Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current
standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously
administered (pegylated)-interferon-α and ribavirin for 24 weeks (for genotypes 2 and 3) to
48 weeks (for genotype 1). The sustained viral response rates (SVR) in patients infected with
genotypes 2 and 3 are ~80% but remain <50% in patients infected with genotype 1. The
treatment is quite toxic with approximately 30% of patients experiencing adverse events (i.e.
depression, fever, anemia, fatigue) requiring dose reduction or discontinuation of therapy.
This regimen is contraindicated in women who are pregnant and in patients with decompensated
liver disease. The absence of acceptable therapies for many patients with HCV infections
makes new therapies desirable for this disease.