The 2-year follow-up results for a randomized placebo-controlled study of 47 patients with multidrug-resistant pulmonary tuberculosis treated with either the new diarylquinoline TMC207, recently renamed bedaquiline, or placebo, added to the first 8 weeks of a background regimen, are presented. Bedaquiline significantly reduced the time to culture conversion over 24 weeks (hazard ratio, 2.253; 95% confidence interval, 1.08 to 4.71; P = 0.031). With the exception of nausea reported in 26% of patients receiving bedaquiline and none receiving placebo, adverse events occurred at similar frequencies in both groups of patients: bilateral hearing impairment, extremity pain, acne, and noncardiac chest pain occurred in 13 and 21%, 17 and 13%, 9 and 17%, and 4 and 17% of patients, respectively, receiving bedaquiline or placebo. Excluding resistance to ethambutol and ethionamide, only one patient receiving bedaquiline acquired resistance to companion drugs, but five patients receiving placebo (4.8% versus 21.7%; P = 0.18) acquired resistance to companion drugs, and resistance to ofloxacin was acquired in four patients receiving placebo and none receiving bedaquiline (0% versus 22%; 0 = 0.066).
Original Source [2]
Links:
[1] http://admin.indiaenvironmentportal.org.in/feature-article/randomized-pilot-trial-eight-weeks-bedaquiline-tmc207-treatment-multidrug-resistant
[2] http://aac.asm.org/content/56/6/3271.full
[3] http://admin.indiaenvironmentportal.org.in/category/author/h-diacon
[4] http://admin.indiaenvironmentportal.org.in/category/author/p-r-donald
[5] http://admin.indiaenvironmentportal.org.in/category/author/pym-et-al
[6] http://admin.indiaenvironmentportal.org.in/category/journal/antimicrobial-agents-and-chemotherapy
[7] http://admin.indiaenvironmentportal.org.in/category/thesaurus/tuberculosis
[8] http://admin.indiaenvironmentportal.org.in/category/thesaurus/drugs
[9] http://admin.indiaenvironmentportal.org.in/category/thesaurus/medical-research
[10] http://admin.indiaenvironmentportal.org.in/category/thesaurus/south-africa