LM2010_banner-logo

Interferon and Ribavirin

 

Albumin Interferon

·        80. Safety and efficacy of albinterferon-alfa-2b every four weeks plus ribavirin for treatment of chronic hepatitis C genotype 2/3. 

 

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:

 

Pegasys (pegylated interferon alfa-2a) plus Copegus (ribavirin): 

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.

·        79. 36 versus 48 weeks of treatment with peginterferon alfa-2a plus ribavirin for genotype 1/4 patients with undetectable HCV RNA at week 8: Final results of a randomized multicenter study

·        800. Real-Time PCR Comparison of 48-Week and 72-Week Therapy with Peginterferon Alfa-2a(40kd) and Ribavirin for Cevr Cases in a Multicenter Clinical Trial: R-Zero Study.

·        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

·        825. Efficacy and safety of an intensified regimen of pegylated interferon alfa-2a plus ribavirin (RBV) in HCV genotype 1 non-responders: final results of the SYREN trial. 

 

PegIntron

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

·        130. Completely individualized treatment durations with peginterferon-alfa-2b and ribavirin in HCV genotype 1-infected patients and importance of IL28B genotype (INDIV-2 study). 

·        797. High Correlation Between Week 4 and Week 12 as the Definition for Null Response to Peginterferon alfa (PEG) plus Ribavirin (R) Therapy: Results from the IDEAL Trial. 

 

Pegylated Interferon – General information

·        129. The IL28B genotype is a major determinant in the induction of a virological response by high-dose peginterferon and ribavirin in null-responders to standard-of-care therapy

·        798. Predictive value of IL-28 polymorphism of effect of interferon therapy in patients with genotype 2a and 2b chronic hepatitis C. 

·        814. Individualized Concentration Monitored High Dose Ribavirin in Combination with Peginterferon to Hepatitis C Genotype 1 Patients with Previous Nonresponse

·        816. Impaired Fasting Glucose is Associated with Lower Rates of Sustained Virologic Response (SVR) in Patients with Genotype 1 Chronic Hepatitis C (CHC): Retrospective Analysis of the IDEAL Study.

·        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. 

·        822. Analysis of Site Performance in Academic and Community-Based Centers in the IDEAL Study. 

 

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)

·        1854. In Vitro Activity of the Combination of Pegylated Interferon-Lambda (PEG-IFN-λ) with Direct-Acting Antivirals in the HCV Replicon Model. 

·        1868. Interferon lambda plays a critical role on antiviral response by hepatotropic inducer of innate immunity in human hepatocyte.