Z Gastroenterol 2019; 57(09): e274-e275
DOI: 10.1055/s-0039-1695339
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 real-world effectiveness of elbasvir/grazoprevir (EBR/GZR) in PWID on opioid substitution therapy with HCV genotype 1 (GT1) infection: results from the German Hepatitis C Registry (DHC-R)

S Christensen
1   CIM Muenster, Muenster, 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
,
J Reimer
10   University Hospital Hamburg, Hamburg, Deutschland
11   Health North Hospital Group Bremen, Bremen, Deutschland
› Author Affiliations
Further Information

Publication History

Publication Date:
13 August 2019 (online)

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    Background:

    In most high-income countries, people who inject drugs (PWID) are the main population affected by chronic HCV infection with an estimated prevalence of 60 – 80%. In the clinical study C-EDGE CO-STAR EBR/GZR has proven high efficacy in PWID on opioid substitution therapy (OST), even with ongoing drug use. Until now, information on the real-world efficacy of EBR/GZR in PWID is still limited. We therefore investigated this in a large GT1 real-world cohort of the German Hepatitis C Registry.

    Methods:

    From September 2016 until July 2018, 992 patients (pts) with GT1 infection were treated at physician discretion with EBR/GZR ± ribavirin (RBV) for 12 to 16 weeks in 130 medical practices and outpatient departments. The analysis was restricted to 613 pts who completed 12 or 24 weeks of follow-up or discontinued treatment early; demographic data are shown for this ITT population. Sustained virologic response (SVR) data are shown for 599 pts (Per Protocol (PP) population).

    Results:

    Demographics of 499 pts without former drug use (Non-OST/NDU) were compared with 67 PWID on OST (OST) and 47 former/current drug users not receiving OST (Non-OST/DU): mean age 56 vs. 45 vs. 47 years, male gender 54 vs. 81 vs. 72%, GT1a 23 vs. 74 vs. 70%, baseline viral load > 800,000 IU/mL 56 vs. 52 vs. 53%, cirrhosis 18 vs. 18 vs. 13%, HIV co-infection 3 vs. 6 vs. 19%, cardiovascular disease 40 vs. 13 vs. 13% and psychiatric disorder 10 vs. 13 vs. 28%. NS5A RAS were tested in 15 vs. 37 vs. 34% and were detectable in 12 vs. 0 vs. 13%. EBR/GZR treatment was used in 96 vs. 78 vs. 85% of pts and EBR/GZR+RBV in 4 vs. 22 vs. 15%. ITT and PP SVR rates were 96.2% and 98.6% in Non-OST/NDU pts, 89.6% and 98.4% in OST and 93.6% and 9.,7% in Non-OST/DU pts. Comparative statistics for ITT and PP SVR results showed a significant difference (p = 0.025) in SVR for Non-OST/NDU vs. OST in the ITT analysis, which was mainly due to LTFU.

    Conclusions:

    Despite controversies concerning HCV treatment in PWID, this analysis demonstrates a high real-world efficacy of EBR/GZR in OST and in Non-OST/DU pts. A significant difference among groups was only observed in ITT SVR for OST vs. Non-OST/NDU pts. Nevertheless, these findings suggest that reservations to initiate therapy in these groups are unwarranted.


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