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 log(10) 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.
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 log(10) 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.
Authors: Suk Bae Kim; Il Han Song; Young Min Kim; Ran Noh; Ha Yan Kang; Hyang Ie Lee; Hyeon Yoong Yang; An Na Kim; Hee Bok Chae; Sae Hwan Lee; Hong Soo Kim; Tae Hee Lee; Young Woo Kang; Eaum Seok Lee; Seok Hyun Kim; Byung Seok Lee; Heon Young Lee Journal: World J Gastroenterol Date: 2012-12-21 Impact factor: 5.742
Authors: Byung Kook Kim; Soon Young Ko; So Young Kwon; Eugene Park; Jeong Han Kim; Won Hyeok Choe; Chang Hong Lee Journal: Hepat Mon Date: 2013-04-01 Impact factor: 0.660
Authors: Won Gil Chung; Hong Joo Kim; Young Gil Choe; Hyo Sun Seok; Chang Wook Chon; Yong Kyun Cho; Byung Ik Kim; Young Yool Koh Journal: Clin Mol Hepatol Date: 2012-06-26