Unitaid chair appeals for publicly funded research to defeat TB

Unitaid’s Chair Philippe Douste-Blazy has appealed for more public funding of research to help defeat tuberculosis, a disease which kills 1.5 million people every year.

“Left to their own devices, market forces will not deliver the solutions that the world needs,” Dr Douste-Blazy said in an article in the Guardian published on World TB Day. “The international community must do more to support public funding of research. Their support can play a catalytic role in helping to defeat this ancient scourge, which is still one of the most lethal infectious diseases.”

Dr Douste-Blazy also said that resistance to TB medicines threatens to stall, or even to reverse, progress in the fight against the disease unless shorter, more effective treatment regimens were introduced.

“If left unchecked, these trends could derail plans to cut TB deaths by 95% in the next 20 years, as enshrined in the World Health Organisation’s global strategy,” said Dr Douste-Blazy.

Calling for innovative ideas to help change the trajectory of the pandemic, he concluded: “We can make it happen together, working with the private and public sector. We can turn the tide against tuberculosis.”

Read more: “14,600 pills over two years – there has to be a better way to treat TB” – The Guardian

Unitaid seeks proposals to scale up better TB treatment for children

Unitaid today launched its latest call for funding proposals, focused on scaling up better tuberculosis (TB) treatment for children.

Innovative approaches are being sought to ease adoption of new TB drugs and make them more accessible to children in need.

If your organization is interested in submitting a proposal, please read the full details of how to prepare and submit a proposal here.

Improved tuberculosis treatment for children is one of three areas in which Unitaid will focus its TB investments following approval from the Executive Board last week.

Calls for funding proposals will be issued later for the other two areas: increasing access to improved and shorter treatments for drug-resistant tuberculosis; and preventive therapy for populations at greatest risk of developing active tuberculosis disease.

The three areas for intervention are seen as crucial by the Executive Board in helping to meet a global target to end the epidemic by 2035. 

Through calls for proposals, Unitaid seeks new ideas that enable organizations and governments to scale up their responses to health challenges. After rigorous analysis and vetting, Unitaid funds the best proposals that offer value for money and potential for real global-health impact.

TB is one of the top 10 causes of death in children: over 140,000 children die each year of this curable disease. While an estimated 1 million children need TB treatment each year, only 359,000 cases of TB in children were reported in 2014. Until now, no child-friendly TB medicines in the right doses and formulations were available. Children who did receive treatment often received inappropriate medicines, including split or crushed adult tablets. The lack of appropriate diagnostic and treatment options highlights – and reinforces – the neglect of children with TB.

The launch of the first new child-friendly formulations was announced in December 2015, as a direct result of the STEP-TB project, implemented by TB Alliance and the World Health Organization (WHO). These fixed-dose combinations (FDC) of the three most commonly used drugs to treat drug-sensitive TB (rifampicin, isoniazid, and pyrazinamide) are child friendly; they are dissolvable and flavoured, offer simpler treatment, and facilitate correct dosing, improving adherence and child survival.

Under the call published today, Unitaid is soliciting proposals to address market-specific challenges, to ease adoption of new medicines to displace current suboptimal treatments, and to expand access to better TB medicines to reach more children in need.

Video: A partnership to revolutionize MDR-TB treatments around the world

Tuberculosis (TB) has now overtaken HIV as the deadliest infection worldwide, and we’re also losing ground to drug-resistant TB. Worse still: treatments for ‘multidrug-resistant tuberculosis’ (MDR-TB) are long, ineffective and have terrible side effects, including acute psychosis and permanent deafness.

After 50 years without new TB drugs, two were developed recently: bedaquiline and delamanid.

We’re partnering with leading medical organizations to get these drugs to patients in 15 countries, and revolutionise MDR-TB treatments. It’s called endTB.

Meet the TB Expert: Draurio Barreira

Where did you grow up?

I grew up in Brazil, in Rio de Janeiro mainly. When I was young my family moved around all over the country. I must have moved 29 times in my life! I graduated as a physician in Rio. I was a medical doctor for 29 years, specialising in public health and epidemiology.

How did you come to work in global health?

I treated patients just for two years in the Amazon region. After a postgrad in Rio, I moved to epidemiology and public health. I like big challenges and I like thinking about how to run health programmes. It’s my personal preference, rather than treating patients. Medicine is a nice profession because you can feel useful to an individual, a community, a city or a country. I prefer work with programmes where you can make a difference for many people at the same time.

When did you become interested in tuberculosis?

I started out working with HIV /AIDS as programme manager for Rio, and led the epidemiology unit for the national level AIDS programme in Brazil. Then in 2007 I became head of the TB unit. So the connection was HIV co-infection.

Brazil has a concentrated HIV epidemic – you find the virus in in men who have sex with men, sex workers and those who use injectable drugs. This makes it easier to target the programmes, but HIV always comes with stigma. Sex and drugs are not always easy topics for people to talk about. For TB it’s a different type of stigma. It’s much more about transmissible diseases – people avoiding TB patients for fear of infection.

What were the main challenges for TB programmes in Brazil?

Administrative fragmentation was really bad in Brazil. People didn’t talk to each other – that was a big challenge. I believe it was my main legacy in the TB programme in Brazil was that I could work with everybody. I created a steering committee with people from all sectors: academics, civil society, patients, nurse and medical societies.

Probably the main problem for TB in Brazil is lack of information – not only the population, but also health professionals. Some 50% of the population doesn’t know that TB still exists – they see it as a disease of the past. Among health professionals, 50 % don’t know the symptoms or how to treat it. And then there’s the stigma – doctors often tell patients that they have some other disease, such as pneumonia, to protect them from stigma.

Tuberculosis has been around for thousands of years. Why is it still with us?

One main challenge is that it’s an airborne transmissible disease: just by breathing you can catch the bacterium and develop the sickness.

The other main issue is that it’s disease related to poverty, so it is neglected by industry, wider society, and health systems. TB changed a lot in the 90s after AIDS came along; now TB became an opportunistic disease. So AIDS contributed in that sense to fighting TB – though the numbers of cases increased, it was no longer neglected.

TB is also a problem for vulnerable populations. Brazil has the worst TB figures for prisons, where people are stacked like animals in terrible conditions. Homeless people, indigenous people and those living with HIV are also vulnerable.

What is UNITAID doing to alleviate the burden of tuberculosis around the world?

UNITAID’s role is to promote access to diagnostics and treatment for those suffering from TB and other diseases.

The test for TB stayed the same from the 19th century right up to 2012. Now we have new diagnostic tools, and the first new TB drugs since WW2 have just come out. But it’s still not enough. You may have the best treatment and diagnostics, but if you do not promote access to the people in need you will not eliminate TB.

The theme for World TB Day this year is “Unite to end TB”. Do you think tuberculosis can be eradicated?

It’s important to say that we are not talking about complete eradication. No country eradicates TB – even the richest. We are talking about eliminating the disease as a public health issue. That means fewer than 10 cases per 100,000 people. This is already a reality in 30 countries.  My country has 33 cases per 100,000. So it’s well on the way. Many countries could achieve this before 2035 and they will.

But for the whole world to achieve the target, we need new tools. We need a vaccine. We need shorter treatments and diagnostics that are easy to use.

What remains to be done?

Defeating tuberculosis is not only a matter of diagnostics and treatment but also of alleviating poverty.

At the World Health Assembly in 2014 we fought for three pillars: Diagnostics and Treatment, but also Social protection and Research. We need to advance in all three pillars, and I believe we will.

TB patients should not be charged for treatment – they are already penalized by the social conditions that gave them the disease. So it’s unfair to make them pay for medicines or diagnostics. This is clearly expressed in the new End TB strategy. It’s a pool of actions we need at the same time.

I am optimistic about ending TB. My career has been a very rich experience. I have had the opportunity to run programmes at municipal, state, and national level in Brazil, and now – at UNITAID – I get to think globally.

Unitaid publishes updated disease narrative for tuberculosis

Today Unitaid published an updated “disease narrative” for tuberculosis – a rigorous analysis of the context surrounding the disease – to help guide its investments.

A primary goal of Unitaid is to identify how it can best contribute to the global response with carefully targeted investments that help, for example, to overcome specific obstacles such as high prices for medicines that show promise.

These “areas for intervention”, pinpointing where Unitaid’s investments can most effectively help advance global health goals to end tuberculosis, are the building blocks of our work. They also enable our partners to achieve more with scarce resources.

The narrative published today reviews tuberculosis, including the overall disease burden; the strategies that are being pursued in order to meet global health goals; actions of partners in pursuing those goals; the extent of any gaps in the response; and the opportunities for intervention by Unitaid.

On the basis of the disease narrative and following consultation with its partners, Unitaid maps out each of the areas in which it can intervene and proposes them to the Board for validation. Unitaid then launches calls for proposal from potential grantees after identifying specific interventions within each area.

The Executive Board last week gave the green light for Unitaid to invest in increasing access to improved and shorter treatments for drug-resistant tuberculosis; better tuberculosis treatment for children; and preventive therapy for populations at greatest risk of developing active tuberculosis disease.

Unitaid to invest in effective approaches to end tuberculosis

Unitaid will invest in increasing access to improved and shorter treatments for drug-resistant tuberculosis; better tuberculosis treatment for children; and preventive therapy for populations at greatest risk of developing active tuberculosis disease.

The three “areas for intervention” in which Unitaid will target investments were endorsed by Unitaid’s Executive Board, which sees them as crucial in helping to meet a global target to end the epidemic by 2035.

“There is a great need for investment to speed access to new tuberculosis medicines and diagnostics,” said Unitaid’s Acting Executive Board Chair H.E. Marta Maurás Pérez. “We can complement global efforts to fight this largely curable disease by focusing on specific areas.”

Every year, 1.5 million people die from active tuberculosis disease, with 9.6 million new cases detected globally in 2014. Active tuberculosis is infectious and often fatal if untreated. In contrast, people with latent tuberculosis do not feel sick or have symptoms and cannot spread the disease to others.

Shaped by rigorous analysis and partner consultations, Unitaid is seeking to address serious challenges that threaten to stall – or reverse – progress in the fight against tuberculosis. “There is strong evidence we can help achieve global public health impact if we intervene in better and more effective treatments and in preventive therapy,” said Unitaid’s Executive Director Lelio Marmora.

Of an estimated 480,000 tuberculosis cases that were resistant to multiple drugs in 2014, only a quarter were detected and reported. Only half of those treated were cured, because treatment is lengthy, often ineffective and has severe side effects. To address this situation, Unitaid will support efforts to scale up new regimens as they emerge to improve treatment of multidrug-resistant TB treatment.

Medicines suitable for children in the right doses and formulations are now available, thanks to a previous Unitaid intervention with TB Alliance and WHO. “We will explore how further support can help these new formulations reach the children that need them most,” said Philippe Douste-Blazy, Unitaid’s Executive Board Chair. An estimated 1 million children need tuberculosis treatment every year, but most currently do not receive effective and appropriate treatment.

During consultations, partners highlighted the importance of improving options for tuberculosis prevention in the future. For persons whose immune systems are weak, especially children and those living with HIV, the risk of developing tuberculosis disease is considerably higher than for persons with normal immune systems. Unitaid will therefore support improved access to preventive tuberculosis treatment in groups at high risk of developing active tuberculosis disease. Unitaid’s investment will support optimal use of emerging regimens and formulations and enable their use at scale.

Diagnostic tools are critical in the fight against tuberculosis and need to be integrated in the overall approach to end the disease. Diagnostic needs have, therefore, been embedded in each area for intervention.

Unitaid’s investments are aligned with WHO’s End TB Strategy that aims to optimize existing treatments and diagnostics in the short term, and introduce new, innovative tools in the long term.

Unitaid report considers how to make essential medicines affordable

A new UNITAID study considers how to make essential medicines available and affordable to those in need.

Drawing examples from intellectual-property issues in the treatment of HIV, hepatitis C, tuberculosis and cancer, the authors recommend various options that governments can take to lower prices and increase access to essential medicines.

In May 2015, the World Health Organization (WHO) added several medicines – including some for the treatment of cancer, tuberculosis and hepatitis C – to its Model List of Essential Medicines. These new medicines, which are currently priced out of reach to most patients – present a key opportunity to use the List as a tool for access, argue the authors.

The World Trade Organization’s TRIPS agreement sets minimum standards for the protection of intellectual property rights – so members can no longer exclude entire fields of technology, such as medicines, from patentability. Innovative new medicines are increasingly patented around the world, and are thus available only at monopoly prices that prevent widespread access.

This paper suggests numerous options that governments could consider to counter this trend. Such options include:

  • Negotiating prices with originator companies for discounts in certain territories;
  • Ensuring sustainable supplies of low-cost generics, including through voluntary or compulsory licensing or “government use” of patents;
  • Ensuring sustainable development of future essential medicines through models that delink the cost of medicines development from the final price of the medical product.

“The recent shifts in the WHO Essential Medicines paradigm demand a bold approach to avoid unnecessary delays in making these medicines available to the populations in need,” write the authors.

LINK TO REPORT [PDF, 280 KB]

Unitaid hails initiative to make treatment for drug-resistant TB more accessible

UNITAID welcomes an agreement by Otsuka Pharmaceutical Co. and the Stop TB Partnership to  make delamanid, a life-saving drug used for treating multidrug-resistant tuberculosis (MDR-TB), more widely available to populations in need in developing countries.

The partnership will allow countries to access delamanid – one of two new drugs approved to fight MDR-TB – through Stop TB’s Global Drug Facility. The procurement facility  helps make available high quality and affordable TB medicines and diagnostics to those in need.

Delamanid and another MDR-TB drug – bedaquiline – are the first new medicines in decades with potential to dramatically improve MDR-TB treatment and to bring down numbers of people dying from the disease.

“UNITAID strongly endorses this concrete step to allow access to this promising new drug,” said UNITAID’s Executive Director, Lelio Marmora. “We intend to increase our activities to help expand its access in the near future.”

MDR-TB and extensively drug resistant TB (XDR-TB) are on the increase and pose a serious global health challenge. Existing treatment regimens for MDR- and XDR-TB can last two years or more and are expensive and toxic compared with treatments for regular TB.

The initiative may also bring hope for children with MDR-TB. Delamanid has been tested with children and results from trials that are now under way are expected in 2018.

UNITAID supports the endTB Project, implemented by Partners in Health (PiH), Médecins sans Frontières (MSF) and Interactive Research & Development (IRD). The project aims to provide adequate use of delamanid and bedaquiline and to facilitate the incorporation of these drugs into  shorter and improved treatment regimens.

Globally, almost half a million patients are estimated to be infected with MDR-TB every year and only around 20 per cent of them are starting treatment. The inclusion of a new drug in the list of medicines available for procurement is an important step towards achieving shorter, more affordable and better tolerated treatments for the people in need.