Treatment Efficacy of Clevudine, Entecavir and Lamivudine in Treatment-naive Patients with HBeAg-Positive Chronic Hepatitis B.
10.4166/kjg.2010.56.6.365
- Author:
Suk Hyang BAE
1
;
Yang Hyun BAEK
;
Sung Wook LEE
;
Sang Young HAN
Author Information
1. Department of Gastroenterology, Dong-A University College of Medicine, Busan, Korea. syhan@dau.ac.kr
- Publication Type:Original Article ; Controlled Clinical Trial ; English Abstract
- Keywords:
Clevudine;
Entecavir;
Lamivudine;
Chronic hepatitis B
- MeSH:
Adult;
Alanine Transaminase/blood;
Antiviral Agents/*administration & dosage;
Arabinofuranosyluracil/administration & dosage/*analogs & derivatives;
DNA, Viral/blood;
Drug Administration Schedule;
Drug Resistance, Viral;
Female;
Guanine/administration & dosage/*analogs & derivatives;
Hepatitis B e Antigens/*blood;
Hepatitis B, Chronic/*drug therapy;
Humans;
Lamivudine/*administration & dosage;
Male;
Middle Aged;
Retrospective Studies;
Treatment Outcome
- From:The Korean Journal of Gastroenterology
2010;56(6):365-372
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND/AIMS: Clevudine is a potent antiviral agent that has demonstrated efficacy in patients with chronic hepatitis B. This study compared the efficacy of clevudine (C), entecavir (E) and lamivudine (L) in treatment-naive patient with HBeAg-positive chronic hepatitis B. METHODS: A total of 146 treatment-naive patients with HBeAg-positive chronic hepatitis B received clevudine, entecavir or lamivudine. C group (n=39) received 30 mg of clevudine, E group (n=39) received 0.5 mg of entecavir and L group (n=68) received 100 mg of lamivudine once a day for more than 48 weeks. The efficacy analysis estimated the mean changes of the HBV DNA levels as a virologic response, the normalization of the ALT levels (less than 35 IU/L) as a biochemical response and loss of HBeAg or seroconversion as a serologic response. The serum HBV DNA level was quantified by hybrid capture and real-time PCR assay. RESULTS: Before the administration of clevudine, entecavir and lamivudine, the mean HBV DNA and ALT levels and the gender and age were well balanced among the three groups (p>0.05). For the virologic response at 48 weeks, the mean changes of the HBV DNA levels from baseline of the C, E and L groups were -3.8+/-2.2, -4.5+/-1.9 and -2.5+/-2.1 log copies/mL. C and E group showed superior antiviral activity compared to that of L group (p<0.0001), but no significant differences in antiviral response were noted between C and E groups. For the biochemical response at 48 weeks, the normalization of the ALT levels (less than 35 IU/L) among the C, E and L groups was 82%, 74% and 71%, respectively (p=0.46). The rates of undetectable serum HBV DNA (less than 300 copies/mL) of the C, E and L groups were 39%, 69% and 27%, respectively (p<0.0001). For the serologic response at 48 weeks, the loss of HBeAg was 13%, 31% and 24% and the seroconversion was 10%, 23% and 17%, respectively. There was no difference of efficacy among the three groups regarding ALT normalization or serologic response (p>0.05). Viral breakthrough in C group was noted at 24 weeks (5%) and 48 weeks (21%), but no biochemical breakthrough was noted. The elevation of the serum CK level was noted in only 1 patient of group C at 48 weeks (2.56%) after therapy. For the patients without or with liver cirrhosis (LC), C and E group showed superior antiviral activity compared to that of the L group, but the antiviral activity was more effective in non- LC group than LC group (p<0.0001 vs p=0.036). CONCLUSIONS: Clevudine therapy compared with lamivudine for 48 weeks showed significantly potent antiviral efficacy in treatment-naive patients with HBeAg-positive chronic hepatitis B, and especially in the non-LC patients. However, the antiviral efficacy of clevudine was similar to that of entecavir even though taking into account relatively short follow up period and retrospective study.
