Z Gastroenterol 2016; 54 - KV230
DOI: 10.1055/s-0036-1587006

Low frequency of drug-drug interactions (DDIs) with the novel all oral antivirals elbasvir (EBV) and grazoprevir (GRZ) in patients with HCV genotype 1 infection in German real-world

P Buggisch 1, H Löhr 2, G Teuber 3, H Steffens 4, M Kraus 5, P Geyer 6, B Weber 7, T Witthöft 8, U Naumann 9, E Zehnter 10, D Hartmann 11, B Dreher 11, M Bilzer 11
  • 1IFI Institut an der Asklepios Klinik St Georg, Hamburg, Deutschland
  • 2Gastroenterologische Praxis, Wiesbaden, Deutschland
  • 3Praxis für Innere Medizin, Frankfurt, Deutschland
  • 4Praxis für Innere Medizin, Berlin, Deutschland
  • 5Kreiskliniken Altötting-Burghausen, Medizinische Klinik II, Burghausen, Deutschland
  • 6Gastroenterologische Gemeinschaftspraxis, Fulda, Deutschland
  • 7Praxiszentrum Friedrichsplatz, Kassel, Deutschland
  • 8Gastroenterologische Gemeinschaftspraxis, Stade, Deutschland
  • 9Suchtmedizinische Schwerpunktpraxis, Berlin, Deutschland
  • 10Praxis für Gastroenterologie, Dortmund, Deutschland
  • 11MSD Pharma GmbH, Haar, Deutschland

Background: The effectiveness of HCV treatment has dramatically improved with the approval of direct-acting antivirals (DAAs). However, a high frequency of clinically relevant DDIs between the regular outpatient medications and DAAs has been reported for HCV treatment with sofosbuvir in combination with simeprevir, daclatasvir or ledipasvir (30%-40%) while patients (pts) treated with ombitasvir/paritaprevir/ritonavir ± dasabuvir had a risk > 60% (Clin Infect Dis 2016;62: 561 – 567). Recently, the NS3/4a protease inhibitor GRZ in combination with the NS5A polymerase inhibitor EBV has been shown to be highly effective and well tolerated in various subgroups of HCV patients. We therefore aimed to assess the clinical relevance of DDIs between the regular outpatient medications and FDA-approved EBV/GRZ therapy in a large German real-world cohort.

Methods: From April 2012 until January 2014, pre-existing co-morbidities and outpatient medications were documented from 469 pts with HCV G1 infection by 97 practices and hospitals in Deutschland. DDIs were assessed based on information available at www.hep-druginteractions.org and the prescribing information for EBV/GRZ in March 2016.

Results: 599 co-morbidities were documented for 329 of 469 pts (70%) before HCV treatment. The most frequently reported co-morbidities were obesity (19%), cardiovascular diseases (18%), psychiatric disorders (14%), opiate dependency (13%), gastrointestinal diseases (11%), metabolic disorders (8%) and thyroid gland diseases (7%). Co-medications were documented for 233 of 469 pts (50%). Of overall 564 co-medications 39% were related to treatment of neuropsychiatric disorders including opiate dependency, 19% were cardiovascular drugs, 14% were agents for gastrointestinal and metabolic diseases and 6% for thyroid diseases. Interestingly, only 23 co-medications in 21 of 469 pts (4.5%) had the potential to interact with EBV/GRZ. Of these, 7 pts (1.5%) had a contraindication which was related to HIV-medication in 3 pts.

Conclusions: Preexisting co-morbidities and co-medications are a frequent problem in pts undergoing HCV G1 treatment in German real-life. Compared to previously approved DAAs there seems to be a low risk of DDIs between outpatient medication and the novel DAA therapy with EBV/GRZ.