Z Gastroenterol 2018; 56(08): e288-e289
DOI: 10.1055/s-0038-1668886
Kurzvorträge
Leber und Galle
Therapie der Hepatitis B und C: Outcome, Grundlagen der Resistenzentwicklung und therapeutische Auswege – Freitag, 14. September 2018, 09:55 – 11:55, 22a
Georg Thieme Verlag KG Stuttgart · New York

Utilization of elbasvir/grazoprevir (EBR/GZR) and adoption of resistance associated substitutions (RAS) testing in real-world treatment of HCV genotype 1 (GT1) infection: results from the German Hepatitis C Registry (DHC-R)

H Hinrichsen
1   Gastroenterologisch – Hepatologisches Zentrum, Kiel, Deutschland
,
H Klinker
2   Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik II, Würzburg, Deutschland
,
A Stoehr
3   Ifi Institut für interdisziplinäre Medizin, Hamburg, Deutschland
,
C John
4   Internistische Facharztpraxis, Berlin, Deutschland
,
R Heyne
5   Leberzentrum Checkpoint, Berlin, Deutschland
,
G Klausen
6   Schwerpunktpraxis Berlin-Mitte, Berlin, Deutschland
,
KG Simon
7   MVZ Dres. Eisenbach, Simon, Schwarz GbR, Leverkusen, Deutschland
,
M Cornberg
8   Hannover Medical School, Hannover, Deutschland
,
M Kuhn
9   Praxis für Gastroenterologie, Kassel, Deutschland
,
U Naumann
10   UBN-Praxis, Berlin, Deutschland
,
M Bilzer
11   Bilzer Consulting, München, Deutschland
,
V Günther
12   MSD Sharp & Dohme GmbH, Haar, Deutschland
,
V Witte
12   MSD Sharp & Dohme GmbH, Haar, Deutschland
,
S Zeuzem
13   Johann Wolfgang Goethe Universität, Frankfurt, Deutschland
› Author Affiliations
Further Information

Publication History

Publication Date:
13 August 2018 (online)

Also available at
 
 

    Background:

    According to the European label HCV GT1b infection as well as GT1a infection with baseline viral load (BVL)< 800,000 IU/mL can be treated with EBR/GZR for 12 weeks. For GT1a infection with BVL> 800,000 IU/mL baseline NS5A RAS-testing and lengthening of EBR/GZR to 16 weeks together with RBV is recommended if NS5A RAS are present or when RAS-testing is not available. The present analysis investigated the real-world utilization of these recommendations and the possible impact on EBR/GZR effectiveness in a large GT1 cohort of the German Hepatitis C Registry.

    Methods:

    From September 2016 until December 2017, 714 patients (pts) with genotype 1 infection were treated with EBR/GZR+/-RBV for 12 to 16 weeks in 116 medical practices and hospital outpatient departments. The present interim analysis was restricted to 707 pts with documented GT1 subtypes.

    Results:

    In total, 242 pts with GT1a infection (34.2%) and 465 pts with GT1b infection (65.8%) received EBR/GZR-based treatment and showed the following characteristics (GT1a vs. GT1b): mean age 49 vs. 56 years, female gender 29 vs. 46%, liver cirrhosis 17 vs. 17%, opioid substitution 29 vs. 4%, HIV co-infection 9 vs. 2%, renal dysfunction 7 vs. 11% and treatment-naïve 74 vs. 77%. RAS at baseline were tested in 62 of 125 GT1a pts (50%) with BVL> 800.000 IU/mL. 5 pts (8%) had NS5A RAS of which 3 were treated with EBR/GZR+RBV and 2 with EBR/GZR. Furthermore, 7 pts without RAS and 34 pts without RAS testing received RBV. In total, 44/125 of GT1a pts (35%) with high BVL were treated with EBR/GZR+RBV. Although not recommended by the European guidelines, NS5A RAS were tested in 49 of 112 GT1a pts (44%) with low BVL and in 29 of 465 pts (6%) with GT1b infection while 9 of 112 pts (8%) with GT1a and low BVL and 2 of 465 pts (0.4%) with GT1b infection received RBV. By now SVR results were available from 116/707 pts. Overall per protocol SVR12 was 100%.

    Conclusions:

    In German real-world practice, 92% of pts with GT1 receiving EBR/GZR are treated without RBV. Addition of RBV is mainly restricted to pts with high BVL> 800,000 IU/mL of which 50% are tested for NS5A RAS at baseline. The current treatment with EBR/GZR seems to be highly effective. Full SVR12 data by GT1 subtypes and BVL will be presented at the conference.


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