Unitaid joins Health Partners to launch new treatment for drug-resistant TB

Leading medical organizations team up to bring new TB treatments to those in need.

endTB will provide access to new anti-TB drugs for more than 3,000 people and run clinical trials to identify safer and more effective treatments.

Paris / Boston / Dubai, 20 March 2015 – International organizations Partners In Health (PIH), Médecins Sans Frontières (MSF), Interactive Research and Development (IRD) and their financial partner UNITAID will start in April the endTB project, a partnership aimed at radically changing the management of multidrug-resistant tuberculosis (MDR-TB).

By 2019, endTB will provide access to two new anti-TB drugs (bedaquiline and delamanid), for 2 600 MDR-TB patients in 16 countries. These are the first new anti-TB drugs developed in over 50 years and these drugs offer new hope to patients suffering from MDR-TB.  endTB will use the new anti-TB drugs according to World Health Organization (WHO) recommendations in a closely monitored group of patients.  And, an innovative endTB clinical trial will test completely novel MDR-TB treatment regimens in 600 more MDR-TB patients.  The shorter, more user-friendly regimens being tested will be nothing short of revolutionary if they are found to be safe and effective.

endTB’s 4 goals from endTB on Vimeo.

Although approved for treatment of MDR-TB for more than a year, the two drugs have scarcely been used. Access to the new drugs in countries with high burdens of MDR-TB has been almost exclusively through compassionate use programs, requiring a case-by-case authorization from the manufacturer for patients with no other treatment options.

As of today, it is estimated that fewer than 1,000 patients have received bedaquiline. Although delamanid is provided through compassionate use, it has yet to reach more than handful of patients. endTB, however, will lay the ground work for appropriate delivery of these drugs to hundreds of thousands of patients suffering from MDR-TB.

“The main obstacle today is that there is limited knowledge about these drugs. Many of the countries where the patients in need live are not in the position to provide the enhanced safety monitoring that is still needed for their use”, said Dr. Aamir Khan, end TB project leader at IRD. “Also, in most of countries bedaquiline and delamanid are not licensed. And even in countries where they are registered, drug procurement mechanisms are today extremely long and complicated”.

Current treatment for tuberculosis (TB) consists of six months on a cocktail of various antibiotics. MDR-TB is defined as the resistance of the TB bacterium to at least the two most powerful first-line antibiotics, rifampicin and isoniazid. The extreme form of MDR-TB, known as extensively drug resistant TB (XDR-TB), occurs when resistance appears to second-line drugs too.

Out of the estimated 500,000 people that develop MDR-TB every year, about 10% are XDR-TB. Currently, there are very few drugs with good efficacy for these patients; the drugs have to be combined in treatments that last up to two years, with severe side effects and only 50% success rate for MDR-TB overall – less than 20% for XDR-TB.

endTB will provide access to new anti-TB drugs for more than 3,000 people and run clinical trials to identify safer and more effective treatments.

Paris / Boston / Dubai, 20 March 2015 – International organizations Partners In Health (PIH), Médecins Sans Frontières (MSF), Interactive Research and Development (IRD) and their financial partner UNITAID will start in April the endTB project, a partnership aimed at radically changing the management of multidrug-resistant tuberculosis (MDR-TB).

By 2019, endTB will provide access to two new anti-TB drugs (bedaquiline and delamanid), for 2 600 MDR-TB patients in 16 countries. These are the first new anti-TB drugs developed in over 50 years and these drugs offer new hope to patients suffering from MDR-TB.  endTB will use the new anti-TB drugs according to World Health Organization (WHO) recommendations in a closely monitored group of patients.  And, an innovative endTB clinical trial will test completely novel MDR-TB treatment regimens in 600 more MDR-TB patients.  The shorter, more user-friendly regimens being tested will be nothing short of revolutionary if they are found to be safe and effective.

endTB’s 4 goals from endTB on Vimeo.

Although approved for treatment of MDR-TB for more than a year, the two drugs have scarcely been used. Access to the new drugs in countries with high burdens of MDR-TB has been almost exclusively through compassionate use programs, requiring a case-by-case authorization from the manufacturer for patients with no other treatment options.

As of today, it is estimated that fewer than 1,000 patients have received bedaquiline. Although delamanid is provided through compassionate use, it has yet to reach more than handful of patients. endTB, however, will lay the ground work for appropriate delivery of these drugs to hundreds of thousands of patients suffering from MDR-TB.

“The main obstacle today is that there is limited knowledge about these drugs. Many of the countries where the patients in need live are not in the position to provide the enhanced safety monitoring that is still needed for their use”, said Dr. Aamir Khan, end TB project leader at IRD. “Also, in most of countries bedaquiline and delamanid are not licensed. And even in countries where they are registered, drug procurement mechanisms are today extremely long and complicated”.

Current treatment for tuberculosis (TB) consists of six months on a cocktail of various antibiotics. MDR-TB is defined as the resistance of the TB bacterium to at least the two most powerful first-line antibiotics, rifampicin and isoniazid. The extreme form of MDR-TB, known as extensively drug resistant TB (XDR-TB), occurs when resistance appears to second-line drugs too.

Out of the estimated 500,000 people that develop MDR-TB every year, about 10% are XDR-TB. Currently, there are very few drugs with good efficacy for these patients; the drugs have to be combined in treatments that last up to two years, with severe side effects and only 50% success rate for MDR-TB overall – less than 20% for XDR-TB.

End-of-project evaluation: Support for MDR-TB scale-up initiative

Unitaid’s Expand-TB and TBXpert MTB-TIF projects detect over a quarter of all MDR-TB cases

The projects make a significant contribution to WHO’s estimate of 30 percent increase in case detection.

Unitaid welcomes new data in the World Health Organization’s new global report on tuberculosis (TB) which shows a 30 percent increase in case detection of multi-drug resistant TB (MDR-TB) in 2013, much of which is attributed to the roll out of the Unitaid-funded EXPAND-TB and TBXpert projects.

Unitaid’s EXPAND-TB project enabled the installation of sophisticated testing platform technology in TB reference laboratories across 27 countries, bearing 40 percent of the MDR-TB burden. This provided the capability to detect MDR-TB for the first time for many countries.

The TBXpert project, launched in 2013, provided GeneXpert machines to 21 countries in the largest global scale up of the technology at the time. The technology reduces test result times from weeks to a few hours, including for drug-resistant strains and for HIV co-infected TB patients, enabling patients to be put immediately on treatment. The project signalled to other funders that such technology was both viable and essential in low resource settings to make significant strides in detecting cases.

Moreover, together with the Bill and Melinda Gates Foundation, PEPFAR and USAID, Unitaid negotiated a 40 percent global price reduction for the GeneXpert machine’s test cartridges for 145 countries. This has enabled all major funders such as the Global Fund and national programmes to benefit from the more affordable price indefinitely and has saved over $50 million so far for purchasers including Brazil and South Africa. WHO reports that as of June 2014, the technology is already in use by 108 countries with cartridge orders now reaching over a million per quarter.

“With $8 billion as the WHO’s estimated annual global need to tackle the disease, and an annual funding gap of nearly $2 billion, the introduction of ever-more effective diagnostic tools and medicines at affordable prices continues to be vital for the available funding to detect as many cases and successfully treat as many people as possible” said Lelio Marmora, Executive Director of Unitaid.

With an increase in diagnostics and monitoring, the WHO report highlights how more patients in need of treatment are being found, including for MDR-TB. Unitaid is already striving to scale up access to new world-class MDR-TB regimens that are less arduous and of shorter duration making it easier for patients to complete their courses and for the disease to be treated. These new medicines are estimated to drive a tenfold decrease in new infections. Unitaid also provides emergency access to MDR-TB medicines for all countries at risk through its Strategic Rotating Stockpile, essential to avoid treatment interruptions.

However, Unitaid’s analysis shows how, overall, the market for MDR-TB treatment is small and fragmented with up to 40 different regimens, posing a variety of difficulties and inefficiencies for access to MDR-TB treatment. Unitaid therefore continually works to improve this patchy and unpredictable market by exploring new ways for demand forecasting, treatment simplification, production stabilization, and improved purchaser coordination.

Unitaid and the Global Fund announce formal collaboration

UNITAID and the Global Fund to Fight AIDS, Tuberculosis and Malaria have signed a collaboration agreement around a market-shaping agenda to maximize the value for money from each organization’s investments.

Both organizations invest to increase access to health products for HIV/AIDS, tuberculosis and malaria for those who need them most. UNITAID focuses on global product markets, investing to speed up and increase access to better adapted and more affordable commodities, and Global Fund investments support countries in efforts to expand health programmes, including health products.

The new agreement focuses on three main areas: More rapid development and uptake of high-quality adapted medicines and diagnostics geared toward increasing access for underserved populations; Promoting simpler treatments, including fixed-dose combinations and point-of-care diagnostics that improve adherence and reduce patients’ pill burden; Improving value for money of donor investments by achieving greater market improvements with resulting public health impact.

“Our organizations have worked together since UNITAID was created,” said Dr Philippe Duneton, Executive Director ai of UNITAID. “We have already had significant successes from our collaboration, but we have ambitions to do much more.  It is now more important than ever  to speed up access to the newest and best medicines and technologies for those most in need.   This is what this new agreement is designed to achieve.”

Dr Mark Dybul, Executive Director of the Global Fund, added: “UNITAID and the Global Fund have complementary roles which are mutually reinforcing. From one perspective, UNITAID is upstream and the Global Fund is downstream.”

UNITAID pushes the innovation, the market-shaping for commodities and the market forces that will put them in the range of affordability, Dr Dybul said. The Global Fund is then well-positioned to work directly with countries to enable them to expand access, improving patient care and ultimately saving more lives.

Three priority areas for engagement have been identified as: Strategic cooperation in market shaping and access interventions; strategic cooperation in sharing market intelligence; and measuring market and public health impact. The priority areas will build on the successful collaboration to date and maximize the combined impact of UNITAID and Global Fund interventions.

Unitaid’s 2013 Annual Report: “Transforming Markets, Saving Lives”

Report shows UNITAID’s approach vital to remove market barriers so millions can have equitable access to new treatments for infectious diseases.

Highly-effective treatments and diagnostics for HIV, malaria, tuberculosis (TB) are emerging, some for the first time in decades, but UNITAID’s 2013 Annual Report [PDF, 4 MB] shows that considerable ‘market barriers’ need to be removed so these products can reach millions of people in low- and middle-income countries.

Entitled “Transforming Markets, Saving Lives,” this report highlights barriers – including high prices, patents, and the lack of adapted formulations – but also demonstrates how UNITAID is addressing these challenges through investments to shape markets. From accelerating market entry of new and affordable diagnostic tools to stimulating the development of paediatric formulations, the report shows that UNITAID is playing a key – and essential – role.

“This report is especially timely as it follows almost $160 million in new UNITAID market interventions announced on 6 May 2014, including investments to ensure low- and middle-income populations have access to new high performing treatments for hepatitis C and drug-resistant tuberculosis,” said Dr Philippe Douste Blazy, Chairman of the UNITAID Executive Board. “These are the first major global investments in these game-changing medicines from any large funder. “

UNITAID’s Annual Report brings together market intelligence collected by the organization over the year to inform its investments. Among the topics covered in this report:

  • UNITAID is leading the way in increasing access to new diagnostics for HIV/AIDS, malaria and TB. In 2013, this included new monitoring technologies for HIV, rapid TB diagnostics and the introduction of malaria testing in the private sector. Nevertheless, the report highlights the need for more new technologies enter the market to bring down prices.
  • A lack of paediatric formulations contributes to the large mortality in children from these three diseases, as described in detail in the report. While UNITAID sped up access to child-adapted medicines for HIV and TB in 2013, more work is needed.
  • Promising new medicines for HIV/AIDS, hepatitis C and tuberculosis are emerging, yet the report shows that patent barriers and high prices are barriers to access for low-income populations. UNITAID is leading the way in “upstream” work to reduce prices, address fragmented markets and find an equitable solution to intellectual property issues.

Download Report 2013 [PDF, 4 MB]

Unitaid approves grants of $160 million for hepatitis C, malaria chemoprevention and drug-resistant tuberculosis

Breakthrough new medicines for hepatitis C and drug-resistant TB and largest-yet global programme for seasonal malaria chemoprevention to be made available for low- and middle-income countries as part of $160 million of new grants funded by Unitaid.

Geneva 6 May 2014 – The Unitaid Executive Board committed $160 million in new grants, including investments to ensure low- and middle-income populations have access to new high performing treatments for hepatitis C and drug-resistant tuberculosis, and the largest-yet global programme for seasonal malaria chemoprevention. These innovative investments will reduce prices, overcome market barriers to access for patients, and generate crucial data on new products to speed up their introduction for those most in need.

A grant has been made to Médecins Sans Frontières (MSF) for the first major global scale-up for low- and middle-income countries of the new highly-anticipated hepatitis C medicines. It is one of two initial investments for Unitaid in this viral disease, and will lead to substantially larger hepatitis C cure rates for people living with HIV through reducing medicine prices to $500-1000 per patient. The current cost of one particular new and extremely effective hepatitis C treatment in the United States is $84,000 per patient. (more details below)

“Until recently, the only treatment for hepatitis C involved an expensive combination of injections and tablets that lasted a year with limited efficacy,” said Dr Philippe Douste-Blazy, Chairman of the Unitaid Executive Board. “Treatments which have recently been made available can cure the disease in weeks but currently have a heavy price tag. Our investment will lower the prices of these treatments and therefore increase access, and is a decision the public health community has been waiting months for.”

Meanwhile, a grant to Partners In Health will accelerate access to new treatments for multidrug-resistant tuberculosis (MDR-TB), including the first new tuberculosis drug to be approved in 40 years by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This project will push availability of these promising new medicines and help transform the heavily fragmented treatment market for MDR-TB to enable cost-efficiencies, simpler treatments, and reduced prices to increase the cure rate from 48% to 70% and increase the number of cases averted ten-fold. (more details below)

“The currently-used treatment for MDR-TB is expensive, has serious side effects, and only about half of those who finish the two-year course are cured,” said Dr Philippe Duneton, Unitaid’s Executive Director a.i.. “Unitaid’s investment will help make MDR-TB treatment simpler, shorter, more affordable and more effective, thereby improving cure rates and helping to halt the disease’s spread.”

“We’re grateful for this support from Unitaid, and particularly for their partnership, with which we’re hoping to make diagnosis and treatment of drug-resistant tuberculosis more effective and more tolerable for patients, as well as more readily accessible and lower-cost” said Dr Paul Farmer, Chief Strategist and Co-founder of Partners in Health.  “Unitaid has given us a way to use the power of markets to serve the poor, driving down the cost of essential commodities and helping to deliver them to the people who need them most.”

Other new grants, described below, are equally as revolutionary, including the world’s largest-yet programme to roll-out malaria prevention treatment to children in the Sahel region of Africa which will save an estimated 50,000 lives.

More Details on All the Grants Approved by Unitaid’s Executive Board this week:

(from above) Up to $15 million to Médecins Sans Frontières (MSF) to reduce barriers in product markets to enable improved treatment of hepatitis C in low- and middle-income countries. Patients will be screened, diagnosed and treated in India, Iran, Kenya, Mozambique, Myanmar, and Ukraine to catalyse demand for newly-available medicines. MSF anticipates that this will help to reduce the price to $500-1000 per treatment course by the end of the intervention through negotiations and entry of new generic manufacturers. An estimated 150-180 million people worldwide are infected with HCV and up to 500,000 die every year. Approximately 16% of the HIV-infected population (over 5 million people) is co-infected with HCV.  Those co-infected with HIV and HCV are much more likely to develop liver illnesses than those with only HCV.

(from above) Up to $60.4 million to Partners in Health (PIH) to radically change the MDR-TB medicines market and accelerate uptake of newly released MDR-TB medicines (bedaquiline and delamanid) in 17 countries. Over the course of four years, PIH will enrol 3200 patients on treatment involving new TB medicines and devise a more user-friendly and effective treatment regimen. Currently the small and fragmented MDR-TB medicines market features many medicine buyers and a large number of possible drug combinations. High-burden MDR-TB countries are currently estimated to use upwards of 40 or 50 unique MDR-TB regimens, leading to inefficiencies in ordering and manufacture and unnecessarily high prices. Today only an estimated 17% of MDR-TB patients receive treatment.  The investment will consolidate the market for MDR-TB drugs, and expand access to new, effective, and user-friendly treatment regimens for patients with MDR-TB. MDR-TB spreads through the air, especially in confined living conditions, and caused an estimated 170,000 deaths in 2012.

Up to $67.4 million to the Malaria Consortium to implement the largest-yet global programme to increase seasonal malaria chemoprevention (SMC) – the use of anti-malarials during the rainy season to prevent malaria.  By giving children prophylactics at monthly intervals during this high-risk period, drug levels are maintained in the blood to prevent malaria.  WHO has recommended SMC since 2012 and estimates that it can prevent 75% of cases, but in 2013, only 3% of eligible children received treatment. This grant will increase capacity and reduce prices for SMC products in Burkina Faso, Chad, Guinea, Mali, Niger, Nigeria and Gambia. The project will supply an estimated 30 million treatments every year to protect 7.5 million children, the population segment most at risk of dying from this disease. It is estimated that 50,000 deaths will be prevented.

Up to $3.7 million to the Northwestern Global Health Foundation (NWGHF) to support the market entry of a best-in-class early infant diagnostic (EID) test for HIV.  The test can be used in remote settings by community health care workers and gives results while patients wait.There are still 1.4 million infants born with HIV each year.  Fewer than an third receive a test and of those who test positive, over half never receive their results.  Infants retain maternal antibodies against HIV for over a year after birth, hence highly sensitive molecular testing for babies is essential for accurate diagnosis. Currently-available tests are complicated to use, require sophisticated infrastructure, and skilled technicians to operate them. NWGHF’s new technology is less expensive and is simple enough to be used at the point-of-care. Unitaid’s grant will facilitate more widespread adoption of this technology and lower the cost of testing in 29 countries where over 90% of HIV-positive infants are born.  This will help to increase the number of children on treatment.  Studies show that EID and prompt treatment can reduce infant mortality by 76%.

Up to $5.2 million to Coalition Internationale Sida to work with partners in Brazil, China, Ecuador, Egypt, Georgia, Indonesia, Malaysia, Morocco, South Africa, Thailand and Ukraine to advance access to new treatments for hepatitis C for HIV co-infected patients.   The project will develop an alliance between the countries to pool efforts to negotiate lower prices.  This is the second of two Unitaid grants to support hepatitis C projects.

Up to $6 million to the Tides Centre/International Treatment Preparedness Coalition to remove barriers to generic competition for second- and third-line HIV antiretrovirals in middle-income countries outside Sub-Saharan Africa where 20% of the HIV burden exists. By removing these barriers, this investment aims to lower prices in four countries (Argentina, Brazil, Thailand and Ukraine) and expand the overall market for new antiretrovirals thereby increasing access for an additional 130,000 people and generating annual cost savings of $150 million. Patent barriers mean prices remain high for non-generic HIV medicines.

HIV and congenital syphilis diagnostics technology landscape

World TB Day 2014: Unitaid urges focus on better treatment of multidrug-resistant TB

UNITAID investments in better testing for multidrug-resistant tuberculosis (MDR-TB) have led to a dramatic increase in cases detected, but a pressing issue remains – treatment of  MDR-TB is extremely difficult and expensive.

Only 50% of those who endure the two years of gruelling treatment are cured, and until better medicines are introduced, this highly-contagious diseases will remain a dangerous global threat.

World TB Day this year is focused on the three million people who are infected with TB and “missed” by health systems. Through UNITAID-funded projects implemented by the World Health Organization (WHO) and the Stop TB Partnership, more patients are being identified in high-burden countries. These initiatives have scaled up lab-based services and introduced new rapid technologies which shorten the time to diagnose drug-resistant strains of TB from weeks to only a few hours.  UNITAID has made grants to the EXPAND-TB project which is providing state-of-the-art testing facilities to 100 labs in 27 high burden countries with 40% of the problem, and through its TBXpert project which has brought 220 state-of-the-art GeneXpert machines to 21 countries and a 40% price reduction for the test cartridges, for 145 countries.

“The improvements in testing are encouraging although we need to do better as access to MDR-TB testing is still very low, at around 20%” said Philippe Duneton, Executive Director ai UNITAID. “But the challenge is also to have simpler, shorter, more affordable, drug regimens again MDR-TB.”

Some encouraging signs have started to emerge. Just over a year ago, the US Food and Drug Administration (FDA) approved the first new TB medicine in over 40 years, last year the European Medicines Agency (EMA) granted temporary approval of a second MDR-TB drug, and new shorter regimens, including one which lasts only nine months, are showing great potential.  With more MDR-TB patients being identified through improved testing, UNITAID’s TB Medicines Landscape report highlights the growing challenge of how to ensure that these new medicines are widely available at affordable prices to improve treatment success rates.

Medicines for the 500,000 annual paediatric total TB cases also remains a particular issue, with none currently available which meet WHO guidelines.  UNITAID is working with the TB Alliance to develop adapted formulations and make them available as quickly as possible.

One of the main problems for TB lies in the market for treatments.  It remains small and fragmented with upwards of forty different regimens being ordered by a multitude of different purchasers.  This presents a situation with few incentives to manufacturers to invest and innovate for new medicines, where demand is difficult to pool in order to negotiate price reductions, and where forecasting to plan production and avoid product shortages is hard to do.  UNITAID’s Strategic Rotating Stockpile is providing one immediate solution for MDR-TB medicines in particular:  a supply of drugs is constantly available for quick access by any country facing stock outs.  This helps prevent treatment interruptions for patients, particularly important for the MDR strains of the disease.

A TB Market Forum held by UNITAID in 2013 identified four areas for future investment for improving access to TB medicines: finding simpler treatments, improving forecasting and procurement, stabilising production, and developing more strategic coordination amongst purchasers.  A simplified TB treatment market will allow for better and more affordable medicines and therefore greatly transform the lives of those still affected by the disease.

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