First all-oral XDR-TB drug regimen trial launches in South Africa

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The TB Alliance Wednesday announced the launch of the first clinical trial testing an all-oral regimen to treat extensively- drug resistant tuberculosis. With a three drug combination the Nix-TB regimen trial seeks to cure patients within six to nine months. The trial will launch at three sites in South Africa and will include patients as young as 14 and patients co-infected with HIV with a CD4 count of 50 or higher.

The regimen is comprised of bedaquiline, which received provisional approval from the U.S. Food and Drug Administration in 2013 to treat drug-resistant tuberculosis, pretomanid a new type of antibacterial drug, and linezolid which is used off-label to treat TB.

The TB Alliance and partner Janssen Pharmaceuticals hope the trial, will pave the way for shorter, safer, and less costly treatment regimens for both multidrug-resistant and drug-susceptible TB. In South Africa, it costs more than 100 times more to treat a patient with XDR-TB than one with tuberculosis that responds to first line medicine —   $26,392, as opposed to the $257 cost of treating drug-susceptible TB.

No regulatory approved XDR-TB treatments exist, so current treatment regimens are often individualized with healthcare providers using antibiotics not normally used for TB as well as toxic medicines not meant for the long treatment durations XDR-TB requires. They can result in deafness, psychosis, or other debilitating side effects, last up to two years and have little success, curing only 16 percent of patients.

The patients who fail treatment and have no other options return to their communities, where they spread the disease even further.

“TB must be treated in multi-drug combinations or regimens to enhance efficacy and prevent the development of resistance,” Mel Spigelman, President and CEO of the TB Alliance said in a statement. “The Nix-TB trail fills a critical gap and capitalizes on the availability of novel drugs by studying them together in the most vulnerable TB population.

He hopes, he said that the study leads to a “clear understanding of how to use the treatments to maximize their impact on the epidemic.”

On Thursday Dr. Bern-Thomas Nyang’wa, project manager and TB specialist for Médecins Sans Frontières, which is one of the largest non-government agencies treating drug-resistant TB, said in a statement, “Optimal treatment regiments shouldn’t contain injectable drugs, and should offer patients real hope of being cured.”

“We hope that Nix-TB will be able to quickly expand to include MDR-TB patients, who are desperately in need of better treatment options as well,” Nyang’wa said.

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