25 May 2023 : Clinical Research
Impact of Converting from Immediate-Release Tacrolimus to Envarsus on BK Viremia Incidence in Kidney Transplant Patients with Rapid Metabolism
Graham Towns1ABCDEFG, Gaurav Agarwal1ABCDEFG*, Ashutosh Tamhane1CDE, Clifton Kew1AEDOI: 10.12659/MSM.939748
Med Sci Monit 2023; 29:e939748
Table 2 Results comparing the groups converted from IR-Tac to Envarsus and those kept on IR-Tac at various time points post-transplant.
| Variables | All (n= 88) | Envarsus group (n=43) | IR-Tac group (n=45) | p-value |
|---|---|---|---|---|
| Creatinine in mg/dL, mean (SD) | ||||
| 3 months | 1.7 (0.7) | 1.6 (0.4) | 1.8 (0.9) | 0.194 |
| 6 months | 1.7 (0.9) | 1.6 (0.4) | 1.8 (1.1) | 0.323 |
| 9 months | 1.6 (0.6) | 1.5 (0.4) | 1.6 (0.7) | 0.267 |
| 12 months | 1.6 (0.6) | 1.6 (0.5) | 1.6 (0.6) | 0.749 |
| Tacrolimus dose in mg/day, mean (SD) | ||||
| 3 months | 13.3 (3.8) | 13.2 (3.9) | 13.3 (3.6) | 0.855 |
| 6 months | 11.9 (5.1) | 12.4 (5.8) | 11.4 (4.3) | 0.391 |
| 9 months | 10.6 (4.9) | 11.3 (5.4) | 10.0 (4.0) | 0.233 |
| 12 months | 9.8 (4.4) | 10.3 (4.8) | 9.3 (4.0) | 0.296 |
| Tacrolimus level in ng/dL, mean (SD) | ||||
| 3 months | 9.2 (2.8) | 8.8 (2.9) | 9.6 (2.7) | 0.189 |
| 6 months | 8.0 (2.8) | 8.6 (2.6) | 7.4 (2.9) | 0.041 |
| 9 months | 7.6 (2.4) | 7.6 (2.3) | 7.5 (2.6) | 0.911 |
| 12 months | 7.5 (2.7) | 7.4 (3.1) | 7.6 (2.3) | 0.747 |
| C/D ratio, mean (SD) | ||||
| 3 months | 0.7 (0.3) | 0.7 (0.3) | 0.8 (0.3) | 0.533 |
| 6 months | 0.8 (0.5) | 0.8 (0.5) | 0.8 (0.5) | 0.639 |
| 9 months | 0.8 (0.5) | 0.8 (0.4) | 0.9 (0.5) | 0.570 |
| 12 months | 0.9 (0.6) | 0.8 (0.3) | 1.0 (0.8) | 0.161 |
| MMF dose in mg/day, median (Q1–Q3) | ||||
| 3 months | 2000 (1500–2000) | 2000 (1500–2000) | 2000 (1500–2000) | 0.327 |
| 6 months | 2000 (1500–2000) | 2000 (1375–2000) | 2000 (1500–2000) | 0.818 |
| 9 months | 1500 (1000–2000) | 1500 (1000–2000) | 1500 (1000–2000) | 0.501 |
| 12 months | 1500 (1000–2000) | 1500 (1000–2000) | 1500 (1000–2000) | 0.209 |
| Cumulative incidence of BK viruria n (%) | ||||
| 3 months | 23 (26.1) | 10 (23.3) | 13 (28.9) | 0.720 |
| 6 months | 30 (34.4) | 12 (27.9) | 18 (40.0) | 0.331 |
| 9 months | 36 (40.9) | 16 (37.2) | 20 (44.4) | 0.636 |
| 12 months | 39 (44.3) | 18 (41.9) | 21 (46.7) | 0.811 |
| Cumulative incidence of BK viremia n (%) | ||||
| 3 months | 11 (12.5) | 3 (7.0) | 8 (17.8) | 0.227 |
| 6 months | 19 (21.6) | 6 (14.0) | 13 (28.9) | 0.149 |
| 9 months | 21 (23.9) | 6 (14.0) | 15 (33.3) | 0.059 |
| 12 months | 23 (26.1) | 8 (18.6) | 15 (33.3) | 0.184 |
| Peak BK viral load in IU/mL, median (Q1–Q3), range() | ||||
| 6 months | 0 (0–0), 0–401,000 | 0 (0–0), 0–154,421 | 0 (0–511), 0–401,000 | 0.086 |
| 9–12 months | 0 (0–0), 0–80,188 | 0 (0–0), 0–80,188 | 0 (0–0), 0–78,412 | 0.558 |
| Thoughout the study | 0 (0–465.25), 0–401,000 | 0 (0–0), 0–154,421 | 0 (0–1,790), 0–401,000 | 0.139 |
| C/D ratio – tacrolimus concentration to drug ratio; IR-Tac – immediate release tacrolimus; Q1 – first quartile; Q3 – third quartile; SD – standard deviation. | ||||