Table 5.
Univariate and Multivariate Predictors of Hepatic Decompensation in Patients Treated with Simeprevir Plus Sofosbuvir
| Baseline Covariate | Univariate* | Multivariate 1§ ¶ | Multivariate 2§ $ | |||
|---|---|---|---|---|---|---|
| OR (95% CI) | p-value | OR (95% CI) | p-value | OR (95% CI) | p-value | |
| CP-B/C cirrhosis | 8.12 (2.17–30.7) | <0.01 | 10.5 (2.03–54.1) | <0.01 | -- | -- |
| Total bilirubin ≥ 1.3 mg/dL | 9.81 (2.63–36.5) | <0.01 | -- | -- | 7.29 (1.72–31.0) | <0.01 |
| INR ≥ 1.3 | 1.88 (0.74–3.01) | <0.01 | -- | -- | ||
| Albumin ≥ 3.5 g/dL | 0.17 (0.05–0.65) | <0.01 | -- | -- | -- | -- |
| Platelets ≥ 100 K/mm3 | 0.48 (0.16–1.47) | 0.19 | -- | -- | -- | -- |
| Any hepatic encephalopathy | 6.56 (2.15–19.8) | <0.01 | -- | -- | 4.82 (1.27–18.4) | 0.02 |
| Any ascites | 4.20 (1.41–12.5) | 0.01 | -- | -- | -- | -- |
| MELD, per 1 unit | 1.34 (1.13–1.59) | <0.01 | -- | -- | -- | -- |
Univariate results of variables with p<0.20. Baseline covariates examined included age, sex, race/ethnic group (White, non-Hispanic vs. Hispanic vs. Black vs. Asian vs. Other), HCV genotype 1a (vs. 1b or other), HCV treatment experienced (vs. no treatment), laboratory indices [bilirubin, creatinine, international normalized ratio (INR), albumin and platelet count], CP class (CP-B/C vs. CP-A), MELD, HCV viral load, log-transformed (VL) and presence/absence of varices.
Adjusted for sex, race and center effect
Multivariate model 1 with CP-B/C cirrhosis included in the model
Multivariate model 2 without CP-B/C cirrhosis included in the model
CP = Child-Pugh, INR = international normalized ratio, MELD = model for end-stage liver disease