Background
Methods
Study design
Study setting and study population
Study sample
Data sources and measurement
Data collection
Data analysis
Ethical considerations
Results
Baseline characteristics
Factors | ART Prior | ART After | p-value |
---|---|---|---|
N (%) (N = 545) | N (%) (N = 402) | ||
Age | 36 (31–43)* | 35.5 (31–42)* | 0.557b |
Sex | |||
Male | 264 (48.4) | 193 (48.0) | 0.896c |
Female | 281 (51.6) | 209 (52.0) | |
Categories of MDR-TB | |||
Category I (New) | 107 (19.6) | 107 (26.6) | 0.026*c |
Category II | 438 (80.4) | 295 (73.4) | |
Pre-treatment smear status | |||
Negative | 166 (30.5) | 134 (33.3) | 0.595b |
Positive | 317 (58.2) | 221 (55.0) | |
Not available | 62 (11.4) | 47 (11.7) | |
Site of TB | |||
Pulmonary | 432 (79.3) | 346 (86.1) | 0.007*c |
Extra-Pulmonary + Pulmonary | 113 (20.7) | 56 (13.9) | |
BMI categories (Kg/m2) | |||
Severely Underweight (<16) | 68 (15.4) | 41 (11.4) | 0.174c |
Underweight (≥16–18.49) | 130 (29.4) | 111 (31.0) | |
Normal (≥18.5–24.99) | 195 (44.1) | 176 (49.2) | |
Overweight/ obese (25–29.99) | 49 (11.1) | 30 (8.4) | |
Co-trimoxazole Prophylaxis | |||
No | 21 (4.4) | 32 (9.7) | 0.003*c |
Yes | 459 (95.6) | 297(90.3) | |
CD4 cell count (mls/mm3) | 160.5 (89–270)a | 156 (66–257)a | 0.1906b |
CD4 Categories (mls/mm3) | |||
<150 | 241 (46.5) | 187 (48.1) | 0.296c |
150–349 | 209 (40.4) | 140 (36.0) | |
≥350 | 68 (13.1) | 62 (15.9) | |
Haemoglobin (g/dl) | 11.3 (2.4)* | 10.8(2.2)* | 0.0012*d |
Haemoglobin (g/dl) | |||
Severe Anaemia (<7.0) | 24 (4.5) | 13 (3.3) | 0.009*c |
Moderate Anaemia (7.0–9.9) | 120 (22.3) | 123 (31.0) | |
Mild Anaemia (10–10.99) | 85 (15.8) | 70 (17.7) | |
Normal (≥11) | 308 (57.4) | 190 (48.0) | |
Duration on ART | 218 (70–570)b | 57.5 (32–111.5)b | |
Outcome duration or Person time (days) | 251 (90–725)b | 720 (330–945)b | 0.0286*b |
Treatment-initiation-delay | 11 (5–22)b | 10 (6–21)b | 0.921b |
Infiltrative changes on x-ray | |||
No | 24 (4.5) | 11 (2.8) | 0.179c |
Yes | 513 (95.5) | 385 (97.2) | |
Cavitary change on x-ray | |||
No | 315 (58.7) | 237 (59.8) | 0.715b |
Yes | 222 (41.3) | 159 (40.2) | |
Fibrotic changes on x-ray | |||
No | 77 (14.3) | 58 (14.7) | 0.883c |
Yes | 460 (85.7) | 337 (85.3) | |
Other Opportunistic Infections | |||
No | 399 (73.4) | 228 (57.1) | <0.001*c |
Yes | 145 (26.6) | 171 (42.9) | |
Comorbidity | |||
No | 461 (85.8) | 345 (88.0) | 0.337c |
Yes | 76 (14.2) | 47 (12.0) | |
Adverse events | |||
No | 295 (54.8) | 239 (61.1) | 0.055c |
Yes | 243 (45.2) | 152 (38.9) | |
Regimen type at baseline | |||
Standardised | 370 (68.5) | 295 (75.1) | 0.029*c |
Modified individualised | 170 (31.5) | 98 (24.9) |
Outcomes of MDR-TB by ART treatment groups
Factors | ART Prior | ART After | p-value |
---|---|---|---|
N (%) | N (%) | ||
Final Outcomes | |||
Still on treatment | 5 (0.9) | 8 (2.0) | 0.096 |
Transferred out | 26 (4.8) | 18 (4.5) | |
Treatment Defaulted | 105 (19.3) | 101 (25.1) | |
Treatment Completed | 92 (16.9) | 71 (17.7) | |
Cure | 182 (33.4) | 130 (32.3) | |
Failure | 16 (2.9) | 12 (3.0) | |
Died | 119 (21.8) | 62 (15.4) | |
Died | |||
No | 426 (78.2) | 340 (84.6) | 0.013* |
Yes | 119 (21.8) | 62 (15.4) | |
Failure | |||
No | 529 (97.1) | 390 (97.0) | 0.965 |
Yes | 16 (2.9) | 12 (3.0) | |
Total | 545 | 402 |
Pattern of co-morbidities among HIV co-infected MDR-TB patients
Comorbidities | N (%) |
---|---|
Diabetes | 15 (9.4) |
Hypertension | 18 (11.2) |
Congestive heart failure | 11 (6.9) |
Kidney diseases | 12 (7.5) |
Cerebrovascular diseases | 13 (8.1) |
Epilepsy | 13 (8.1) |
Severe sepsis | 29 (18.1) |
DVT | 14 (8.8) |
COADs | 10 (6.2) |
Chronic liver Disease | 3 (1.9) |
Cancers | 2 (1.3) |
Others | 20 (12.5) |
Predictors of mortality
aUnivariable Analysis | bMultivariable Analysis | |||
---|---|---|---|---|
Factor | OR (95 % CI) | p-value | OR (95 % CI) | p-value |
ART regimen | ||||
After | 1.00 | 1.00 | ||
Prior | 1.49 (1.06–2.09) | 0.021* | 1.65 (1.00–2.73) | 0.050* |
Age | 1.01 (0.99–1.03) | 0.481 | ||
Sex | ||||
Female | 1.00 | 1.00 | ||
Male | 1.08 (0.78–1.49) | 0.661 | 1.58 (0.94–2.66) | 0.085 |
Site of TB | ||||
Pulmonary | 1.00 | |||
Extra-Pulmonary + Pulmonary | 1.40 (0.94–2.09) | 0.098 | ||
BMI categories (kg/m2) | ||||
Severely Underweight (<16) | 4.61 (2.77–7.68) | <0.001* | 3.71 (1.89–7.29) | <0.001* |
Underweight (≥16–18.49) | 2.33 (1.49–3.65) | <0.001* | 2.35 (1.30–4.26) | 0.005* |
Normal (≥18.5–24.99) | 1.00 | 1.00 | ||
Overweight/ obese (25–29.99) | 1.20 (0.57–2.51) | 0.630 | 2.30 (0.92–5.71) | 0.074 |
Co-trimoxazole Prophylaxis | ||||
No | 1.00 | 1.00 | ||
Yes | 1.33 (0.62–2.89) | 0.464 | 1.30 (0.47–3.54) | 0.613 |
CD4 Categories (mls/mm3) | ||||
<150 | 2.88 (1.62–5.14) | <0.001* | 1.56 (0.73–3.38) | 0.243 |
150–349 | 0.91 (0.48–1.72) | 0.770 | 0.63 (0.28–1.42) | 0.266 |
≥350 | 1.00 | 1.00 | ||
Haemoglobin (g/dl) | 0.76 (0.70–0.82) | <0.001* | 0.90 (0.79–1.02) | 0.090 |
Infiltrative changes on x-ray | ||||
No | 1.00 | |||
Yes | 0.74 (0.33–1.67) | 0.470 | ||
Cavitary changes on x-ray | ||||
No | 1.00 | 1.00 | ||
Yes | 1.25 (0.89–1.74) | 0.191 | 1.76 (1.08–2.85) | 0.023* |
Fibrotic changes on x-ray | ||||
No | 1.00 | |||
Yes | 1.17 (0.71–1.91) | 0.527 | ||
Other Opportunistic Infections | ||||
No | 1.00 | 1.00 | ||
Yes | 2.54 (1.82–3.55) | <0.001* | 1.80 (1.10–2.94) | 0.019* |
Comorbidity | ||||
No | 1.00 | 1.00 | ||
Yes | 3.97 (2.64–5.97) | <0.001* | 2.26 (1.20–4.27) | 0.012* |
Adverse events | ||||
No | 1.00 | 1.00 | ||
Yes | 1.45 (1.04–2.02) | 0.028* | 1.09 (0.68–1.77) | 0.720 |
Regimen type at baseline | ||||
Standardised | 1.00 | |||
Modified individualised | 1.55 (1.10–2.19) | 0.013* |
Predictors of treatment failure
aUnivariable Analysis | bMultivariable Analysis | |||
---|---|---|---|---|
Factor | IRR (95 % CI) | p-value | IRR (95 % CI) | p-value |
ART regimen | ||||
After | 1.00 | 1.00 | ||
Prior | 1.01 (0.47–2.15) | 0.988 | 0.80 (0.35–1.84) | 0.606 |
Age groups | ||||
18–45 | 1.00 | |||
46–76 | 0.79 (0.27–2.28) | 0.662 | ||
BMI | 0.97 (0.87–1.07) | 0.547 | 1.01 (0.94–1.09) | 0.766 |
Haemoglobin (g/dl) | ||||
Severe Anaemia (<7.0) | 2.69 (0.78–9.30) | 0.117 | 4.72 (1.47–15.08) | 0.009* |
Moderate Anaemia (7.0–9.99) | 1.09 (0.46–2.57) | 0.839 | 0.97 (0.40–2.34) | 0.944 |
Mild Anaemia (10–10.99) | 0.43 (0.10–1.87) | 0.260 | 0.25 (0.03–1.82) | 0.172 |
Normal (≥11) | 1.00 | 1.00 | ||
Infiltrative changes | ||||
No | 1.00 | |||
Yes | 1.01 (0.14–7.47) | 0.990 | ||
Cavitary changes | ||||
No | 1.00 | 1.00 | ||
Yes | 1.81 (0.85–3.87) | 0.125 | 2.14 (0.96–4.78) | 0.064 |
Fibrotic changes | ||||
No | 1.00 | |||
Yes | 1.36 (0.41–4.50) | 0.620 | ||
Comorbidity | ||||
No | 1.00 | 1.00 | ||
Yes | 1.79 (0.72–4.41) | 0.207 | 2.39 (1.05–5.43) | 0.039* |
Adverse events | ||||
No | 1.00 | 1.00 | ||
Yes | 0.54 (0.24–1.23) | 0.142 | 0.48 (0.21–1.09) | 0.080 |
Regimen type at baseline | ||||
Standardised | 1.00 | 1.00 | ||
Modified individualised | 2.48 (1.18–5.20) | 0.016* | 2.15 (0.98–4.71) | 0.056 |