Table 5.
Predictors of safety outcomes
| Baseline characteristics | Univariate |
Multivariate |
||
|---|---|---|---|---|
| IRR (95% CI) | P-value | IRR (95% CI) | P-value | |
| Safety outcome: worsening renal function* | ||||
| eGFR ≤45 (vs. eGFR >45) | 13.6(6.5–28.7) | <0.001 | 4.71 (1.85–12.0) | 0.001 |
| Male (vs. female) | 0.83 (0.38–1.78) | 0.63 | 1.47 (0.68–3.17) | 0.33 |
| Age≥65 (vs. age<65) | 1.18(0.45–3.09) | 0.73 | 1.21 (0.41–3.57) | 0.73 |
| Black or AA race (vs. non-Black or non-AA) | 0.90 (0.27–2.95) | 0.86 | 0.78(0.20–3.14) | 0.73 |
| Genotype 1 (vs. non-1) | 0.67 (0.31–1.45) | 0.31 | 0.45(0.20–1.02) | 0.06 |
| Prior HCV treatment (vs. treatment naive) | 0.52 (0.24–1.13) | 0.10 | 0.50(0.23–1.07) | 0.07 |
| Cirrhosis (vs. no cirrhosis) | 3.23 (1.48–2.55) | 0.01 | 1.98(0.56–6.95) | 0.29 |
| MELD ≥ 10 (vs. MELD < 10) | 0.46 (0.22–0.98) | 0.05 | 1.11 (0.45–2.77) | 0.82 |
| Any transplant† (vs. no transplant) | 1.70(0.35–8.31) | 0.52 | 1.28(0.53–3.10) | 0.58 |
| Diabetes (vs. no diabetes) | 4.14(1.95–8.77) | <0.001 | 2.07(0.87–4.90) | 0.10 |
| Haemoglobin (per g/dL) | 0.52 (0.44–0.62) | <0.001 | 0.61 (0.50–0.75) | <0.001 |
| Safety outcome: any serious adverse event | ||||
| eGFR ≤ 45 (vs. eGFR > 45) | 3.43 (2.14–5.50) | <0.001 | 1.59(0.93–2.73) | 0.09 |
| Male sex (vs. female) | 0.76(0.54–1.08) | 0.12 | 1.04 (0.74–1.46) | 0.83 |
| Age ≥ 65 (vs. age < 65) | 0.99 (0.62–1.59) | 0.96 | 0.96(0.62–1.50) | 0.86 |
| Black or AA race (vs. non-Black or non-AA) | 0.84 (0.41–1.47) | 0.54 | 0.89(0.51–1.54) | 0.67 |
| Genotype 1 (vs. non-genotype 1) | 0.86 (0.59–1.23) | 0.40 | 0.69 (0.48–0.99) | 0.05 |
| Prior HCV treatment (vs. treatment naïve) | 0.86 (0.61–1.20) | 0.37 | 0.80(0.57–1.12) | 0.19 |
| Cirrhosis (vs. no cirrhosis) | 3.17 (2.10–4.77) | <0.001 | 1.94 (1.13–3.36) | 0.02 |
| MELD ≥ 10 (vs. MELD < 10) | 0.43 (0.31–0.61) | <0.001 | 0.74(0.48–1.14) | 0.17 |
| Any transplant† (vs. no transplant) | 2.10(1.11–4.01) | 0.02 | 0.95(0.62–1.46) | 0.81 |
| Diabetes (vs. no diabetes) | 1.46(1.02–2.11) | 0.04 | 1.02(0.71–1.46) | 0.93 |
| Haemoglobin (per g/dL) | 0.65 (0.60–0.70) | <0.001 | 0.69 (0.64–0.76) | <0.001 |
*
Genotype was excluded as would not converge, not enough variation to examine this predictor.
†
Includes liver alone transplant, kidney alone transplant and simultaneous liver–kidney transplant.
AA, African American; HCV, hepatitis C virus; RBV, ribaviri.
Bold text signifies results for primary predictor and for statistically significant covariates in multivariate model.