title: A comparison of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive patients: a prospective cohort study in China.
abstract: There are few studies directly comparing the efficacy and safety of telbivudine and entecavir. The present prospective cohort study aimed to evaluate the long-term efficacy and safety of these compounds in 196 hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B for a median follow-up period of 172 weeks; 97 were treated with telbivudine and 99 were treated with entecavir. Patients showing suboptimal responses could also take adefovir at 24-48 weeks and all patients with viral breakthrough were started on adefovir. The 240-week cumulative proportions of patients showing undetectable hepatitis B DNA levels and serum alanine transaminase (ALT) normalization were similar in the two study groups. Viral breakthrough developed in 14% of the telbivudine group and in 2% of the entecavir group (p 0.002). Interestingly, the cumulative proportions of patients treated with entecavir and telbivudine showing HBeAg seroconversion were 12% versus 21% at 48 weeks (p 0.041), 15% versus 38% at 96 weeks (p 0.001), 24% versus 50% at 144 weeks (p 0.001), 33% versus 53% at 192 weeks (p 0.004) and 36% versus 53% at 240 weeks (p 0.005), respectively. Patients treated with telbivudine were therefore significantly more likely to show HBeAg seroconversion than those receiving entecavir and similar results were observed in study sub-groups matched for age, serum ALT, and HBV DNA levels. A safety analysis identified no differences between grade 3/4 creatine kinase elevations in the study groups and only telbivudine was associated with improved kidney function.
authors.affiliation: Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: P
authors.initials: P
authors.lastname: Hu
authors.affiliation: Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China; Department of Hepatitis Disease, Shanghai Public Health Clinical Centre, Fudan University, Shanghai, China.
authors.forename: X
authors.initials: X
authors.lastname: Qi
authors.affiliation: Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: H
authors.initials: H
authors.lastname: Ren
authors.affiliation: Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China. Electronic address: richengmao@gmail.com.
authors.forename: R-C
authors.initials: RC
authors.lastname: Mao
authors.affiliation: Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Medical Molecular Virology of the Ministries of Education and Health (MOH & MOE), Fudan University, Shanghai, China. Electronic address: jmzhang@fudan.edu.cn.
authors.forename: J-M
authors.initials: JM
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers; D002681:China; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D006513:Hepatitis B e Antigens / Q000097:blood / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy / Q000276:immunology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077712:Telbivudine; D013936:Thymidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D006513:Hepatitis B e Antigens; D000077712:Telbivudine; C413685:entecavir; D006147:Guanine; D013936:Thymidine
keywords: Chronic hepatitis B; entecavir; hepatitis B e antigen seroconversion; long-term treatment; telbivudine