Comparison of entecavir and clevudine for treatment of chronic hepatitis B

Kim, Dong Hwan; Kim, Sun Hye; Kim, Jeong Ho; Park, Byung Kyu; Suh, Jeong Hun; Cho, Yong Suk; Choi, Jong Won; Lee, Chun Kyon

Abstract

BACKGROUND/AIMS
Entecavir (ETV) and clevudine (CLV) are potent inhibitors of hepatitis B virus (HBV) DNA polymerase and have demonstrated clinical efficacy. No comparative study has reported on these two medications among patients with naive chronic hepatitis B (CHB). We assessed the clinical outcome of CHB patients treated with either ETV or CLV.
METHODS
A nonrandomized comparative study was conducted retrospectively. The clinical results from treatments of either 0.5 mg ETV (n=56) or 30 mg CLV (n=45) were analyzed during a 1 year period. The median reduction in serum HBV DNA, undetectable HBV DNA, HBeAg seroconversion, and normalization of alanine transaminase (ALT) were compared between the two groups.
RESULTS
After 1 year on antiviral therapy, the median reduction in serum HBV DNA from baseline to the endpoint was greater in patients in the ETV group than in those in the CLV (5.73 vs. 4.5 log copies/mL, p=0.009) group. ALT normalization occurred in 85.5% (47/55) of the ETV cases and 77.3% (34/40) of the CLV cases (p=0.215). HBV DNA was undetectable in 80.0% (44/55) of the ETV group and 78.0% (32/41) of the CLV group (p=0.505). HBeAg seroconversion occurred in 15.4% (6/39) of those administered ETV and in 14.3% (4/28) administered CLV (p=0.593). Within 12 months, a virological breakthrough was documented in three patients undergoing CLV treatment, and CLV-related myopathy developed in three other patients.
CONCLUSIONS
ETV and CLV showed excellent antiviral effects in patients with CHB. ETV was superior for viral suppression and showed fewer side effects than CLV.