Renal safety of adefovir dipivoxil for two-year treatment in Chinese patients with chronic hepatitis B / 中华临床感染病杂志

ABSTRACT

Objective To assess the renal safety of adefovir dipivoxil (ADV) in Chinese patients with chronic hepatitis B (CHB).Methods A retrospective study was performed on 1 013 CHB patients from Chinese ADV multicenter clinical trials (ADF30001 and ADF106632).All patients were administrated with ADV 10 mg daily.The serum creatinine and phosphorus levels were measured in different time pointsduring 104-week treatment.Nephrotoxicity was defined as an increase ≥44.2 μ mol/L from baseline in serum creatinine or a serum phosphorus value of ＜ 0.4845 mmol/L on two consecutive occasions.Paired t test was used to analyze serum creatinine and phosphorous data before treatment and at different time points during treatment.Results At week 28,week 52,week 80 and week 104,the median levels of serum creatinine were 74.963,76.996,76.820 and 77.969 μmol/L,respectively,and there were no significant differences from baseline (t =0.91,0.23,0.59 and 0.97,P ＞ 0.05).No patient experienced a ≥ 44.2 μmol/L increase from baseline.For serum phosphorus,the median levels at week 28,week 80 and week 104 were 1.098,1.088 and 1.048 mmol/L,and there were significant decreases from baseline (t =2.34,3.06 and 4.94,P ＜0.05 or ＜ 0.01).The cumulative incidence of serum phosphorus abnormality was 0.8％ (8/104).There were no confirmed serum phosphorous decreases to ＜ 0.4845 mmol/L.Conclusion Two years treatment with ADV (10 mg/d) does not result in marked nephrotoxicity,indicating that ADV 10 mg daily is well tolerated by Chinese patients.