title: Ten-year follow-up of hepatitis B relapse after cessation of lamivudine or telbivudine treatment in chronic hepatitis B patients.
abstract: The high rate of relapse after cessation of nucleos(t)ide analogues (NUCs) treatment in chronic hepatitis B (CHB) patients leads us to reassess the feasibility for off-therapy, but long-term follow-up data are scarce. We assessed the feasibility for off-therapy by a long-term observation of relapse in response to lamivudine (LAM) and telbivudine (LdT). Eighty-six NUC-naive CHB patients, treated with LAM (n = 46) or LdT (n = 40) who reached the guidelines recommended for off-therapy, were followed for up to 10 years. Hepatitis B virus (HBV), viral serology and biochemistries were periodically determined. COX model was used to predict the risk of relapse. A total of 52.3% of patients experienced relapse within a median of 115 months (range, 61-122 months). A total of 93.3% of relapses occurred within 48 months. Relapse rates in hepatitis B e antigen (HBeAg)-positive (n = 56) and HBeAg-negative (n = 30) patients were 39.3% and 76.7%, respectively (p < 0.01). HBeAg-positive patients who achieved an early viral response (EVR), defined as undetectable HBV DNA within 6 months, had a lower relapse rate compared to non-EVR patients (21.4% vs. 59.2%, p < 0.01). EVR patients who had both lower HBV DNA (<10(6) copies/mL) at baseline and lower hepatitis B surface antigen (HBsAg) at end of treatment had a relapse rate of 10.7%. The high relapse rates in CHB patients over this 10-year follow-up make LAM or LdT off therapy infeasible in most of the cases, except in the case of HBsAg loss and/or seroconversion. HBeAg-positive patients with EVR, lower HBV DNA and HBsAg had lower relapse rates and could be good candidates for off-therapy. Long-term monitoring, especially during the first 4 years, is critical for patients off-therapy.
authors.affiliation: Department of Infectious Diseases, Zhejiang Provincial People's Hospital, Zhejiang Chinese Medicinal University, China. Electronic address: panhongying@sohu.com.
authors.forename: H-Y
authors.initials: HY
authors.lastname: Pan
authors.affiliation: Department of Medicine, Pujiang People's Hospital, China.
authors.forename: H-Y
authors.initials: HY
authors.lastname: Pan
authors.affiliation: Zhejiang Chinese Medicinal University, China.
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Infectious Diseases, Zhejiang Provincial People's Hospital, Zhejiang Chinese Medicinal University, China.
authors.forename: D-H
authors.initials: DH
authors.lastname: Yang
authors.affiliation: Department of Infectious Diseases, Zhejiang Provincial People's Hospital, Zhejiang Chinese Medicinal University, China.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Huang
authors.affiliation: Department of Infectious Diseases, Zhejiang Provincial People's Hospital, Zhejiang Chinese Medicinal University, China.
authors.forename: Y-X
authors.initials: YX
authors.lastname: Tong
authors.affiliation: Department of Internal Medicine, Hangzhou Xixi Hospital, Hangzhou, Zhejiang, China.
authors.forename: C-R
authors.initials: CR
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, Hangzhou Xixi Hospital, Hangzhou, Zhejiang, China.
authors.forename: J
authors.initials: J
authors.lastname: Yan
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000032:analysis; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology*; D006511:Hepatitis B Antigens / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000453:epidemiology* / Q000276:immunology / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012008:Recurrence; D012189:Retrospective Studies; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006511:Hepatitis B Antigens; D000077712:Telbivudine; D019259:Lamivudine; D013936:Thymidine
keywords: Chronic hepatitis B; long-term durability; nucleoside analogues