Short article : Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study
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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
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| Enthalten in: |
European journal of gastroenterology & hepatology - 28(2016), 8 vom: 04. Aug., Seite 923-6 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zeuzem, Stefan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 17.07.2017 Date Revised 13.12.2023 published: Print ClinicalTrials.gov: NCT01132313 Citation Status MEDLINE |
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| doi: |
10.1097/MEG.0000000000000649 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM259976172 |
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| 100 | 1 | |a Zeuzem, Stefan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Short article |b Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study |
| 264 | 1 | |c 2016 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 17.07.2017 | ||
| 500 | |a Date Revised 13.12.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01132313 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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%) | ||
| 520 | |a 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) | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 7 | |a Acrylates |2 NLM | |
| 650 | 7 | |a Aminoisobutyric Acids |2 NLM | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a Benzimidazoles |2 NLM | |
| 650 | 7 | |a interferon-lambda, human |2 NLM | |
| 650 | 7 | |a Interleukins |2 NLM | |
| 650 | 7 | |a Oligopeptides |2 NLM | |
| 650 | 7 | |a Protease Inhibitors |2 NLM | |
| 650 | 7 | |a Quinolines |2 NLM | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 650 | 7 | |a Thiazoles |2 NLM | |
| 650 | 7 | |a Ribavirin |2 NLM | |
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| 700 | 1 | |a Mantry, Parvez |e verfasserin |4 aut | |
| 700 | 1 | |a Soriano, Vicente |e verfasserin |4 aut | |
| 700 | 1 | |a Buynak, Robert J |e verfasserin |4 aut | |
| 700 | 1 | |a Dufour, Jean-François |e verfasserin |4 aut | |
| 700 | 1 | |a Pockros, Paul J |e verfasserin |4 aut | |
| 700 | 1 | |a Wright, David |e verfasserin |4 aut | |
| 700 | 1 | |a Angus, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Buti, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Stern, Jerry O |e verfasserin |4 aut | |
| 700 | 1 | |a Kadus, Werner |e verfasserin |4 aut | |
| 700 | 1 | |a Vinisko, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Böcher, Wulf |e verfasserin |4 aut | |
| 700 | 1 | |a Mensa, Federico J |e verfasserin |4 aut | |
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