*Please note that called a noninferiority margin and is set by the trial investigators based on the in the narrative text “B” represents bedaquline, but anticipated performance of the control regimen (in the case of S31/ A3549, in the tables “J” represents based on the proportion of unfavorable outcomes observed among participants bedaquiline and “B” represents randomized to the control arms of pr. [...] moxifloxacin-containing regimen (2HPZM/2HPM) non-inferior to the existing six-month standard of care.11 S31/ A5349 offers the first advance over the In the case of S31/A5349, existing standard of care for the treatment of drug-sensitive TB in 40 years. [...] A sub study to evaluate the palatability and acceptability of the FDCs, and to describe challenges administering treatment to children in the SHINE study, found that the FDCs compared favorably to other formulations, albeit with some practical challenges to administration identified, and drug manipulation required by caregivers to administer treatment to children who found the formulations bitter. [...] 20 PIPELINE REPORT 2020 To gauge how the EBA of delpazolid might compare to the EBA of other oxazolidinones in use or in development for TB, we calculated the percent of the EBA of HRZE achieved by linezolid and sutezolid in 14-day EBA studies conducted previously in South Africa. [...] Moving forward, it’s critically important that the multitude of efforts and approaches to TB drug and regimen development be complementary and collaborative in nature, and work to fill earlier the data gaps that plagued the development and introduction of the first new TB drugs in the last 40 years—bedaquiline, delamanid, and pretomanid.
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