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Article: Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir

TitleEarly hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir
Authors
Issue Date2009
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
Citation
Hepatology, 2009, v. 49 n. 1, p. 72-79 How to Cite?
AbstractThis study was undertaken to compare the early antiviral activity and viral kinetic profiles of entecavir (ETV) versus adefovir (ADV) in hepatitis B e antigen positive nucleoside-naïve adults with chronic hepatitis B (CHB). Sixty-nine nucleoside-naïve CHB patients with baseline HBV DNA of 10 8 copies/mL or more were randomized 1:1 to open-label treatment with entecavir 0.5 mg/day or adefovir 10 mg/day for a minimum of 52 weeks. The primary efficacy analysis compared mean reduction in HBV DNA at week 12 adjusted for baseline levels using linear regression. Entecavir was superior to adefovir for mean change from baseline in HBV DNA at week 12 (-6.23 log 10 copies/mL versus -4.42 log 10 copies/mL, respectively; mean difference -1.58 log 10 copies/mL; P < 0.0001). Both drugs demonstrated biphasic viral kinetics, with a first phase of rapid decline lasting 10 days. A significant difference favoring ETV was reached at day 10 (day 10 ETV-ADV difference estimate: -0.66 log 10 copies/mL; 95% CI [-0.30, -0.01]). Early virological response was found to be predictive of subsequent virological response, with those having lower HBV DNA levels at day 10 being more likely to achieve HBV DNA of less than 300 copies/mL at week 48. In addition, there was considerably less variability in the extent of HBV DNA reductions in patients treated with entecavir versus adefovir. Both the mean decrease in serum HBV DNA and the proportion of patients achieving HBV DNA less than 300 copies/mL were greater in entecavir-treated than adefovir-treated patients at weeks 2, 4, 8, 12, 24, and 48. At week 48, one (3%) ETV-treated versus 15 (47%) ADV-treated patients had HBV DNA of 10 5 copies/mL or more. Both antivirals were well tolerated. Conclusion: Entecavir therapy resulted in earlier and superior reduction in HBV DNA compared with adefovir in nucleoside-naïve HBeAg-positive patients with CHB. Copyright © 2008 by the American Association for the Study of Liver Diseases.
Persistent Identifierhttp://hdl.handle.net/10722/59183
ISSN
2015 Impact Factor: 11.711
2015 SCImago Journal Rankings: 4.752
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLeung, Nen_HK
dc.contributor.authorPeng, CYen_HK
dc.contributor.authorHann, HWen_HK
dc.contributor.authorSollano, Jen_HK
dc.contributor.authorLaoTan, Jen_HK
dc.contributor.authorHsu, CWen_HK
dc.contributor.authorLesmana, Len_HK
dc.contributor.authorYuen, MFen_HK
dc.contributor.authorJeffers, Len_HK
dc.contributor.authorSherman, Men_HK
dc.contributor.authorMin, Aen_HK
dc.contributor.authorMencarini, Ken_HK
dc.contributor.authorDiva, Uen_HK
dc.contributor.authorCross, Aen_HK
dc.contributor.authorWilber, Ren_HK
dc.contributor.authorLopezTalavera, Jen_HK
dc.date.accessioned2010-05-31T03:44:31Z-
dc.date.available2010-05-31T03:44:31Z-
dc.date.issued2009en_HK
dc.identifier.citationHepatology, 2009, v. 49 n. 1, p. 72-79en_HK
dc.identifier.issn0270-9139en_HK
dc.identifier.urihttp://hdl.handle.net/10722/59183-
dc.description.abstractThis study was undertaken to compare the early antiviral activity and viral kinetic profiles of entecavir (ETV) versus adefovir (ADV) in hepatitis B e antigen positive nucleoside-naïve adults with chronic hepatitis B (CHB). Sixty-nine nucleoside-naïve CHB patients with baseline HBV DNA of 10 8 copies/mL or more were randomized 1:1 to open-label treatment with entecavir 0.5 mg/day or adefovir 10 mg/day for a minimum of 52 weeks. The primary efficacy analysis compared mean reduction in HBV DNA at week 12 adjusted for baseline levels using linear regression. Entecavir was superior to adefovir for mean change from baseline in HBV DNA at week 12 (-6.23 log 10 copies/mL versus -4.42 log 10 copies/mL, respectively; mean difference -1.58 log 10 copies/mL; P < 0.0001). Both drugs demonstrated biphasic viral kinetics, with a first phase of rapid decline lasting 10 days. A significant difference favoring ETV was reached at day 10 (day 10 ETV-ADV difference estimate: -0.66 log 10 copies/mL; 95% CI [-0.30, -0.01]). Early virological response was found to be predictive of subsequent virological response, with those having lower HBV DNA levels at day 10 being more likely to achieve HBV DNA of less than 300 copies/mL at week 48. In addition, there was considerably less variability in the extent of HBV DNA reductions in patients treated with entecavir versus adefovir. Both the mean decrease in serum HBV DNA and the proportion of patients achieving HBV DNA less than 300 copies/mL were greater in entecavir-treated than adefovir-treated patients at weeks 2, 4, 8, 12, 24, and 48. At week 48, one (3%) ETV-treated versus 15 (47%) ADV-treated patients had HBV DNA of 10 5 copies/mL or more. Both antivirals were well tolerated. Conclusion: Entecavir therapy resulted in earlier and superior reduction in HBV DNA compared with adefovir in nucleoside-naïve HBeAg-positive patients with CHB. Copyright © 2008 by the American Association for the Study of Liver Diseases.en_HK
dc.languageengen_HK
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/en_HK
dc.relation.ispartofHepatologyen_HK
dc.rightsHepatology. Copyright © John Wiley & Sons, Inc.en_HK
dc.titleEarly hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefoviren_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0270-9139&volume=49&issue=1&spage=72&epage=9&date=2009&atitle=Early+hepatitis+B+virus+DNA+reduction+in+hepatitis+B+e+antigen-positive+patients+with+chronic+hepatitis+B:+A+randomized+international+study+of+entecavir+versus+adefovir.en_HK
dc.identifier.emailYuen, MF:mfyuen@hkucc.hku.hken_HK
dc.identifier.authorityYuen, MF=rp00479en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1002/hep.22658en_HK
dc.identifier.pmid19065670-
dc.identifier.scopuseid_2-s2.0-58949087420en_HK
dc.identifier.hkuros161067en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-58949087420&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume49en_HK
dc.identifier.issue1en_HK
dc.identifier.spage72en_HK
dc.identifier.epage79en_HK
dc.identifier.isiWOS:000262127400011-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLeung, N=26643107200en_HK
dc.identifier.scopusauthoridPeng, CY=7401797990en_HK
dc.identifier.scopusauthoridHann, HW=23080190400en_HK
dc.identifier.scopusauthoridSollano, J=6602099153en_HK
dc.identifier.scopusauthoridLaoTan, J=18437024700en_HK
dc.identifier.scopusauthoridHsu, CW=36120244800en_HK
dc.identifier.scopusauthoridLesmana, L=26039273200en_HK
dc.identifier.scopusauthoridYuen, MF=7102031955en_HK
dc.identifier.scopusauthoridJeffers, L=35421644600en_HK
dc.identifier.scopusauthoridSherman, M=7402148225en_HK
dc.identifier.scopusauthoridMin, A=7003997160en_HK
dc.identifier.scopusauthoridMencarini, K=26024252000en_HK
dc.identifier.scopusauthoridDiva, U=16174659300en_HK
dc.identifier.scopusauthoridCross, A=7202736404en_HK
dc.identifier.scopusauthoridWilber, R=7006167856en_HK
dc.identifier.scopusauthoridLopezTalavera, J=26642888200en_HK

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