Unitaid and TB Alliance announce world’s first appropriate TB medicines for children in correct doses

Unitaid, TB Alliance and partners announced today the availability of child-friendly tuberculosis (TB) medicines in the correct doses.

The improved treatments are the first to meet the dosage guidelines set by the World Health Organization (WHO) in 2010. They are dispersible and palatable, simple to administer and affordable. The availability of these products is a result of a project largely funded by Unitaid.

According to the WHO, at least 1 million children become ill with TB each year and 140,000 children die of this curable disease. To date, children around the world have not yet had access to appropriate TB medicines.

“The availability of correctly dosed medications will improve treatment for children everywhere,” said Dr. Mel Spigelman, President and CEO of TB Alliance, an international non-profit organization, ahead of the 46th Union World Conference on Lung Health in Cape Town, South Africa. “This is an important step toward ending the neglect that has characterized the care of children with TB for far too long.” TB Alliance has partnered with WHO, Unitaid, USAID, and others in the development and introduction of these products.

TB now ranks as the world’s leading infectious disease killer along with HIV. The disease is curable with treatment, which consists of multiple drugs and must be taken for a minimum of six months. Children need different doses of TB medicines than adults. Today, for parents and care providers to approximate the correct dose for a child, they must crush or chop available drugs, and piece together the treatment regimen. Splitting TB pills, which gives the medication a bitter taste and usually results in imprecise dosing, makes the treatment journey even more difficult for children and their families. Such challenges can also make treatment less effective, leading to poor health outcomes and the development of more difficult to treat drug-resistant TB in children.

“No child should die of TB, yet for too long, we have not had the medicines or the functioning market needed to mount a sustainable response against childhood TB,” said Mr. Lelio Marmora, Executive Director of Unitaid. “Unitaid’s investment in addressing this problem will increase access to correctly dosed, quality-assured, affordable TB medicines for children that will help save lives.”

WHO revised their guidelines for childhood TB treatment in 2010, recognizing that children need higher doses of the medicines than what they were receiving. Lacking incentives and clear market information, companies, however, did not produce any products conforming to the new guidelines.

Over the past three years, TB Alliance has worked with manufacturers to develop properly-formulated TB medicines that are easier to administer in children. In addition to Unitaid, USAID and other funders also provided support for this effort, which included work to address market barriers to ensure new treatments will reach children in need.

“If we are to end the TB epidemic by 2030, we must bring children with TB out of the shadows and ensure they are properly diagnosed, treated and cured,” said Dr. Mario Raviglione, Director of the Global TB Programme at WHO, speaking at the launch. “The new fixed-dose formulations for children will offer hope for the 400 children who needlessly die of TB each day. Urgent action is needed to ensure these medicines reach those in need and rapidly improve child survival from TB.”

The new TB medicines are fixed dose combinations (FDCs) of the three most commonly used drugs to treat drug-sensitive TB (rifampicin, isoniazid, and pyrazinamide). These are not new drugs, but rather improved formulations that are dissolvable and flavored so that they are simple for providers and parents to administer and easy for children to take. The FDCs are rifampicin + isoniazid + pyrazinamide, which is used for the initial two months of treatment, followed by four months of rifampicin + isoniazid. The formulations are in the process of being prequalified by WHO but are now available under the WHO’s Expert Review Panel mechanism.

“My three-year old daughter and my newborn son had TB—they were so sick and it was so difficult to give them the medication that I began to lose hope,” said Monique Davids, a mother and care provider from Cape Town, South Africa. “TB is already such a long struggle for families; with these new simpler medicines, at least the treatment doesn’t have to be such an ordeal anymore.”

TB Alliance is working with WHO, UNICEF, Management Sciences for Health and other organizations to encourage uptake in countries with high TB burdens and to reach children affected by TB at all levels or sectors of healthcare. Initial roll-out of the new medicines is expected in early 2016.

“Childhood TB is a problem that can be solved when we choose to act,” says Dr. Enos Masini, National Tuberculosis Program Manager, Kenya. “We need to make sure all children with TB are diagnosed and treated with the best medicines possible. I’m proud to say Kenya plans to adopt these new products for our children immediately, which will greatly improve our response to treating drug-sensitive TB.”

About Childhood Tuberculosis

Tuberculosis is a leading infectious disease killer and is caused by bacteria that spreads through microscopic droplets released into the air when someone with the untreated, active form of tuberculosis coughs or sneezes. Infants and young children are at special risk of having severe, often fatal forms of TB, which can leave them blind, deaf, paralyzed or mentally disabled. At least 1 million children have TB and 400 die each day from the disease. However, almost two-thirds of children thought to have TB are never diagnosed or treated. TB is a family disease that is often passed from parents to their children. 

About TB Alliance (Global Alliance for TB Drug Development)

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, European Commission, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, 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 tballiance.org.

About Unitaid

Unitaid is an international organization based in Geneva that is finding new ways with partners to prevent, treat and diagnose HIV/AIDS, tuberculosis and malaria more quickly, more cheaply and more effectively. Its investments help turn ground breaking ideas into effective solutions that enable partners to achieve the highest impact for those in need.

Contacts

Joanna Breitstein, TB Alliance, Joanna.breitstein@tballiance.org, cell +1 917 842 8416 or Preeti Singh, Burness, cell +1 703-862-2515

For interviews with Philippe Duneton, Deputy Executive Director, Unitaid, please contact Andrew Hurst, hursta@unitaid.who.int, cell. +41795616807

For interviews with Dr. Mario Raviglione, please contact Monica Dias, WHO, diash@who.int, cell. +41 79 477 0435, or Dominique De Santis, WHO, desantisd@who.int, cell. +41 79 467 3538

Unitaid welcomes new UK fund to fight malaria, TB and other neglected tropical diseases

UNITAID strongly welcomes the creation by the United Kingdom of a new 1 billion pound sterling fund to tackle malaria, tuberculosis and other infectious diseases.

The fund, to be known as the Ross Fund, will enable the development and testing of vaccines, drugs, diagnostics, treatments and other technologies to help combat some of the world’s most serious infectious diseases in developing countries, including Ebola.

The Ross Fund was launched this week by UK Chancellor of the Exchequer (Finance Minister) George Osborne. The fund is named after Sir Ronald Ross, who discovered that malaria is transmitted by mosquitoes.

The Fund will also focus on the global fight to eradicate malaria, and will partner with the Bill and Melinda Gates Foundation in this work.

“The establishment of a fund by the UK targeting malaria, TB and also encompassing Ebola and neglected tropical diseases is a most welcome step,” said UNITAID Executive Director Lelio Marmora. “UNITAID supports efforts to find health solutions to help accelerate the end of AIDS, TB, malaria and other infectious diseases.”

Unitaid s’appuie sur ses récits et approches sur les maladies pour orienter ses investissements

Unitaid s’efforce de maximiser son impact sur la santé en investissant dans les personnes les plus exposées aux maladies et les plus démunies.

Un des principaux objectifs d’Unitaid est d’identifier comment contribuer au mieux à la riposte mondiale par des investissements bien ciblés aidant, par exemple, à surmonter des obstacles spécifiques tels que les prix élevés de médicaments prometteurs.

Ces « domaines d’intervention », qui désignent les domaines dans lesquels les investissements d’Unitaid peuvent apporter la contribution la plus efficace à la réalisation des objectifs de santé mondiale visant à mettre fin au VIH/SIDA, à la tuberculose et au paludisme, sont les pierres angulaires de notre travail. Ils permettent également à nos partenaires d’obtenir de meilleurs résultats avec des ressources limitées.

Le choix de chaque domaine d’intervention d’Unitaid s’appuie sur une analyse rigoureuse du contexte de chaque maladie, contenue dans un récit cohérent sur la maladie.

Les récits permettent d’analyser chaque maladie, y compris le fardeau global de la maladie, les stratégies mises en œuvre pour atteindre les objectifs de santé mondiale, les actions des partenaires dans la poursuite de ces objectifs, l’ampleur des éventuelles lacunes dans la réponse et les possibilités d’intervention d’Unitaid.

Ils apportent un cadre, un contexte et une échelle de priorités aux interventions d’Unitaid, et font ressortir les opportunités potentielles pour mener à bien les activités des partenaires et soutenir la réalisation des objectifs de santé mondiale.

Sur la base du récit sur la maladie et après avoir consulté ses partenaires, Unitaid recense chacun des domaines dans lesquels elle peut intervenir et les propose au Conseil pour validation. Unitaid lance ensuite des appels à propositions auprès des bénéficiaires potentiels des financements, après avoir identifié des interventions spécifiques dans chaque domaine.

Un certain nombre de défis communs ont été identifiés au travers de plusieurs récits portant sur des maladies spécifiques ; ces défis transversaux peuvent bénéficier de solutions communes. Ils sont identifiés par le biais de documents expliquant la démarche – le premier étant l’approche d’Unitaid en matière de propriété intellectuelle

Unitaid report reviews new TB diagnostics and calls for more innovation

More than 50 companies are actively developing new products to diagnose tuberculosis (TB), a disease that killed 1.5 million people in 2013, but many countries still rely on older sputum-based methods, according to a report published by UNITAID.

The updated edition of the UNITAID Tuberculosis Diagnostics Technology and Market Landscape report  reviews current and potential  technologies and critical market challenges to improved access to better TB diagnostics.

Rapid and accurate diagnosis of TB is vital for timely initiation of treatment. However, many people infected with the disease do not have access to adequate means of diagnosis.

Of 9 million people who fell ill with TB in 2013, only 6.1 million cases were reported to national TB programs, WHO data show. This means 3 million people with TB were ‘missed’ and did not receive a diagnosis.

Access to diagnosis for people with multidrug-resistant TB (MDR-TB) and for children with tuberculosis is particularly challenging. More than 70 percent of all people estimated to have MDR TB were not detected in 2013. Most conventional tests struggle to identify the disease in children, a highly vulnerable population.

The report notes that despite a promising pipeline of new diagnostic tools, including molecular diagnostics and nucleic acid amplification test technologies, there was a relative absence of non-sputum based diagnostics on the horizon for children, among other areas of high unmet need.

Globally, the scale-up of Xpert remains the most important recent development in the TB diagnostics market, with more than 10 million Xpert cartridges procured at reduced prices, an initiative enabled by UNITAID, United States President’s Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID), and the Bill & Melinda Gates Foundation.

The also report reviews the most recent data on Xpert’s impact, as well as looking at related unmet needs more broadly.

Unitaid brings innovation to the global response to HIV/AIDS, TB and malaria

UNITAID is taking steps to accelerate grant-making and maximize impact and value for money by targeting specific areas where its investments can best contribute to ending HIV/AIDS, tuberculosis and malaria as global epidemics.

At a meeting in Rio de Janeiro, the Executive Board announced it would as a first step focus investments in three areas, all of them identified in consultation with partners, as being crucial to help achieve a global target of putting 90 percent of all people diagnosed with HIV on treatment by 2020.

The three areas are: improving antiretroviral therapy for adults in low and middle-income countries; enabling the expanded use, or “scale-up”, of first pre-exposure prophylaxis (PrEP) as a means of preventing HIV transmission; and the development of better tools to diagnose hepatitis C virus (HCV), in particular for people who are co-infected with HIV/HCV.

Meeting the 2020 goals – which also include ensuring 90 percent of people living with HIV are aware of their HIV status and that 90 percent of those on treatment have viral suppression – will require the number of people on treatment in low and middle-income countries to more than double within 5 years.

“With the introduction of these ambitious new changes, UNITAID is intensifying efforts to end the three diseases, making the best strategic use of investments in areas where there is greatest need, ” said Executive Board Chair Philippe Douste-Blazy,

Each of these areas is subject to market constraints that are holding back scaled-up use of effective new treatments, diagnostics and other tools and putting the achievement of global health targets at risk.

“By working closely with our partners to identify where the greatest needs are and where UNITAID can intervene we will contribute to a more coordinated and effective response,” said UNITAID’s Executive Director Lelio Marmora.

Mr. Marmora also thanked Fiocruz, a prominent health institute attached to Brazil’s Health Ministry, for organizing the Board meeting. “We are especially grateful to Fiocruz, which has played such a dominant role in fighting disease in Brazil over the past century, for hosting such a productive meeting.”

The Executive Board also approved the introduction of a new operating model, which aims to make grant development faster, more focused and efficient, while ensuring that grants are fully consistent with global health goals and help global health partners achieve more with scarce resources.

Under the new approach UNITAID will launch targeted calls for proposals from grant applicants, guided by the specific areas of intervention that are identified through engagement with partners and countries.

UNITAID’s mission is to find new ways to treat, diagnose and prevent the three diseases faster, better and more effectively.

Health leaders see partnership driving innovation

Top public health officials from South Africa, Chile, Brazil, Cote d’Ivoire and France, and from organizations targeting HIV, TB and malaria met in Geneva to discuss leveraging innovation to accelerate the end of the three epidemics.

Opening the event on Sunday on the eve of the World Health Assembly, Philippe Douste-Blazy, Under Secretary General for the UN and Chair of the UNITAID board, said there was a clear link between innovative solutions and progress in global health.

Calling for increased efforts to promote innovation, Dr. Douste-Blazy cited GeneXpert as an example of a new diagnostic technique which had reduced the time it takes to detect TB from many weeks to a matter of hours.

The event, co-hosted by UNITAID and the Medicines Patent Pool (MPP) featured global and country perspectives to inform discussions at the World Health Assembly this week on the achievements of the Millennium Development Goals (MDGs).

Minister of Health for South Africa, Aaron Motsoaledi, said UNITAID and the Medicines Patent Pool had played a big part in bringing down the prices of antiretroviral drugs and putting large numbers of patients on treatment. “This is where UNITAID and MPP have played a significant part and I would hope that they are able to expand their role to other diseases such as TB.”

Lelio Marmora, Executive Director of UNITAID said the past eight years since UNITAID’s creation had shown how facilitating access to new solutions can have a game-changing impact on global health. “Cutting prices by 70% of critical medicines for HIV, by 40% for a new test for multi-drug resistant tuberculosis, and making it possible for more than 300 million of the best anti-malarials to be supplied, have contributed to significant progress against three major global pandemics,” he said. “We must continue to realize ever greater opportunities to leverage innovation to achieve the global goals.”

Others who addressed the meeting included MPP Chairman Charles Clift, Brazil’s Health Minister Arthur Chiaro, Chilean Health Minister, Carmen Castillo, Cote d’Ivoire’s Health Minister Raymonde Goudou Coffie and Benoit Vallet, General Director for Health at France’s Ministry of Social Affairs, Health and Women’s Rights.

As part of a global response to HIV/AIDS, TB and malaria, UNITAID was created in 2006 to play a catalytic role in global health, transforming game-changing ideas into practical solutions that overcome obstacles to progress. It does so by speeding the delivery of new, better and more affordable medicines and technologies; and, by investing in innovative solutions that match identified needs.  Ultimately it allows the broader landscape of donors, countries, communities, and other purchasers to do more with less in resource-limited settings.

UNITAID created the Medicines Patent Pool (MPP) in 2010 as a key component of its market shaping efforts to improve access to HIV medicines. The MPP aims to lower the prices of HIV medicines and facilitate the development of better-adapted therapies, such as simplified “fixed-dose combinations” (FDCs) and special formulations for children through voluntary licensing and patent pooling. “As the world’s only patent pool for HIV medicines, MPP partners with a range of stakeholders – including industry and civil society – to increase access to WHO-recommended ARVs in low and middle income countries,” said Greg Perry last evening. “We think this approach has merit and can play a key role in scaling up treatment for millions of people living with HIV and thus meeting HIV global targets.”

Seeking big improvements in drug resistant TB treatment

Drug resistant strains of tuberculosis, which are hard to detect and treat, killed an estimated 210,000 people in 2013 and now threaten to infect and kill millions more unless improved diagnostics and shorter treatments become widely available.

Every year all forms of tuberculosis (TB) kill more than 1.5 million people and at least 3 million new TB cases go undiagnosed.

As countries around the world mark World TB Day under the theme “Reach the 3 million”, UNITAID and its partners are underscoring their efforts to promote use of new diagnostic techniques and drugs that will make it possible to more than halve treatment times for MDR-TB, a disease which infected an estimated 480,000 people in 2013.

A report by the United Kingdom’s All Party Parliamentary Group on Global TB, published today, has warned that up to 75 million people could lose their lives to multi drug-resistant TB (MDR-TB) over the next 35 years if the world fails to tackle drug resistance.

The parliamentary report said that treatment for drug resistant TB is so “complex, expensive and toxic” that less than half of people successfully complete treatment. If treatment courses for MDR-TB were shorter and less arduous, more patients would complete treatment and fewer cases of resistance would develop, the report noted.

UNITAID is now investing $60 million with Partners in Health, Medicins Sans Frontieres and Interactive Research and Development to make new, more effective medicines available and improve patients’ chances of being cured from 48% to 70%, and drive a sharp fall in new infections.

Up to 50 different MDR-TB medicine combinations are in use globally, usually involving a gruelling two-year course of multiple pills daily and injections with harmful side effects such as deafness. The new drugs have the potential to make it possible to treat the disease in less than nine months and to eliminate the need for injections.

The spread of drug-resistant TB strains has been fuelled by patients receiving intermittent medication or failing to complete treatment. Rising numbers of patients are also now contracting MDR-TB from people with a drug-resistant strain of the disease.

Over the next four years, 2,600 patients will be enrolled on treatment with the new TB drugs in 17* countries through the UNITAID investment. A more user-friendly and effective treatment regimen will also be devised following a clinical trial with 600 patients.

“UNITAID’s investment will help make MDR-TB treatment more effective and easier-to-bear, thereby helping patients to be better treated and to halt the disease’s spread” said Lelio Marmora, Executive Director UNITAID.  “This new investment is part of our broader TB portfolio that is introducing innovations for a more effective global response to the disease.”

He said new medicines to treat drug resistant TB were urgently needed, in part due to the three-fold increase in new cases diagnosed since 2009.

UNITAID has also been investing to expand use of up new state-of-the-art diagnostic technologies such as GeneXpert®, which can shorten the time to diagnose drug resistant forms of TB from weeks to only a matter of hours.

*Peru, Lesotho, Kazakhstan, Ethiopia, Kenya, Georgia, Armenia, Kyrgyszstan, Swaziland, India, Myanmar, Belarus, Pakistan, Indonesia, Bangladesh, DPRK, and Nepal

Unitaid urges support for ‘pharmaceuticals exemption’ for LDCS

UNITAID is concerned about the expiry of the ‘pharmaceuticals exemption’ for least-developed countries (LDCs) which originates from the Doha Declaration on the TRIPS Agreement and Public Health.

Due to this exemption, least developed countries (LDCs) are not obliged to grant or enforce patents and data protection for pharmaceuticals.

“As an organization that funds projects to improve access to medicines for HIV, TB and malaria in 94 countries, including many LDCs, UNITAID strongly supports the request by the least-developed counties for an extension of the transition period for pharmaceuticals.” said Lelio Marmora, Executive Director of UNITAID. “This exemption has facilitated access to affordable medicines in LDCs, and UNITAID urges WTO Members to unconditionally approve the request by the LDCs.”

The TRIPS Agreement makes it mandatory for countries to grant patents, including for medicines. “Patents can spur innovation, but can also delay generic competition, and have a negative impact on access to medicines, especially in poor countries.”

However, TRIPS also contains a number of flexibilities and safeguards. These flexibilities can be, and have been, used to ensure access to medicines – clearly an important social and public health objective for many WTO Members, as well as for the international community. The flexibilities and safeguards essentially relate to instances where countries have the freedom to interpret, define or defer the implementation of certain provisions of the Agreement.

One of the most important flexibilities for least developed countries (LDCs) is that they are not obliged to implement key sections of the TRIPS Agreement – notably the granting of patents and the provision of data protection – with regards to pharmaceuticals. This exemption will expire at the end of this year. Yet LDCs still face many constraints with regard to ensuring access to medicines for their populations. In this context, LDCs have requested an extension of this important exemption “until they cease to be a least developed country”.

“UNITAID believes that it is crucial that countries can make use of ‘TRIPS flexibilities’ in order to safeguard access to medicines.” said Mr Marmora “This certainly should apply to the most vulnerable members of the international community: the LDCs.”