Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b

Robert Flisiak; Seiji Kawazoe; Olga Znoyko; Nimer Assy; Adrian Gadano; Jia Horng Kao; Kwan Sik Lee; Ricardo Zwirtes; Simon Portsmouth; Yuping Dong; Dong Xu; Hiromitsu Kumada; Subasree Srinivasan

doi:10.1089/jir.2015.0173

Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b

Robert Flisiak, Seiji Kawazoe, Olga Znoyko, Nimer Assy, Adrian Gadano, Jia Horng Kao, Kwan Sik Lee, Ricardo Zwirtes, Simon Portsmouth, Yuping Dong, Dong Xu, Hiromitsu Kumada, Subasree Srinivasan

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

10 Scopus citations

Abstract

The study objective was to compare the efficacy and safety of peginterferon lambda-1a combined with ribavirin/ daclatasvir (Lambda/RBV/DCV), versus peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in patients chronically infectedwith hepatitis C virus (HCV), genotype 1b. This was a prospective, randomized, openlabel, phase 3 study (NCT01718158) in adults (aged ‡18 years) who were treatment naïve or prior relapsers to peginterferon alfa/ribavirin therapy. The primary endpoint was sustained virologic response at post-Treatment followupweek 12 (SVR12). Patients were randomized in a 2:1 ratio to receive 24weeks of Lambda/RBV/DCV or responseguided 24 or 48weeks ofAlfa/RBV/TVR.Overall, 440 patientswere treated (294with Lambda/RBV/DCV; 146 with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8%in the Lambda/RBV/DCV arm and 70.5% in theAlfa/RBV/TVRarm(difference between arms: 18.3%; 95%confidence interval: 9.9-25.7;P< 0.0001). Patients in the Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic abnormalities, flu-like symptoms, serious AEs, and discontinuations due toAEs, but more liver abnormalities than those in theAlfa/RBV/TVR group. In conclusion, treatment with Lambda/RBV/DCV led to higher SVR12 rates and amore favorable safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b infection.

Original language	English
Pages (from-to)	635-643
Number of pages	9
Journal	Journal of Interferon and Cytokine Research
Volume	36
Issue number	11
DOIs	https://doi.org/10.1089/jir.2015.0173
State	Published - Nov 2016
Externally published	Yes

Bibliographical note

Publisher Copyright:
© Mary Ann Liebert, Inc.

Funding

We would like to acknowledge Eric Vandeloise for his significant contributions to the execution of the study. We would also like to thank the many investigators who contributed time and effort to this study, as well as Ryan Woodrow and Dena McWain of Infusion Communications for medical writing support and editorial assistance. This analysis and writing and editorial support was fully funded by Bristol-Myers Squibb.

Funders	Funder number
Bristol-Myers Squibb

Keywords

Clinical trial
Daclatasvir
Hepatitis c
Interferon lambda-1a
Ribavirin

UN SDGs

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

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10.1089/jir.2015.0173

Cite this

Flisiak, R., Kawazoe, S., Znoyko, O., Assy, N., Gadano, A., Kao, J. H., Lee, K. S., Zwirtes, R., Portsmouth, S., Dong, Y., Xu, D., Kumada, H., & Srinivasan, S. (2016). Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b. Journal of Interferon and Cytokine Research, 36(11), 635-643. https://doi.org/10.1089/jir.2015.0173

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title = "Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b",

abstract = "The study objective was to compare the efficacy and safety of peginterferon lambda-1a combined with ribavirin/ daclatasvir (Lambda/RBV/DCV), versus peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in patients chronically infectedwith hepatitis C virus (HCV), genotype 1b. This was a prospective, randomized, openlabel, phase 3 study (NCT01718158) in adults (aged ‡18 years) who were treatment na{\"i}ve or prior relapsers to peginterferon alfa/ribavirin therapy. The primary endpoint was sustained virologic response at post-Treatment followupweek 12 (SVR12). Patients were randomized in a 2:1 ratio to receive 24weeks of Lambda/RBV/DCV or responseguided 24 or 48weeks ofAlfa/RBV/TVR.Overall, 440 patientswere treated (294with Lambda/RBV/DCV; 146 with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8%in the Lambda/RBV/DCV arm and 70.5% in theAlfa/RBV/TVRarm(difference between arms: 18.3%; 95%confidence interval: 9.9-25.7;P< 0.0001). Patients in the Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic abnormalities, flu-like symptoms, serious AEs, and discontinuations due toAEs, but more liver abnormalities than those in theAlfa/RBV/TVR group. In conclusion, treatment with Lambda/RBV/DCV led to higher SVR12 rates and amore favorable safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b infection.",

keywords = "Clinical trial, Daclatasvir, Hepatitis c, Interferon lambda-1a, Ribavirin",

author = "Robert Flisiak and Seiji Kawazoe and Olga Znoyko and Nimer Assy and Adrian Gadano and Kao, {Jia Horng} and Lee, {Kwan Sik} and Ricardo Zwirtes and Simon Portsmouth and Yuping Dong and Dong Xu and Hiromitsu Kumada and Subasree Srinivasan",

note = "Publisher Copyright: {\textcopyright} Mary Ann Liebert, Inc.",

year = "2016",

month = nov,

doi = "10.1089/jir.2015.0173",

language = "אנגלית",

volume = "36",

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Flisiak, R, Kawazoe, S, Znoyko, O, Assy, N, Gadano, A, Kao, JH, Lee, KS, Zwirtes, R, Portsmouth, S, Dong, Y, Xu, D, Kumada, H & Srinivasan, S 2016, 'Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b', Journal of Interferon and Cytokine Research, vol. 36, no. 11, pp. 635-643. https://doi.org/10.1089/jir.2015.0173

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T1 - Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b

AU - Flisiak, Robert

AU - Kawazoe, Seiji

AU - Znoyko, Olga

AU - Assy, Nimer

AU - Gadano, Adrian

AU - Kao, Jia Horng

AU - Lee, Kwan Sik

AU - Zwirtes, Ricardo

AU - Portsmouth, Simon

AU - Dong, Yuping

AU - Xu, Dong

AU - Kumada, Hiromitsu

AU - Srinivasan, Subasree

PY - 2016/11

Y1 - 2016/11

N2 - The study objective was to compare the efficacy and safety of peginterferon lambda-1a combined with ribavirin/ daclatasvir (Lambda/RBV/DCV), versus peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in patients chronically infectedwith hepatitis C virus (HCV), genotype 1b. This was a prospective, randomized, openlabel, phase 3 study (NCT01718158) in adults (aged ‡18 years) who were treatment naïve or prior relapsers to peginterferon alfa/ribavirin therapy. The primary endpoint was sustained virologic response at post-Treatment followupweek 12 (SVR12). Patients were randomized in a 2:1 ratio to receive 24weeks of Lambda/RBV/DCV or responseguided 24 or 48weeks ofAlfa/RBV/TVR.Overall, 440 patientswere treated (294with Lambda/RBV/DCV; 146 with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8%in the Lambda/RBV/DCV arm and 70.5% in theAlfa/RBV/TVRarm(difference between arms: 18.3%; 95%confidence interval: 9.9-25.7;P< 0.0001). Patients in the Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic abnormalities, flu-like symptoms, serious AEs, and discontinuations due toAEs, but more liver abnormalities than those in theAlfa/RBV/TVR group. In conclusion, treatment with Lambda/RBV/DCV led to higher SVR12 rates and amore favorable safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b infection.

AB - The study objective was to compare the efficacy and safety of peginterferon lambda-1a combined with ribavirin/ daclatasvir (Lambda/RBV/DCV), versus peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in patients chronically infectedwith hepatitis C virus (HCV), genotype 1b. This was a prospective, randomized, openlabel, phase 3 study (NCT01718158) in adults (aged ‡18 years) who were treatment naïve or prior relapsers to peginterferon alfa/ribavirin therapy. The primary endpoint was sustained virologic response at post-Treatment followupweek 12 (SVR12). Patients were randomized in a 2:1 ratio to receive 24weeks of Lambda/RBV/DCV or responseguided 24 or 48weeks ofAlfa/RBV/TVR.Overall, 440 patientswere treated (294with Lambda/RBV/DCV; 146 with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8%in the Lambda/RBV/DCV arm and 70.5% in theAlfa/RBV/TVRarm(difference between arms: 18.3%; 95%confidence interval: 9.9-25.7;P< 0.0001). Patients in the Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic abnormalities, flu-like symptoms, serious AEs, and discontinuations due toAEs, but more liver abnormalities than those in theAlfa/RBV/TVR group. In conclusion, treatment with Lambda/RBV/DCV led to higher SVR12 rates and amore favorable safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b infection.

KW - Clinical trial

KW - Daclatasvir

KW - Hepatitis c

KW - Interferon lambda-1a

KW - Ribavirin

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Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

Access to Document

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