To compare the impact of Telbivudine (LDT) and Entecavir (ETV) administration on estimates of glomerular filtration rate for anti-viral therapy in patients with hepatitis B virus (HBV)-related compensated cirrhosis by an open, prospective randomized controlled study.

Patients with HBV-related compensated cirrhosis at clinic or hospitalized in Shaoxing Municipal Hospital from January 2012 to June 2013 were included. A total of 170 patients were randomly divided into LDT (600 mg/d) or ETV (0.5 mg/d) groups at a ratio of 1∶1 according to the random number table method. All patients were treated for more than 36 months. The LDT group was optimized according to the roadmap.Patients with poor response or resistance in both treatment group were added with Adefovir dipivoxil (ADV) 10 mg/d for optimal treatment. The clinical outcome, creatinine (CR), estimated glomerular filtration rate (eGFR) of patients before and after 36 months of treatment were compared between two groups. All categorical data were analyzed using chi-square test and data accorded with normal distribution were compared by t test.

After 36 months of treatment, the virological and biochemical responses in LDT group and ETV group were similar. The mean CR levels at month 24 and 36 in LDT group were (74.25±22.98) μmol/L and (70.72±24.75) μmol/L, respectively, which were both lower than baseline level ([83.09±17.68] μmol/L, t=2.811 and 3.145, respectively, both P<0.01). The mean CR levels at month 36 between two groups were statistically different (t=3.431, P=0.001). The mean eGFR levels at month 12, 24 and 36 in LDT group were all significantly lower than that at baseline (t=3.976, 8.297 and 10.629, respectively, all P<0.01). The mean eGFR levels at month 24 and 36 between two groups were statistically different (t=9.684 and 15.019, respectively, both P<0.01). A total of 64 patients including 34 in LDT group and 30 in ETV group had mild nephritic injury at baseline. The mean eGFR in patients with mild nephritic injury at baseline in LDT group at month 12, 24 and 36 were significantly different compared to baseline (t=6.098, 10.191 and 14.378, respectively, all P<0.01). The mean eGFR level at month 36 in ETV group had statistical difference compared to baseline (t=2.058, P<0.05). The mean eGFR levels at months 12, 24 and 36 were all statistical different between two groups (all P<0.01). The mean eGFR levels at month 24 and 36 in the optimized group were superior to ETV group (P<0.01).

In patients with HBV-related compensated cirrhosis, LDT and ETV treatment have similar clinical efficacy. LDT is more effective in protecting nephritic function than ETV.

HBV related compensated cirrhosis; Estimates of glomerular filtration rate; Telbivudine; Entecavir