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Article: Telbivudine in combination with adefovir versus adefovir monotherapy in HBeAg-positive, lamivudine-resistant chronic hepatitis B

TitleTelbivudine in combination with adefovir versus adefovir monotherapy in HBeAg-positive, lamivudine-resistant chronic hepatitis B
Authors
KeywordsAdefovir
Hepatitis B
Lamivudine-Resistant
Telbivudine
Issue Date2012
PublisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0
Citation
Hepatology International, 2012, v. 6 n. 4, p. 696-706 How to Cite?
AbstractPurpose: Lamivudine (LAM) resistance is common on lamivudine monotherapy for chronic hepatitis B. This study examined the safety and efficacy of telbivudine (LDT) given with adefovir (ADV) versus ADV monotherapy in patients with chronic, lamivudine-resistant HBV infection. Methods: An open-label, 96 week study with planned recruitment of 150 HBeAg-positive, lamivudine-experienced Asian patients with a confirmed YMDD resistance mutation, randomized 1:1 to receive ADV alone or with LDT. The study was terminated early due to difficulty in enrolling monotherapy patients. At termination, 42 patients had received study medication for 8-61 weeks. Due to incomplete enrolment, summary statistics only were prepared, without significance testing. Results: A total of 42 patients underwent rescue therapy (switch to ADV or LDT + ADV; n = 21 per group). Median treatment duration was 48 weeks in both groups. HBV DNA changes from baseline were greater in the LDT + ADV arm at all time points (Week 48: -7.4 log 10 vs. -4.9 log 10 copies/ml), and serum DNA was undetectable (<300 copies/mL) at week 48 in 38.5% (5/13) on LDT + ADV versus 0% (0/9) on ADV monotherapy Two patients (9.6%) on ADV monotherapy experienced virologic breakthrough without evidence of ADV resistance, but none on LDT + ADV; and no confirmed ADV resistance was observed in any on-treatment sample. HBeAg loss occurred in three patients on LDT + ADV and one patient on ADV monotherapy through week 48. Safety profiles were similar between the arms. Conclusion: LDT + ADV combination treatment showed better outcomes against lamivudine resistant HBV than ADV alone, with a similar safety profile. © 2011 Asian Pacific Association for the Study of the Liver.
Persistent Identifierhttp://hdl.handle.net/10722/163407
ISSN
2015 Impact Factor: 1.125
2015 SCImago Journal Rankings: 0.669
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorAhn, SHen_US
dc.contributor.authorKweon, YOen_US
dc.contributor.authorPaik, SWen_US
dc.contributor.authorSohn, JHen_US
dc.contributor.authorLee, KSen_US
dc.contributor.authorKim, DJen_US
dc.contributor.authorPiratvisuth, Ten_US
dc.contributor.authorYuen, MFen_US
dc.contributor.authorChutaputti, Aen_US
dc.contributor.authorChao, YCen_US
dc.contributor.authorTrylesinski, Aen_US
dc.contributor.authorAvila, Cen_US
dc.date.accessioned2012-09-05T05:30:59Z-
dc.date.available2012-09-05T05:30:59Z-
dc.date.issued2012en_US
dc.identifier.citationHepatology International, 2012, v. 6 n. 4, p. 696-706en_US
dc.identifier.issn1936-0533en_US
dc.identifier.urihttp://hdl.handle.net/10722/163407-
dc.description.abstractPurpose: Lamivudine (LAM) resistance is common on lamivudine monotherapy for chronic hepatitis B. This study examined the safety and efficacy of telbivudine (LDT) given with adefovir (ADV) versus ADV monotherapy in patients with chronic, lamivudine-resistant HBV infection. Methods: An open-label, 96 week study with planned recruitment of 150 HBeAg-positive, lamivudine-experienced Asian patients with a confirmed YMDD resistance mutation, randomized 1:1 to receive ADV alone or with LDT. The study was terminated early due to difficulty in enrolling monotherapy patients. At termination, 42 patients had received study medication for 8-61 weeks. Due to incomplete enrolment, summary statistics only were prepared, without significance testing. Results: A total of 42 patients underwent rescue therapy (switch to ADV or LDT + ADV; n = 21 per group). Median treatment duration was 48 weeks in both groups. HBV DNA changes from baseline were greater in the LDT + ADV arm at all time points (Week 48: -7.4 log 10 vs. -4.9 log 10 copies/ml), and serum DNA was undetectable (<300 copies/mL) at week 48 in 38.5% (5/13) on LDT + ADV versus 0% (0/9) on ADV monotherapy Two patients (9.6%) on ADV monotherapy experienced virologic breakthrough without evidence of ADV resistance, but none on LDT + ADV; and no confirmed ADV resistance was observed in any on-treatment sample. HBeAg loss occurred in three patients on LDT + ADV and one patient on ADV monotherapy through week 48. Safety profiles were similar between the arms. Conclusion: LDT + ADV combination treatment showed better outcomes against lamivudine resistant HBV than ADV alone, with a similar safety profile. © 2011 Asian Pacific Association for the Study of the Liver.en_US
dc.languageengen_US
dc.publisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0en_US
dc.relation.ispartofHepatology Internationalen_US
dc.subjectAdefoviren_US
dc.subjectHepatitis Ben_US
dc.subjectLamivudine-Resistanten_US
dc.subjectTelbivudineen_US
dc.titleTelbivudine in combination with adefovir versus adefovir monotherapy in HBeAg-positive, lamivudine-resistant chronic hepatitis Ben_US
dc.typeArticleen_US
dc.identifier.emailYuen, MF:mfyuen@hkucc.hku.hken_US
dc.identifier.authorityYuen, MF=rp00479en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1007/s12072-011-9314-7en_US
dc.identifier.pmid21989925-
dc.identifier.scopuseid_2-s2.0-84874116506en_US
dc.identifier.hkuros210700-
dc.identifier.volume6-
dc.identifier.issue4-
dc.identifier.spage696en_US
dc.identifier.epage706en_US
dc.identifier.isiWOS:000310224800004-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridAhn, SH=7401989551en_US
dc.identifier.scopusauthoridKweon, YO=7004694832en_US
dc.identifier.scopusauthoridPaik, SW=7102643032en_US
dc.identifier.scopusauthoridSohn, JH=14621705600en_US
dc.identifier.scopusauthoridLee, KS=52563928100en_US
dc.identifier.scopusauthoridKim, DJ=41561360000en_US
dc.identifier.scopusauthoridPiratvisuth, T=6603268498en_US
dc.identifier.scopusauthoridYuen, MF=7102031955en_US
dc.identifier.scopusauthoridChutaputti, A=6603176195en_US
dc.identifier.scopusauthoridChao, YC=23117629900en_US
dc.identifier.scopusauthoridTrylesinski, A=6603116476en_US
dc.identifier.scopusauthoridAvila, C=35557957200en_US
dc.identifier.citeulike9923577-

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