A Retrospective Study Of Adefovir Dipivoxil On Treatment In Patients With HBeAg-positive Chronic Hepatitis B

Objective: To observe the efficacy of Adefovir dipivoxil (ADV) monotherapy for HBeAg positive patients with chronic hepatitis B, and to investigate the predictors of better outcomes after 96 weeks.Methods: 93 adult patients with chronic hepatitis B who were positive for HBeAg were analyzed retrospectively. Each patient were treated with Adefovir dipivoxil 10mg/day monotherapy. Observe the efficacy after 48 weeks and 96 weeks of treatment. According to the situation of serum alanine aminotransferase(ALT) normalization, HBV DNA level and HBeAg negative drop / conversion, efficacy scores were introduced to represent the general efficacy. Stratified methods were used to analyze the importance of the baseline serum hepatitis B virus (HBV) DNA ,ALT as markers of outcomes.Results: A total of 93 cases of HBeAg-positive CHB patients with complete medical records were enrolled in the study. After taking adefovir dipivoxil for 48 weeks and 96 weeks, the rate of ALT normalization was 69.9% and 73.9%,the serum HBV DNA negative rate was 53.8% and 66.7%, HBeAg loss rate was 25.8% and 40.6% ,HBeAg seroconversion rate was 14.0% and 18.8%, efficacy scores were 5.46±0.16 and 5.00±0.17,separately.The HBeAg loss rate at 96 weeks was siganificantly higher than 48 weeks.No significant difference was found in terms of baseline serum HBV DNA level, age and sex among the complete responsers, partial responsers and non-responsers except the former had higher ALT at baseline. Patients with baseline ALT levels over 5 times the upper limit of normal (ULN) had significantly higher HBeAg seroconversion rate and lower efficacy scores than those with a baseline ALT level less than 2 times ULN (P <0.005,P =0.03).There were no differences in the rate of undetectable HBV DNA,HBeAg seroconversion rate and HBeAg loss rate between the group of higher viral load (HBV DNA≥107 copies/ml) and lower viral load (HBV DNA<107copies/ml). Patients with undetectable HBV DNA at week 12 or 24 had significantly higher HBeAg loss rate, lower efficacy scores at week 96. Patients with undetectable HBV DNA levels at week 48 had significantly higher rate of loss of HBeAg and HBeAg seroconversion and significantly lower efficacy scores at week 96.The ROC curves indicated the serum HBVDNA level at week 12,24,48 could predict the loss of HBeAg at week 96.The areas under the curves were all,the cutoff values of HBVDNA level were 3.35,3.485,3.34(log10copies/ml)。The specificity, positive predictive value and accuracy of week 12 was higher than week 24 and 48,but the sensitivity was the lowest.The HBVDNA level at week 48 related with the incidence of drug resistance(P =0.028,OR=3.360)closely.Conclusions: In patients with HBeAg-positive chronic hepatitis B, 96 weeks of 10 mg adefovir dipivoxil per day reduced serum HBVDNA and alanine aminotransferase levels, and the HBeAg loss rate at week 96 was siganificantly higher than week 48. A higher serum ALT level(5×ULN)on baseline could predict higher rate of HBeAg seroconversion. Baseline HBV DNA level had no significant impact on efficacy of 2 years. Early viral suppression (12w or 24w or 48) could predict higher rate of loss of HBeAg.HBVDNA level at 12w was the best predictors.The HBVDNA level at 48w was the predictor of drug resistance.