The interim results (between April 2015 and July 2016) on the first 15 participants enrolled in the study, of whom 7 were HIV positive, showed that 12 of them completed 6 months of therapy. The majority were culture negative by week 8 and no patient needed an extension of treatment. As of July 1, 2016 there have been no clinical or micro biological relapses.
As of now, 30 patients have completed 6 months of treatment and all have negative cultures of their sputum. There have been no relapses to date, although the study is still ongoing. The rest of the patients are in various stages of treatment and follow-up. 4 patients have died, but this is a substantially lower mortality than ever reported before.
The early results of this greatly simplified and shortened all oral regimen for XDR-TB appear to be encouraging in terms of both efficacy and safety. The regimen appears safe but requires medical supervision. Linezolid, which has been used off-label to treat MDR-TB, has considerable toxicity but was managed in a clinical study setting.
This is the first injection-free regimen for XDR-TB that, if successful, could transform XDR-TB treatment, with patients being cured by taking a relatively short, simple, oral and effective regimen. Importantly, the regimen would also reduce the complexity and cost of the treatment to a fraction of what it is today, facilitating the global implementation of XDR-TB treatment in resource-poor nations.
These regimens can be deployed in the context of currently available or forthcoming diagnostics. These regimens may revolutionise and markedly reshape the treatment landscape for TB by offering a common therapy for virtually all people with drug-sensitive and drug-resistant TB, and a closely related treatment for those with extensively drug-resistant TB.
Shobha Shukla, Citizen News Service - CNS
(Shobha Shukla is providing thematic coverage from the 47th Union World Conference on Lung Health, Liverpool, United Kingdom, with kind support from TB Alliance (Global Alliance for TB Drug Development). Follow her on Twitter @Shobha1Shukla)
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