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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, P14
Thongsawat, S6
Cooksley, G8
Gane, E7
Fried, MW11
Chow, WC
Paik, SW
Chang, WY
Berg, T10
Flisiak, R3
McCloud, P
Pluck, N13
 
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
2013 Impact Factor: 54.420
 
DOIhttp://dx.doi.org/10.1056/NEJMoa043470
 
ISI Accession Number IDWOS:000230133800005
 
DC FieldValue
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
 
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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
2013 Impact Factor: 54.420
 
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
 
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<contributor.author>Luo, KX</contributor.author>
<contributor.author>Marcellin, P</contributor.author>
<contributor.author>Thongsawat, S</contributor.author>
<contributor.author>Cooksley, G</contributor.author>
<contributor.author>Gane, E</contributor.author>
<contributor.author>Fried, MW</contributor.author>
<contributor.author>Chow, WC</contributor.author>
<contributor.author>Paik, SW</contributor.author>
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<contributor.author>Flisiak, R</contributor.author>
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<description.abstract>BACKGROUND: 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&lt;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.</description.abstract>
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Author Affiliations
  1. Singapore General Hospital
  2. SungKyunKwan University, School of Medicine
  3. Uniwersytet Medyczny w Bialymstoku
  4. Nanfang Hospital
  5. The University of Hong Kong
  6. Chiang Mai University
  7. Middlemore Hospital, Auckland
  8. Royal Brisbane Hospital
  9. Kaohsiung Medical University Chung-Ho Memorial Hospital
  10. null
  11. The University of North Carolina at Chapel Hill
  12. Songklanakarin Hospital
  13. Roche Products Limited UK
  14. Hopital Beaujon