Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin

SOUND-C3, a Phase 2b study

Stefan Zeuzem, Jean François Dufour, Maria Buti, Vicente Soriano, Robert J. Buynak, Parvez Mantry, Jawahar Taunk, Jerry O. Stern, Richard Vinisko, John Paul Gallivan, Wulf Böcher, Federico J. Mensa, Barton Cobert, Regino Gonzalwz-Peralta, Stuart Campbell Ray, Andrew Talal

Research output: Contribution to journalArticle

Abstract

Background & Aims: The safety and efficacy of the interferon-free combination of faldaprevir (NS3/A4 protease inhibitor), deleobuvir (BI 207127, non-nucleoside polymerase inhibitor), and ribavirin in treatment-naïve patients chronically infected with HCV genotype-1 was explored. Methods: SOUND-C3 was a multicenter, open-label Phase 2b study. Treatment-naïve patients chronically infected with HCV genotype-1a (IL28B CC genotype only; n = 12) and genotype-1b (n = 20) were assigned to 16 weeks of treatment with faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and weight-based ribavirin. Patients with compensated liver disease, including cirrhosis, were eligible for inclusion in this study. The primary endpoint was sustained virological response 12 weeks after completion of therapy. Results: Sustained virological response rates 12 weeks after completion of therapy were 17% and 95% in patients infected with HCV genotype-1a and genotype-1b respectively. All four patients with cirrhosis achieved sustained virological response 12 weeks after completion of therapy. The most frequently reported adverse events of at least moderate intensity were anaemia (16%), nausea, vomiting and fatigue (9% each). Three (9%) patients discontinued because of adverse events. Conclusions: The interferon-free regimen of faldaprevir, deleobuvir and ribavirin was efficacious in patients infected with genotype-1b and generally well tolerated.

Original languageEnglish (US)
Pages (from-to)417-421
Number of pages5
JournalLiver International
Volume35
Issue number2
DOIs
StatePublished - Feb 1 2015

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Ribavirin
Chronic Hepatitis C
Interferons
Genotype
Therapeutics
Fibrosis
N-((cyclopentyloxy)carbonyl)-3-methylvalyl-4-((8-bromo-7-methoxy-2-(2-((2-methylpropanoyl)amino)-1,3-thiazol-4-yl)quinolin-4-yl)oxy)-N-(1-carboxy-2-ethenylcyclopropyl)prolinamide
deleobuvir
Protease Inhibitors
Nausea
Vomiting
Fatigue
Liver Diseases
Anemia
Safety
Weights and Measures

Keywords

  • Genotype-1
  • Interferon-free
  • SVR12
  • Treatment-naïve

ASJC Scopus subject areas

  • Hepatology
  • Medicine(all)

Cite this

Zeuzem, S., Dufour, J. F., Buti, M., Soriano, V., Buynak, R. J., Mantry, P., ... Talal, A. (2015). Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin: SOUND-C3, a Phase 2b study. Liver International, 35(2), 417-421. https://doi.org/10.1111/liv.12693

Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin : SOUND-C3, a Phase 2b study. / Zeuzem, Stefan; Dufour, Jean François; Buti, Maria; Soriano, Vicente; Buynak, Robert J.; Mantry, Parvez; Taunk, Jawahar; Stern, Jerry O.; Vinisko, Richard; Gallivan, John Paul; Böcher, Wulf; Mensa, Federico J.; Cobert, Barton; Gonzalwz-Peralta, Regino; Ray, Stuart Campbell; Talal, Andrew.

In: Liver International, Vol. 35, No. 2, 01.02.2015, p. 417-421.

Research output: Contribution to journalArticle

Zeuzem, S, Dufour, JF, Buti, M, Soriano, V, Buynak, RJ, Mantry, P, Taunk, J, Stern, JO, Vinisko, R, Gallivan, JP, Böcher, W, Mensa, FJ, Cobert, B, Gonzalwz-Peralta, R, Ray, SC & Talal, A 2015, 'Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin: SOUND-C3, a Phase 2b study', Liver International, vol. 35, no. 2, pp. 417-421. https://doi.org/10.1111/liv.12693
Zeuzem, Stefan ; Dufour, Jean François ; Buti, Maria ; Soriano, Vicente ; Buynak, Robert J. ; Mantry, Parvez ; Taunk, Jawahar ; Stern, Jerry O. ; Vinisko, Richard ; Gallivan, John Paul ; Böcher, Wulf ; Mensa, Federico J. ; Cobert, Barton ; Gonzalwz-Peralta, Regino ; Ray, Stuart Campbell ; Talal, Andrew. / Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin : SOUND-C3, a Phase 2b study. In: Liver International. 2015 ; Vol. 35, No. 2. pp. 417-421.
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abstract = "Background & Aims: The safety and efficacy of the interferon-free combination of faldaprevir (NS3/A4 protease inhibitor), deleobuvir (BI 207127, non-nucleoside polymerase inhibitor), and ribavirin in treatment-na{\"i}ve patients chronically infected with HCV genotype-1 was explored. Methods: SOUND-C3 was a multicenter, open-label Phase 2b study. Treatment-na{\"i}ve patients chronically infected with HCV genotype-1a (IL28B CC genotype only; n = 12) and genotype-1b (n = 20) were assigned to 16 weeks of treatment with faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and weight-based ribavirin. Patients with compensated liver disease, including cirrhosis, were eligible for inclusion in this study. The primary endpoint was sustained virological response 12 weeks after completion of therapy. Results: Sustained virological response rates 12 weeks after completion of therapy were 17{\%} and 95{\%} in patients infected with HCV genotype-1a and genotype-1b respectively. All four patients with cirrhosis achieved sustained virological response 12 weeks after completion of therapy. The most frequently reported adverse events of at least moderate intensity were anaemia (16{\%}), nausea, vomiting and fatigue (9{\%} each). Three (9{\%}) patients discontinued because of adverse events. Conclusions: The interferon-free regimen of faldaprevir, deleobuvir and ribavirin was efficacious in patients infected with genotype-1b and generally well tolerated.",
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AU - Buti, Maria

AU - Soriano, Vicente

AU - Buynak, Robert J.

AU - Mantry, Parvez

AU - Taunk, Jawahar

AU - Stern, Jerry O.

AU - Vinisko, Richard

AU - Gallivan, John Paul

AU - Böcher, Wulf

AU - Mensa, Federico J.

AU - Cobert, Barton

AU - Gonzalwz-Peralta, Regino

AU - Ray, Stuart Campbell

AU - Talal, Andrew

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