Article: Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B

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TitlePeginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B
AuthorsLau, GK
Piratvisuth, T12
Luo, KX
Marcellin, P13
Thongsawat, S6
Cooksley, G9
Gane, E7
Fried, MW11
Chow, WC
Paik, SW
Chang, WY
Berg, T10
Flisiak, R2
McCloud, P
Pluck, N14
Issue Date2005
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
CitationNew England Journal of Medicine, 2005, v. 352 n. 26, p. 2682-2695 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa043470
AbstractBACKGROUND: Current treatments for chronic hepatitis B are suboptimal. In the search for improved therapies, we compared the efficacy and safety of pegylated interferon alfa plus lamivudine, pegylated interferon alfa without lamivudine, and lamivudine alone for the treatment of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B. METHODS: A total of 814 patients with HBeAg-positive chronic hepatitis B received either peginterferon alfa-2a (180 microg once weekly) plus oral placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), or lamivudine alone. The majority of patients in the study were Asian (87 percent). Most patients were infected with hepatitis B virus (HBV) genotype B or C. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, significantly more patients who received peginterferon alfa-2a monotherapy or peginterferon alfa-2a plus lamivudine than those who received lamivudine monotherapy had HBeAg seroconversion (32 percent vs. 19 percent [P<0.001] and 27 percent vs. 19 percent [P=0.02], respectively) or HBV DNA levels below 100,000 copies per milliliter (32 percent vs. 22 percent [P=0.01] and 34 percent vs. 22 percent [P=0.003], respectively). Sixteen patients receiving peginterferon alfa-2a (alone or in combination) had hepatitis B surface antigen (HBsAg) seroconversion, as compared with 0 in the group receiving lamivudine alone (P=0.001). The most common adverse events were those known to occur with therapies based on interferon alfa. Serious adverse events occurred in 4 percent, 6 percent, and 2 percent of patients receiving peginterferon alfa-2a monotherapy, combination therapy, and lamivudine monotherapy, respectively. Two patients receiving lamivudine monotherapy had irreversible liver failure after the cessation of treatment--one underwent liver transplantation, and the other died. CONCLUSIONS: In patients with HBeAg-positive chronic hepatitis B, peginterferon alfa-2a offers superior efficacy over lamivudine, on the basis of HBeAg seroconversion, HBV DNA suppression, and HBsAg seroconversion.
ISSN0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
DOIhttp://dx.doi.org/10.1056/NEJMoa043470
ISI Accession Number IDWOS:000230133800005
DC Field
Value
dc.contributor.authorLau, GK
dc.contributor.authorPiratvisuth, T
dc.contributor.authorLuo, KX
dc.contributor.authorMarcellin, P
dc.contributor.authorThongsawat, S
dc.contributor.authorCooksley, G
dc.contributor.authorGane, E
dc.contributor.authorFried, MW
dc.contributor.authorChow, WC
dc.contributor.authorPaik, SW
dc.contributor.authorChang, WY
dc.contributor.authorBerg, T
dc.contributor.authorFlisiak, R
dc.contributor.authorMcCloud, P
dc.contributor.authorPluck, N
dc.date.accessioned2007-03-23T04:38:17Z
dc.date.available2007-03-23T04:38:17Z
dc.date.issued2005
dc.description.abstractBACKGROUND: Current treatments for chronic hepatitis B are suboptimal. In the search for improved therapies, we compared the efficacy and safety of pegylated interferon alfa plus lamivudine, pegylated interferon alfa without lamivudine, and lamivudine alone for the treatment of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B. METHODS: A total of 814 patients with HBeAg-positive chronic hepatitis B received either peginterferon alfa-2a (180 microg once weekly) plus oral placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), or lamivudine alone. The majority of patients in the study were Asian (87 percent). Most patients were infected with hepatitis B virus (HBV) genotype B or C. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, significantly more patients who received peginterferon alfa-2a monotherapy or peginterferon alfa-2a plus lamivudine than those who received lamivudine monotherapy had HBeAg seroconversion (32 percent vs. 19 percent [P<0.001] and 27 percent vs. 19 percent [P=0.02], respectively) or HBV DNA levels below 100,000 copies per milliliter (32 percent vs. 22 percent [P=0.01] and 34 percent vs. 22 percent [P=0.003], respectively). Sixteen patients receiving peginterferon alfa-2a (alone or in combination) had hepatitis B surface antigen (HBsAg) seroconversion, as compared with 0 in the group receiving lamivudine alone (P=0.001). The most common adverse events were those known to occur with therapies based on interferon alfa. Serious adverse events occurred in 4 percent, 6 percent, and 2 percent of patients receiving peginterferon alfa-2a monotherapy, combination therapy, and lamivudine monotherapy, respectively. Two patients receiving lamivudine monotherapy had irreversible liver failure after the cessation of treatment--one underwent liver transplantation, and the other died. CONCLUSIONS: In patients with HBeAg-positive chronic hepatitis B, peginterferon alfa-2a offers superior efficacy over lamivudine, on the basis of HBeAg seroconversion, HBV DNA suppression, and HBsAg seroconversion.
dc.description.naturepublished_or_final_version
dc.format.extent176172 bytes
dc.format.extent3155 bytes
dc.format.mimetypeapplication/pdf
dc.format.mimetypetext/plain
dc.identifier.citationNew England Journal of Medicine, 2005, v. 352 n. 26, p. 2682-2695 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa043470
dc.identifier.doihttp://dx.doi.org/10.1056/NEJMoa043470
dc.identifier.hkuros115830
dc.identifier.isiWOS:000230133800005
dc.identifier.issn0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
dc.identifier.openurl
dc.identifier.pmid15987917
dc.identifier.scopuseid_2-s2.0-21244447705
dc.identifier.urihttp://hdl.handle.net/10722/43075
dc.languageeng
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License
dc.subject.meshAntiviral agents - administration & dosage - adverse effects - therapeutic use
dc.subject.meshHepatitis b, chronic - drug therapy
dc.subject.meshInterferon alfa-2a - adverse effects - therapeutic use
dc.subject.meshLamivudine - adverse effects - therapeutic use
dc.subject.meshPolyethylene glycols - adverse effects - therapeutic use
dc.titlePeginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B
dc.typeArticle
Author Affiliations
  1. Singapore General Hospital
  2. Uniwersytet Medyczny w Bialymstoku
  3. Nanfang Hospital
  4. SungKyunKwan University, School of Medicine
  5. The University of Hong Kong
  6. Chiang Mai University
  7. Middlemore Hospital, Auckland
  8. Kaohsiung Medical University Chung-Ho Memorial Hospital
  9. Royal Brisbane Hospital
  10. null
  11. The University of North Carolina at Chapel Hill
  12. Songklanakarin Hospital
  13. Hopital Beaujon
  14. Roche Products Limited UK