Table 5.
Adverse events and events of interest at 12 months
| Events | Patients | ||||
|---|---|---|---|---|---|
| Basiliximab + belatacept HD + MMF | Belatacept HD + MMF | Belatacept LD + MMF | Tac + MMF | Tac | |
| (n = 50) | (n = 48) | (n = 49) | (n = 53) | (n = 50) | |
| HCV at baseline, n | 23 | 23 | 21 | 25 | 24 |
| HCV recurrence,1 n (%) | 14 (60.9) | 7 (30.4) | 6 (28.6) | 13 (52.0) | 9 (37.5) |
| Serious adverse events, n (%) | 28 (56.0) | 29 (60.4) | 37 (75.5) | 40 (75.5) | 35 (70.0) |
| Infections and infestations | 11 (22.0) | 12 (25.0) | 13 (26.5) | 12 (22.6) | 12 (24.0) |
| Malignancies, n | 1 | 0 | 2 | 2 | 2 |
| PTLD | 12 | 0 | 1 | 0 | 0 |
| All infections and infestations, n (%) | 32 (64.0) | 39 (81.3) | 30 (61.2) | 31 (58.5) | 29 (58.0) |
| Bacterial | 5 (10.0) | 11 (22.9) | 11 (22.4) | 6 (11.3) | 13 (26.0) |
| Fungal infections | 6 (12.0) | 9 (18.8) | 14 (28.6) | 6 (11.3) | 5 (10.0) |
| Viral infections3 | 10 (20.0) | 11 (22.9) | 14 (28.6) | 9 (17.0) | 7 (14.0) |
| CMV | 5 (10.0) | 4 (8.3) | 10 (20.4) | 4 (7.5) | 1 (2.0) |
| Herpes | 3 (6.0) | 3 (6.3) | 4 (8.2) | 3 (5.7) | 2 (4.0) |
| Adverse events of nervous system disorders, n (%) | 23 (46.0) | 19 (39.6) | 15 (30.6) | 34 (64.2) | 34 (68.0) |
| Headache | 10 (20.0) | 8 (16.7) | 5 (10.2) | 14 (26.4) | 14 (28.0) |
| Tremor | 2 (4.0) | 2 (4.2) | 4 (8.2) | 17 (32.1) | 13 (26.0) |
| Adverse events of renal and urinary disorders, n (%) | |||||
| Renal failure | 1 (2.0) | 4 (8.3) | 3 (6.1) | 5 (9.4) | 14 (28.0) |
| Acute renal failure | 2 (4.0) | 5 (10.4) | 2 (4.1) | 13 (24.5) | 8 (16.0) |
| Renal impairment | 0 (0) | 1 (2.1) | 0 (0) | 1 (1.9) | 8 (16.0) |
CMV, cytomegalovirus; HAI, histological activity index; HCV, hepatitis C virus; HD, high dose, LD, low dose; MMF, mycophenolate mofetil; PML, progressive multifocal leukoencephalopathy; PTLD, posttransplant lymphoproliferative disease; Tac, tacrolimus.
1
HCV recurrence confirmed histologically by central pathologist; modified HAI grading score ≥5/18 and fibrosis score ≥2.
2
PTLD case occurred after month 12.
3
One case of PML in belatacept HD + MMF.