Z Gastroenterol 2015; 53 - KG150
DOI: 10.1055/s-0035-1559176

Daclatasvir plus Sofosbuvir with or without Ribavirin in patients infected with HCV genotype 3: Interim results of a multicenter compassionate use program in Europe

T Welzel 1, J Petersen 2, M Gschwantler 3, M Cornberg 4, A Zoufaly 5, T Berg 6, U Naumann 7, M Van der Valk 8, O Weiland 9, M Jimenez-Exposito 10, S Zeuzem 11
  • 1Universitätsklinikum der Johann Wolfgang Goethe Universität, Medizinische Klinik 1, Frankfurt am Main, Deutschland
  • 2Institut für Interdisziplinäre Medizin, IFI, Hamburg, Deutschland
  • 3Wilhelminenspital, Wien, Österreich
  • 4Medizinische Hochschule Hannover, Hannover, Deutschland
  • 5Kaiser Franz-Josef Spital, Wien, Österreich
  • 6Universitätsklinikum Leipzig, Leipzig, Deutschland
  • 7Praxiszentrum Kaiserdamm, Berlin, Deutschland
  • 8University of Amsterdam, Amsterdam, Niederlande
  • 9Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Schweden
  • 10Bristol-Myers Squibb, Rueil-Mailmaison, Frankreich
  • 11Universitätsklinikum der Johann Wolfgang Goethe Universität, Medizinische Klinik 1, Frankfurt am Main, Deutschland

Einleitung: Treatment of HCV genotype 3 (GT3) infection remains a high medical need. Compared to HCV non-GT3, pts with HCV GT3 have faster rates of fibrosis progression, higher prevalence of severe steatosis, and a higher incidence of hepatocellular carcinoma. Treatment options for HCV GT3 pts are limited, and debate continues on the optimal regimen and duration of treatment, especially in those with cirrhosis. This analysis reports interim findings from a compassionate use program (CUP) of Daclastavir (DCV) plus Sofosbuvir (SOF) with or without Ribavirin (RBV) opened in 5 European countries.

Material und Methoden: This multicenter CUP (ClinicalTrials.gov, NCT02097966) enrolled adult pts with chronic HCV infection at a high risk of hepatic decompensation or death within 12 months if left untreated, and who had no available treatment options. Patients received DCV 60 mg + SOF 400 mg QD with RBV added at the physician's discretion. Recommended duration of treatment was 24 weeks. This preliminary interim analysis includes 91 HCV GT3 pts with available data at Jan 16th, 2015.

Ergebnisse: Most pts were male (63, 69%), HCV mono-infected (80, 88%), treatment experienced (51, 56%), and cirrhotic (85, 93%) (Child-Pugh C, 9/85, 11%). Seven (8%) pts were liver transplanted. Duration of treatment was 24 weeks in most pts (87, 96%). The most frequent adverse events (AEs) (all grades) were anemia (12%), fatigue (9%), and nausea (8%). Four patients discontinued due to AEs and 2 pts died due to events considered as non-treatment related (multiorgan failure, liver related (non-HCC)). The table below shows the preliminary efficacy results. Efficacy and safety data will be updated for presentation.

Schlussfolgerung: In this preliminary analysis, an all-oral regimen using DCV+SOF with/without RBV was very well tolerated and results in good on-treatment virological response in pts with GT3. SVR12 data will be presented.

Tab. 1: On-treatment efficacy of DCV+SOF ± RBV in GT3 pts

HCV RNA < LLOQ, TD or TND

DCV + SOF

(N = 54)

DCV + SOF + RBV

(N = 37)

Overall

(N = 91)

On-treatment week 4

40/50 (80%)

22/27 (81%)

62/77 (80%)

On-treatment week 12

41/41 (100%)

29/29 (100%)

70/70 (100%)

On-treatment week 24

21/21 (100%)

9/9 (100%)

30/30 (100%)

LLOQ = Lower limit of quantification; TD = Target detected; TND = Target not detected