Abstract
AimCurrently, there is no consensus on the retreatment recommendation of chronic hepatitis B (CHB) patients with viral rebound after cessation of treatment. In the search of reasonable treatment, we compared the efficacy and safety of adefovir (ADV) plus lamivudine (LAM) and LAM alone for the retreatment of patients with viral relapse but without genotypic resistance after cessation of LAM.MethodsThis is a prospective controlled study, and a total of 53 hepatitis B e antigen (HBeAg)-positive patients with viral rebound but without resistance were received either LAM plus ADV or LAM alone treatment.ResultsAfter 1-year treatment, more patients who received LAM plus ADV than those who received LAM alone had ALT normalization (84% versus 53.6%, P = 0.018) or HBV DNA levels below 1000 copies/mL (80% versus 42.9%, P < 0.006). Seven patients receiving LAM plus ADV had HBeAg seroconversion, as compared with 0 in patients receiving ALM alone (28% versus 0%, P = 0.003). During 1-year retreatment, five patients receiving LAM alone had virological breakthrough and all of them had LAM resistance strains (rtM204V/I), while no LAM- or ADV- associated resistance strains were detected in patients receiving LAM plus ADV. All patients receiving LAM plus ADV were well tolerated, and no serious side effects were noted.ConclusionsPatients treated with LAM plus ADV exhibited significantly greater virological, biochemical and serological responses compared with LAM alone. These data suggested that combination of LAM plus ADV would be a good option for the retreatment of CHB patients with viral relapse after cessation of LAM.
Highlights
Estimated 350~400 million individuals worldwide are chronically infected with hepatitis B virus (HBV)[1], and chronic hepatitis B(CHB) can progress to cirrhosis, hepatocellular carcinoma (HCC), and death[2]
Characteristics of the study patients A total of 53 hepatitis B e antigen (HBeAg)-positive CHB patients were analyzed in the study, which comprised of 25 patients in LAM plus ADV and 28 patients in LAM alone retreatment (Figure 1)
Biochemical response Serum ALT levels declined in both treatment groups, but ALT level was normalized in a higher proportion of LAM plus ADV than LAM alone retreatment in total
Summary
Estimated 350~400 million individuals worldwide are chronically infected with hepatitis B virus (HBV)[1], and chronic hepatitis B(CHB) can progress to cirrhosis, hepatocellular carcinoma (HCC), and death[2]. Nucleos(t)ide analogs approved for treatment of CHB include lamivudine (LAM), adefovir (ADV), entecavir, telbivudine and tenofovir, and they have been considered to have a good effect in suppressing virus replication with reaching virological response irrespective of the occurrence of HBeAg seroconversion. How to therapy those patients with viral relapse has become an urgent problem that we have to face[12]. There is no consensus on the retreatment of viral relapse with or without resistance after cessation of nucleos(t)ide analogs treatment It is still unknown whether there is significant difference between original drug monotherapy or combined with other drugs without cross-resistance
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