Three years clinical observation on Telbivudine in the treatment of chronic hepatits B

Objective:To investigate the efficacy and safety of applying Telbivudine in the treatment of chronic hepatitis B(CHB)for consecutive 3 years.Methods :Totally 62 patients with CHB who received monotherapy of Telbivudine in the department of infectious diseases in the second affiliated hospital of Chongqing medical university took Telbivudine 600 mg orally once per day.The virology,serology and biochemical indicators of 62 patients were detected and analyzed before and at the 156th week after the treatment.The 62 patients who received the treatment for 3 years were divided into two groups according to the hepatitis B virus(HBV)DNA level(lg3 copy/ml and ≥lg3 copy/ml)and comparison was made at the 156th week during the treatment in order to know the efficacy and safety of the treatment.Chi-square test or calibration chi-square test was applied to do the efficacy comparison.Results:After 156 weeks of treatment,HBV DNA negative rate was 79.0%,Alanine aminotransferase(ALT)normalization rate was 72.6%,HBeAg seroconversion rate was 39.7% and drug resistant rate was 11.3%.In HBeAg-positive patients(with HBV DNAlg3 copy/ml at the 24th week),the HBV DNA negative rate at the 156th week was significantly higher than that of HBeAg-positive patients(with HBV DNA≥lg3 copy/ml at the 24th week)(χ 2 =13.98,P0.005),the HBeAg seroconversion rate was higher(P 0.05)and the drug resistant rate was lower(χ 2 =4.17,P0.05)between these patients.During the treatment,37.1% of patients had creatine kinase(CK)elevation,but there was no case stopping treatment for severe adverse effect.Conclusions:Three years of clinical research indicates that Telbivudine,with the advantages of high HBeAg serocon version and low drug resistance rate,can inhibit HBV DNA replication rapidly and normalize ALT.It is a safe and effective antiviral drug.HBV DNA levels at the 24th week of Telbivudine treatment is a good predictor of the efficacy at the 156th week.