Table 4.
Clinical Characteristics | Bedaquiline in Regimen n = 58 No. (%) | No Bedaquiline in Regimen n = 50 No. (%) | P Value |
---|---|---|---|
Age: years, mean; SD | 28.7; 6.08 | 27.0; 6.01 | .150 |
Hb, g/dl: mean; SD | 10.4; 1.55 | N = 46; 10.4; 1.65 | .928 |
Body Mass Index (BMI): kg/m2 mean; SD | 23.7; 4.70 | N = 48; 24.2; 5.08 | .543 |
TB characteristics | |||
Culture positive at treatment initiation | 42 (72%) | N = 31; (63%) | .405 |
Previous tuberculosis or MDR/ RR-tuberculosis | N = 35; 19 (54%) | N = 47; 19 (40%) | .265 |
Site of tuberculosis: pulmonary | 57 (100%) | 51 (100%) | NA |
Chest radiograph | .923 | ||
Extensive disease | N = 51; 23 (45%) | N = 46; 22 (48%) | |
Resistance pattern: no (%) | 1.000 | ||
RR-/Rif-mono/MDR-tuberculosis | 45 (78%) | 38 (76%) | |
Pre-XDR-/XDR-tuberculosis | 13 (22%) | 12 (24%) | |
HIV characteristics | |||
HIV-positive, no. (%) | 48 (83%) | 40 (80%) | .806 |
HIV-positive patients on ART before MDR/RR-tuberculosis treatment started | N = 48; 37 (77%) | N = 40; 37 (90%) | .155 |
Baseline CD4 count, median cells/mm3 [IQR] | N = 45; 335 [138–500] | N = 36; 395 [219–540] | .352 |
Pregnancy characteristics | |||
Pregnant before MDR/RR-tuberculosis treatment started | 47 (81%) | 42 (84%) | .802 |
Gestational age at treatment start: weeks, median [IQR] | 23 [13–28] | 20.5 [15–28] | .905 |
Foetal exposure to any second-line drugs: days, median [IQR] | 110 [66–203] | 141 [70–213] | .562 |
Fetal exposure to bedaquiline: days, median [IQR] | 77 [28–140] | NA | NA |
Abbreviations: ART, antiretroviral therapy; Hb, hemoglobin; HIV, human immunodeficiency virus; IQR, interquartile range; MDR/RR-TB, multidrug/rifampicin-resistant TB; NA, not applicable; Pre-XDR, pre-extensively drug-resistant; Rif-mono, rifampicin monoresistant; SD, standard deviation; TB, tuberculosis; XDR, extensively drug-resistant.
aExtensive disease was classified as bilateral disease and/or cavities on chest radiograph.