Table 3.
SAPiT trial: Clinical outcomes from tuberculosis and HIV treatment
| Treatment arm |
Integrated vs sequential treatment arm p-value | ||||
|---|---|---|---|---|---|
| Integrated n=343 | Sequential n=171 | ||||
| Tuberculosis treatment outcomes1 | Retreatment tuberculosis | First episode tuberculosis | Retreatment tuberculosis | First epsode tuberculosis | |
| Tuberculosis cured2 | 67 (57.8%) | 131 (57.7%) | 31 (53.5%) | 67 (59.3%) | 1.00 |
| Tuberculosis treatment successfully completed3 | 16 (13.8%) | 42 (18.5%) | 5 (8.6%) | 16 (14.2%) | 0.20 |
| Treatment success (Tuberculosis cure + successful tuberculosis treatment completion) | 83 (71.6%) | 173 (76.2%) | 36 (62.1%) | 83 (73.5%) | 0.07 |
| Died prior to tuberculosis treatment completion | 7 (6.0%) | 12 (5.3%) | 6 (10.3%) | 9 (8.0%) | 0.19 |
| Treatment interruption | 2 (1.7%) | 3 (1.3%) | 3 (5.2%) | 7 (6.2%) | 0.0096 |
| Treatment failure | 0 | 0 | 0 | 1 (0.9%) | 0.33 |
| Loss to follow-up prior to Tuberculosis treatment outcome | 13 (11.2%) | 13 (5.7%) | 6 (10.3%) | 6 (5.3%) | 1.00 |
| Transferred to other clinics - Tuberculosis treatment outcome not known | 1 (0.9% | 5 (2.2%) | 2 (3.5%) | 1 (0.9%) | 1.00 |
| Other outcome | 1 (0.9%) | 1 (0.4%) | 0 | 0 | |
| Tuberculosis treatment outcome pending (still on treatment at time of analysis) | 9 (7.8%) | 20 (8.8%) | 5 (8.6%) | 6 (5.3%) | 0.49 |
| HIV treatment outcomes | |||||
| At 12 months post-randomization: | |||||
| Proportion with viral load <400 copies/ml (95% CI) | 90% (199/221) (85.1 to 93.5) | 77.8% (70/90) (67.6 to 85.6) | 0.006 | ||
| Mean CD4 count increase from baseline cells/mm3 (95% CI) | 148.7 (N=207) (130.5 to 166.9) | 100.7 (N=84) (77.5 to 124.0) | 0.004 | ||
| At 6 months post-antiretroviral therapy initiation: | |||||
| Proportion with viral load <400 copies/ml (95% CI) | 91.1% (174/191) (85.9 to 94.6) | 86.7% (39/45) (72.5 to 94.5) | 0.40 | ||
| Mean CD4 count increase from baseline cells/mm3 (95% CI) | 124.2 (N=187)(105.4 to 143.1) | 116.3 (N=41) (88.0 to 144.6) | 0.71 | ||
1
This tuberculosis treatment outcome analysis only includes patients who were enrolled at least 7 months prior to the date of analysis
2
Tuberculosis cure = acid-fast bacilli smear negative close to time of tuberculosis treatment completion
3
Tuberculosis treatment successfully completed = consumed more than 85% of their prescribed tuberculosis medication