16 Apr Chronic Hepatitis C: RESTORE Study Results

MedicalResearch.com Interview with:
Christophe Moreno, MD, PhD
Directeur clinique, clinique d’Hépatologie
Service de Gastroentérologie
Hépatopancréatologie et Oncologie Digestive

MedicalResearch.com: What are the main findings of the study?

Dr. Moreno: The RESTORE study is an open label, phase 3 study, evaluating Simeprevir in combination with PegIFN and ribavirin in genotype 4 Chronic Hepatitis C patients, either naïve or treatment experienced. Results of this study demonstrated high efficacy of this combination, with an overall SVR rate of 65.4%. Efficacy is particularly high in treatment naïve and prior relapsers patients, with SVR rate of 82.9% and 86.4%, respectively.

Moreover, treatment naïve patients and prior relapsers were eligible to a shorter treatment duration of 24 weeks if they met response-guided therapy (RGT) criteria (defined by an HCV RNA below 25 at week 4 and undetectable at week 12). 89.5% met RGT criteria. Of those, 94.1% achieved a SVR.

MedicalResearch.com:  Were any of the findings unexpected?

Dr. Moreno: No unexpected finding was observed in the RESTORE trial. In particular, the safety profile was good, and comparable to the one observed in studies of Simeprevir in combination with PegIFN and ribavirin in Chronic Hepatitis C (CHC) genotype 1 patients.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Moreno: Simeprevir in combination with PegIFN and ribavirin become one of the new standard of care for Chronic Hepatitis C genotype 4 patients. This regimen offers a particularly high chance of SVR with a shorter treatment duration of 24 weeks in treatment naïve and experienced patients.

MedicalResearch.com:  What recommendations do you have for future research as a result of this study?

Dr. Moreno: An ongoing trial is evaluating Simeprevir in combination with PegIFN and ribavirin in Chronic Hepatitis C genotype 4 naïve patients with mild or moderate fibrosis, with a very rapid virological response.

Future research would evaluate Simeprevir in combination with another DAA (with antiviral activity against genotype 4), in order to propose an IFN-free regimen to this group of patients in the future.

Citation:

ONCE-DAILY SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN IN TREATMENT-NAÏVE OR TREATMENT-EXPERIENCED CHRONIC HCV GENOTYPE 4-INFECTED PATIENTS: SVR12 RESULTS OF A PHASE III TRIAL

MORENO ET AL. ONCE-DAILY SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN IN TREATMENT-NAÏVE OR TREATMENT-EXPERIENCED CHRONIC HCV GENOTYPE 4-INFECTED PATIENTS: SVR12 RESULTS OF A PHASE III TRIAL. ABSTRACT PRESENTED AT THE INTERNATIONAL LIVER CONGRESS™ 2014

Last Updated on April 16, 2014 by Marie Benz MD FAAD