JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1

on behalf of the OMEGA-1 study team, Stefan Zeuzem, Stefan Bourgeois, Susan Greenbloom, Maria Buti, Alessio Aghemo, Pietro Lampertico, Ewa Janczewska, Seng Gee Lim, Christophe Moreno, Peter Buggisch, Edward Tam, Chris Corbett, Wouter Willems, Leen Vijgen, Bart Fevery, Sivi Ouwerkerk-Mahadevan, Oliver Ackaert, Maria Beumont, Ronald KalmeijerRekha Sinha, Michael Biermer

Research output: Contribution to journalArticle

Abstract

The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3%; GT1b, 42.5%; GT2, 12.3%; GT4, 14.2%; GT5, 1.4%; GT6, 0%) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9%) or 8 weeks (97.8%) of treatment were noninferior to a historical control (98%). Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.

Original languageEnglish
Pages (from-to)2349-2363
JournalHepatology
Volume69
Issue number6
DOIs
Publication statusPublished - Jan 1 2019

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Hepacivirus
Fibrosis
Therapeutics
Simeprevir
Recurrence
Ribavirin
Chronic Hepatitis C
Virus Diseases
Liver Cirrhosis
Interferons
Antiviral Agents
Genotype
Safety

ASJC Scopus subject areas

  • Hepatology

Cite this

on behalf of the OMEGA-1 study team, Zeuzem, S., Bourgeois, S., Greenbloom, S., Buti, M., Aghemo, A., ... Biermer, M. (2019). JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1. Hepatology, 69(6), 2349-2363. https://doi.org/10.1002/hep.30527

JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis : OMEGA-1. / on behalf of the OMEGA-1 study team; Zeuzem, Stefan; Bourgeois, Stefan; Greenbloom, Susan; Buti, Maria; Aghemo, Alessio; Lampertico, Pietro; Janczewska, Ewa; Lim, Seng Gee; Moreno, Christophe; Buggisch, Peter; Tam, Edward; Corbett, Chris; Willems, Wouter; Vijgen, Leen; Fevery, Bart; Ouwerkerk-Mahadevan, Sivi; Ackaert, Oliver; Beumont, Maria; Kalmeijer, Ronald; Sinha, Rekha; Biermer, Michael.

In: Hepatology, Vol. 69, No. 6, 01.01.2019, p. 2349-2363.

Research output: Contribution to journalArticle

on behalf of the OMEGA-1 study team, Zeuzem, S, Bourgeois, S, Greenbloom, S, Buti, M, Aghemo, A, Lampertico, P, Janczewska, E, Lim, SG, Moreno, C, Buggisch, P, Tam, E, Corbett, C, Willems, W, Vijgen, L, Fevery, B, Ouwerkerk-Mahadevan, S, Ackaert, O, Beumont, M, Kalmeijer, R, Sinha, R & Biermer, M 2019, 'JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1', Hepatology, vol. 69, no. 6, pp. 2349-2363. https://doi.org/10.1002/hep.30527
on behalf of the OMEGA-1 study team, Zeuzem S, Bourgeois S, Greenbloom S, Buti M, Aghemo A et al. JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1. Hepatology. 2019 Jan 1;69(6):2349-2363. https://doi.org/10.1002/hep.30527
on behalf of the OMEGA-1 study team ; Zeuzem, Stefan ; Bourgeois, Stefan ; Greenbloom, Susan ; Buti, Maria ; Aghemo, Alessio ; Lampertico, Pietro ; Janczewska, Ewa ; Lim, Seng Gee ; Moreno, Christophe ; Buggisch, Peter ; Tam, Edward ; Corbett, Chris ; Willems, Wouter ; Vijgen, Leen ; Fevery, Bart ; Ouwerkerk-Mahadevan, Sivi ; Ackaert, Oliver ; Beumont, Maria ; Kalmeijer, Ronald ; Sinha, Rekha ; Biermer, Michael. / JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis : OMEGA-1. In: Hepatology. 2019 ; Vol. 69, No. 6. pp. 2349-2363.
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abstract = "The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-na{\"i}ve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3{\%}; GT1b, 42.5{\%}; GT2, 12.3{\%}; GT4, 14.2{\%}; GT5, 1.4{\%}; GT6, 0{\%}) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9{\%}) or 8 weeks (97.8{\%}) of treatment were noninferior to a historical control (98{\%}). Viral relapse occurred in 5 patients (1.4{\%}; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9{\%} and 97.8{\%}, respectively, and was well tolerated.",
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T1 - JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis

T2 - OMEGA-1

AU - on behalf of the OMEGA-1 study team

AU - Zeuzem, Stefan

AU - Bourgeois, Stefan

AU - Greenbloom, Susan

AU - Buti, Maria

AU - Aghemo, Alessio

AU - Lampertico, Pietro

AU - Janczewska, Ewa

AU - Lim, Seng Gee

AU - Moreno, Christophe

AU - Buggisch, Peter

AU - Tam, Edward

AU - Corbett, Chris

AU - Willems, Wouter

AU - Vijgen, Leen

AU - Fevery, Bart

AU - Ouwerkerk-Mahadevan, Sivi

AU - Ackaert, Oliver

AU - Beumont, Maria

AU - Kalmeijer, Ronald

AU - Sinha, Rekha

AU - Biermer, Michael

PY - 2019/1/1

Y1 - 2019/1/1

N2 - The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3%; GT1b, 42.5%; GT2, 12.3%; GT4, 14.2%; GT5, 1.4%; GT6, 0%) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9%) or 8 weeks (97.8%) of treatment were noninferior to a historical control (98%). Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.

AB - The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3%; GT1b, 42.5%; GT2, 12.3%; GT4, 14.2%; GT5, 1.4%; GT6, 0%) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9%) or 8 weeks (97.8%) of treatment were noninferior to a historical control (98%). Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.

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