Table 3.
The effect of TB treatment on virologic and immunologic response outcomes, stratified by cART regimen
| Outcome | Efavirenz-based cART (n=79) |
LPV/r-based cART (n=120) |
Efavirenz-based cART (n=79) | LPV/r-based cART (n=120) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||||
| Children receiving TB treatment (n=39) |
Children not receiving TB treatment (n=40) |
Children receiving TB treatment (n=53) |
Children not receiving TB treatment (n=67) |
|||||||||
| Virologic suppression | ||||||||||||
| Time to suppression, median | 5.5 | (3.1 – 7.6)a | 7.7 | (5.7 – 13.4) | 5.3 | (3.3 – 7.6) | 5.8 | (3.1 – 6.9) | 9.5 | (5.8 – 16.7) | 6.8 | (5.2 – 12.4) |
| months (IQR) | ||||||||||||
| Crude HR (95% CI)b | 1.78 | (1.30, 2.43)a | 1.0 | 1.06 | (0.66, 1.69) | 1.0 | 0.83 | (0.55, 1.26) | 1.0 | |||
| Adjusted HR (95% CI)b | 1.26 | (0.63, 2.51)c | 1.0 | 1.66 | (0.88, 3.16)d,e | 1.0 | 1.04 | (0.64, 1.69)d,f | 1.0 | |||
| Virologic rebound g | ||||||||||||
| HIV RNA >1000 copies/mL, no. (%) |
17/71 | (23.9) | 22/93 | (23.7) | 6/35 | (17.1) | 11/36 | (30.6) | 12/42 | (28.6) | 10/51 | (19.6) |
| Time to rebound, median months (IQR) |
18.4 | (15.1 – 23.7) | 17.8 | (12.0 – 21.3) | 19.2 | (17.4 – 21.0) | 18.4 | (14.5 – 23.8) | 18.0 | (13.6 – 21.1) | 15.1 | (11.7 – 23.5) |
| Crude HR (95% CI)b | 1.11 | (0.59, 2.11) | 1.0 | 0.65 | (0.24, 1.76) | 1.0 | 1.66 | (0.70, 4.00) | 1.0 | |||
| Adjusted HR (95% CI)b | 0.62 | (0.15, 2.52)c | 1.0 | 1.03 | (0.26, 4.12)d,e | 1.0 | 2.34 | (0.80, 6.83)d,f | 1.0 | |||
| Immunologic response | ||||||||||||
| CD4%, median (IQR) | ||||||||||||
| cART initiation | 15.8 | (9.6 – 20.7)a | 18.5 | (13.0 – 25.1) | 15.5 | (7.5 – 20.6) | 16.6 | (12.4 – 21.7) | 15.2 | (10.2 – 21.1)h | 22.0 | (16.0 – 27.4) |
| 3 months | 21.6 | (15.3 – 32.2) | 26.1 | (20.2 – 32.4) | 21.6 | (14.0 – 30.3) | 22.0 | (15.8 – 33.4) | 23.5 | (18.8 – 29.1)h | 29.1 | (22.2 – 35.6) |
| 6 months | 26.2 | (20.4 – 32.2) | 28.5 | (22.0 – 34.9) | 26.2 | (19.7 – 31.3) | 26.1 | (20.9 – 34.6) | 23.7 | (14.5 – 30.9)h | 32.7 | (26.7 – 36.9) |
| 12 months | 28.6 | (23.7 – 33.1) | 30.6 | (23.6 – 37.1) | 28.0 | (23.7 – 32.0) | 29.4 | (23.6 – 33.1) | 24.7 | (21.4 – 33.6)h | 31.7 | (28.0 – 39.5) |
| 24 months | 34.0 | (26.1 – 38.4) | 32.7 | (26.2 – 37.3) | 32.8 | (25.0 – 36.5) | 35.6 | (26.4 – 41.3) | 30.8 | (20.4 – 38.1) | 33.6 | (27.8 – 36.8) |
| Increase in CD4%, median (IQR) | ||||||||||||
| 3 months | 6.5 | (4.7 – 10.3) | 7.4 | (2.5 – 12.4) | 6.9 | (3.6 – 10.5) | 6.4 | (4.9 – 9.8) | 7.7 | (3.1 – 11.3) | 7.3 | (2.5 – 13.7) |
| 6 months | 10.9 | (6.9 – 14.8) | 9.7 | (5.1 – 14.0) | 11.6 | (6.7 – 15.3) | 9.3 | (7.2 – 13.5) | 9.7 | (4.7 – 12.2) | 10.0 | (5.3 – 14.2) |
| 12 months | 14.5 | (9.7 – 18.3) | 12.2 | (6.8 – 16.3) | 16.7 | (10.8 – 19.1) | 13.3 | (9.1 – 16.7) | 13.6 | (7.6 – 18.2) | 10.7 | (4.7 – 16.2) |
| 24 months | 15.6 | (12.2 – 20.7) | 13.2 | (5.2 – 19.1) | 15.5 | (12.3 – 19.3) | 15.6 | (8.6 – 20.8) | 12.9 | (7.0 – 19.1) | 13.2 | (3.2 – 18.7) |
| Severe immunodeficiency, no. (%)i | ||||||||||||
| 3 months | 26/43 | (60.5) | 31/72 | (43.1) | 13/21 | (61.9) | 13/22 | (59.1) | 18/33 | (54.5) | 13/39 | (33.3) |
| 6 months | 28/65 | (43.1) | 30/86 | (34.9) | 15/33 | (45.5) | 13/32 | (40.6) | 23/40 | (57.5)h | 7/46 | (15.2) |
| 12 months | 11/49 | (22.4) | 16/67 | (23.9) | 5/21 | (23.8) | 6/28 | (21.4) | 10/27 | (37.0)h | 6/40 | (15.0) |
| 24 months | 1/50 | (2.0) | 6/51 | (11.8) | 1/22 | (4.5) | 0/28 | (0.0) | 6/26 | (23.1)h | 0/25 | (0.0) |
Abbreviations: cART, combination antiretroviral therapy; CD4%, CD4 cell percentage; CI, confidence interval; HR, hazard ratio; IQR, interquartile range; LPV/r, lopinavir/ritonavir; TB, tuberculosis.
The efavirenz-based vs. LPV/r-based cART comparison was statistically significant (P <0.05).
Hazard ratios account for 24 months of follow-up after cART initiation.
Multivariable models included TB treatment at cART initiation, timing of cART initiation relative to the 2010 change in guidelines, age at cART initiation, sex, cART regimen, and baseline HIV RNA, CD4 cell percentage, hemoglobin, and weight-for-age z-score. Adjusted models include individuals who had complete covariate data: n=164 for the suppression model and n=139 for the rebound model.
Multivariable models included TB treatment at cART initiation, timing of cART initiation relative to the 2010 change in guidelines, age at cART initiation, sex, and baseline HIV RNA, CD4 cell percentage, hemoglobin, and weight-for-age z-score.
Adjusted models include individuals who had complete covariate data: n=61 for the suppression model and n=56 for the rebound model.
Adjusted models include individuals who had complete covariate data: n=103 for the suppression model and n=83 for the rebound model.
Virologic rebound was assessed among the 164 individuals who suppressed <50 copies/mL at any point following cART initiation.
The TB treatment vs. no TB treatment comparison was statistically significant (P <0.05).
Severe immunodeficiency was defined according to World Health Organization age-specific classifications 21: CD4% <25% in children <11 months, CD4% <20% in children 12-35 months, CD4% <15% in children 36-59 months, and CD4 cell count <200 cells/μL or CD4% <15% in children >5 years.