Comparison between clevudine and entecavir treatment for antiviral‐naïve patients with chronic hepatitis B

Background and Aims: There has been no study comparing the clinical efficacy of clevudine and entecavir in antiviral‐naïve patients with chronic hepatitis B (CHB). Methods: A total of 128 antiviral‐naïve CHB patients were included to receive clevudine 30 mg (n=55) or entecavir 0.5 mg (n=73) once daily for a mean follow‐up period of 18.4 months. Results: Thirty‐three (60.0%) in the clevudine group and 40 (54.8%) in the entecavir group were HBeAg positive (P>0.05). At 6 months from the baseline, the mean decreases in HBV‐DNA were 4.86 and 4.72 log₁₀ copies/ml in the clevudine and entecavir groups respectively (P>0.05). The proportion of patients with undetectable serum HBV‐DNA (<300 copies/ml) at 6 months was 65.5 and 74.0% in the clevudine and entecavir groups respectively (P>0.05). The proportion of patients with normal alanine aminotransferase levels at 6 months was 74.5 and 84.9% in the clevudine and entecavir groups respectively. During the mean follow‐up of 18.4 months, genotypic resistance was noted in three patients (5.5%) in the clevudine group and no cases in the entecavir group. Eight patients (14.6%) in the clevudine group experienced symptoms, signs and laboratory abnormalities relevant to clevudine‐induced myopathy. Conclusions: Clevudine and entecavir treatment effectively suppresses HBV replication in most antiviral‐naïve patients with CHB. During a mean follow‐up of 18.9 months, a small proportion (5.5%) of patients in the clevudine group developed genotypic resistance. However, a substantial proportion (14.6%) of patients in the clevudine group had an adverse effect of clevudine‐induced myopathy.