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Article: Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B

TitlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
Authors
Issue Date2004
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217 How to Cite?
AbstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society
Persistent Identifierhttp://hdl.handle.net/10722/43076
ISSN
2019 Impact Factor: 74.699
2015 SCImago Journal Rankings: 14.619
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorMarcellin, Pen_HK
dc.contributor.authorLau, GKen_HK
dc.contributor.authorBonino, Fen_HK
dc.contributor.authorFarci, Pen_HK
dc.contributor.authorHadziyannis, Sen_HK
dc.contributor.authorJin, Ren_HK
dc.contributor.authorLu, ZMen_HK
dc.contributor.authorPiratvisuth, Ten_HK
dc.contributor.authorGermanidis, Gen_HK
dc.contributor.authorYurdaydin, Cen_HK
dc.contributor.authorDiago, Men_HK
dc.contributor.authorGurel, Sen_HK
dc.contributor.authorLai, MYen_HK
dc.contributor.authorButton, Pen_HK
dc.contributor.authorPluck, Nen_HK
dc.date.accessioned2007-03-23T04:38:19Z-
dc.date.available2007-03-23T04:38:19Z-
dc.date.issued2004en_HK
dc.identifier.citationNew England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/43076-
dc.description.abstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Societyen_HK
dc.format.extent122021 bytes-
dc.format.extent3155 bytes-
dc.format.mimetypeapplication/pdf-
dc.format.mimetypetext/plain-
dc.languageengen_HK
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.relation.ispartofNew England Journal of Medicine-
dc.rightsFrom New England Journal of Medicine, Patrick Marcellin, George K.K. Lau, Ferruccio Bonino, et al., Peginterferon Alfa-2a Alone, Lamivudine Alone, and the Two in Combination in Patients with HBeAg-Negative Chronic Hepatitis B, vol. 351, p. 1206-1217. Copyright © 2004 Massachusetts Medical Society. Reprinted with permission.en_HK
dc.subject.meshAntiviral agents - adverse effects - therapeutic useen_HK
dc.subject.meshHepatitis b, chronic - blood - drug therapy - virologyen_HK
dc.subject.meshInterferon alfa-2a - adverse effects - therapeutic useen_HK
dc.subject.meshLamivudine - adverse effects - therapeutic useen_HK
dc.subject.meshPolyethylene glycols - adverse effects - therapeutic useen_HK
dc.titlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.doi10.1056/NEJMoa040431-
dc.identifier.pmid15371578en_HK
dc.identifier.scopuseid_2-s2.0-4544239807-
dc.identifier.hkuros100589-
dc.identifier.volume351-
dc.identifier.issue12-
dc.identifier.spage1206-
dc.identifier.epage1217-
dc.identifier.isiWOS:000223861300009-

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