INFERGEN SUMMARY
Interferon alfacon-1 is a recombinant non-naturally occurring type-I interferon. The 166-amino acid sequence of Interferon alfacon-1 was derived by scanning the sequences of several natural interferon alpha subtypes and assigning the most frequently observed amino acid in each corresponding position.1 Four additional amino acid changes were made to facilitate the molecular construction, and a corresponding synthetic DNA sequence was constructed using chemical synthesis methodology. Interferon alfacon-1 differs from interferon alfa-2b at 20/166 amino acids (88% homology), and comparison with interferon-beta shows identity at over 30% of the amino acid positions. Interferon alfacon-1 is produced in
Escherichia coli
(E. coli)
cells that have been genetically altered by insertion of a synthetically constructed sequence that codes for Interferon alfacon-1. Prior to final purification, Interferon alfacon-1 is allowed to oxidize to its native state, and its final purity is achieved by sequential passage over a series of chromatography columns.
INFERGEN is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis, such as viral hepatitis B or autoimmune hepatitis, should be ruled out prior to initiation of therapy with INFERGEN. In some patients with chronic HCV infection, INFERGEN normalizes serum ALT, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.
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NEWS HIGHLIGHTSMedia Articles Related to Infergen (Interferon Alfacon-1)
Real-World Treatment Patterns, Non-Adherence, And Costs In Chronic Hepatitis C
Source: Liver Disease / Hepatitis News From Medical News Today [2010.01.24]
Failure to adhere to treatment regimens is a common problem among patients treated for chronic hepatitis C virus (HCV). The costs associated with non-adherence are high, according to a study appearing in an upcoming issue of Value in Health...
Treatment For Chronic Hepatitis C: A Phase II Study
Source: Liver Disease / Hepatitis News From Medical News Today [2010.01.18]
The current standard treatment for chronic hepatitis C with pegylated-interferon (PEG-IFN) and ribavirin is effective in approximately 50%-60% of patients, so that a substantial proportion of patients remain unresponsive...
A Novel And Simple Formula To Predict Treatment Success In Chronic Hepatitis C
Source: Liver Disease / Hepatitis News From Medical News Today [2010.01.16]
The likelihood of treatment success of 48 wk peg-interferon (PEG-IFN) plus ribavirin (RBV) therapy for chronic hepatitis C may be predicted by viral kinetics on therapy. In particular, recent studies have shown that sustained virological response (SVR) can be predicted by a rapid virological response (RVR), and an early virological response (EVR)...
Pharmasset Initiates Phase 2a Trial With PSI-7977, A Chirally Pure Isomer Of PSI-7851
Source: Liver Disease / Hepatitis News From Medical News Today [2010.01.23]
Pharmasset, Inc. (Nasdaq: VRUS) announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV)...
Published Studies Related to Infergen (Interferon Alfacon-1)
Efficacy of consensus interferon in treatment of HbeAg-positive chronic hepatitis B: a multicentre, randomized controlled trial. [2009.07.09]
BACKGROUND: Consensus interferon (CIFN) is a newly developed type I interferon. AIMS: This multicentre, controlled trial was conducted to determine the efficacy of CIFN and to compare it with alpha-1b-interferon (IFN-alpha1b) in the treatment of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B... CONCLUSION: These findings suggest that 9 microg CIFN is effective in the treatment of patients with HBeAg-positive chronic hepatitis B. It can gradually induce ALT normalization and HBV DNA clearance and HBeAg loss or HBeAg/HBeAb seroconversion.
Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin after nonresponse to pegylated interferon/ribavirin: DIRECT results. [2009.06]
CONCLUSION: Retreatment of PEG-IFN and RBV nonresponders with CIFN and RBV is safe and efficacious and can be considered a retreatment strategy for patients failing previous therapy with PEG-IFN/RBV, especially in interferon-sensitive patients with lower baseline fibrosis scores.
Thyroid disorders and occurrence of nonorgan-specific autoantibodies (NOSA) in patients with chronic hepatitis C before and during antiviral induction therapy with consensus interferon (interferon alfacon-1). [2009.05]
BACKGROUND AND AIM: Thyroid disorders represent a common side effect of antiviral therapy in patients with chronic hepatitis C (CHC). However, there is strong evidence for a higher prevalence of thyroidal antibodies (TA) and nonorgan-specific autoantibodies (NOSA) even before interferon (IFN) administration. Here, we report for the first time on the distribution and occurrence of TA and NOSA before, during, and after treatment with daily highdosed IFN alfacon-1 [consensus IFN (CIFN)]... CONCLUSIONS: During CIFN induction therapy, alterations in TSH levels and an increased prevalence of TA and NOSA are quite common, especially in females. Clinically relevant symptoms occur, however, only in a small number (1.4%). Thus, treatment with daily and high-dose CIFN does not appear to increase the incidence of (severe) thyroidal or other autoimmune disorders compared with standard IFN in patients with CHC.
Antiviral response of HCV genotype 1 to consensus interferon and ribavirin versus pegylated interferon and ribavirin. [2007.06]
Achieving an antiviral response at a reasonable cost is a challenge in the treatment of patients with chronic hepatitis C. A previous study indicated that consensus interferon with ribavirin had promising activity against hepatitis C virus (HCV) genotype 1... It is possible that if consensus interferon is administered daily rather than three times weekly, eradication of HCV could be achieved in a larger proportion of patients infected with HCV genotype 1.
Different doses of consensus interferon plus ribavirin in patients with hepatitis C virus genotype 1 relapsed after interferon monotherapy: a randomized controlled trial. [2006.11.14]
AIM: To assess the efficacy of different schedules of consensus interferon (CIFN) plus ribavirin in retreating chronic hepatitis C patients who relapsed after recombinant interferon (rIFN) monotherapy... CONCLUSION: CIFN in combination with ribavirin when given to HCV genotype 1 relapsers after rIFN monotherapy obtains an unsatisfactory rate of sustained viral clearance independently of dosage of the drug. This may be due to its scarce tolerability.
Clinical Trials Related to Infergen (Interferon Alfacon-1)
Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-Alfa and Ribavirin [Active, not recruiting]
This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with
Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and
Ribavirin therapy. The study will be conducted at approximately 50 sites across the United
States.
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy [Completed]
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of
two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily
for 48 weeks and no treatment in patients chronically infected with hepatitis C who are
nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Patients are randomized 1: 1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both
administered daily) or no treatment for up to 48 weeks.
The protocol and informed consent form that will be used must be approved by the
Investigator’s Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the
study is initiated.
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy [Completed]
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of
two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily
for 48 weeks and no treatment in patients chronically infected with hepatitis C who are
nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated
during at least 24 weeks of no treatment in IRHC-001.
At the time of randomization into IRHC-001, the no treatment arm patients will be
concurrently randomized in a 1: 1 ration to receive Interferon Alfacon-1 (9 or 15 µg) +
Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be
eligible for consideration to receive treatment in IRHC-002 until they have completed a
minimum of 24 weeks of participation in IRHC-001.
The protocol and informed consent form that will be used must be approved by the
Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the
study is initiated.
Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus [Not yet recruiting]
This observational prospective registry is designed to evaluate the safety, adherence, and
efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1)
and other prescribed therapies in patients chronically infected with HCV. The primary
endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.
Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy [Completed]
The main purpose of this study is to evaluate the safety and tolerability of combination
therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin
(based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are
non-responders to previous pegylated interferon alfa plus ribavirin therapy.
This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg
administered by injection daily plus ribavirin 800-1400 mg (based on body weight)
administered by mouth daily for 48 weeks
* If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by
week 4, as determined by the principal investigator, then the dosage of Infergen will be
changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body
weight) administered by mouth daily for 48 weeks
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