title: Off-treatment efficacy of 3-year nucleos(t)ide analogues in chronic hepatitis B patients.
abstract: Lamivudine, telbivudine, and entecavir are the first-line drugs covered by the Taiwan National Health Insurance as 3-year treatments for patients with chronic hepatitis B virus (HBV), but the optimal treatment duration of each remains unclear. We aimed to detect HBV treatment-cessation durability, and compare the predictors in patients with and without clinical relapse. In this retrospective cohort study, 210 patients with chronic HBV who tested hepatitis B e-antigen positive or hepatitis B e-antigen negative were treated for 3 years with a nucleos(t)ide analogue. Of these, 102 patients continued therapy after 3 years, while 88 patients stopped treatment and were followed for 1 year due to financial difficulties. Efficacy was assessed in terms of alanine aminotransferase (ALT) level normalization, HBV DNA clearance, virus breakthrough, clinical relapse, and liver decompensation. The durability predictors were evaluated by host factors, HBV DNA, and drug differences. Eighty patients (14 on lamivudine, 19 on telbivudine, and 47 on entecavir) were recruited. There was no difference in clinical-relapse rate among lamivudine, telbivudine, and entecavir (35.7% vs. 36.8% vs. 31.9%, respectively; p = 0.916), and liver decompensated hepatitis was absent. In baseline clinical characteristics, there were no differences between the clinical-relapse and nonrelapse groups in age, sex, cirrhosis, prior treatment, HBV DNA, pretreatment ALT, or hepatitis B e-antigen (HBeAg). The mean 3(rd) year serum ALT level differed significantly between clinical-relapse and nonrelapse patients (37.5 U/L vs. 27.7 U/L, respectively; p = 0.044). The 3-year nucleos(t)ide analogue off-treatment in patients with chronic HBV delivered according to the Taiwan National Health Insurance guidelines had an overall 33.8% 1-year clinical-relapse rate without any decompensated hepatitis flare-ups.
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medical College, New Taipei City, Taiwan.
authors: Ching-Chung
authors: CC
authors: Lin
authors: Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung Branch, Taitung, Taiwan; Department of Nursing, Meiho University, Pingtung, Taiwan.
authors: Ming-Jong
authors: MJ
authors: Bair
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Chih-Jen
authors: CJ
authors: Chen
authors: Mackay Medical College, New Taipei City, Taiwan.
authors: Keng-Han
authors: KH
authors: Lee
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Ming-Jen
authors: MJ
authors: Chen
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medical College, New Taipei City, Taiwan.
authors: Chia-Yuan
authors: CY
authors: Liu
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Chen-Wang
authors: CW
authors: Chang
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Kuang-Chun
authors: KC
authors: Hu
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medical College, New Taipei City, Taiwan.
authors: Tai-Cherng
authors: TC
authors: Liou
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medical College, New Taipei City, Taiwan.
authors: Shee-Chan
authors: SC
authors: Lin
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Horng-Yuan
authors: HY
authors: Wang
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Cheng-Hsin
authors: CH
authors: Chu
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
authors: Shou-Chuan
authors: SC
authors: Shih
authors: Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medical College, New Taipei City, Taiwan. Electronic address: tewang@mmh.org.tw.
authors: Tsang-En
authors: TE
authors: Wang
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000494:pharmacology / Q000627:therapeutic use; D012189:Retrospective Studies; D000077712:Telbivudine; D000068698:Tenofovir / Q000494:pharmacology / Q000627:therapeutic use; D013936:Thymidine / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D063065:Organophosphonates; D000077712:Telbivudine; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; C053001:adefovir; D000068698:Tenofovir; D000410:Alanine Transaminase; D000225:Adenine; D013936:Thymidine
keywords: Alanine aminotransferase; Entecavir; Hepatitis B virus; Lamivudine; Telbivudine