Abstract: Objective To evaluate the clinical efficacy of tenofovir disoproxil fumarate (TDF) for nucleos(t)ide-analogue (NAs) experienced chronic hepatitis B (CHB) patients.Method A total of 34 CHB patients who had been previously treated with NAs and received subsequently TDF for 48 weeks were retrospectively investigated. Among the 34 patients, 18 failed to response to primary treatment; 16 developed antiviral drug resistance; 29 were male and 5 female, with average age as 43.3 ± 7.8 years old. Measurement of HBV DNA loading and alanine aminotransferase (ALT) level were carried out at week 0, 12,24 and 48, respectively.The hepatitis B e antigen (HBeAg) seroconversion rate and clinical adverse events rate at week 48 were also recorded.Statistical analyses were performed using standardized mean difference, Student's t-test and one-way analysis of variance.Results During the treatment period, the HBV DNA undetectable rate at week 12, 24, 48 are 35.3%, 67.6% and 94.1%, respectively. The ALT level at week 0, 12, 24, 48 are (63.9±18.9) U/L, (49.8±11.9) U/L, (42.7±7.3) U/L and (35.1±3.9) U/L, respectively, which showed significant differences (F= 36.3, P<0.05). At week 48, ALT normalization rate, HBeAg loss rate and HBeAg seroconversion rate were 91.1%, 25% and 20%, respectively. During the treatment, virus breakthrough rate was 0 and creatine kinase levels were no more than 2 times the upper limit of normal. The serum creatinine (Scr) level at week 0 and 48 are (75.1± 11.1) μmol/L and (76.8± 10.8) μmol/L, which showed no significant difference (t=0.578, P=0.565). All patients showed a normal level of Scr, bone mineral density and serum phosphate throughout the treatment period.Conclusion For NAs experienced CHB patients, TDF can help to efficiently suppress HBV DNA replication and achieve a high rate of ALT normalization with a low rate of adverse events.

Key words: Chronic hepatitis B, Tenofovir disoproxil fumarate