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  3. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study.
 

Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study.

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BORIS DOI
10.7892/boris.93550
Date of Publication
August 2016
Publication Type
Article
Division/Institute

Departement Klinische...

Author
Zeuzem, Stefan
Mantry, Parvez
Soriano, Vicente
Buynak, Robert J
Dufour, Jean-François
Departement Klinische Forschung, Hepatologie Forschung
Universitätsklinik für Viszerale Chirurgie und Medizin, Hepatologie
Universitätsklinik für Viszerale Chirurgie und Medizin, Hepatologie
Pockros, Paul J
Wright, David
Angus, Peter
Buti, Maria
Stern, Jerry O
Kadus, Werner
Vinisko, Richard
Böcher, Wulf
Mensa, Federico J
Subject(s)

600 - Technology::610...

Series
European journal of gastroenterology & hepatology
ISSN or ISBN (if monograph)
0954-691X
Publisher
Lippincott Williams & Wilkins
Language
English
Publisher DOI
10.1097/MEG.0000000000000649
PubMed ID
27140229
Description
BACKGROUND

SOUND-C3 was a multicentre, open-label, phase 2b study exploring the safety and efficacy of the interferon-free combination of faldaprevir (an NS3/A4 protease inhibitor), deleobuvir (BI 207127, a non-nucleoside polymerase inhibitor) and ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) genotype-1 infection. Results in patients with HCV genotype-1b and in IL28B CC genotype patients with HCV genotype-1a have been described previously. This report describes the results in IL28B non-CC genotype patients with HCV genotype-1a.

METHODS

Patients were randomized to receive faldaprevir 120 mg once daily with deleobuvir at either 800 mg twice daily (b.i.d.; N=26) or 600 mg three times daily (t.i.d.; N=25), and weight-based ribavirin for 24 weeks. The primary endpoint was sustained virological response 12 weeks after treatment (SVR12).

RESULTS

In each group, five patients completed 24 weeks of treatment. SVR12 rates were 19% (5/26) and 8% (2/25) in the b.i.d. and t.i.d. groups, respectively. On-treatment breakthrough [50% (13/26) and 68% (17/25) in the b.i.d. and t.i.d. groups, respectively] was the most frequent reason for not achieving SVR12. Adverse events led to premature treatment discontinuation in six (23%) patients in the b.i.d. group and in two patients (8%) in the t.i.d. group. The majority of adverse events were mild or moderate; the most frequently reported were nausea (67%), fatigue (35%) and diarrhoea (35%).

CONCLUSION

In this small study, the interferon-free regimen of faldaprevir, deleobuvir and ribavirin resulted in high rates of virological breakthrough and low rates of SVR12 in IL28B non-CC genotype patients infected with genotype-1a HCV (http://www.clinicaltrials.gov NCT01132313).
Handle
https://boris-portal.unibe.ch/handle/20.500.12422/148441
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Faldaprevir, deleobuvir and ribavirin in IL28B non-CC.pdftextAdobe PDF100.35 KBpublisherpublished restricted
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