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A randomized phase 2b study of peginterferon lambda-1a for the treatment of chronic HCV infection.

Publication ,  Journal Article
Muir, AJ; Arora, S; Everson, G; Flisiak, R; George, J; Ghalib, R; Gordon, SC; Gray, T; Greenbloom, S; Hassanein, T; Hillson, J; Horga, MA ...
Published in: J Hepatol
December 2014

BACKGROUND & AIMS: Peginterferon lambda-1a (Lambda) is a type-III interferon with similar antiviral activity to alfa interferons but with a diminished extrahepatic receptor distribution, reducing the risk for extrahepatic adverse events. METHODS: This was a randomized, blinded, actively-controlled, multicentre phase 2b dose-ranging study in patients chronically infected with HCV genotypes 1-4. Treatment-naive patients received Lambda (120/180/240 μg) or peginterferon alfa-2a (alfa; 180 μg) once-weekly with ribavirin for 24 (genotypes [GT] 2,3) or 48 (GT1,4) weeks. RESULTS: Rates of undetectable HCV-RNA at week 12 (complete early virologic response [cEVR]; primary end point) were significantly higher in GT1,4 patients receiving Lambda vs. alfa (170/304, 56% vs. 38/103, 37%); with similar cEVR rates for GT2,3 (80/88, 91% vs. 26/30, 87%). Rates of undetectable HCV-RNA at week 4 were significantly higher on 180 μg (15/102, 15% GT1,4; 22/29, 76% GT2,3) and 240 μg (17/104, 16% GT1,4; 20/30, 67% GT2,3) Lambda than alfa (6/103, 6% GT1,4; 9/30, 30% GT2,3). Sustained virologic responses (post-treatment week 24) were comparable between Lambda and alfa for GT1,4 (37-46% Lambda; 37% alfa) and GT2,3 (60-76% Lambda; 53% alfa). Aminotransferase and/or bilirubin elevations were the primary dose-limiting abnormalities for Lambda; a sponsor-mandated 240 to 180 μg dose reduction was therefore implemented. Serious adverse events were comparable (3-13% Lambda; 3-7% alfa). Grade 3-4 haemoglobin, neutrophil, and platelet reductions were lower on Lambda than alfa. Among alfa patients, 28/133 (21%) had peginterferon and 31/133 (23%) had ribavirin dose reductions for haematologic abnormalities vs. 0/392 and 8/392 (2%) on Lambda. Lambda demonstrated fewer musculoskeletal (16-28% vs. 47-63%) and influenza-like events (8-23% vs. 40-46%) than alfa. CONCLUSION: Lambda was associated with improved or similar rates of virologic response with fewer extrahepatic adverse events than alfa in chronic HCV infection.

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Published In

J Hepatol

DOI

EISSN

1600-0641

Publication Date

December 2014

Volume

61

Issue

6

Start / End Page

1238 / 1246

Location

Netherlands

Related Subject Headings

  • Treatment Outcome
  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interleukins
  • Interferons
  • Interferon-alpha
 

Citation

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Muir, A. J., Arora, S., Everson, G., Flisiak, R., George, J., Ghalib, R., … EMERGE study group. (2014). A randomized phase 2b study of peginterferon lambda-1a for the treatment of chronic HCV infection. J Hepatol, 61(6), 1238–1246. https://doi.org/10.1016/j.jhep.2014.07.022
Muir, Andrew J., Sanjeev Arora, Gregory Everson, Robert Flisiak, Jacob George, Reem Ghalib, Stuart C. Gordon, et al. “A randomized phase 2b study of peginterferon lambda-1a for the treatment of chronic HCV infection.J Hepatol 61, no. 6 (December 2014): 1238–46. https://doi.org/10.1016/j.jhep.2014.07.022.
Muir AJ, Arora S, Everson G, Flisiak R, George J, Ghalib R, et al. A randomized phase 2b study of peginterferon lambda-1a for the treatment of chronic HCV infection. J Hepatol. 2014 Dec;61(6):1238–46.
Muir, Andrew J., et al. “A randomized phase 2b study of peginterferon lambda-1a for the treatment of chronic HCV infection.J Hepatol, vol. 61, no. 6, Dec. 2014, pp. 1238–46. Pubmed, doi:10.1016/j.jhep.2014.07.022.
Muir AJ, Arora S, Everson G, Flisiak R, George J, Ghalib R, Gordon SC, Gray T, Greenbloom S, Hassanein T, Hillson J, Horga MA, Jacobson IM, Jeffers L, Kowdley KV, Lawitz E, Lueth S, Rodriguez-Torres M, Rustgi V, Shemanski L, Shiffman ML, Srinivasan S, Vargas HE, Vierling JM, Xu D, Lopez-Talavera JC, Zeuzem S, EMERGE study group. A randomized phase 2b study of peginterferon lambda-1a for the treatment of chronic HCV infection. J Hepatol. 2014 Dec;61(6):1238–1246.
Journal cover image

Published In

J Hepatol

DOI

EISSN

1600-0641

Publication Date

December 2014

Volume

61

Issue

6

Start / End Page

1238 / 1246

Location

Netherlands

Related Subject Headings

  • Treatment Outcome
  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interleukins
  • Interferons
  • Interferon-alpha