Z Gastroenterol 2020; 58(01): e64
DOI: 10.1055/s-0039-3402279
Poster Visit Session V Viral Hepatitis and Immunology: Saturday, February 15, 2020, 11:00 am – 11:45 am, Lecture Hall P1
Georg Thieme Verlag KG Stuttgart · New York

Real-world efficacy of elbasvir/grazoprevir in HCV GT1 infected diabetics: results from the German Hepatitis C Registry

J Schattenberg
1   Medizinische Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität, Mainz, Germany
,
A Stoehr
2   ifi – Institute for Interdisciplinary Medicine, Study Centre St. Georg, Hamburg, Germany
,
M Cornberg
3   Hannover Medical School, Hannover, Germany
,
H Klinker
4   University Hospital Würzburg, Würzburg, Germany
,
R Heyne
5   Leberzentrum am Checkpoint, Berlin, Germany
,
C John
6   Private Practice of Internal Medicine, Berlin, Germany
,
KG Simon
7   MVZ Dres. Eisenbach, Simon, Schwarz GbR, Leverkusen, Germany
,
M Bilzer
8   Bilzer Consulting, München, Germany
,
V Guenther
9   MSD Sharp & Dohme GmbH, Haar, Germany
,
V Witte
9   MSD Sharp & Dohme GmbH, Haar, Germany
,
S Zeuzem
10   Johann Wolfgang Goethe University, Frankfurt, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
03 January 2020 (online)

 

Question:

Type 2 diabetes mellitus is a well-described extrahepatic manifestation of HCV infection. Here, we investigated the real-world effectiveness of EBR/GZR in patients (pts) without and with diabetes in a large GT1 cohort of the German Hepatitis C Registry (DHC-R). In addition, we evaluated the impact of HCV treatment on diabetes disease progression.

Methods:

From 09/2016 until 07/2018, 992 pts with GT1 infection were treated with EBR/GZR +/- RBV for 12 to 16 weeks in 130 medical practices and hospital outpatient departments in Germany. The present analysis was restricted to 879 and 93 pts without/with diabetes who completed follow-up. The primary outcome was per protocol sustained virologic response at 12 or 24 weeks post treatment (SVR12 or SVR24).

Results:

879 pts (90%) without and 93 pts with diabetes (10%) showed the following characteristics: mean age 53 vs. 63 years, female gender 44 vs. 41%, BMI 26 vs. 29, GT1b 69 vs. 78% and cirrhosis 18 vs. 38%. In diabetics the rate of comorbidities was 2-fold higher than in pts without diabetes (8.3 vs. 3.7/patient). This was mainly related to a higher frequency of cardiovascular diseases (65 vs. 29%) and renal dysfunctions (24 vs. 7%) including hemodialysis (13 vs. 4%). In line with this observation, the use of outpatient medications was 2.5-fold higher in diabetic pts (5.6 vs. 2.1/patient) mainly by the intake of agents acting on renin/angiotensin (60 vs. 22%), beta blocking agents (39 vs. 19%), calcium channel blockers (25 vs. 10%), drugs for acid related disorders (41 vs. 15%) and diuretics (36 vs. 10%). PP SVR rates were similar in pts with (97.6%, 82/84) and without diabetes (97.5%, 766/786). Where available, HbA1c levels in pts with diabetes post SVR were compared to baseline and showed a lower percentage of 60% (3/5) vs. 100% (5/5) of pts with values exceeding the norm. HbA1c mean before treatment was 7.5% +/- 2.2% (N = 5) compared to 6.4% +/-1.1% (N = 5) at 24 weeks of follow-up. Likewise, the proportion of pts on antidiabetics decreased from 77% (65/84) at baseline to 56% (47/84) post SVR. Due to small patient numbers these results need to be interpreted with caution.

Conclusions:

In German real-world, treatment of GT1 infection with EBR/GZR results in a SVR rate of ≥97.5% in pts with/without diabetes. There seems to be a trend towards lower HbA1c levels and a reduction in intake of antidiabetics post SVR compared to baseline. This observation, however, needs to be confirmed in a larger study population.