Trial for new drug-resistant TB treatment to begin

March 19, 2012 by Jean-Louis Santini

A global health alliance Monday unveiled plans for the first clinical tests of a new treatment regimen for tuberculosis, including for patients with resistance to existing multidrug programs.

The TB Alliance, which is funded by several governments and foundations, said the new drug combination offers promise in the fight against TB, which kills an estimated 1.4 million people each year, mostly in Africa.

Health experts said the new program could be particularly useful for an estimated 650,000 people around the world who suffer from multidrug-resistant TB (MDR-TB), a number expected to rise, and could shorten treatment times.

"There is new momentum and new hope in TB research, as shown by this and several other novel regimen trials that will soon be launched," said Mel Spigelman, president and chief executive of the TB Alliance.

"This novel TB drug regimen has the potential to unlock a new and more efficient approach to tackling TB.

"In essence, it's a step toward erasing the distinction between TB and MDR-TB -- and in the process, dramatically shortening, simplifying, and improving treatment," he added.

Currently, someone with TB must take a course of drugs daily for six months, while those with MDR-TB must take a daily injection for the first six months and a dozen or more pills each day for 18 months or more.

Many TB patients fail to complete treatment because they cannot tolerate the difficult side effects of the medications or cannot adhere to the long-term treatment, according to the TB Alliance.

This leads to drug resistant forms of the disease, or even extensively drug-resistant TB known as XDR-TB.

"The current TB treatment takes too long, and all around the world, patients needlessly suffer because today's treatment is completely inadequate," said Francis George Apina of the Network of Men Living with HIV/AIDS in Kenya.

The TB Alliance receives funding from the Bill & Melinda Gates Foundation, Irish Aid, Britain's Department for International Development, the US Agency for International Development, and the US Food and Drug Administration.

The new regimen being tested could shorten required treatment to as little as four months in both patients with TB and some forms of drug-resistant TB, compared with the current six to 24 months. Costs will also be vastly reduced.

Once known as "consumption" for the slow wasting away of terminally-ill patients, one out of every three people is thought to be infected by the airborne TB organism, though only a fraction go on to develop the disease.

A total of 8.8 million people worldwide fell ill with the contagious lung disease in 2010 and around 1.4 million died, according to the World Health Organization (WHO).

The new trials will take place at eight sites in South Africa, Tanzania, and Brazil, the alliance said.

Dr Anthony Fauci, director of the US-based National Institute of Allergy and Infectious Diseases, said he was "optimistic" on the outlook for treating TB.

"We have put a lot of effort over the last few years in developing new drugs regimens and the clinical trial is a step in the right direction to trial and get new TB drugs, particularly for those against drugs resistance," he said.

"It's the first time we have tried to address the multi-resistance problem with a combination of new drugs. We tried before but not in combination," he added.

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