Table 1.
Baseline Characteristics and Comparison of Sofosbuvir/Ledipasvir (SOD/LDV) With Glecaprevir/Pibrentasvir (GLE/PIB) Treatment.
| Variable | All (N = 941) | SOF/LDV (N = 825) | GLE/PIB (N = 116) | Difference Between 2 Groupsa | Individual Effect on Creatinine Before-After Changeb | |
|---|---|---|---|---|---|---|
| Age | 58.1 ± 9.1 | 58.5 ± 8.6 | 55.7 ± 11.7 | 0.02 | 0.15 | |
| Males | 561 (60%) | 491 (60%) | 70 (60%) | 0.87 | 0.21 | |
| Race | Black | 522 (55%) | 467 (57%) | 55 (47%) | <0.001 | 0.74 |
| White | 390 (41%) | 339 (41%) | 51 (44%) | |||
| Genotype | 1A | 732 (78%) | 659 (80%) | 73 (63%) | <0.001 | 0.01 |
| 1B | 185 (20%) | 160 (19%) | 25 (22%) | |||
| 2 | 11 (1%) | 0 (0%) | 11 (9%) | |||
| 3–6 | 11 (1%) | 4 (0.5%) | 7 (6%) | |||
| Duration of treatment (mean ± SD) | 11.3 ± 3.6 | 11.5 ± 3.7 | 9.6 ± 2.3 | <0.001 | 0.43 | |
| Fibrosis stage | F0-1 | 196 (21%) | 179 (22%) | 17 (15%) | 0.46 | 0.30 |
| F2 | 292 (31%) | 254 (31%) | 38 (33%) | |||
| F3 | 119 (13%) | 105 (13%) | 14 (12%) | |||
| F4 | 309 (33%) | 266 (32%) | 43 (37%) | |||
| SVR12 | 689 (98%) | 615 (98%) | 74 (100%) | 0.2 | 0.38 | |
| Diabetes mellitus | 212 (23%) | 196 (24%) | 16 (14%) | 0.02 | 0.78 | |
| Hypertension | 551 (59%) | 490 (59%) | 61 (53%) | 0.16 | 0.19 | |
| Diuretics | 270 (29%) | 253 (31%) | 17 (15%) | <0.001 | 0.01 | |
| ACEi/ARBs | 355 (38%) | 312 (38%) | 43 (37%) | 0.88 | 0.73 | |
| HAART | 5 (1%) | 5 (1%) | 0 (0%) | 0.40 | <0.001 | |
| Metformin | 104 (11%) | 97 (12%) | 7 (6%) | 0.07 | 0.59 | |
| NSAIDs | 134 (14%) | 118 (14%) | 16 (14%) | 0.88 | 0.69 | |
| Other nephrotoxic drugs | 42 (4%) | 40 (5%) | 2 (2%) | 0.13 | 0.21 | |
| CKD stage | 2 | 99 (11%) | 92 (11%) | 7 (6%) | <0.001 | <0.001 |
| 3 | 47 (5%) | 40 (5%) | 7 (6%) | |||
| 4 | 4 (0.004%) | 1 (0.001%) | 3 (3%) | |||
| 5 | 5 (1%) | 0 (0%) | 5 (4%) | |||
| Creatinine pre-treatment (mean ± SD) | 0.97 ± 0.71 | 0.91 ± 0.24 | 1.39 ± 1.86 | 0.01 | ||
| Creatinine post-treatment (mean ± SD) | 1.03 ± 0.73 | 0.97 ± 0.40 | 1.41 ± 1.73 | 0.01 | ||
| Creatinine at month 6 (mean ± SD) | 1.01 ± 0.58 | 0.97 ± 0.30 | 1.42 ± 1.76 | 0.07 | ||
| Creatinine increased ≥0.1 after treatment | 288 (31%) | 258 (31%) | 30 (26%) | 0.24 | ||
| Creatinine increased ≥0.2 after treatment | 112 (12%) | 97 (12%) | 15 (13%) | 0.72 | ||
| Creatinine increased ≥0.3 after treatment | 54 (6%) | 46 (6%) | 8 (7%) | 0.57 | ||
Abbreviations:SD, standard deviation; SVR12, sustained virologic response at 12 weeks after treatment; ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; HAART, highly active antiretroviral therapy; NSAIDs, nonsteroidal anti-inflammatory drugs; CKD, chronic kidney disease; Cr, creatinine.
a
Chi square test for categorical variables, T test or Wilcoxon test as appropriate for continuous variables.
b
Wald Statistics for type 3 analysis.