Direct-acting antiviral agents in the treatment of chronic Hepatitis C – “Real-life” experience from an academic centre and two specialized clinical practices

Abstract

The introduction of the new direct antiviral agents has revolutionized the therapy of chronic hepatitis C. Today we are able to cure the vast majority of our patients with an 8- to 12-week therapy course of an antiviral combination therapy with an excellent safety profile. Real-life data are very important to further develop our experience with the new therapeutics and help us to improve the care of our patients in our everyday clinical practice.

In our study, we present the retrospective analysis of a representative German cohort of 344 patients with chronic hepatitis C treated with the new direct antiviral agents. The patients were recruited in an academic center of southern Germany (University Clinic of Ulm, Clinic of Internal Medicine I) and in 2 highly specialized clinical practices in the city center and the near region of Ulm. Within this in-detail characterized study cohort, we analyzed the efficacy and safety of antiviral therapy under real-life conditions.

In 322 patients, we could document SVR12 data and found an excellent overall SVR12 rate of 97.8 % across all genotypes. In more detail, we could show comparable SVR12 results of 99 % and 99.2 % in patients with the hepatitis C virus subtypes 1a and 1b of and an excellent SVR12 rate of 93.1 % in genotype 3 patients without liver cirrhosis. Nevertheless, SVR12 rates tend to be lower in patients with the presence of liver cirrhosis, especially in genotype 3 patients with the lowest SVR12 rate in the whole study group of only 80 %. In general, there were no major safety issues except of 1 patient treated with a protease-inhibitor-based regimen who developed a generalized skin reaction and needed hospitalization and premature end of antiviral therapy.

In summary, our analysis of this well characterized representative cohort of 344 patients adds more information in the field of real-life experience with the new antiviral therapeutics and could therefore contribute to improve the care of our patients. Together with the existing real-life data, we now can proceed in achieving the aim of viral eradication of hepatitis C virus within our population.

Zusammenfassung

Die Einführung der neuen direkt antiviral wirksamen Medikamente hat die Therapie der chronischer Hepatitis C revolutioniert. Heute sind wir in der Lange die überwiegende Mehrheit unserer Patienten mit einer 8 – 12 Wochen dauernden und überaus sicheren antiviralen Kombinationstherapie zu heilen. „Real-Life“ Daten sind überaus wichtig um unsere Erfahrungen mit den neuen Therapeutika zu verbessern und uns bei der Versorgung unserer Patienten im klinischen Alltag zu unterstützen.

In der vorliegenden Studie haben wir eine repräsentative Kohorte mit 344 Patienten mit chronischer Hepatitis C, die mit den neuen direkt antiviral wirksamen Substanzen behandelt wurden retrospektiv analysiert. Die Erhebung der Patientendaten erfolgte in der Hepatitis C-Sprechstunde der Klinik für Innere Medizin I am Universitätsklinikum Ulm und in zwei Schwerpunktpraxen (eine infektiologische und eine gastroenterologische Praxis) in Ulm und der nahen Umgebung Ulms. Wir führten eine detaillierte Analyse dieser Patientenkohorte bezüglich der Wirksamkeit und Sicherheit der neuen direkt antiviral wirksamen Medikamente durch.

Bei 322 Patienten konnten wir die HCV-RNA 12 Wochen nach Therapieende dokumentieren und fanden eine exzellente SVR12 Rate von insgesamt 97,8 % über alle Genotypen hinweg. Die SVR12 Rate betrug beim Genotyp 1a 99 %, beim Genotyp 1b 99,2 % und 93,1 % bei Patienten mit Genotyp 3 ohne Leberzirrhose. Dennoch war die SVR12 Rate tendenziell niedriger bei Patienten, insbesondere bei Genotyp 3 Patienten, die mit 80 % die niedrigste SVR12 Rate im gesamten Kollektiv aufwiesen. Im Allgemeinen gab es keine relevanten Sicherheitsbedenken, lediglich bei einer Patientin, die eine Proteasenhibitor-haltige Therapie erhielt kam es zu einer ausgeprägten generalisierten Hautreaktion mit nachfolgendem stationären Aufenthalt und vorzeitigem Abbruch der antiviralen Therapie.

Zusammenfassend erweitert unsere Analyse dieser sehr gut charakterisierten Patientenkohorte mit insgesamt 344 Patienten den Kenntnisstand bezüglich der Anwendung der neuen antiviralen Therapien im klinischen Alltag und trägt hierdurch zur Verbesserung der Versorgung dieser Patienten bei. Gemeinsam mit den bereits vorliegenden „real-life“ Daten, kommen wir dadurch dem übergeordneten Ziel der Elimination der Hepatitis C-Infektion in unserer Bevölkerung näher.

Schlüsselwörter

Hepatitis C - direkt-antiviral wirksame Medikamente - SVR12 - „Real-life“ Daten

Key words

hepatitis C - direct-acting antiviral agents - SVR12 - real-life data

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