Table 5.
Risk Factor | Patients, No. | Deaths No. (%) | Crude HR on Univariate Analysis (95% CI) | P Value | Adjusted HR on Multivariate Analysisa (95% CI) | P Value |
---|---|---|---|---|---|---|
Treatment group | .01 | .023 | ||||
Early ART | 281 | 13 (4.6) | 1 | 1 | ||
Late ART | 259 | 27 (10.4) | 2.31 (1.19–4.48) | 2.28 (1.15–4.50) | ||
Sex | .28 | |||||
Male | 355 | 23 (6.5) | 1 | |||
Female | 185 | 17 (9.2) | 1.41 (.76–2.65) | |||
Age at inclusion, y | .77 | |||||
≤29 | 129 | 11 (8.5) | 1 | |||
30–39 | 240 | 16 (6.7) | 0.76 (.35–1.63) | |||
≥40 | 171 | 13 (7.6) | 0.88 (.39–1.96) | |||
BMI at W50b, kg/m2 | .12 | |||||
≤17.0 | 30 | 5 (16.7) | 3.46 (1.27–9.40) | |||
17.0–18.4 | 76 | 4 (5.3) | 1.00 (.33–3.07) | |||
18.5–20.0 | 122 | 9 (7.4) | 1.33 (.58–3.05) | |||
>20.0 | 295 | 15 (5.1) | 1 | |||
CD4 at W50b, cells/µL | .31 | |||||
≤100 | 49 | 4 (8.2) | 2.16 (.43–10.94) | |||
101–200 | 220 | 10 (4.5) | 1.19 (.27–5.29) | |||
201–350 | 179 | 17 (9.5) | 2.29 (.58–9.06) | |||
>350 | 71 | 2 (2.8) | 1 | |||
Plasma HIV RNA at W50b | .67 | |||||
Undetectable | 498 | 31 (6.2) | 1 | |||
≥2.4 log10 copies/mL | 20 | 2 (10.0) | 1.37 (.33–5.67) | |||
Hemoglobin at W50b, g/dL | .33 | |||||
>10.0 | 495 | 30 (6.1) | 1.80 (.55–5.85) | |||
≤10.0 | 23 | 3 (13.0) | 1 | |||
Tuberculosis outcome at W50 | .005 | |||||
Cured or treatment completed | 512 | 33 (6.4) | 1 | |||
Ongoing treatment | 19 | 3 (15.8) | 3.03 (.93–9.92) | |||
Not cured and no treatment | 9 | 4 (44.4) | 7.04 (2.49–19.91) | |||
Chest radiograph at W50b | .72 | |||||
Normal | 410 | 23 (5.6) | 1 | |||
Abnormal | 102 | 8 (7.8) | 1.18 (.46–3.02) | |||
History of TB-IRIS | .13 | |||||
No | 405 | 34 (8.4) | 1 | |||
Yes | 135 | 6 (4.4) | 0.53 (.22–1.27) | |||
ART at W50 | <.001 | |||||
Stavudine-lamivudine-efavirenz | 441 | 28 (6.3) | 1 | |||
Other combination | 79 | 5 (6.3) | 1.00 (.39–2.59) | |||
None | 20 | 7 (35.0) | 7.22 (3.14–16.58) | |||
Temporarily lost to follow-up at W50 | <.001 | .01 | ||||
No | 527 | 33 (6.3) | 1 | 1 | ||
Yes | 13 | 7 (53.8) | 11.53 (5.09–26.13) | 4.34 (1.53–12.33) | ||
Fluconazole prophylaxis at W50 | .24 | |||||
No | 295 | 27 (9.1) | 1.78 (.88–3.59) | |||
Yes (never interrupted) | 213 | 11 (5.2) | 1 | |||
Yes (previously interrupted) | 32 | 2 (6.2) | 1.25 (.28–5.62) | |||
Cotrimoxazole at W50 | .001 | .02 | ||||
No | 104 | 16 (15.4) | 3.03 (1.61–5.70) | 2.62 (1.19–5.77) | ||
Yes | 436 | 24 (5.5) | 1 | 1 |
Abbreviations: ART, antiretroviral therapy; BMI, body mass index; CI, confidence interval; HIV, human immunodeficiency virus; HR, hazard ratio; TB-IRIS, paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome; W50, week 50.
a Multivariate model is stratified on viral load at enrollment for which proportional hazard ratio assumption was not verified.
b Factors with imputed values.