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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
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
Citation
Gastroenterology, 2009, v. 136 n. 5 Suppl 1, p. A868 Abstract no.W1817 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-naïve 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 ADVexperienced 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/10722/224427
ISSN
2015 Impact Factor: 18.187
2015 SCImago Journal Rankings: 7.170

 

DC FieldValueLanguage
dc.contributor.authorLai, CL-
dc.contributor.authorElion, RA-
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.authorMencarini, KA-
dc.contributor.authorZhang, H-
dc.contributor.authorIloeje, UH-
dc.contributor.authorKreter, B-
dc.date.accessioned2016-04-05T03:51:32Z-
dc.date.available2016-04-05T03:51:32Z-
dc.date.issued2009-
dc.identifier.citationGastroenterology, 2009, v. 136 n. 5 Suppl 1, p. A868 Abstract no.W1817-
dc.identifier.issn0016-5085-
dc.identifier.urihttp://hdl.handle.net/10722/224427-
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-naïve 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 ADVexperienced 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.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro-
dc.relation.ispartofGastroenterology-
dc.rightsPosting accepted manuscript (postprint): © <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.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.identifier.hkuros181161-
dc.identifier.volume136-
dc.identifier.issue5 Suppl 1-
dc.identifier.spageA868 Abstract no.W1817-
dc.identifier.epageA868 Abstract no.W1817-
dc.publisher.placeUnited States-

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