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J Hepatol. 2015 May;62(5):1047-55. doi: 10.1016/j.jhep.2014.12.031. Epub 2015 Jan 14.

Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4.

Author information

1
CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: Christophe.Moreno@erasme.ulb.ac.be.
2
Hôpital Henri Mondor, AP-HP, Université Paris-Est, INSERM U955, Créteil, France.
3
Hôpital Beaujon, Clichy, France.
4
ZNA Campus Stuivenberg, Antwerp, Belgium.
5
UZ Antwerpen, Antwerp, Belgium.
6
Hôpital Paul-Brousse, Centre Hépatobiliaire, Université Paris Sud, Villejuif, France.
7
Hôpital de la Croix Rousse, Hepatology Department, Hospices Civils de Lyon and INSERM U1052, Lyon, France.
8
Hôpital Tenon, AP-HP, Université Pierre et Marie Curie, Paris, France.
9
Janssen Research & Development, Titusville, NJ, USA.
10
Janssen Infectious Diseases BVBA, Beerse, Belgium.
11
Janssen Research & Development, Beerse, Belgium.

Abstract

BACKGROUND & AIMS:

Simeprevir (SMV) is a once-daily (QD), oral hepatitis C virus (HCV) NS3/4A protease inhibitor approved for treatment of genotype (GT) 1 and GT4 infection. This Phase III, open-label, single-arm study (RESTORE; NCT01567735) evaluated efficacy/safety of SMV with peginterferon-α-2a/ribavirin (PR) in patients with chronic HCV GT4 infection.

METHODS:

107 patients were included. Treatment-naïve (n=35) and prior relapse patients (n=22) received SMV 150mg QD+PR (12 weeks), followed by PR alone (12 or 36 weeks, response-guided [HCV RNA <25IU/ml detectable/undetectable at week 4 and <25IU/ml undetectable at week 12]). Prior non-responders (partial, n=10; null, n=40) received SMV/PR (12 weeks), followed by PR for 36 weeks. The primary endpoint was sustained virologic response 12 weeks after end of treatment (SVR12).

RESULTS:

Median age: 49.0years; 28.0% Black/African; 7.5% IL28B CC; 28.8% METAVIR F4. Overall, 65.4% (70/107) of patients achieved SVR12 (82.9% [29/35] treatment-naïve; 86.4% [19/22] prior relapsers; 60.0% [6/10] prior partial responders; 40.0% [16/40] prior null responders). In treatment-naïve and prior relapser patients fulfilling response-guided criteria for 24 weeks of treatment (88.6% [31/35] and 90.9% [20/22]), SVR12 rates were high: 93.5% [29/31] and 95.0% [19/20], respectively. Overall on-treatment failure and relapse rates were 23.4% (25/107) and 14.6% (12/82), respectively. Adverse events (AEs) were mainly grade 1/2; serious AEs were infrequent (4.7%) and considered unrelated to SMV.

CONCLUSIONS:

Efficacy and safety of SMV 150mg QD for 12 weeks with PR in treatment-naïve or -experienced patients with chronic HCV GT4 infection were in line with previous reports for HCV GT1 infection.

KEYWORDS:

Chronic; Efficacy; Genotype 4; Hepatitis C virus; Protease inhibitor; Response-guided; Safety; Simeprevir; Sustained virologic response; TMC435 (10/10)

PMID:
25596313
DOI:
10.1016/j.jhep.2014.12.031
[Indexed for MEDLINE]

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