International Groups Launch Attack on Drug-Resistant TB

By John Gever
GENEVA, 2 july 2008-- State-of-the-art diagnostic tests for multidrug-resistant tuberculosis, as well as drugs for treating it, will be made available to certain African and Asian nations under two new programs announced here.
Led by the World Health Organization, the programs will spend $26 million to deploy rapid molecular tests for MDR-TB in 16 countries in Africa and central and south Asia over the next four years.
Another $34 million will go to purchase drugs to treat MDR-TB in those countries and 38 others where the disease is endemic.
The new tests will shorten to two days the time needed to determine whether a given TB strain will respond to standard first-line drugs -- rifampicin and isoniazid. Standard culture-based methods now used in developing countries typically require three to four months to yield results.
The PCR-based line probe assays were developed by two European companies, Hain Lifesciences in Germany and Innogenetics in Belgium. The latter's assay detects rifampicin-resistant TB strains. Hain's can identify resistance to both drugs.
Both assays are commercially available in Europe and other countries, but not the United States.
In a telephone press conference, Richard O'Brien, M.D., of the Foundation for Innovative New Diagnostics, one of the sponsors of the new initiative, said Hain is now in discussions with the FDA about having its assay approved in the U.S.
Dr. O'Brien said Innogenetics had not expressed interest in FDA approval for its product.
He said that although the new initiative does not directly affect the U.S. or other developed countries, the new tests could improve TB testing there as well.
"Any country that has a possibility of having a patient with MDR-TB should consider using [these tests]," he said.
He added that the American Thoracic Society, the Infectious Disease Society of America, and the CDC are updating their joint TB diagnostic statement to recommend use of rapid molecular tests for MDR-TB.
A WHO committee last month recommended full-scale implementation of the Hain and Innogenetics tests following a successful field trial in South Africa. It showed that the tests were accurate and feasible under real-world conditions in a developing country, the committee's report said.
The drug-purchase program will focus on currently approved second-line TB drugs known to be effective against MDR-TB, said Salmaan Keshavjee, M.D., of Brigham and Women's Hospital in Boston. Dr. Keshavjee chairs WHO's Green Light Committee, which negotiates prices of drugs with producers and develops guidelines for treatment of drug-resistant TB.
Money for both programs will come from UNITAID, an international organization funded by a tax on airline tickets levied by France, Chile, South Korea, and several African nations. Brazil and more than a dozen other countries, mainly in Africa, are expected to follow suit soon.
Neither program will be addressing the growing problem of extensively drug-resistant TB, in which second-line drugs are also ineffective, according to Mario Raviglione, M.D., director of the WHO's Stop TB Department. An estimated 40,000 cases are now seen worldwide annually.