Comparison between clevudine and entecavir treatment for antiviral-naïve patients with chronic hepatitis B.
OBJECTIVE
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.
Kim
Hong Joo
HJ
Department of Internal Medicine, Division of Gastroenterology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. hongjoo3.kim@samsung.com
Park
Dong Il
DI
Park
Jung Ho
JH
Cho
Yong Kyun
YK
Sohn
Chong Il
CI
Jeon
Woo Kyu
WK
Kim
Byung Ik
BI
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001086:Arabinofuranosyluracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced; D056910:Republic of Korea; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D014779:Virus Replication / Q000187:drug effects
D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D001086:Arabinofuranosyluracil; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase; C034935:clevudine