Table 3.
Clinical Outcomes of Tuberculosis and Antiretroviral Therapy in the SAPIT trial.
| Tuberculosis treatment outcomes | ||||
|---|---|---|---|---|
| CD4 < 50 (number (%)) |
CD4 ≥ 50 (number (%)) |
|||
| Early integrated group (N = 37) |
Late integrated group (N = 35) |
Early integrated group (n = 177) |
Late integrated group (n = 180) |
|
| Tuberculosis cured† | 23 (62%) | 24 (69%) | 108 (61%) | 114 (63%) |
| Tuberculosis treatment successfully completed‡ | 8 (22%) | 4 (11%) | 32 (18%) | 34 (19%) |
| Treatment successδ | 31 (84%) | 28 (80%) | 140 (79%) | 148 (82%) |
| Died prior to tuberculosis treatment completion | 3 (8%) | 4 (11%) | 11 (6%) | 7 (4%) |
| Treatment interruption | 0 (0%) | 1 (3%) | 5 (3%) | 3 (2%) |
| Failure on first line regimen | 1 (3%) | 0 (0%) | 5 (3%) | 2 (1%) |
| Loss to follow-up prior to tuberculosis treatment outcome | 1 (3%) | 1 (3%) | 12 (7%) | 15 (8%) |
| Transferred to other clinics Tuberculosis treatment outcome not known | 1 (3%) | 1 (3%) | 4 (2%) | 5 (3%) |
| HIV treatment outcomes | ||||
|
Early integrated group Number/total number Percent (95% CI) |
Late integrated group Number/total number Percent (95% CI) |
p-value | ||
| Viral load <400 copies/ml at: | ||||
| 6 month after-ART initiation: | ||||
| Overall | 161/179 | 166/179 | 0.45 | |
| 89.9% (84.3 – 93.8) | 92.7% (87.6; 95.9) | |||
| CD4 count < 50 | 30/34 | 32/35 | 0.71 | |
| 88.2% (71.6 – 96.2) | 91.4% (75.8 – 97.8) | |||
| CD4 count ≥ 50 | 131/145 | 134/144 | 0.52 | |
| 90.3% (84.0 – 94.4) | 93.1% (87.3 – 96.4) | |||
| 12 months after-randomization: | ||||
| Overall | 147/159 | 130/147 | 0.25 | |
| 92.5% (86.9; 95.9) | 88.4% (81.9; 92.9) | |||
| CD4 count < 50 | 30/32 | 23/27 | 0.40 | |
| 93.8% (77.8 – 98.9) | 85.2% (65.4 – 95.1) | |||
| CD4 count ≥ 50 | 117/127 | 107/120 | 0.51 | |
| 92.1% (85.6 – 96.0) | 89.2% (81.9 – 93.9) | |||
| 18 months after-randomization: | ||||
| Overall | 144/153 | 135/143 | 1.00 | |
| 94.1% (88.8; 97.1) | 94.4% (88.9; 97.4) | |||
| CD4 count < 50 | 28/30 | 25/26 | 1.00 | |
| 93.3% (76.5 – 98.8) | 96.2% (78.4 – 99.8) | |||
| CD4 count ≥ 50 | 116/123 | 110/117 | .1.00 | |
| 94.3% (88.2 – 97.5) | 94.0% (87.6 – 97.4) | |||
| Mean CD4+ count increase from baseline – cells/mm3 at | ||||
|
mean increase (95% CI, N) |
mean increase (95% CI, N) |
|||
| At 6 months post-antiretroviral therapy initiation: | ||||
| Overall | 132.4 | 131.6 | 0.95 | |
| (113; 152, n=178) | (111; 152, n=179) | |||
| CD4 count < 50 | 124.0 (94; 154, n = 34) |
103.6 (83; 124, n = 35) |
0.25 | |
| CD4 count ≥ 50 | 134.5 (111; 157, N = 144) |
138.4 (113; 163, n = 144) |
0.82 | |
| 12 months after-randomization: | ||||
| Overall | 183.1 (162; 204, n=159) |
124.7 (105; 145, n=147) |
0.009 | |
| CD4 count < 50 | 170.1 (127; 213, n = 32) |
111.0 (81; 141, n = 27) |
0.03 | |
| CD4 count ≥ 50 | 186.4 (163; 210, n = 127) |
127.8 (104; 152, n = 120) |
0.001 | |
| 18 months after-randomization: | ||||
| Overall | 217.4 (192; 243, n=152) |
172.2 (150; 194, n=142) |
0.009 | |
| CD4 count < 50 | 206.8 (166; 248, n = 30) |
172.6 (134; 212, n = 26) |
0.22 | |
| CD4 count ≥ 50 | 220.0 (189; 251, n = 122) |
172.1 (146; 198, n = 116) |
0.02 | |
Tuberculosis cure was in accordance with the 2004 South African National tuberculosis Control Program Guideline, which states that "a patient who is smear-negative at, or one month prior to, the completion of treatment and on at least one previous occasion." Most study patients were unable to produce sputum after the first few months of tuberculosis treatment, making demonstration of a cure difficult.
Successful completion of therapy was defined as the use of more than 85% of the prescribed medication.
Treatment success is defined as Tuberculosis cure and successful tuberculosis treatment completion
Therapy failure was defined as the presence of a positive smear or culture for Mycobacterium tuberculosis obtained at least 5 months after the initiation of tuberculosis therapy.