Author information:
Toranomon Hospital, Tokyo, Japan.
Abstract
AIM:
The efficacy and safety of simeprevir in combination with peginterferon α-2b and ribavirin (PegIFNα-2b/RBV) were investigated in patients infected with hepatitis C virus (HCV) genotype-1 who were treatment-naïve or had previously received interferon (IFN)-based therapy. Combination therapy with peginterferon α-2b and ribavirin (PegIFNα-2b/RBV) has been widely used in treatment-naïve patients with hepatitis C virus (HCV) genotype-1. Options are limited for re-treatment of patients in whom previous interferon-based therapy failed.
METHODS:
CONCERTO-4 (NCT01366638) was an open-label, non-comparative, multicenter study of once-daily simeprevir (TMC435) 100 mg in combination with PegIFNα-2b/RBV in treatment-naïve and -experienced patients (prior relapsers or non-responders to interferon-based therapy) with chronic HCV genotype-1 infection. Twelve-week combination treatment was followed by 24/48-week response-guided PegIFNα-2b/RBV therapy for treatment-naïve patients and prior relapsers, and 48-week PegIFNα-2b/RBV therapy for prior non-responders. Patients were followed for 72 weeks after treatment initiation. The proportions of patients with sustained viral response (SVR; undetectable HCV RNA) at treatment end and 12 weeks after the last treatment (SVR12) were among the major efficacy endpoints. Safety, including adverse events (AEs), was monitored.
RESULTS:
Of the 79 patients treated, the proportion achieving SVR12 was highest among treatment-naïve patients (91.7%) and prior relapsers (100%) vs 38.5% of prior non-responders. All treatment-naïve patients and prior non-responders who achieved SVR12 also achieved SVR at treatment end and 24 weeks after last dose; 96.6% of prior relapsers achieved both endpoints. Most AEs were of grade 1 or 2 severity. Grade 3 AEs occurred in 17 patients, most frequently neutropenia (6.3%).
CONCLUSION:
Simeprevir combined with PegIFNα-2b/RBV was effective in patients infected with HCV genotype-1, both for initial treatment of naïve patients and for re-treatment of patients in whom previous interferon-based therapy had failed.