替比夫定
医学
HBeAg
胃肠病学
内科学
血清转化
人口
拉米夫定
慢性肝炎
乙型肝炎病毒
免疫学
乙型肝炎表面抗原
病毒
环境卫生
作者
Edward Gane,Yuming Wang,Yun‐Fan Liaw,Jinlin Hou,Satawat Thongsawat,Mo-Bin Wan,Young Myoung Moon,Jidong Jia,Chao You,Junqi Niu,Nancy Leung,Didier Samuel,Chao‐Wei Hsu,Weibin Bao,Patricia López,Claudio Ávila
标识
DOI:10.1111/j.1478-3231.2011.02490.x
摘要
In the GLOBE trial, telbivudine demonstrated superior efficacy to lamivudine at 2 years in patients with chronic hepatitis B (CHB).To investigate the long-term efficacy and safety of telbivudine in the telbivudine-treated cohort from the GLOBE trial.Virological and biochemical responses were assessed in 213 HBeAg-positive and 186 HBeAg-negative CHB patients who continued telbivudine treatment for 3 years.Undetectable hepatitis B virus DNA and HBeAg seroconversions were achieved by 77 and 37% of HBeAg-positive patients respectively. Cumulative HBeAg seroconversion rate was 46%. HBeAg seroconversion was sustained at 52 weeks off therapy in 84% of the patients enrolled in the off-treatment follow-up arm of the study. Undetectable viraemia and normal alanine aminotransferase (ALT) levels at 3 years were achieved by 85 and 83% of HBeAg-negative patients respectively. Genotypic resistance rates for the study population who continued therapy during the third year were 11.3 in HBeAg-positive and 6.5% in HBeAg-negative patients. Patients with undetectable viraemia at treatment week 24 had optimal outcomes at 3 years. In the HBeAg-positive population, cumulative HBeAg seroconversion occurred in 58%. Resistance rates for HBeAg-positive and HBeAg-negative patients were 3.6 and 6.2% respectively. The telbivudine safety profile during prolonged therapy was similar to that in the GLOBE trial.Three years of telbivudine treatment yielded high rates of viral suppression and ALT normalization with a favourable safety profile. High rates of HBeAg seroconversion were achieved with prolonged telbivudine therapy and were sustained in the majority of patients over 52 weeks off therapy.
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