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Article from NEJM Journal Watch Treating Multidrug-Resistant Tuberculosis with a 6-Month Oral Regimen Review of a 6-Month Oral Treatment Protocol for Multidrug-Resistant Tuberculosis by Neil M.
Ampel, MD in a South African trial , a 6-month regimen containing bedaquiline, linezolid, and levofloxacin was significantly better than a 9- to 20-month regimen that did not contain these drugs
.
1/3 of tuberculosis (TB) deaths are from rifampicin-resistant (isoniazid-resistant or non-resistant) Mycobacterium tuberculosis (multidrug-resistant or rifampicin-resistant) TB[MDR/RR-TB])
.
Only about 57 percent of patients were reported to be successfully treated, in part because the treatment regimen took up to 20 months to complete
.
We conducted an open-label randomized trial in South Africa that included 111 adults with MDR/RR-TB
.
They compared standard therapy (9 to 20 months of kanamycin; moxifloxacin; ethionamide, terizidone, or high-dose isoniazid; and clofazimine) with the above intervention (6 to 9 months of an oral regimen of bedaquiline, linezolid, and levofloxacin, plus two other drugs [high-dose isoniazid or ethionamide or terizidone]) ])
.
The trial was terminated early after bedaquiline became part of the standard of care for MDR/RR-TB in South Africa
.
The primary outcome was good outcome (cure and completion of treatment without treatment failure, relapse, reinfection, prolonged treatment discontinuation, or death)
.
By 24 months after treatment initiation, 23% of participants in the standard-care group achieved these outcomes, compared with 51% in the intervention group (P=0.
006)
.
Fifty-six percent of patients in the standard-care group discontinued due to adverse events, compared with 30% in the intervention group (P=0.
007)
.
There was no significant difference in the rate of negative sputum culture between the two groups; however, among patients receiving bedaquiline for other drug toxicity, the rate of negative sputum culture in the intervention group was higher than in the standard care group (hazard ratio, 2.
6; P=0.
003)
.
There was no difference in all-cause mortality between the two groups
.
Commentary These results suggest that for patients with MDR-TB, a short-course regimen containing the new drug may lead to better outcomes
.
However, as the authors point out, there is still room for improvement in the above protocol, especially with regard to drug toxicity
.
Reviewed article Esmail A et al.
An all-oral 6-month regimen for multidrug-resistant TB (the NExT Study): A multicenter, randomized controlled trial.
Am J Respir Crit Care Med 2022 Feb 17; [e-pub].
(https://doi.
org/10.
1164/rccm.
202107-1779OC) Related readings NEJM Journal Watch NEJM Journal Watch (NEJM Journal Watch) is published by the NEJM Group, asking internationally renowned doctors to comment on important papers in the medical field, helping doctors understand and apply latest developments
.
"NEJM Frontiers of Medicine" translates several articles every week, publishes them on the app and official website, and selects 2-3 articles and publishes them on WeChat
.
Copyright Information This article was translated, written or commissioned by the NEJM Frontiers in Medicine, jointly created by Jiahui Medical Research and Education Group (J-Med) and The New England Journal of Medicine (NEJM)
.
The full text of the Chinese translation and the included figures are exclusively authorized by the NEJM Group
.
If you want to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal responsibility
.
Ampel, MD in a South African trial , a 6-month regimen containing bedaquiline, linezolid, and levofloxacin was significantly better than a 9- to 20-month regimen that did not contain these drugs
.
1/3 of tuberculosis (TB) deaths are from rifampicin-resistant (isoniazid-resistant or non-resistant) Mycobacterium tuberculosis (multidrug-resistant or rifampicin-resistant) TB[MDR/RR-TB])
.
Only about 57 percent of patients were reported to be successfully treated, in part because the treatment regimen took up to 20 months to complete
.
We conducted an open-label randomized trial in South Africa that included 111 adults with MDR/RR-TB
.
They compared standard therapy (9 to 20 months of kanamycin; moxifloxacin; ethionamide, terizidone, or high-dose isoniazid; and clofazimine) with the above intervention (6 to 9 months of an oral regimen of bedaquiline, linezolid, and levofloxacin, plus two other drugs [high-dose isoniazid or ethionamide or terizidone]) ])
.
The trial was terminated early after bedaquiline became part of the standard of care for MDR/RR-TB in South Africa
.
The primary outcome was good outcome (cure and completion of treatment without treatment failure, relapse, reinfection, prolonged treatment discontinuation, or death)
.
By 24 months after treatment initiation, 23% of participants in the standard-care group achieved these outcomes, compared with 51% in the intervention group (P=0.
006)
.
Fifty-six percent of patients in the standard-care group discontinued due to adverse events, compared with 30% in the intervention group (P=0.
007)
.
There was no significant difference in the rate of negative sputum culture between the two groups; however, among patients receiving bedaquiline for other drug toxicity, the rate of negative sputum culture in the intervention group was higher than in the standard care group (hazard ratio, 2.
6; P=0.
003)
.
There was no difference in all-cause mortality between the two groups
.
Commentary These results suggest that for patients with MDR-TB, a short-course regimen containing the new drug may lead to better outcomes
.
However, as the authors point out, there is still room for improvement in the above protocol, especially with regard to drug toxicity
.
Reviewed article Esmail A et al.
An all-oral 6-month regimen for multidrug-resistant TB (the NExT Study): A multicenter, randomized controlled trial.
Am J Respir Crit Care Med 2022 Feb 17; [e-pub].
(https://doi.
org/10.
1164/rccm.
202107-1779OC) Related readings NEJM Journal Watch NEJM Journal Watch (NEJM Journal Watch) is published by the NEJM Group, asking internationally renowned doctors to comment on important papers in the medical field, helping doctors understand and apply latest developments
.
"NEJM Frontiers of Medicine" translates several articles every week, publishes them on the app and official website, and selects 2-3 articles and publishes them on WeChat
.
Copyright Information This article was translated, written or commissioned by the NEJM Frontiers in Medicine, jointly created by Jiahui Medical Research and Education Group (J-Med) and The New England Journal of Medicine (NEJM)
.
The full text of the Chinese translation and the included figures are exclusively authorized by the NEJM Group
.
If you want to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal responsibility
.