A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Graham R. Foster; Kazuaki Chayama; Wan Long Chuang; Hugo Fainboim; Martti Farkkila; Adrian Gadano; Giovanni B. Gaeta; Christophe Hézode; Yukiko Inada; Jeong Heo; Hiromitsu Kumada; Sheng Nan Lu; Patrick Marcellin; Christophe Moreno; Stuart K. Roberts; Simone I. Strasser; Alexander J. Thompson; Joji Toyota; Seung Woon Paik; John M. Vierling; Anna L. Zignego; David Cohen; Fiona McPhee; Megan Wind-Rotolo; Subasree Srinivasan; Matthew Hruska; Heather Myler; Simon D. Portsmouth

doi:10.1186/s40064-016-2920-z

A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Graham R. Foster, Kazuaki Chayama, Wan Long Chuang, Hugo Fainboim, Martti Farkkila, Adrian Gadano, Giovanni B. Gaeta, Christophe Hézode, Yukiko Inada, Jeong Heo, Hiromitsu Kumada, Sheng Nan Lu, Patrick Marcellin, Christophe Moreno, Stuart K. Roberts, Simone I. Strasser, Alexander J. Thompson, Joji Toyota, Seung Woon Paik, John M. VierlingAnna L. Zignego, David Cohen, Fiona McPhee, Megan Wind-Rotolo, Subasree Srinivasan^*, Matthew Hruska, Heather Myler, Simon D. Portsmouth

^*Corresponding author for this work

School of Medicine

Research output: Contribution to journal › Journal Article › peer-review

10 Scopus citations

Abstract

Background and purpose: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. Methods: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). Results: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. Conclusion: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.

Original language	English
Article number	1365
Journal	SpringerPlus
Volume	5
Issue number	1
DOIs	https://doi.org/10.1186/s40064-016-2920-z
State	Published - 01 12 2016

Bibliographical note

Publisher Copyright:
© 2016, The Author(s).

Keywords

Genotype 2
Genotype 3
Hepatitis C virus
Peginterferon alfa-2a
Peginterferon lambda-1a

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/s40064-016-2920-z

Cite this

Foster, G. R., Chayama, K., Chuang, W. L., Fainboim, H., Farkkila, M., Gadano, A., Gaeta, G. B., Hézode, C., Inada, Y., Heo, J., Kumada, H., Lu, S. N., Marcellin, P., Moreno, C., Roberts, S. K., Strasser, S. I., Thompson, A. J., Toyota, J., Paik, S. W., ... Portsmouth, S. D. (2016). A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3. SpringerPlus, 5(1), Article 1365. https://doi.org/10.1186/s40064-016-2920-z

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title = "A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3",

abstract = "Background and purpose: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. Methods: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). Results: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. Conclusion: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.",

keywords = "Genotype 2, Genotype 3, Hepatitis C virus, Peginterferon alfa-2a, Peginterferon lambda-1a",

author = "Foster, {Graham R.} and Kazuaki Chayama and Chuang, {Wan Long} and Hugo Fainboim and Martti Farkkila and Adrian Gadano and Gaeta, {Giovanni B.} and Christophe H{\'e}zode and Yukiko Inada and Jeong Heo and Hiromitsu Kumada and Lu, {Sheng Nan} and Patrick Marcellin and Christophe Moreno and Roberts, {Stuart K.} and Strasser, {Simone I.} and Thompson, {Alexander J.} and Joji Toyota and Paik, {Seung Woon} and Vierling, {John M.} and Zignego, {Anna L.} and David Cohen and Fiona McPhee and Megan Wind-Rotolo and Subasree Srinivasan and Matthew Hruska and Heather Myler and Portsmouth, {Simon D.}",

note = "Publisher Copyright: {\textcopyright} 2016, The Author(s).",

year = "2016",

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doi = "10.1186/s40064-016-2920-z",

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Foster, GR, Chayama, K, Chuang, WL, Fainboim, H, Farkkila, M, Gadano, A, Gaeta, GB, Hézode, C, Inada, Y, Heo, J, Kumada, H, Lu, SN, Marcellin, P, Moreno, C, Roberts, SK, Strasser, SI, Thompson, AJ, Toyota, J, Paik, SW, Vierling, JM, Zignego, AL, Cohen, D, McPhee, F, Wind-Rotolo, M, Srinivasan, S, Hruska, M, Myler, H & Portsmouth, SD 2016, 'A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3', SpringerPlus, vol. 5, no. 1, 1365. https://doi.org/10.1186/s40064-016-2920-z

TY - JOUR

T1 - A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

AU - Foster, Graham R.

AU - Chayama, Kazuaki

AU - Chuang, Wan Long

AU - Fainboim, Hugo

AU - Farkkila, Martti

AU - Gadano, Adrian

AU - Gaeta, Giovanni B.

AU - Hézode, Christophe

AU - Inada, Yukiko

AU - Heo, Jeong

AU - Kumada, Hiromitsu

AU - Lu, Sheng Nan

AU - Marcellin, Patrick

AU - Moreno, Christophe

AU - Roberts, Stuart K.

AU - Strasser, Simone I.

AU - Thompson, Alexander J.

AU - Toyota, Joji

AU - Paik, Seung Woon

AU - Vierling, John M.

AU - Zignego, Anna L.

AU - Cohen, David

AU - McPhee, Fiona

AU - Wind-Rotolo, Megan

AU - Srinivasan, Subasree

AU - Hruska, Matthew

AU - Myler, Heather

AU - Portsmouth, Simon D.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Background and purpose: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. Methods: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). Results: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. Conclusion: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.

AB - Background and purpose: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. Methods: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). Results: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. Conclusion: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.

KW - Genotype 2

KW - Genotype 3

KW - Hepatitis C virus

KW - Peginterferon alfa-2a

KW - Peginterferon lambda-1a

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DO - 10.1186/s40064-016-2920-z

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