Abstract
The long-term effects of telbivudine (TBV) on decompensated hepatitis B virus (HBV)-related cirrhosis were still not established. This study aimed to investigate the efficacy and safety of TBV in such cohort of patients as compared to lamivudine (LAM) and entecavir (ETV). We retrospectively evaluated 130 treatment-naïve patients with HBV-related decompensated cirrhosis who started treatment with TBV (n = 31), LAM (n = 45) or ETV (n = 54). After 24 months of treatment, cumulative virological response (VR) rates (HBV DNA <500 copies/mL) were 83.7, 65.3 and 89.1 % in TBV, LAM and ETV groups, respectively (p = 0.009). Reduction in HBV DNA levels in TBV was −3.66 ± 0.56, significantly higher than LAM (−3.34 ± 0.59; p < 0.05) and lower than ETV group (−3.98 ± 0.52; p < 0.05). The rates of HBeAg loss or seroconversion and normalization of alanine aminotransferase (ALT) were similar among the groups. Child-Turcotte-Pugh (CTP) score and model for end-stage liver disease score in TBV were significantly improved compared to at baseline without difference among the groups. TBV resulted in similar cumulative rates of survival and incidence of hepatocellular carcinoma (HCC) to LAM and ETV. Frequencies of complications from cirrhosis, including variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis, were comparable among the groups. Four patients (16.7 %) in TBV displayed virological breakthrough, lower than LAM and higher than ETV (p = 0.004). Cox regression analysis showed that baseline HBV DNA (hazard ratio 0.743; 95 % confidence interval 0.582–949, p = 0.017) was an independent predictor for VR at 24 months. Long-term therapy with TBV was effective and safe in HBV-related decompensated cirrhosis.
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Authors’ contribution
Li-Hong Yang and Jin-Hui Yang were involved in study concept and design; Wan Yue-Meng and Yu-Hua Li were involved in acquisition of data, analyzed and interpreted the data, drafted the manuscript, and critically revised the manuscript for important intellectual content; Hua-Mei Wu was involved in acquisition of data and statistical analysis; Li-Hong Yang, Jin-Hui Yang, Jing Yang and Ying Xu were involved in administrative, technical or material support, and supervised the study.
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All procedures followed were in accordance with the ethical standards of the ethics committee of the Second Affiliated Hospital of Kunming Medical University on human experimentation and with the Declaration of Helsinki 1975, as revised in 2008.
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Wan Yue-Meng and Yu-Hua Li share the first authorship.
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Yue-Meng, W., Li, YH., Wu, HM. et al. Telbivudine versus lamivudine and entecavir for treatment-naïve decompensated hepatitis B virus-related cirrhosis. Clin Exp Med 17, 233–241 (2017). https://doi.org/10.1007/s10238-016-0420-7
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DOI: https://doi.org/10.1007/s10238-016-0420-7