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. Author manuscript; available in PMC: 2019 Feb 25.
Published in final edited form as: Curr Opin HIV AIDS. 2018 Nov;13(6):469–477. doi: 10.1097/COH.0000000000000506

Table 1.

Studies of fluoroquinolone-containing regimens used as basis for 2017 WHO DS-TB treatment guidelines update

REMoxTB RIFAQUIN OFLOTUB
Control arm HRZE × 8 weeks followed by HR × 18 weeks HRZE × 8 weeks followed by HR × 16 weeks HRZE × 8 weeks followed by HR × 16 weeks
Experimental arms Arm 1: HRZE × 8 weeks followed by HRM × 9 weeks
Arm 2: MRZE × 8 weeks followed by RM × 9 weeks
Arm 1: MRZE × 8 weeks followed by MPZE twice weekly × 8 weeks
Arm 2: MRZE x weeks followed by MPZE once weekly × 16 weeks
HRZG × 8 weeks followed by HRG × 8 weeks
HIV eligibility criteria PLWH already on ART and with CD4 < 250 cells/ml3 were ineligible
N=110 PLWH (7%) enrolled; median CD4 not reported
PLWH who required ART were initially ineligible; as the trial progressed, PLWH were eligible
CD4 count < 200 cells/ml3 were initially ineligible, but this was subsequently amended to 150 cells/ml3
N=158 PLWH (27%) enrolled; median CD4 314 cells/ml (IQR 253–441 cells/ml3)
PLWH with WHO stage 3 infection (except those presenting with only the loss of weight criterion) and all PLWH with WHO stage 4 infection were ineligible
N=110 PLWH (7%) enrolled; median CD4 not reported
Primary outcome Unfavorable outcomes: Treatment failure or relapse within 18 months of randomization Unfavorable outcomes: Treatment failure, relapse or death within 12–18 months of randomization Unfavorable outcomes: Treatment failure, recurrence, study withdrawal or death within 24 months after end of treatment
Secondary outcome Grade 3 or 4 adverse events Grade 3 or 4 adverse events Serious adverse events
Results Unfavorable outcomes were more frequent in both experimental arms compared to the control arm.
No significant difference in grade 3 or 4 adverse events between arms.
No significant difference in 8 week culture conversion although both experimental arms had shorter time to culture conversion on solid and liquid media.
The 6-month experimental arm was as effective as the control arm and the 4-month arm was not noninferior to the control arm with respect to unfavorable outcomes
No significant difference in grade 3 or 4 adverse events between arms.
The experimental arm was not noninferior to the control arm with respect to unfavorable outcomes
No significant difference in serious adverse events between arms
HIV subgroup analyses No difference in unfavorable outcomes according to HIV status No difference in unfavorable outcomes according to HIV status Fewer unfavorable outcomes in the experimental group compared to the control group

E, ethambutol; G, gatifloxacin; H, isoniazid; M, moxifloxacin; P, rifapentine; PLWH, people living with HIV; R, rifampin; Z, pyrazinamide.