Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4
- Moreno, Christophe
- Lenz, Oliver
- Ouwerkerk-Mahadevan, Sivi
- Fevery, Bart
- Peeters, Monika P.
- Beumont, Maria
- Jessner, Wolfgang
- Hezode, Christophe
- Marcellin, Patrick
- Bourgeois, Stefan
- Francque, Sven
- Samuel, Didier
- Zoulim, Fabien
- Grange, Jean Didier
- Shukla, Umesh
DOIAbstract
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 150 mg QD + PR (12 weeks), followed by PR alone (12 or 36 weeks, response-guided [HCV RNA <25 IU/ml detectable/undetectable at week 4 and <25 IU/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...
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