Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis c virus genotype 2 or 3

David R. Nelson, Yves Benhamou, Wanlong Chuang, Eric J. Lawitz, Maribel Rodrigueztorres, Robert Flisiak, Jens W F Rasenack, Wiesaw Kryczka, Chuanmo Lee, Vincent G. Bain, Stephen Pianko, Keyur Patel, Patrick W. Cronin, Erik Pulkstenis, G. Mani Subramanian, John G. McHutchison

Research output: Contribution to journalArticle

Abstract

Background & Aims A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. Methods In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, 2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%8%) and severe (13%16%) adverse events, and discontinuations owing to adverse events (3.6%5.5%). Conclusion Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.

Original languageEnglish (US)
JournalGastroenterology
Volume139
Issue number4
DOIs
StatePublished - Oct 2010
Externally publishedYes

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Hepatitis Viruses
Chronic Hepatitis
Hepacivirus
Interferons
interferon alfa-2b
Genotype
Chronic Hepatitis C
gamma-Glutamyltransferase
Ribavirin
Alanine Transaminase
Fibrosis
Therapeutics
RNA
Safety
Peptides
albinterferon alfa-2b
peginterferon alfa-2a

Keywords

  • ACHIEVE
  • AlbIFN
  • Pegylated Interferon-α
  • Sustained Virologic Response

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

Cite this

Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis c virus genotype 2 or 3. / Nelson, David R.; Benhamou, Yves; Chuang, Wanlong; Lawitz, Eric J.; Rodrigueztorres, Maribel; Flisiak, Robert; Rasenack, Jens W F; Kryczka, Wiesaw; Lee, Chuanmo; Bain, Vincent G.; Pianko, Stephen; Patel, Keyur; Cronin, Patrick W.; Pulkstenis, Erik; Subramanian, G. Mani; McHutchison, John G.

In: Gastroenterology, Vol. 139, No. 4, 10.2010.

Research output: Contribution to journalArticle

Nelson, DR, Benhamou, Y, Chuang, W, Lawitz, EJ, Rodrigueztorres, M, Flisiak, R, Rasenack, JWF, Kryczka, W, Lee, C, Bain, VG, Pianko, S, Patel, K, Cronin, PW, Pulkstenis, E, Subramanian, GM & McHutchison, JG 2010, 'Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis c virus genotype 2 or 3', Gastroenterology, vol. 139, no. 4. https://doi.org/10.1053/j.gastro.2010.06.062
Nelson, David R. ; Benhamou, Yves ; Chuang, Wanlong ; Lawitz, Eric J. ; Rodrigueztorres, Maribel ; Flisiak, Robert ; Rasenack, Jens W F ; Kryczka, Wiesaw ; Lee, Chuanmo ; Bain, Vincent G. ; Pianko, Stephen ; Patel, Keyur ; Cronin, Patrick W. ; Pulkstenis, Erik ; Subramanian, G. Mani ; McHutchison, John G. / Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis c virus genotype 2 or 3. In: Gastroenterology. 2010 ; Vol. 139, No. 4.
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abstract = "Background & Aims A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. Methods In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, 2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7{\%}8{\%}) and severe (13{\%}16{\%}) adverse events, and discontinuations owing to adverse events (3.6{\%}5.5{\%}). Conclusion Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.",
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AU - Nelson, David R.

AU - Benhamou, Yves

AU - Chuang, Wanlong

AU - Lawitz, Eric J.

AU - Rodrigueztorres, Maribel

AU - Flisiak, Robert

AU - Rasenack, Jens W F

AU - Kryczka, Wiesaw

AU - Lee, Chuanmo

AU - Bain, Vincent G.

AU - Pianko, Stephen

AU - Patel, Keyur

AU - Cronin, Patrick W.

AU - Pulkstenis, Erik

AU - Subramanian, G. Mani

AU - McHutchison, John G.

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N2 - Background & Aims A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. Methods In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, 2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%8%) and severe (13%16%) adverse events, and discontinuations owing to adverse events (3.6%5.5%). Conclusion Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.

AB - Background & Aims A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. Methods In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, 2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%8%) and severe (13%16%) adverse events, and discontinuations owing to adverse events (3.6%5.5%). Conclusion Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.

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