File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

Article: Long-Term Safety of Lamivudine Treatment in Patients with Chronic Hepatitis B

TitleLong-Term Safety of Lamivudine Treatment in Patients with Chronic Hepatitis B
Authors
Issue Date2003
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
Citation
Gastroenterology, 2003, v. 125 n. 6, p. 1714-1722 How to Cite?
AbstractBackground & Aims: Data on the long-term safety of lamivudine are limited. The aim of this analysis was to determine the incidence of hepatitis flares, hepatic decompensation, and liver-disease-related (LDR) serious adverse events (SAE) during long-term lamivudine treatment. Methods: We reviewed data on 998 patients with HBeAg-positive compensated chronic hepatitis B who received lamivudine for up to 6 years (median, 4 years) and 200 patients who received placebo for 1 year. Results: Hepatitis flares occurred in 10% of the lamivudine-treated patients in year 1 and in 18%-21% in years 2-5. A temporal association between hepatitis flares and lamivudine-resistant mutations increased from 43% in year 1 to >80% in year 3. Ten hepatic decompensation events occurred in 8 (<1%) lamivudine-treated patients. Fifty-three (5%) lamivudine-treated patients experienced a total of 60 LDR SAEs. Four patients died, 2 from liver-related causes. The proportion of patients with a documented lamivudine-resistant mutation increased from 23% in year 1 to 65% in year 5. During each year of the study, patients with lamivudine-resistant mutations experienced significantly more hepatitis flares than patients without lamivudine-resistant mutations (P < 0.005). The occurrence of hepatic decompensation (0%-2%) and LDR SAEs (1%-10%) among patients with lamivudine resistance resistant stable during the first 4 years with mutations and increased afterward to 6% (P = 0.03) and 20% (P = 0.009), respectively. Conclusions: This study demonstrated that lamivudine treatment for up to 6 years has an excellent safety profile in patients with HBeAg-positive compensated liver disease, but patients with long-standing lamivudine-resistant mutations may experience worsening liver disease.
Persistent Identifierhttp://hdl.handle.net/10722/78550
ISSN
2015 Impact Factor: 18.187
2015 SCImago Journal Rankings: 7.170
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLok, ASFen_HK
dc.contributor.authorLai, CLen_HK
dc.contributor.authorLeung, Nen_HK
dc.contributor.authorYao, GBen_HK
dc.contributor.authorCui, ZYen_HK
dc.contributor.authorSchiff, ERen_HK
dc.contributor.authorDienstag, JLen_HK
dc.contributor.authorHeathcote, EJen_HK
dc.contributor.authorLittle, NRen_HK
dc.contributor.authorGriffiths, DAen_HK
dc.contributor.authorGardner, SDen_HK
dc.contributor.authorCastiglia, Men_HK
dc.date.accessioned2010-09-06T07:44:07Z-
dc.date.available2010-09-06T07:44:07Z-
dc.date.issued2003en_HK
dc.identifier.citationGastroenterology, 2003, v. 125 n. 6, p. 1714-1722en_HK
dc.identifier.issn0016-5085en_HK
dc.identifier.urihttp://hdl.handle.net/10722/78550-
dc.description.abstractBackground & Aims: Data on the long-term safety of lamivudine are limited. The aim of this analysis was to determine the incidence of hepatitis flares, hepatic decompensation, and liver-disease-related (LDR) serious adverse events (SAE) during long-term lamivudine treatment. Methods: We reviewed data on 998 patients with HBeAg-positive compensated chronic hepatitis B who received lamivudine for up to 6 years (median, 4 years) and 200 patients who received placebo for 1 year. Results: Hepatitis flares occurred in 10% of the lamivudine-treated patients in year 1 and in 18%-21% in years 2-5. A temporal association between hepatitis flares and lamivudine-resistant mutations increased from 43% in year 1 to >80% in year 3. Ten hepatic decompensation events occurred in 8 (<1%) lamivudine-treated patients. Fifty-three (5%) lamivudine-treated patients experienced a total of 60 LDR SAEs. Four patients died, 2 from liver-related causes. The proportion of patients with a documented lamivudine-resistant mutation increased from 23% in year 1 to 65% in year 5. During each year of the study, patients with lamivudine-resistant mutations experienced significantly more hepatitis flares than patients without lamivudine-resistant mutations (P < 0.005). The occurrence of hepatic decompensation (0%-2%) and LDR SAEs (1%-10%) among patients with lamivudine resistance resistant stable during the first 4 years with mutations and increased afterward to 6% (P = 0.03) and 20% (P = 0.009), respectively. Conclusions: This study demonstrated that lamivudine treatment for up to 6 years has an excellent safety profile in patients with HBeAg-positive compensated liver disease, but patients with long-standing lamivudine-resistant mutations may experience worsening liver disease.en_HK
dc.languageengen_HK
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastroen_HK
dc.relation.ispartofGastroenterologyen_HK
dc.subject.meshAdolescenten_HK
dc.subject.meshAdulten_HK
dc.subject.meshAgeden_HK
dc.subject.meshAntiviral Agents - adverse effectsen_HK
dc.subject.meshDrug Resistance, Viralen_HK
dc.subject.meshFemaleen_HK
dc.subject.meshHepatitis B virus - drug effects - geneticsen_HK
dc.subject.meshHepatitis B, Chronic - drug therapyen_HK
dc.subject.meshHumansen_HK
dc.subject.meshLamivudine - adverse effectsen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMiddle Ageden_HK
dc.subject.meshMutationen_HK
dc.subject.meshRetrospective Studiesen_HK
dc.titleLong-Term Safety of Lamivudine Treatment in Patients with Chronic Hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0016-5085&volume=125&spage=1714&epage=1722&date=2003&atitle=Long-term+Safety+Of+Lamivudine+Treatment+In+Patients+With+Chronic+Hepatitis+Ben_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1053/j.gastro.2003.09.033en_HK
dc.identifier.pmid14724824en_HK
dc.identifier.scopuseid_2-s2.0-10744225554en_HK
dc.identifier.hkuros87524en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-10744225554&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume125en_HK
dc.identifier.issue6en_HK
dc.identifier.spage1714en_HK
dc.identifier.epage1722en_HK
dc.identifier.isiWOS:000187177600023-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLok, ASF=35379868500en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridLeung, N=26643107200en_HK
dc.identifier.scopusauthoridYao, GB=7201888010en_HK
dc.identifier.scopusauthoridCui, ZY=7202504441en_HK
dc.identifier.scopusauthoridSchiff, ER=7102846957en_HK
dc.identifier.scopusauthoridDienstag, JL=24498972800en_HK
dc.identifier.scopusauthoridHeathcote, EJ=16232754400en_HK
dc.identifier.scopusauthoridLittle, NR=7003686236en_HK
dc.identifier.scopusauthoridGriffiths, DA=7202323349en_HK
dc.identifier.scopusauthoridGardner, SD=7201943931en_HK
dc.identifier.scopusauthoridCastiglia, M=6602636951en_HK

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats