Groundbreaking TB drug trial under way


9 November 2010


A novel three-drug combination with the potential of simplifying and shortening TB treatment from two years to less than six months is currently been tested on patients in South Africa.


The announcement of the first clinical trial of the TB drug combination was made in Pretoria on Monday by the Global Alliance for TB Drug Development, a non-profit organisation dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis.


The trial, which will take place at the Lung Institute at the University of Cape Town and the TASK Research Centre in Belville, involves 68 participants, each receiving two weeks of treatment and three months of follow-up to evaluate the drugs’ effectiveness, safety and tolerability.


The Department of Health has welcomed the development, noting that it could benefit not only South Africa but the whole world in the fight against TB.


“We welcome the fresh development, which will assist in bringing down the period of taking the treatment, which is one of the main reasons for patients defaulting,” said department spokesperson Fidel Hadebe.


Novel three-drug combination


The three-drug combination promises to be capable of treating both drug-sensitive (DS-TB) and multidrug-resistant TB (MDR-TB).


This is particularly significant for MDR-TB patients, who currentlty have to take numerous different drugs, including injections, daily for up to two years.


The Phase II trial, called NC001 or New Combination 1, tests the new TB drug candidates PA-824 and moxifloxacin in combination with pyrazinamide, an existing antibiotic commonly used in TB treatment today.


If successful, the experimental regimen will offer a shorter, simpler, safer and more affordable treatment option for MDR-TB, an emerging global health threat.


‘Monumental advance’ in treatment


TB Alliance CEO Mel Spigelman said what was needed was an entirely new regimen of TB drugs rather than one single drug to eradicate the pandemic.


“The potential to offer a single regimen to treat both DS and MDR-TB represents a monumental advance in the treatment of patients worldwide and a tremendous step toward simplifying the delivery of TB treatment globally,” Spigelman said.


He noted that treating active TB requires a combination of drugs to prevent the development of drug resistance, adding that researchers traditionally tested one new drug at a time in a series of lengthy and expensive clinical trials, meaning it would take decades to develop a completely novel drug combination.


Growing pipeline of TB drugs


World Health Organisation’s Stop TB department MD Mario Raviglione said there was a desperate need for new and better TB treatments to address the pandemic, which kills nearly two million people each year.


He said that with increased investments in TB, there were nine promising TB compounds from six antibiotic classes in the pipeline, making combination testing of new TB drugs possible.


“It is extremely encouraging to see a growing pipeline of TB drug candidates that may revolutionise TB care, and committed sponsors moving with speed and efficiency towards new regimens,” said Raviglione.


SAinfo reporter



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