Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R)

Johannes Vermehren; Yvonne Serfert; Markus Cornberg; Albrecht Stoehr; Hartwig Klinker; Karl-Georg Simon; Gerlinde Teuber; Katja Deterding; Julian Schulze zur Wiesch; Maria-Christina Jung; Michael P. Manns; Stefan Zeuzem; Heiner Wedemeyer; Christoph Sarrazin

doi:10.1055/a-1217-7669

Zeitschrift für Gastroenterologie, Table of Contents

Z Gastroenterol 2020; 58(09): 841-846
DOI: 10.1055/a-1217-7669

Originalarbeit

Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R)

Sofosbuvir, Velpatasvir und Voxilaprevir für Patienten mit chronischer Hepatitis C und Versagen auf eine direkt antivirale Therapie: Ergebnisse aus dem Deutschen Hepatitis C-Register (DHC-R)

Johannes Vermehren

¹Gastro-Praxis Wiesbaden, Wiesbaden, Germany

²University Hospital Frankfurt, Frankfurt am Main, Germany

,

Yvonne Serfert

³Leberstiftungs-GmbH Deutschland, Hannover, Germany

,

Markus Cornberg

⁴Hannover Medical School, Hannover, Germany

,

Albrecht Stoehr

⁵ifi-Institute for Interdisciplinary Medicine, Hamburg, Germany

,

Hartwig Klinker

⁶University Hospital Würzburg, Würzburg, Germany

,

Karl-Georg Simon

⁷MVZ Dres. Eisenbach, Simon, Schwarz GbR, Leverkusen, Germany

,

Gerlinde Teuber

⁸Hepatologische Schwerpunktpraxis, Frankfurt am Main, Germany

,

Katja Deterding

⁴Hannover Medical School, Hannover, Germany

⁹Essen University Hospital, University of Duisburg-Essen, Essen, Germany

,

Julian Schulze zur Wiesch

¹⁰University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany

,

Maria-Christina Jung

¹¹Leberzentrum München, München, Germany

,

Michael P. Manns

⁴Hannover Medical School, Hannover, Germany

,

Stefan Zeuzem

²University Hospital Frankfurt, Frankfurt am Main, Germany

,

Heiner Wedemeyer∗^*

³Leberstiftungs-GmbH Deutschland, Hannover, Germany

⁴Hannover Medical School, Hannover, Germany

⁹Essen University Hospital, University of Duisburg-Essen, Essen, Germany

,

Christoph Sarrazin^*

²University Hospital Frankfurt, Frankfurt am Main, Germany

¹²St. Josefs-Hospital Wiesbaden, Wiesbaden, Germany

› Author Affiliations

Abstract

Despite the high effectiveness of direct-acting antivirals for the treatment of hepatitis C, a small proportion of patients do not respond to approved regimens. The combination regimen of SOF/VEL/VOX was recently approved for patients with failure to prior NS5A-based treatment. In this German real-world cohort including patients with cirrhosis (27.3 %) and previous decompensation events, 12 weeks of SOF/VEL/VOX resulted in high virologic response rates irrespective of disease severity and prior DAA regimen. Adverse events were mostly mild or moderate and comparable to those seen in the approval studies.

Zusammenfassung

Trotz der hohen Effektivität der direkt antiviralen Therapie der chronischen Hepatitis C kommt es bei einem kleinen Teil der Patienten zu einem fehlenden virologischen Ansprechen auf die zugelassenen Therapieregime. Die Kombinationstherapie aus Voxilaprevir, Velpatasvir, Sofosbuvir wurde kürzlich für die Therapie von Patienten mit Versagen auf eine NS5A-basierte Behandlung zugelassen. In der vorliegenden Deutschen Register-Kohorte wurde bei Patienten einschließlich solcher mit Zirrhose und vorangegangener Dekompensation bei einer Therapie mit VOX/VEL/SOF über 12 Wochen hohe SVR-Raten unabhängig von der Schwere der Erkrankung und vorheriger DAA-Therapien erreicht. Dabei wurden lediglich geringe bis mäßige Nebenwirkungen beobachtet, die sich nicht von denen in den Zulassungsstudien unterschieden.

Key words

hepatitis C virus - real world setting - sustained virological response

Schlüsselwörter

HCV - DAA - Relapse - Dekompensation

Full Text

References

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