Serum HBV DNA level at week 12 is superior to viral response at week 24 in predicting long-term treatment outcome of telbivudine for chronic hepatitis B patients

Background Telbivudine,one of the five nucleoside antiviral drugs,was reported to be superior to lamivudine in a better biochemical,virological,and histological response for treatment-naive patients in the GLOBE trial.The aim of this study was to determine the antiviral potency,viral resistance,and the significance of early response for long-term telbivudine treatment.Methods We recruited 161 patients of chronic hepatitis B(CHB)on telbivudine between January 2009 and September2011 in Macau,China.The serum hepatitis B virus DNA levels,hepatitis B e antigen(HBeAg)seroconversion,alanine aminotransferase(ALT)normalization,and viral resistance were analyzed.Results The median age and follow-up duration were 48 years and 16.9 months.All patients were followed up for at least 6 months,while data were collected for 132,120,95,and 53 patients at 12,24,48,and 96 weeks respectively.The cumulative HBeAg seroconversion rate was 20.8%and only three patients(1.9%)presented with telbivudine low level resistance.The ALT normalization rates were 76.9%at 48 weeks and 77.6%at 96 weeks.Undetectable HBV DNA was achieved by 1.8%,31.6%,60%,and 74.1%in HBeAg positive patients and 29.3%,60.3%,84%,and 84.6%in HBeAg negative patients at each time point.Week 12 HBV DNA level<1000 copies/ml(<200 lU/ml)was a better predictor of viral suppression at 2-year follow-up(P=0.001,OR=27.00)than undetectable HBV DNA level at week 24(P=0.120,OR=4.81).Conclusions Two-year telbivudine treatment yielded high rates of viral suppression and ALT normalization.Serum HBV DNA level at week 12 is a superior predictor for long-term viral suppression.