[Treatment efficacy of clevudine, entecavir and lamivudine in treatment-naive patients with HBeAg-positive chronic hepatitis B].

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.

• Authors: Suk Hyang Bae, Yang Hyun Baek, Sung Wook Lee, Sang Young Han
• Journal: The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi (Korean J Gastroenterol) Vol. 56 Issue 6 Pg. 365-72 (Dec 2010) ISSN: 1598-9992 [Print] Korea (South)
• PMID: 21173560 (Publication Type: Controlled Clinical Trial, Journal Article)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Lamivudine
• Arabinofuranosyluracil
• entecavir
• Guanine
• Alanine Transaminase
• clevudine

Topics

• 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