HUDDINGE, Sweden I October 10, 2014 I Medivir AB
(STO:MVIR-B) today announces that its partner Janssen recently initiated
patient enrolment in a phase II study called IMPACT. This study
evaluates the efficacy, safety and pharmacokinetics of the NS3/4A
protease inhibitor simeprevir administered once daily in combination
with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s
(BMS) NS5A replication complex inhibitor daclatasvir. The study
includes treatment-naïve and treatment-experienced patients with
hepatitis C genotype 1 and 4 infection and decompensated liver disease.
In the phase II, open label IMPACT study, patients will receive the
once-daily combination of simeprevir 150 mg, sofosbuvir 400 mg and
daclatasvir 60 mg, for 12 weeks. The primary efficacy endpoint in the
study is the proportion of patients achieving sustained virologic
response 12 weeks after the end of treatment (SVR12). The IMPACT study
represents the first phase II study of the combination of simeprevir,
sofosbuvir and daclatasvir in a regimen without pegylated interferon and
ribavirin.
For more information please visit www.clinicaltrials.gov.
Source: http://www.pipelinereview.com/index.php/2014101055685/Small-Molecules/Medivir-Phase-II-IMPACT-Study-Initiated-to-Evaluate-Simeprevir-in-Combination-with-Sofosbuvir-and-Daclatasvir-to-Treat-Genotype-1-and-4-Hepatitis-C-Patients.htmlLabels: IMPACT study, sofosbuvir and daclatasvir, triple therapy of simeprevir