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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.

Publication ,  Journal Article
Nelson, DR; Benhamou, Y; Chuang, W-L; Lawitz, EJ; Rodriguez-Torres, M; Flisiak, R; Rasenack, JWF; Kryczka, W; Lee, C-M; Bain, VG; Pianko, S ...
Published in: Gastroenterology
October 2010

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, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μg to 900 μg, impacting 38% of this treatment arm. RESULTS: By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%-88.6%), 79.8% (95% confidence interval, 74.9%-84.1%), and 80.0% (95% confidence interval, 75.1%-84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg (P = .009) and 1200 μg (P = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m(2), genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0-F2, 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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Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

October 2010

Volume

139

Issue

4

Start / End Page

1267 / 1276

Location

United States

Related Subject Headings

  • Ribavirin
  • Recombinant Proteins
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Humans
  • Hepatitis C, Chronic
  • Hepacivirus
 

Citation

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Nelson, D. R., Benhamou, Y., Chuang, W.-L., Lawitz, E. J., Rodriguez-Torres, M., Flisiak, R., … ACHIEVE-2/3 Study Team, . (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, 139(4), 1267–1276. https://doi.org/10.1053/j.gastro.2010.06.062
Nelson, David R., Yves Benhamou, Wan-Long Chuang, Eric J. Lawitz, Maribel Rodriguez-Torres, Robert Flisiak, Jens W. F. Rasenack, et al. “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 139, no. 4 (October 2010): 1267–76. https://doi.org/10.1053/j.gastro.2010.06.062.
Nelson DR, Benhamou Y, Chuang W-L, Lawitz EJ, Rodriguez-Torres M, Flisiak R, et al. 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. 2010 Oct;139(4):1267–76.
Nelson, David R., et al. “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, Oct. 2010, pp. 1267–76. Pubmed, doi:10.1053/j.gastro.2010.06.062.
Nelson DR, Benhamou Y, Chuang W-L, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JWF, Kryczka W, Lee C-M, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG, ACHIEVE-2/3 Study Team. 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. 2010 Oct;139(4):1267–1276.
Journal cover image

Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

October 2010

Volume

139

Issue

4

Start / End Page

1267 / 1276

Location

United States

Related Subject Headings

  • Ribavirin
  • Recombinant Proteins
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Humans
  • Hepatitis C, Chronic
  • Hepacivirus