Fig 1.
Enrollment and disposition of study participants.
Abbreviations: PMHZ, investigational regimen comprised of rifapentine/moxifloxacin/isoniazid/pyrazinamide; REHZ, control regimen comprised of rifampin/ethambutol/isoniazid/pyrazinamide; LJ, Löwenstein-Jensen culture; MGIT, Mycobacterial Growth Indicator Tube culture; MITT, modified intention-to-treat analysis population; PP, per-protocol analysis population; DST, drug susceptibility testing; Mtb, Mycobacterium tuberculosis.
Table 1.
Baseline characteristics of participants in the intention-to-treat analysis population.
Abbreviations: AST, aspartate aminotransferase; IQR, inter-quartile range.
Table 2.
Proportions of participants with negative cultures at completion of intensive phase treatment.
Abbreviation: CI, confidence interval; MGIT, Mycobacterial Growth Indicator Tube.
Fig 2.
Kaplan-Meier time to stable culture conversion, per-protocol analysis population.
Solid lines, control REHZ regimen comprised of rifampin/ethambutol/isoniazid/pyrazinamide. Dashed lines, investigational PMHZ regimen comprised of rifapentine/moxifloxacin/isoniazid/pyrazinamide. (A) Löwenstein-Jensen (LJ) solid culture medium (p = 0.67 for comparing equality of the survival curves), and (B) Mycobacterial Growth Indicator Tube (MGIT) liquid culture medium (p = 0.03).
Table 3.
Discontinuation of assigned treatment during the intensive phase, and adverse events within the first 70 days after the initial dose of study drugs.
Notes: 1: The study regimen was discontinued in both participants. In one participant the re-introduction of isoniazid replicated the flu-like symptoms experienced while on the study regimen. In the other participant the re-introduction of rifapentine or pyrazinamide replicated the flu-like symptoms experienced while on the study regimen. 2: The study regimen was discontinued. The rash recurred with re-introduction of isoniazid.
Table 4.
Average rifapentine and moxifloxacin pharmacokinetic parameter estimates in the current study compared to other recent studies using rifapentine alone or given together with moxifloxacin.
Abbreviations: AUC0-24 = area under the concentration-time curve over 24 hours; Cmax = maximum concentration; TBTC = Tuberculosis Trials Consortium.