Interferon and Ribavirin Therapy – New Studies
The current standard of care for treating hepatitis C is the combination of pegylated interferon plus ribavirin. The two approved pegylated interferon plus ribavirin therapies include:
Pre-conference summary: Efficacy (FDA Package Insert): Sustained virological response rates from two multi-international clinical trials were 44 and 51% for Genotype 1; 70% for Genotype 2 through 6; 82% for Genotype 2 and 3.
· 813. PACIFIC: A phase III, randomized, multicenter, dose escalation, efficacy and safety study examining the effects of treatment with peginterferon alfa-2a in patients with Child’s A or B cirrhosis in chronic hepatitis C virus infection.
· 823. Continuous Subcutaneous Administration of High-Dose Interferon Alfa-2b Combined with Ribavirin in Chronic Hepatitis C Patients: A Dose-Finding And Safety Study in Treatment-Experienced Patients
Pre-conference summary: Efficacy (FDA Package Insert): Sustained virological response rates from one large multi-international clinical trial is 41% for genotype 1; 75% for genotype 2 and 3
Pegylated Interferon – General information
· 817. Impact of PegIntron (PEG) maintenance therapy (MT) on fibrosis biomarkers (FibroTest[FT]/Fibrosure) in prior nonresponders with METAVIR fibrosis scores (MFS) of F2/F3: Final results from the EPIC3 program.
Pegylated Interferon Lambda (PEG-IFN-ƛ)
Pre-conference summary: Currently in a phase II study combined with ribavirin to treat HCV genotypes 1 through 4 treatment naïve patients.
· 821. Pegylated Interferon Lambda (PEG-IFN-λ) Phase 2 Dose-Ranging, Active-Controlled Study in Combination with Ribavirin (RBV) for Treatment-Naïve HCV Patients (Genotypes 1, 2, 3 or 4): Safety, Viral Response, and Impact of IL-28B Host Genotype through Week 12.
· 830. Pharmacokinetics of PEG-Interferon Lambda (PEG-IFN-λ) Following Fixed Dosing in Treatment-Naïve Hepatitis C Subjects (Single Dose Interim Data from a Dose-Ranging Phase 2a Study) (Updated October 31, 2010)
· 831. The Effect of Treatment Group, HCV Genotype, and IL28B Genotype on Early HCV Viral Kinetics in a Phase 2a Study of PEG-Interferon Lambda (PEG-IFN-λ) in Hepatitis C Patients. (Updated October 31, 2010)