are exciting and encouraging, but we must be cautious saying we can treat everyone with these regimes,” says David Moore at the London School of Hygiene and Tropical Medicine. “These are only preliminary data, so there’s a danger of jumping the gun.”
News Article | October 28, 2016
One of the world’s largest food and beverage companies is launching a new initiative to help children all over the world. Pepsi is teaming up with the nonprofit TB alliance to engineer new flavors to counteract the bitter taste found in tuberculosis drugs. The company will, “apply proprietary flavor and sensory expertise,” to help develop strategies that can hopefully solve the bitter taste issue. Pepsi won’t receive any financial payments for these efforts whereas the TB Alliance will have free access to the results of this program applying it to its drug development efforts, according to the announcement. “At PepsiCo, we saw a unique opportunity to leverage our R&D talent and flavor expertise to help improve the palatability of certain TB medicines,” said Pepsi’s Dr. Mehmood Khan, the vice chairman and chief scientific officer of Global Research and Development. “In collaboration with the TB Alliance team and others, we are hopeful that we can identify formulation changes that will make it easier for caregivers to administer TB medicines to children. Our work together has the potential to significantly improve the care and well-being of many TB patients and move us one step closer to the goal of eradicating TB in children,” Khan added. The formulation process for tuberculosis drugs is intended for adults, making them difficult to swallow and unpleasant for kids, wrote The New York Times. Parents are recommended to try to crush the pills and mix them into applesauce to disguise the taste, but it has the adverse effect of turning kids off from these treats. Tuberculosis is the leading infectious cause of death worldwide with 1 million children getting diagnosed with TB each year and 210,000 children succumb to it, according to statistics from The World Health Organization, emphasizing how important it is in seeking a solution to boost adherence with this medication.
Gillespie S.H.,University of St. Andrews |
Crook A.M.,University College London |
McHugh T.D.,University College London |
Mendel C.M.,TB Alliance |
And 5 more authors.
New England Journal of Medicine | Year: 2014
Background Early-phase and preclinical studies suggest that moxifloxacin-containing regimens could allow for effective 4-month treatment of uncomplicated, smear-positive pulmonary tuberculosis.Methods We conducted a randomized, double-blind, placebo-controlled, phase 3 trial to test the noninferiority of two moxifloxacin-containing regimens as compared with a control regimen. One group of patients received isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by 18 weeks of isoniazid and rifampin (control group). In the second group, we replaced ethambutol with moxifloxacin for 17 weeks, followed by 9 weeks of placebo (isoniazid group), and in the third group, we replaced isoniazid with moxifloxacin for 17 weeks, followed by 9 weeks of placebo (ethambutol group). The primary end point was treatment failure or relapse within 18 months after randomization.Results Of the 1931 patients who underwent randomization, in the per-protocol analysis, a favorable outcome was reported in fewer patients in the isoniazid group (85%) and the ethambutol group (80%) than in the control group (92%), for a difference favoring the control group of 6.1 percentage points (97.5% confidence interval [CI], 1.7 to 10.5) versus the isoniazid group and 11.4 percentage points (97.5% CI, 6.7 to 16.1) versus the ethambutol group. Results were consistent in the modified intention-totreat analysis and all sensitivity analyses. The hazard ratios for the time to culture negativity in both solid and liquid mediums for the isoniazid and ethambutol groups, as compared with the control group, ranged from 1.17 to 1.25, indicating a shorter duration, with the lower bounds of the 95% confidence intervals exceeding 1.00 in all cases. There was no significant difference in the incidence of grade 3 or 4 adverse events, with events reported in 127 patients (19%) in the isoniazid group, 111 (17%) in the ethambutol group, and 123 (19%) in the control group.Conclusions The two moxifloxacin-containing regimens produced a more rapid initial decline in bacterial load, as compared with the control group. However, noninferiority for these regimens was not shown, which indicates that shortening treatment to 4 months was not effective in this setting. (Funded by the Global Alliance for TB Drug Development and others; REMoxTB ClinicalTrials.gov number, NCT00864383.). Copyright © 2014 Massachusetts Medical Society. All rights reserved.