Table 1.
Children included in analysis: characteristics at ART initiation and subsequent diagnosis of BCG-related regional adenitis due to IRIS
| Deferred ART Group1 (CD4≥25% at enrolment) |
Early ART Part A Group (CD4≥25% at enrolment) |
Early ART Part B Group (CD4 <25% at enrolment) |
Overall | |
|---|---|---|---|---|
| Number of children | 792 | 250 | 40 | 369 |
| Female (%) | 45 (57%) | 145 (58%) | 19 (48%) | 209 (57%) |
| Characteristics at ART initiation | ||||
| Age (weeks) | ||||
| Median (IQR) | 23.2 (17.4 to 33.6) | 7.4 (6.5 to 8.8) | 9.3 (8.1 to 10.5) | 8.3 (7.0 to 11.0) |
| Range | 8.0 to 71.83 | 5.7 to12.0 | 6.1 to 12.0 | 5.7 to 71.7 |
| <12 weeks (%) | 9 (11%) | 250 (100%) | 40 (100%) | 299 (81%) |
| Median (IQR) CD4% | 21% (17 to 28%) | 35% (29 to 41%) | 20% (17 to 24%) | 31% (23 to 38%) |
| CD4% < 25% (%) | 53 (68%) | 19 (8%)4 | 29 (78%)4 | 101 (29%) |
| Median (IQR) CD4 count (cells/mm3) | 1039 (662 to 1528) | 2002 (1493 to 2745) | 1433 (653 to 2204) | 1779 (1136–2496) |
| Median (IQR) CD4 count z-score | −1.2 (−1.7 to −0.7) | −0.2 (−0.7 to 0.5) | −0.7 (−1.7 to 0.0) | −1.0 (−1.8 to −0.3) |
| Median (IQR) weight-for-age z-score | −1.1 (−2.1 to 0.0) | −0.8 (−1.5 to 0.0) | −1.1 (−2.2 to 0.0) | −0.9 (−1.7 to 0.0) |
| HIV-1 RNA > 750,000 copies/ml (%) | 53 (80%) | 138 (55%) | 31 (78%) | 222 (62%) |
| BCG regional adenitis diagnosed within 6 months after ART initiation | ||||
| Number of cases (%) | 13 (16%) | 12 (5%) | 7 (18%) | 32 (8%) |
| Rate per 100 person-years (95% CI) | 54.3 (31.5 to 93.4) | 10.9 (6.2 to 19.1) | 41.7 (19.9 to 87.6) | 21.2 |
| Estimated probability of developing BCG-IRIS5(95% CI) | 17.6% (10.6 to 28.3%) | 5.0% (2.9 to 8.8%) | 17.5% (8.8 to 33.2%) | 9.1% |
1
ART deferred until child fulfilled clinical or immunological criteria.
2
Excluded 2 children who developed BCG-related regional adenitis prior to ART initiation
3
6 children in the deferred ART group were older than 1 year at initiation.
4
Infants in the Early ART groups may have CD4 measured following enrolment prior to starting ART; CD4% had dropped to <25% for some in part A and increased to ≥25% for some in part B.
5
Estimated using Kaplan-Meir methods.