Z Gastroenterol 2020; 58(01): e63-e64
DOI: 10.1055/s-0039-3402277
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 EBR/GZR in HCV GT1 patients with multiple comorbidities and medications: results from the DHC-R

H Hinrichsen
1   Gastroenterology-Hepatology Center Kiel, Kiel, 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)

Also available at
 

Question:

Until now, the impact of comorbidities and DDIs on the outcome of elbasvir/grazoprevir (EBR/GZR) treatment is rather unclear. The present analysis of the DHC-R real-world cohort was aimed to assess the clinical relevance of co-morbidities and DDIs in patients (pts) with chronic HCV GT1 infection undergoing treatment with EBR/GZR.

Methods:

The DHC-R is an ongoing, prospective, observational cohort study. From September 2016 until July 2018, 992 pts with GT1 infection were treated at physician discretion with EBR/GZR +/- ribavirin (RBV) for 12 to 16 weeks in 130 medical practices and hospital outpatient departments. The present analysis was restricted to 613 pts who completed 12 or 24 weeks of follow-up or discontinued the treatment early; demographic data are shown for this ITT population. Sustained virologic response (SVR) data are shown for 599 pts (Per Protocol (PP) population). Comorbidities were documented and clinically relevant DDIs (co-administration of drugs contraindicated or may require dose adjustment/closer monitoring) were assessed based on information available at www.hep-druginteractions.org and the prescribing information for each drug.

Results:

This real-life cohort with 613 pts was predominantly male (59%), median age was 55 years and the majority (67%) was infected with HCV genotype 1b. 17% presented with liver cirrhosis. Pts were treated with EBR/GZR (93%) and with EBR/GZR+RBV (7%). 87% of pts reported 2641 comorbidities, while only 13% had no comorbidities. 1 – 3 comorbidities were observed in 33%, 4 – 6 comorbidities in 30%, > 7 comorbidities in 24% of pts. The frequency of comorbidities was significantly higher in pts with GT1a vs. GT1b infection (94 vs. 84%, p = 0.005), in pts older than 50 – 70 years (90%) or > 70 years (92%) vs. < 50 years (82%) (p = 0.004 and 0.023) as well as in pts with cirrhosis vs. pts without cirrhosis (95 vs. 86%, p = 0.011). Comparable SVR rates were found when pts were analyzed according to the most frequent comorbidities. 65% of pts reported 1547 comedications, while 35% reported no comedications at baseline. Overall, there was a low risk of DDIs with EBR/GZR (contraindicated 0.3% (2/613), DDIs requiring closer monitoring 7% (46/613)). In both groups, pts achieved an SVR of 100%.

Conclusions:

Despite a high frequency of comorbidities and comedications in pts with HCV GT1 infection clinically relevant DDIs are rare. Neither comorbidities nor DDIs seem to have an impact on SVR rates following EBR/GZR treatment.