Abstract:
Objective To analyze the efficacy and safety of initial telbivudine treatment in chronic hepatitis B (CHB) patients.Methods Seventy-three consecutive CHB patients treated with initial telbivudine treatment for at least one year were enrolled in the study between September 2007 and February 2012.Measurements were made of alanine aminotransferase (ALT) , hepatitis B virus (HBV) DNA, and HBV serological markers at baseline, then every month before virological response (HBV DNA<1.0×103 copies/ml) was reached, and every three months after virological response.The cumulative rate of virological response, hepatitis B e antigen (HBeAg) conversion, and resistance were calculated.The value of the HBeAg (PEIU/ml) descending amplitude (log) for predicting HBeAg conversion at 12 and 24 weeks was evaluated.Creatine kinase (CK) levels were measured at intervals according to the patient condition.Results Of the 73 CHB cases, 50 were HBeAg-positive and 23 were HBeAg-negative.The cumulative rate of virological response within one year of treatment was 96% in the HBeAg-positive group and 100% in the HBeAg-negative group, and the rate within two years of treatment was 96% in the HBeAg-positive group and 100% in the HBeAg-negative group.Among the patients achieving virological response, 90% in the HBeAg-positive group and 95% in the HBeAg-negative group occurred within 24 weeks.The cumulative rates of HBeAg conversion within one and two years of treatment were 48% and 61%, respectively.The cumulative rates of resistance for the HBeAg-positive group and the HBeAg-negative group were 2% and 4%, respectively, in one year, and 24% and 11%, respectively, in two years.The cutoff values of HBeAg descending amplitude at 12 and 24 weeks for predicting HBeAg conversion were 0.2557 and 0.3844.The cumulative rate of HBeAg conversion in the cases with HBeAg descending amplitude ≥0.2557 log PEIU/ml at 12 weeks and ≥0.3884 log PEIU/ml at 24 weeks were significantly higher than those from the two years group (χ2=28.996 and 15.036, both P<0.0001) .CK was tested in 66 patients (total of 186 times) , and 78.8% of patients were found to have elevated CK.Of those, 95.6% were 1-2 grade, and only 4.4% were ≥3 grade.The elevated CK cases had no obvious signs of myalgia or myitis, and for all the CK level resolved to normal within three to six months.There were no cases of telbivudine termination due to elevated CK.Conclusion Telbivudine is an effective and safe drug for initial treatment of CHB patients, regardless of HBeAg status.The descending amplitude (log) of HBeAg at 12 and 24 weeks of telbivudine treatment can be a good predictive factor for one and two year HBeAg conversion.