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Conference Paper: Entecavir (ETV) therapy in chronic hepatitis B patients previously treated with adefovir (ADV) with incomplete response on-treatment or relapse off-treatment

TitleEntecavir (ETV) therapy in chronic hepatitis B patients previously treated with adefovir (ADV) with incomplete response on-treatment or relapse off-treatment
Authors
Issue Date2009
PublisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep
Citation
The International Liver Congress TM 2009. 44 Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, 22–26 April 2009. In Journal of Hepatology, 2009, v. 50 n. Suppl 1, p. S334 How to Cite?
AbstractBackground: The primary aims of antiviral therapy for the treatment of chronic hepatitis B (CHB) are the suppression of viral replication and remission of liver disease. However, a significant proportion of CHB patients treated with adefovir (ADV) have a suboptimal response to treatment, increasing the risks of disease progression and development of resistance. Due to the absence of cross-resistance in vitro, entecavir (ETV) therapy is recommended in patients not responding to ADV. Methods: Study ETV-079 was a randomized, open-label study comparing the viral kinetics, efficacy and safety of ETV (0.5 mg/day) with ADV (10 mg/day) in nucleoside-naive HBeAg(+) patients. After 48 weeks of treatment, patients from both arms of this study were eligible to enroll in the rollover study ETV-901 and receive treatment with ETV (1.0 mg/day). Results: Eighteen of the 24 ADV-treated patients who enrolled in ETV-901 from ETV-079 either failed to achieve undetectable HBV DNA (PCR<300 copies/mL) or relapsed following ADV therapy and were subsequently switched to ETV. Among the patients who relapsed off-treatment between ETV-079 and -901, the treatment gap ranged from 1–128 days. At entry into ETV-901, the median HBV DNA for the whole group was 6.31 log10 copies/mL. Median exposure to ETV (1.0 mg) in ETV-901 was 46 weeks, and all 18 patients currently remain on study therapy. At Week 24, the mean reduction in HBV DNA was −4.54 log10 copies/mL and 8/16 (50%) achieved HBV DNA <300 copies/mL. Nine patients had reached Week 48 in ETV-901; all had reductions in HBV DNA to <104 copies/mL and 8/9 (89%) had HBV DNA <300 copies/mL. Genotypic resistance testing was not performed. The safety profile of ETV in these ADV-experienced patients remained consistent with the previously reported experience. Conclusions: The majority of patients who had incomplete virological response or experienced virological relapse following ADV treatment in study ETV-079 had rapid reductions in HBV DNA when switched to ETV in study ETV-901. HBV DNA levels continued to decline to <300 copies/mL in the majority of patients between 24 and 48 weeks of ETV treatment.
Persistent Identifierhttp://hdl.handle.net/10722/62366
ISSN
2015 Impact Factor: 10.59
2015 SCImago Journal Rankings: 4.570

 

DC FieldValueLanguage
dc.contributor.authorLai, CL-
dc.contributor.authorElion, R-
dc.contributor.authorSherman, M-
dc.contributor.authorHann, HW-
dc.contributor.authorTyrell, DL-
dc.contributor.authorHsu, CW-
dc.contributor.authorTan, CK-
dc.contributor.authorPeng, CY-
dc.contributor.authorLeung, N-
dc.contributor.authorMercarni, K-
dc.contributor.authorZhang, H-
dc.contributor.authorIloeje, UH-
dc.contributor.authorKreter, B-
dc.date.accessioned2010-07-13T03:59:43Z-
dc.date.available2010-07-13T03:59:43Z-
dc.date.issued2009-
dc.identifier.citationThe International Liver Congress TM 2009. 44 Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, 22–26 April 2009. In Journal of Hepatology, 2009, v. 50 n. Suppl 1, p. S334-
dc.identifier.issn0168-8278-
dc.identifier.urihttp://hdl.handle.net/10722/62366-
dc.description.abstractBackground: The primary aims of antiviral therapy for the treatment of chronic hepatitis B (CHB) are the suppression of viral replication and remission of liver disease. However, a significant proportion of CHB patients treated with adefovir (ADV) have a suboptimal response to treatment, increasing the risks of disease progression and development of resistance. Due to the absence of cross-resistance in vitro, entecavir (ETV) therapy is recommended in patients not responding to ADV. Methods: Study ETV-079 was a randomized, open-label study comparing the viral kinetics, efficacy and safety of ETV (0.5 mg/day) with ADV (10 mg/day) in nucleoside-naive HBeAg(+) patients. After 48 weeks of treatment, patients from both arms of this study were eligible to enroll in the rollover study ETV-901 and receive treatment with ETV (1.0 mg/day). Results: Eighteen of the 24 ADV-treated patients who enrolled in ETV-901 from ETV-079 either failed to achieve undetectable HBV DNA (PCR<300 copies/mL) or relapsed following ADV therapy and were subsequently switched to ETV. Among the patients who relapsed off-treatment between ETV-079 and -901, the treatment gap ranged from 1–128 days. At entry into ETV-901, the median HBV DNA for the whole group was 6.31 log10 copies/mL. Median exposure to ETV (1.0 mg) in ETV-901 was 46 weeks, and all 18 patients currently remain on study therapy. At Week 24, the mean reduction in HBV DNA was −4.54 log10 copies/mL and 8/16 (50%) achieved HBV DNA <300 copies/mL. Nine patients had reached Week 48 in ETV-901; all had reductions in HBV DNA to <104 copies/mL and 8/9 (89%) had HBV DNA <300 copies/mL. Genotypic resistance testing was not performed. The safety profile of ETV in these ADV-experienced patients remained consistent with the previously reported experience. Conclusions: The majority of patients who had incomplete virological response or experienced virological relapse following ADV treatment in study ETV-079 had rapid reductions in HBV DNA when switched to ETV in study ETV-901. HBV DNA levels continued to decline to <300 copies/mL in the majority of patients between 24 and 48 weeks of ETV treatment.-
dc.languageeng-
dc.publisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep-
dc.relation.ispartofJournal of Hepatology-
dc.rights© <year>. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/-
dc.titleEntecavir (ETV) therapy in chronic hepatitis B patients previously treated with adefovir (ADV) with incomplete response on-treatment or relapse off-treatment-
dc.typeConference_Paper-
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0168-8278&volume=50&issue=Suppl 1&spage=S334&epage=&date=2009&atitle=Entecavir+(ETV)+therapy+in+chronic+hepatitis+B+patients+previously+treated+with+adefovir+(ADV)+with+incomplete+response+on-treatment+or+relapse+off-treatment.en_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/S0168-8278(09)60921-1-
dc.identifier.hkuros161378-
dc.identifier.volume50-
dc.identifier.issueSuppl 1-
dc.identifier.spageS334-
dc.identifier.epageS334-
dc.publisher.placeNetherlands-

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