Department of Medicine and Hepatology, Henry Dunant Hospital, , National and Kapodistrian University of Athens, Athens, Greece; Molecular Biology Laboratory of the Liver Unit at the Evgenidion Hospital , National and Kapodistrian University of Athens, Athens, Greece.
BACKGROUND & AIMS:
Little is known about the biochemical and virologic effects of stopping long-term treatment nucleos(t)ide analogue therapy for hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B (CHB).
We performed a cohort observational study, following 33 HBeAg-negative patients with CHB, undetectable serum HBV DNA, and normal levels of aminotransferases after long-term (4 or 5 years) treatment with adefovir dipivoxyl (ADV). All patients were followed for 5.5 years; follow-up visits included measurements of serum alanine aminotransferase (ALT), hepatitis B surface antigen (HBsAg), and HBV DNA monthly, for the first 6 months and every 3-6 months thereafter. Various factors were measured at baseline, the end of treatment (EOT), and following treatment to identify those associated with clearance of HBsAg.
During the first few months of the post-discontinuation period, all patients experienced virologic and 25 (76%) had biochemical relapse. During follow-up period, 18 patients (55%) who had discontinued antiviral therapy achieved sustained response (SR, HBV DNA <2000 IU/L, persistently normal level of ALT). Among these 13 (72%) cleared HBsAg. Fifteen patients (45%) with virologic and/or biochemical relapse were retreated with oral antiviral agents (11 during the first 18 months and 4 after the third year), without evidence of liver decompensation; only 1 lost HBsAg (6%). Higher pretreatment and EOT levels of ALT, no previous treatment with interferon, and lower level of HBsAg at the EOT were significantly associated with HBsAg clearance, based on multivariate analysis.
In HBeAg-negative patients with CHB, it is safe and effective to discontinue ADV therapy after 4 or 5 years; 55% of patients have SRs and 39% of the patients lose HBsAg.