A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naive chronic hepatitis B patients.

ABSTRACT:

Purpose

Clevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combination of clevudine 20 mg and adefovir compared to clevudine monotherapy.

Methods

Seventy-four patients were randomized to either a combination of clevudine 20 mg and adefovir or clevudine 20 or 30 mg and were treated for 2 years. The viral kinetics for 24 weeks, virological response [VR; hepatitis B virus (HBV) DNA less than 300 copies/ml], and the biochemical response [BR; normal alanine aminotransferase (ALT)] were assessed.

Results

There was no difference in baseline char

SUBMITTER: Tak WY 

PROVIDER: S-EPMC4116600 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature