Background
Methods
Study setting and population
Study measurements
Statistical analysis
Results
Participant enrolment
Baseline characteristics of the study population
Characteristic | Total population | Men n = 401 | Women n = 265 | p-value |
---|---|---|---|---|
DRTB treatment site, n = 666 | 0.006 | |||
National referral hospital | 210 (31.5) | 108 (26.9) | 102 (38.5) | |
Regional referral hospital | 404 (60.7) | 258 (64.3) | 146 (55.1) | |
District hospital | 52 (7.8) | 35 (8.7) | 17 (6.4) | |
Age, median (IQR), years | 36.0 (13.0) | 37.0 (13.0) | 34.0 (13.0) | < 0.001 |
Age (years), n = 643 | 0.007 | |||
< 15 | 11 (1.71) | 6 (1.53) | 5 (1.98) | |
15–34 | 264 (41.06) | 140 (35.81) | 124 (49.21) | |
35–60 | 355 (55.21) | 236 (60.36) | 119 (47.22) | |
> 60 | 13 (2.02) | 9 (2.30) | 4 (1.59) | |
Residence, n = 640 | 0.059 | |||
Rural | 392 (61.25) | 246 (64.23) | 146 (56.81) | |
Urban | 248 (38.75) | 137 (35.77) | 111 (43.19) | |
Employment status, n = 637 | < 0.001 | |||
Unemployed | 170 (26.69) | 72 (18.85) | 98 (38.43) | |
Self employed | 305 (47.88) | 185 (48.43) | 120 (47.06) | |
Formal employment | 162 (25.43) | 125 (32.72) | 37 (14.51) | |
Marital status, n = 632 | < 0.001 | |||
Married | 303 (47.94) | 208 (55.17) | 95 (37.25) | |
Not married | 329 (52.06) | 169 (44.83) | 160 (62.75) | |
History of TB treatment, n = 666 | 0.060 | |||
Yes | 359 (53.90) | 228 (56.86) | 131 (49.43) | |
No | 307 (46.10) | 173 (43.14) | 134 (50.57) | |
Year of treatment initiation, n = 660 | 0.591 | |||
≤ 2013 | 54 (8.18) | 32 (8.08) | 22 (8.33) | |
2014 | 71 (10.76) | 38 (9.60) | 33 (12.50) | |
2015 | 103 (15.61) | 68 (17.17) | 35 (13.26) | |
2016 | 143 (21.67) | 83 (20.96) | 60 (22.73) | |
2017 | 136 (20.61) | 80 (20.20) | 56 (21.21) | |
2018 | 109 (16.52) | 71 (17.93) | 38 (14.39) | |
2019 | 44 (6.67) | 24 (6.06) | 20 (7.58) | |
Alcohol use, n = 464 | < 0.001 | |||
Yes | 183 (39.44) | 143 (51.62) | 40 (21.39) | |
No | 281 (60.56) | 134 (48.38) | 147 (78.61) | |
Cigarette smoking, n = 464 | < 0.001 | |||
Yes | 90 (19.40) | 82 (29.60) | 8 (4.28) | |
No | 374 (80.60) | 195 (70.40) | 179 (95.72) |
Characteristic | Total population | Men, n = 401 | Women, n = 265 | p-value |
---|---|---|---|---|
Type of DRTB at baseline, n = 666 | < 0.001 | |||
Rifampicin resistance | 441 (66.2) | 253 (63.1) | 188 (70.9) | |
MDRTB | 203 (30.5) | 134 (33.4) | 69 (26.0) | |
Poly resistant tuberculosis (TB) | 13 (2.0) | 9 (2.2) | 4 (1.5) | |
Pre-XDRTB | 7 (1.1) | 5 (1.3) | 2 (0.8) | |
XDR-TB | 2 (0.3) | 0 (0.0) | 2 (0.8) | |
Resistance at baseline (n = 612) | ||||
Isoniazid | 208 (34.0) | 138 (37.6) | 70 (28.6) | 0.021 |
Streptomycin | 119 (19.4) | 81 (22.1) | 38 (15.5) | 0.045 |
Ethambutol | 103 (16.8) | 68 (18.5) | 35 (14.3) | 0.169 |
Pyrazinamide | 8 (1.3) | 3 (0.9) | 5 (2.0) | 0.124 |
Aminoglycoside | 6 (1.0) | 4 (1.1) | 2 (0.8) | 0.289 |
Fluroquinolone | 3 (0.5) | 1 (0.3) | 2 (0.8) | 0.345 |
No. of drugs patients was resistant to median (IQR) | 1.0 (1.0) | 1.0 (1.0) | 1.0 (1.0) | 0.189 |
Drugs in treatment regimen | ||||
Kanamycin, n = 665 | 594 (89.32) | 358 (89.50) | 236 (89.06) | 0.856 |
Levofloxacin, n = 665 | 556 (83.6) | 337 (84.3) | 219 (82.6) | 0.583 |
Ethambutol, n = 612 | 103 (16.83) | 68 (18.53) | 35 (14.3) | 0.169 |
Clofazimine, n = 664 | 113 (17.0) | 69 (17.3) | 44 (16.6) | 0.817 |
High dose Isoniazid, n = 664 | 109 (16.4) | 65 (16.3) | 44 (16.6) | 0.915 |
Capreomycin, n = 664 | 77 (11.6) | 37 (9.3) | 40 (15.1) | 0.022 |
Ethionamide/Prothionamide, n = 664 | 659 (99.3) | 396 (99.3) | 263 (99.3) | 0.347 |
Cycloserine, n = 664 | 544 (81.9) | 327 (82.0) | 217 (81.9) | 0.982 |
Bedaquilline | 18 (2.71) | 10 (2.50) | 8 (3.02) | 0.687 |
Linezolid | 9 (1.36) | 6 (1.50) | 3 (1.13) | 1.000 |
Amikacin | 5 (0.75) | 3 (0.75) | 2 (0.75) | 1.000 |
Pyrazinamid | 8 (1.31) | 3 (0.82) | 5 (2.04) | 0.124 |
High-dose isoniazid | 208 (33.99) | 138 (37.60) | 70 (28.57) | 0.021 |
Moxifloxacin | 107 (16.09) | 62 (15.50) | 45 (16.98) | 0.611 |
p-Amino salicylic acid | 8 (1.20) | 4 (1.00) | 4 (1.51) | 0.233 |
Total drugs in regimen, n = 666 | 0.211 | |||
≤ 5 | 394 (59.2) | 245 (61.1) | 149 (56.2) | |
> 5 | 272 (40.8) | 156 (38.9) | 116 (43.8) | |
Time to treatment initiation, median (IQR), days, n = 649 | 9.0 (19.0) | 9.0 (18.0) | 8.0 (19.0) | 0.894 |
Time to culture conversion (months), median (IQR) | 3.0 (4.0) | 2.0 (4.5) | 4.0 (4.0) | 0.475 |
Total treatment duration (months), median (IQR) | 20.0 (13.4) | 20.0 (14.3) | 20.0 (12.0) | 0.995 |
Baseline body mass index, median (IQR), kg/m2 | 18.1 (4.5) | 18.0 (4.1) | 18.4 (5.3) | 0.999 |
Hearing loss, n = 459 | 196 (42.7) | 112 (41.3) | 84 (44.7) | 0.475 |
Cancer, n = 666 | 11 (1.7) | 8 (2.0) | 3 (1.1) | 0.540 |
Diabetes, n = 69 | 20 (29.0) | 12 (30.0) | 8(27.4) | 0.827 |
Psychiatric symptoms or mental illness n = 666 | 34 (5.1) | 16 (4.0) | 18 (6.8) | 0.108 |
Previous exposure to second line drugs n = 666 | 18 (2.7) | 12 (3.0) | 6 (2.3) | 0.571 |
Number of poor prognostic indicators, median (IQR) | 3.0 (2.0) | 3.0 (2.0) | 3.0 (2.0) | 0.124 |
ART use, n = 655 | 622 (95.0) | 374 (95.2) | 248 (94.7) | 0.771 |
History of ART default, n = 491 | 86 (17.5) | 53 (17.7) | 33 (17.2) | 0.878 |
Viral load, n = 68 | 0.822 | |||
Suppressed | 47 (69.1) | 26 (70.3) | 21 (67.7) | |
Non-suppressed | 21 (30.9) | 11 (29.7) | 10 (32.3) | |
Baseline CD4 Counts, median (IQR), n = 190 | 179.5 (311.0) | 197.0 (317.0) | 155.0 (286.0) | 0.773 |
Cotrimoxazole prophylaxis, n = 603 | 587 (97.4) | 351 (97.2) | 236 (97.5) | 0.828 |
Drug in the ART regimen | ||||
Emitricitabine, n = 595 | 11 (1.9) | 6 (1.7) | 5 (2.1) | 0.760 |
Dolutegravir, n = 595 | 14 (2.4) | 10 (2.8) | 4 (1.7) | 0.398 |
Lopinavir, n = 595 | 9 (1.5) | 5 (1.4) | 4 (1.7) | 0.760 |
Nevirapine, n = 595 | 73 (12.3) | 37 (10.3) | 36 (15.3) | 0.067 |
Tenofovir, n = 595 | 460 (77.3) | 290 (80.6) | 170 (72.3) | 0.019 |
Zidovudine, n = 594 | 121 (20.4) | 61 (16.9) | 60 (25.6) | 0.010 |
Years on ART, median (IQR) | 3.0 (4.5) | 3.0 (4.0) | 3.0 (5.0) | 0.314 |
AST (U/l), median (IQR), n = 541 | 39.3 (30.0) | 41.3 (29.0) | 36.3 (26.4) | 0.046 |
ALT (U/l), median (IQR), n = 541 | 16.0 (20.3) | 16.8 (21.1) | 15.8 (19.2) | 0.356 |
GGT (U/l), median (IQR), n = 229 | 63.0 (87.8) | 81.5 (89.0) | 55.5 (66.6) | 0.016 |
ALP (U/l), median (IQR), n = 308 | 132.8 (109.2) | 136.0 (122.6) | 127.0 (97.5) | 0.088 |
Total bilirubin (mg/dl), median (IQR), n = 463 | 0.318 (0.339) | 0.35 (0.37) | 0.28 (0.31) | 0.004 |
Creatinine (μmol/l), median (IQR), n = 543 | 70.2 (32.4) | 75.9 (31.9) | 64.3 (25.7) | < 0.001 |
Haemoglobin (g/dl), median (IQR), n = 580 | 12.1 (3.3) | 12.6 (3.2) | 11.7 (3.5) | < 0.001 |
Anemia | < 0.001 | |||
Normal haemoglobin level | 197 (33.97) | 144 (41.62) | 53 (22.65) | |
Mild | 186 (32.07) | 99 (28.61) | 87 (37.18) | |
Moderate | 149 (25.69) | 82 (23.70) | 67 (28.63) | |
Severe | 48 (8.28) | 21 (6.07) | 27 (11.54) |
Socio-demographic gender differences among patients with DRTB/HIV co-infection
Gender differences in clinical characteristics of patients with DRTB/HIV co-infection
Gender differences in the treatment outcomes of DRTB/HIV co-infection
Treatment outcome | Total population N = 666 | Men n = 401 | Women n = 265 | p-value |
---|---|---|---|---|
Mortality, n = 666 | 0.030 | |||
Yes | 152 (22.82) | 103 (25.69) | 49 (18.49) | |
No | 514 (77.18) | 298 (74.31) | 216 (81.51) | |
Treatment completion and cure, n = 666 | 0.064 | |||
Success | 437 (65.62) | 252 (62.84) | 185 (69.81) | |
No success | 229 (34.38) | 149 (37.16) | 80 (30.19) | |
Treatment loss to follow up, n = 666 | 0.809 | |||
Yes | 73 (10.96) | 43 (10.72) | 30 (11.32) | |
No | 593 (89.04) | 358 (89.28) | 235 (88.68) | |
Treatment failure | 1.000 | |||
Yes | 4 (0.60) | 3 (0.75) | 1 (0.38) | |
No | 662 (99.40) | 398 (99.25) | 264 (99.62) |
Predictors of mortality among patients with DRTB/HIV co-infection
Characteristic | aHR | 95% CI | p-value | |
---|---|---|---|---|
Gender | ||||
Women | 1 | |||
Men | 1.365 | 0.422 | 4.421 | 0.6036 |
Cigarette smoking | ||||
None | 1 | |||
Yes | 4.873 | 1.278 | 18.58 | 0.0204 |
Alanine aminotransferase | 1.047 | 1.023 | 1.072 | 0.0001 |
Number of drugs in DRTB regimen | ||||
< 5 drugs | 1 | |||
≥ 5 drugs | 0.272 | 0.071 | 1.038 | 0.0568 |
History of ART default | ||||
No | 1 | |||
Yes | 3.863 | 1.313 | 11.365 | 0.0141 |
Baseline CD4 count (per 10 cells/mm3) | 0.935 | 0.887 | 0.986 | 0.0132 |