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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World TB Day 2014

Almost half a million people fell ill with multidrug-resistant tuberculosis (MDR-TB) in 2012, yet less than one in 4 of these people was diagnosed, mainly due to a lack of access to quality diagnostic services.

But with an innovative international project, 27 countries are making promising progress in diagnosing MDR-TB, says the World Health Organization (WHO) in the lead-up to World TB Day, 24 March.

The project known as EXPAND-TB (Expanding Access to New Diagnostics for TB), financed by UNITAID, helped to triple the number of MDR-TB cases diagnosed in participating countries.

“Earlier and faster diagnosis of all forms of TB is vital,” says Dr Margaret Chan, WHO’s Director-General. “It improves the chances of people getting the right treatment and being cured, and it helps stop spread of drug-resistant disease.”

The theme for World TB Day 2014 is “Reach the 3 Million”. One third of the estimated 9 million people falling ill with TB each year do not get the care they need. In many countries, it is hard for people to access diagnostic services – particularly for MDR-TB. Some countries have only one central laboratory, which often has limited capacity to diagnose MDR-TB. In some cases, patient samples have to be sent to other countries for testing.  Moreover, traditional diagnostic tests can take more than 2 months to get results.

But the situation is beginning to change.  New technologies can rapidly diagnose TB and drug-resistant TB in as little as two hours.

“The MDR-TB story is being transformed by a fertile mix of collaborators, including those working on access to diagnosis,” says Philippe Meunier, the French Government’s Ambassador for the fight against HIV/AIDS and communicable diseases. “Increased capacity and reduced prices mean more patients can be served, and global health risks would be diminished.”

In 2009, UNITAID provided US$ 87 million to support the EXPAND-TB multi-partner project to enable effective and sustained access, and use of recommended new TB diagnostic technologies in 27 low- and middle-income countries. These countries together carry 40% of the estimated global MDR-TB burden.

The project has delivered impressive results. Over 30% of the MDR-TB cases detected globally in 2012 were from EXPAND-TB countries.  90% of India’s detected MDR-TB cases were through EXPAND-TB supported services.  Use of these tests requires strengthened laboratory services. By the end of 2013, 92 laboratories were fully operational. From 2009 to 2013, the number of MDR-TB cases diagnosed in the 27 countries tripled, with 36 000 diagnosed in 2013 alone.

The project has enabled more patients to be treated with quality-assured second-line TB medicines.  Through that demand, the project has helped to reduce the price of individual medicines and MDR-TB treatment regimens by one third.  Prices have also dropped for diagnostic commodities.

Project partners are WHO and the Global Laboratory Initiative (GLI), the Stop TB Partnership’s Global Drug Facility and FIND. Project funds have been used to purchase testing equipment and commodities, and to train laboratory technicians.

The EXPAND-TB project complements investments in laboratory infrastructure and diagnostic services from international partners, including The Global Fund to Fight AIDS, TB and Malaria, The World Bank and the United States Government.

“The gap in access to TB diagnostics and care is far from filled, but is narrowing. With the impetus of modern laboratories, we are on the right track finally to handle MDR-TB,” says Dr Mario Raviglione, Director of WHO’s Global TB Programme.

Ministries of health are now working on securing domestic funding for the medium-term and working with partners to fill financing shortfalls for quality diagnostic tests and services.

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