Table 2.
IRIS incidence in each of the study arms in the SAPiT trial
| Early integrated-treatment arm | Late integrated-treatment arm | Sequential -treatment arm | IRIS incidence rate ratio (95%CI) ; P- values |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of IRIS event s |
No of death s or AIDS defini ng illnes s |
No. of person- years (n) |
IRIS incidence rate / 100 person- years(95% CI) |
No. of IRIS event s |
No of deaths or AIDS defining illness |
No. of person- years (n) |
IRIS incidence rate / 100 person- years (95% CI) |
No. of IRIS event s |
No of deaths or AIDS definin g illness |
No. of person- years (n) |
IRIS incidence rate / 100 person- years (95% CI) |
Early vs late integrated |
Early vs sequenti al |
Late vs sequentia l |
|
| All patie nts |
43 | 28 |
*219.8 (214) |
19.5 (14.2-26.4) |
18 | 26 |
*239.6 (215) |
7.5 (4.5-11.9) |
19 | 47 | 235.4 (213) |
8.1 (4.9-12.6) |
2.6 (1.5-4.8); <0.001 |
2.4 (1.4-4.4); <0.001 |
0.9 (0.5-1.9); 0.86 |
| <50 cells/ mm3 |
14 | 8 |
*30.8 (37) |
45.5 (24.9-76.4) |
4 | 11 |
*41.3 (35) |
9.7 (2.6-24.8) |
8 | 20 | 40.6 (41) |
19.7 (8.5-38.8) |
4.7 (1.5-19.6); 0.004 |
2.3 (0.9-6.4); 0.05 |
0.5 (0.1-1.8); 0.19 |
| ≥50 cells/ mm3 |
29 | 20 |
*189.0 (177) |
15.3 (10.3-22.0) |
14 | 15 |
*198.3 (180) |
7.1 (3.9-11.8) |
11 | 27 | 194.8 (172) |
5.6 (2.8-10.1) |
2.2 (1.1-4.5); 0.01 |
2.7 (1.3-6.0); 0.003 |
1.3 (0.5-3.0); 0.53 |
| Scenario 1: Assuming patients who dropped-out before ART initiation and within six months post ART initiation stayed in the study and that their IRIS rates were twice that of those who did not drop-out | |||||||||||||||
| All patie nts |
52 | 219.8 (214) |
23.7 (17.2-30.1) |
24 | 239.6 (215) |
10.0 (6.0-14.0) |
26 | 235.4 (213) |
11.0 (6.8-15.3) |
2.4 (1.5-3.8); <0.001 |
2.2 (1.3-3.4); 0.002 |
0.9 (0.5-1.6); 0.73 |
|||
| <50 cells/ mm3 |
16 | 30.8 (37) |
51.9 (26.3-76.9) |
4 | 41.3 (35) |
9.7 (2.6-24.8) |
10 | 40.6 (41) |
24.6 (9.3-39.5) |
5.4 (1.8-16.0); 0.003 |
2.1 (0.9-4.6); 0.06 |
0.4 (0.1-1.3); 0.11 |
|||
| ≥50 cells/ mm3 |
36 | 189.0 (177) |
19.0 (12.8-25.3) |
20 | 198.3 (180) |
10.1 (5.7-14.5) |
16 | 194.8 (172) |
8.2 (4.2-12.2) |
1.9 (1.1-3.3); 0.02 |
2.3 (1.3-4.2); 0.01 |
1.2 (0.6-2.4); 0.54 |
|||
| Scenario 2: Assuming patients who dropped-out before ART initiation and within six months post ART initiation stayed in the study and that their IRIS rates were five times that of those who did not drop-out | |||||||||||||||
| All patie nts |
65 | 219.8 (214) |
29.6 (22.4-36.7) |
33 | 239.6 (215) |
13.8 (9.1-18.4) |
36 | 235.4 (213) |
15.3 (10.3-20.3) |
2.1 (1.4-3.3); <0.001 |
1.9 (1.3-2.9); 0.001 |
0.9 (0.6-1.4); 0.66 |
|||
| <50 cells/ mm3 |
19 | 30.8 (37) |
61.7 (33.7-88.9) |
4 | 41.3 (35) |
9.7 (2.6-24.8) |
13 | 40.6 (41) |
32.0 (14.5-48.9) |
6.4 (2.2-18.7); <0.001 |
1.9 (0.9-3.9); 0.07 |
0.3 (0.1-0.9); 0.04 |
|||
| ≥50 cells/ mm3 |
46 | 189.0 (177) |
24.3 (17.3-31.4) |
29 | 198.3 (180) |
14.6 (9.3-20.0) |
23 | 194.8 (172) |
11.8 (7.0-16.6) |
1.7 (1.05-2.6); 0.03 |
2.1 (1.3-3.4); 0.005 |
1.2 (0.7-2.1); 0.44 |
|||
| Scenario 3: Assuming patients who dropped-out or died before ART initiation and within six months post ART initiation stayed in the study and that their IRIS rates were twice that of those who completed | |||||||||||||||
| All patie nts |
55 | 219.8 (214) |
25.0 (18.9-32.6) |
26 | 239.6 (215) |
10.9 (6.7-15.0) |
31 | 235.4 (213) |
13.2 (8.5-17.8) |
2.3 (1.5-3.7); <0.001 |
1.9 (1.2-3.0); 0.004 |
0.8 (0.5-1.4); 0.47 |
|||
| <50 cells/ mm3 |
17 | 30.8 (37) |
55.2 (28.8-80.9) |
5 | 41.3 (35) |
12.1 (1.6-22.9) |
14 | 40.6 (41) |
34.5 (16.2-52.2) |
4.6 (1.7-12.4); 0.003 |
1.6 (0.8-3.2); 0.19 |
0.4 (0.1-0.98); 0.04 |
|||
| ≥50 cells/ mm3 |
38 | 189.0 (177) |
20.1 (13.7-26.5) |
21 | 198.3 (180) |
10.6 (6.1-15.1) |
17 | 194.8 (172) |
8.7 (4.6-12.9) |
1.9 (1.1-3.2); 0.02 |
2.3 (1.3-4.1); 0.004 |
1.2 (0.6-2.3); 0.55 |
|||
| Scenario 4: Assuming patients who dropped-out or died before ART initiation and within six months post ART initiation stayed in the study and that their IRIS rates were five times that of those who completed | |||||||||||||||
| All patie nts |
74 | 219.8 (214) |
33.7 (26.0-41.3) |
37 | 239.6 (215) |
15.4 (10.4-20.4) |
43 | 235.4 (213) |
18.3 (12.8-23.8) |
2.2 (1.5-3.2); <0.001 |
1.8 (1.3-2.7); 0.001 |
0.8 (0.5-1.3); 0.45 |
|||
| <50 cells/ mm3 |
23 | 30.8 (37) |
74.7 (43.9- 104.5) |
6 | 41.3 (35) |
14.5 (2.9-26.3) |
25 | 40.6 (41) |
61.6 (37.1-84.9) |
5.1 (2.1-12.6); <0.001 |
1.2 (0.7-2.1); 0.50 |
0.2 (0.1-0.6); 0.002 |
|||
| ≥50 cells/ mm3 |
51 | 189.0 (177) |
27.0 (19.6-34.4) |
31 | 198.3 (180) |
15.6 (10.1-21.2) |
28 | 194.8 (172) |
14.4 (9.0-19.7) |
1.7 (1.1-2.7); 0.02 |
1.9 (1.2-3.0); 0.01 |
1.1 (0.7-1.8); 0.75 |
|||
| Scenario 5: Composite endpoint of death or IRIS | |||||||||||||||
| All patie nts |
55 | 219.8 (214) |
25.0 (18.9-32.6) |
32 | 239.6 (215) |
13.4 (9.1-18.9) |
52 | 235.4 (213) |
22.1 (16.5-29.0) |
1.9 (1.2-3.0); 0.003 |
1.1 (0.8-1.7); 0.44 |
0.6 (0.4-0.96); 0.03 |
|||
| <50 cells/ mm3 |
16 | 30.8 (37) |
51.9 (29.7-84.5) |
10 | 41.3 (35) |
24.2 (11.6-44.5) |
22 | 40.6 (41) |
54.2 (33.9-82.0) |
2.1 (0.9-5.3); 0.07 |
1.0 (0.5-1.9); 0.98 |
0.4 (0.2-0.9); 0.03 |
|||
| ≥50 cells/ mm3 |
39 | 189.0 (177) |
20.6 (14.7-28.2) |
22 | 198.3 (180) |
11.1 (7.0-16.8) |
30 | 194.8 (172) |
15.4 (10.4-22.0) |
1.9 (1.1-3.3); 0.01 |
1.3 (0.8-2.2); 0.20 |
0.7 (0.4-1.3); 0.28 |
|||
IRIS – Immune Reconstitution Inflammatory Syndrome
CI – Confidence Interval
*
Person years given in this table are slightly different from those reported in the NEJM 2011 paper due to some changes in the calendar time used for censoring.