Z Gastroenterol 2019; 57(09): e274
DOI: 10.1055/s-0039-1695337
Leber und Galle
Hepatitis C: Donnerstag, 03. Oktober 2019, 08:00 – 09:36, Studio Terrasse 2.1 B
Georg Thieme Verlag KG Stuttgart · New York

High effectiveness of elbasvir/grazoprevir (EBR/GZR) treatment in patients with HCV genotype 1a (GT1a) infection in German real-world: results from the German Hepatitis C Registry (DHC-R)

H Hinrichsen
1   Gastroenterology-Hepatology Center Kiel, Kiel, Deutschland
,
A Stoehr
2   ifi – Institute for Interdisciplinary Medicine, Study Centre St. Georg, Hamburg, Deutschland
,
M Cornberg
3   Hannover Medical School, Hannover, Deutschland
,
H Klinker
4   University Hospital Wuerzburg, Wuerzburg, Deutschland
,
R Heyne
5   Leberzentrum am Checkpoint, Berlin, Deutschland
,
C John
6   Private Practice of Internal Medicine, Berlin, Deutschland
,
KG Simon
7   MVZ Dres. Eisenbach, Simon, Schwarz GbR, Leverkusen, Deutschland
,
M Bilzer
8   Bilzer Consulting, Munich, Deutschland
,
V Guenther
9   MSD Sharp & Dohme GmbH, Haar, Deutschland
,
V Witte
9   MSD Sharp & Dohme GmbH, Haar, Deutschland
,
S Zeuzem
10   Johann Wolfgang Goethe University, Frankfurt, Deutschland
› Author Affiliations
Further Information

Publication History

Publication Date:
13 August 2019 (online)

Also available at
 

Background:

For treatment of HCV GT1a infection with EBR/GZR German guidelines recommend a differentiated approach depending on baseline viral load (BVL). For low BVL ≤800,000 IU/mL treatment with 12 weeks EBR/GZR should be considered, whereas for high BVL > 800,000 IU/mL EBR/GZR for 12 weeks is only recommended in the absence of NS5A RAS. In the presence of NS5A RAS or when RAS-testing is not available, treatment with EBR/GZR + ribavirin (RBV) for 16 weeks is preferred. This analysis investigated the adherence to these recommendations and the real-world effectiveness of EBR/GZR regimens in a large GT1a cohort of the German Hepatitis C Registry.

Methods:

From 09/2016 until 07/2018, 992 patients (pts) with GT1 infection were treated with EBR/GZR ± RBV for 12 to 16 weeks in 130 medical practices and outpatient departments. The analysis was restricted to 195 pts with GT1a infection who completed follow-up. The primary outcome was per protocol (PP) sustained virologic response 12 or 24 weeks post treatment (SVR12 or SVR24).

Results:

88 pts (45%) with low BVL ≤800,000 IU/mL and 107 pts (55%) with high BVL > 800,000 IU/mL showed comparable characteristics: mean age 49 vs. 51 years, female gender 30 vs. 33%, cirrhosis 22 vs. 17%, opioid substitution 26 vs. 24%, HIV co-infection 11 vs. 10% and treatment-naïve 74 vs. 70%. NS5A RAS were tested in 49% vs. 42% of pts with high/low BVL. 4 pts with high BVL (8%) and 2 pts with low BVL (5%) had NS5A RAS of which 50% were treated with EBR/GZR+RBV, respectively. In total, 65% of GT1a pts with high BVL and 94% of pts with low BVL were treated with EBR/GZR without RBV. PP SVR rates stratified by low vs. high BVL were 98,8% vs. 95,1%. All pts with NS5A RAS achieved SVR. When SVR rates were stratified by age, pts with low BVL achieved high SVR rates across all age groups. Interestingly, in pts with high BVL younger than 50 years SVR was 100% but this rate decreased with higher age.

Conclusions:

In German real-world 94% of GT1a infections with low BVL and 65% with high BVL are treated with EBR/GZR for 12 weeks. SVR rates are consistently high. While a decrease in SVR rates in pts with high BVL can be observed, this seems to be limited to pts older than 50 years. Pts younger than 50 years achieve SVR rates of 100% independent of BVL.