Z Gastroenterol 2015; 53 - P78
DOI: 10.1055/s-0035-1551766

Shortening overall treatment to 12 weeks of SIMEPREVIR plus pegylated-interferon/ribavirin according to early virologic response in treatment-naïve patients with chronic HCV genotype 4 infection and mild-to-moderate fibrosis

P Ferenci 1, T Asselah 2, C Moreno 3, A Craxi 4, F Sanai 5, R Ryan 6, O Lenz 7, G Van Dooren 7, I Lonjon-Domanec 8, M Schlag 9, M Buti 10
  • 1Medical University, Vienna, Austria
  • 2Beaujon Hospital, University of Paris, Paris, France
  • 33CUB Hôpital Erasme Hospital, Université Libre de Bruxelles, Brüssel, Belgium
  • 4University of Palermo, Palermo, Italy
  • 5Division of Gastroenterology, Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia
  • 6Janssen Research & Development, Titusville, NJ, United States
  • 7Janssen Infectious Diseases BVBA, Beerse, Belgium
  • 8Janssen Pharmaceuticals, Paris, France
  • 9Janssen-Cilag, Vienna, Austria
  • 10Hospital Valle Hebron and Ciberehd del Institut Carlos III, Barcelona, Spain

Aims: HCV genotype 4 (GT4) is highly prevalent in the Middle East and Sub-Saharan Africa, and is expanding in Europe. To prevent disease progression, short and effective regimens are needed for these patients. This study aims to assess whether treatment with simeprevir+Peg-IFN/ribavirin can be shortened to 12 weeks, based on early viral kinetics, in patients with mild-to-moderate fibrosis.

Design: Phase-3, open-label study, including treatment-naïve patients in Europe and Saudi Arabia with HCV GT4. In patients with HCV-RNA < 25IU/mL (detectable/undetectable in IL28B CC, undetectable in CT/TT [Roche COBAS® Taqman®] at Week 2, and undetectable at Weeks 4 and 8, all treatments were stopped at Week 12. Otherwise, Peg-IFN/ribavirin was continued to Week 24. On-treatment and SVR4 data from the European patients are presented.

Results: 50 patients were enrolled (male: 72%, white: 83%, GT4a/d/other: 36/40/24%, METAVIR F0-F1/F2: 78/22%, IL28B non-CC: 84%). 46 patients completed simeprevir; three discontinued due to an AE; one met a virologic stopping rule. 24/50 were eligible for 12 weeks of treatment. 14/26 patients extending to 24 weeks are currently ongoing with Peg-IFN/ribavirin. Treatment with simeprevir+Peg-IFN/ribavirin was well tolerated: SAE (n = 1); grade 3/4 AE: 26%/0%.

Of the 24 patients eligible for 12 weeks (Table), none discontinued or relapsed to date. Among initial patients evaluable, SVR4 was 94% (16/17; one patient missing SVR4 data).

Tab. 1: Patient eligibility for 12- or 24-week planned treatment duration, by subgroups

n/N (%)

Total

Met 12-week criteria

24/50 (48)

Did not meet 12-week criteria

24/50 (48)

Not classifiable

2/50 (4)

GT4a

Met 12-week criteria

8/18 (44)

Did not meet 12-week criteria

9/18 (50)

Not classifiable

1/18 (6)

GT4 d

Met 12-week criteria

10/20 (50)

Did not meet 12-week criteria

9/20 (45)

Not classifiable

1/20 (5)

GT4 other

Met 12-week criteria

6/12 (50)

Did not meet 12-week criteria

6/12 (50)

IL28B CC

Met 12-week criteria

8/8 (100)

IL28B CT

Met 12-week criteria

12/33 (36)

Did not meet 12-week criteria

19/33 (58)

Not classifiable

2/33 (6)

IL28B TT

Met 12-week criteria

4/9 (44)

Did not meet 12-week criteria

5/9 (56)

Conclusions: 48% of GT4 patients met the criteria for stopping treatment at Week 12. Of these patients, preliminary SVR4 rates are promising in GT4a/d, with SVR12/24 data and SVR data in Saudi Arabian patients forthcoming.