Table 2.
Risk factors for any-grade and grade 3–4 hepatotoxicity development
| Any-grade hepatotoxicity | Grade 3–4 hepatotoxicity | |||||||
|---|---|---|---|---|---|---|---|---|
| Univariate analysis | Multivariate analysis | Univariate analysis | Multivariate analysis | |||||
| Covariate | OR | P | OR | P | OR | P | OR | P |
| (95%CI) | (95%CI) | (95%CI) | (95%CI) | |||||
| Age (years) | 0.834 | 0.370 | ||||||
| > 52 | 1.07 | 0.60 | ||||||
| (0.58–1.95) | (0.20–1.83) | |||||||
| ≤ 52 | 1 | 1 | ||||||
| Gender | 0.400 | 0.233 | ||||||
| Male | 0.76 | 0.52 | ||||||
| (0.40–1.45) | (0.17–1.53) | |||||||
| Female | 1 | 1 | ||||||
| Body weight(kg) | 0.813 | 0.848 | ||||||
| > 60 | 1.08 | 1.11 | ||||||
| (0.59–1.97) | (0.38–3.25) | |||||||
| ≤ 60 | 1 | 1 | ||||||
| History of alcoholism | 0.900 | 0.997 | ||||||
| Yes | 0.95 | 0.00 | ||||||
| (0.42–2.17) | (0.00–NA) | |||||||
| No | 1 | 1 | ||||||
| HTN/DM/CVD | 0.858 | 0.341 | ||||||
| Yes | 1.08 | 1.90 | ||||||
| (0.45–2.61) | (0.51–7.14) | |||||||
| No | 1 | 1 | ||||||
| Liver cirrhosis | 0.790 | 0.492 | 0.043 | 0.682 | ||||
| Yes | 1.17 | 0.47 | 4.08 | 1.88 | ||||
| (0.37–3.62) | (0.05–4.13) | (1.04–15.93) | (0.09–38.43) | |||||
| No | 1 | 1 | 1 | 1 | ||||
| Hepatocellular carcinoma | 0.325 | 0.437 | 0.036 | 0.892 | ||||
| Yes | 1.70 | 2.30 | 4.33 | 1.23 | ||||
| (0.59–4.92) | (0.28–18.83) | (1.10–17.00) | (0.06–25.438) | |||||
| No | 1 | 1 | 1 | 1 | ||||
| HBsAg status | 0.757 | 0.020 | 0.007 | 0.123 | ||||
| Sero-positive | 1.11 | 6.30 | 4.66 | 5.80 | ||||
| (0.58–2.13) | (1.33–29.80) | (1.51–14.32) | (0.62–54.20) | |||||
| Sero-negative | 1 | 1 | 1 | 1 | ||||
| HBeAg status | 0.134 | 0.096 | 0.018 | 0.080 | ||||
| Sero-positive | 3.06 | 4.15 | 7.81 | 6.83 | ||||
| (0.71–13.25) | (0.78–22.18) | (1.42–42.79) | (0.80–58.66) | |||||
| Sero-negative | 1 | 1 | 1 | 1 | ||||
| ECOG performance status | 0.237 | 0.667 | ||||||
| > 1 | 0.48 | 0.64 | ||||||
| (0.14–1.63) | (0.08–5.02) | |||||||
| ≤ 1 | 1 | 1 | ||||||
| Lines of treatment | 0.464 | 0.694 | ||||||
| > 2 | 0.79 | 1.24 | ||||||
| (0.42–1.49) | (0.42–3.68) | |||||||
| ≤ 2 | 1 | 1 | ||||||
| Liver involvement | 0.023 | 0.030 | 0.024 | 0.162 | ||||
| Yes | 2.02 | 2.10 | 3.91 | 2.64 | ||||
| (1.10–3.71) | (1.08–4.10) | (1.20–12.76) | (0.68–10.29) | |||||
| No | 1 | 1 | 1 | 1 | ||||
| Antiviral therapy | 0.528 | 0.475 | 0.016 | |||||
| Yes | 0.78 | 1.55 | 0.10 | |||||
| (0.36–1.70) | (0.47–5.10) | (0.014–0.65) | ||||||
| No | 1 | 1 | 1 | |||||
| Baseline HBV DNA level | 0.032 | 0.012 | 0.003 | 0.080 | ||||
| Detectablea | 3.41 | 0.037 | 2.39 | 0.181 | 6.38 | 0.010 | 7.49 | 0.025 |
| (1.08–10.76) | (0.67–8.53) | (1.57–25.98) | (1.28–43.72) | |||||
| Unknown | 2.63 | 0.015 | 8.09 | 0.005 | 0.71 | 0.615 | 1.60 | 0.668 |
| (1.21–5.71) | (1.87–34.93) | (0.19–2.70) | (0.19–13.61) | |||||
| Undetectable | 1 | 1 | 1 | 1 | ||||
| Treatment modality | 0.143 | 0.241 | 0.312 | 0.515 | ||||
| Combined therapy | 1.60 | 1.49 | 1.75 | 1.51 | ||||
| (0.85–2.98) | (0.77–2.88) | (0.59–5.20) | (0.44–5.25) | |||||
| Monotherapy | 1 | 1 | 1 | 1 | ||||
aHBV DNA < 10 IU/mL
Abbreviations: OR odd ratio; CI confidence interval; HTN hypertension; DM diabetes mellitus; CVD cardiovascular disease; ECOG Eastern Cooperative Oncology Group; HBV hepatitis B virus; HBeAg hepatitis B e antigen; HBsAg hepatitis B surface antigen