ABSTRACT
Objective To evaluate urinary β2-microglobulin (β2-MG) and retinoid binging protein (RBP) in monitoring of early renal impairment in chronic hepatitis B (CHB) patients with long-term adefovir dipivoxil (ADV) treatment. Methods Three hundred and fifty five with CHB admitted in Shaoxing Municipal Hospital from June 2009 to June 2011 were enrolled in the study, among whom 180 cases study group) were treated with ADV monotherapy (n=100) or ADV + lamivudine (LAM) combination therapy (n=80); and 175 cases (control group) were treated with entecavir (ETV). Serum creatinine, urinary β2-MG, RBP and creatinine were measured and glomerular tration rate (eGFR) was estimated regularly during 5-year follow up. Kaplan-Meier method was used to calculate the cumulative incidence of changes in urinary β2-MG and RBP. Results Five-year follow-up results showed that in study group 2, 6, 10, 14 and 24 cases developed urinary β2-MG abnormality in year 1, 2, 3, 4 and 5 of treatment, respectively; and 2, 7, 11, 16 and 20 cases developed urinary RBP abnormality in year 1, 2, 3, 4 and 5 of treatment, respectively; eGFR decreased 20%-30% from baseline in 20 cases, 30%-50% in 13 cases and >50% in 2 cases. The decrease of eGFR ≥30% in 5 years was significantly correlated with urinary RBP and β2-GM abnormality. However, both serum creatinine and eGFR remained stable during the 5 years of follow-up in control group; only 2 cases developed urinary β2-MG abnormality and 3 cases developed urinary RBP abnormality. Conclusions Urinary RBP and β2-MG are sensitive biomarkers of early renal injury during long-term ADV treatment in CHB patients, and ADV should not be used as first-line treatment for CHB.
ABSTRACT
Objective 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.Methods 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.Results 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).Conclusions 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.