Open AccessLamivudine switch therapy in chronic hepatitis B patients achieving undetectable hepatitis B virus DNA after 3 years of entecavir therapy: A prospective, open‐label, multicenter study
Author(s) -
Yeh MingLun,
Huang ChingI.,
Hsieh MingYen,
Huang ChungFeng,
Hsieh MengHsuan,
Huang JeeFu,
Dai ChiaYen,
Lin ZuYau,
Chen ShinnChern,
Yu MingLung,
Chuang WanLong
Publication year - 2016
Publication title -
the kaohsiung journal of medical sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.439
H-Index - 36
eISSN - 2410-8650
pISSN - 1607-551X
DOI - 10.1016/j.kjms.2016.08.014
Subject(s) - medicine , entecavir , lamivudine , chronic hepatitis , virology , hepatitis b virus , hepatitis a virus , hepatitis b , virus
The subsequent maintenance therapy in chronic hepatitis B (CHB) patients after long‐term viral replication suppression is still uncertain. We aim to evaluate the efficacy of lamivudine (LAM) maintenance therapy in CHB patients achieving undetectable hepatitis B virus (HBV) DNA after 3 years of entecavir (ETV) therapy. Consecutive CHB patients who received at least 3 years of ETV and achieved HBV DNA negativity were allocated either LAM switch therapy or stopped ETV therapy in a prospective, open‐label study. Another group of sex‐ and age‐matched patients with continuous ETV therapy for at least 4 years served as historical control group. The primary outcome measurement of the study was relapse of HBV DNA (defined as serum HBV DNA level ≥ 2000 IU/mL). A total of 74 patients, including 42 of LAM switch and 32 of the nonswitch group, were enrolled. There were no significant differences in demographics, except a higher proportion of patients with positive hepatitis B envelope antigen in the nonswitch group at the initiation of ETV therapy. The LAM switch group had significantly lower 1‐year relapse rate of HBV within 1 year compared to the nonswitch group (14.3% vs. 75%, p < 0.001). However, none of the 48 historical control patients developed relapse of HBV, which was significantly lower than the rate in LAM switch group ( p < 0.001). LAM switch was the only factor associated with HBV DNA relapse. In conclusion, continuous long‐term potent nucleot(s)ide analogue therapy is mandatory for prevention of viral relapse in CHB patients.