NEWS HIGHLIGHTSMedia Articles Related to Ribavirin
InterMune Announces Modification To On-Going Phase 2b Study Of ITMN-191 In Patients With Chronic HCV Infection
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.18]
InterMune, Inc. (Nasdaq: ITMN) announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified. The Phase 2b study has four dosage cohorts: SOC; 300mg q8h plus SOC; 600mg q12h plus SOC and 900mg q12h plus SOC. To date, approximately 175 patients have been enrolled in the study.
AASLD: Treating Before Transplant Cuts HCV Recurrence (CME/CE)
Source: MedPage Today Gastroenterology [2009.11.06]
BOSTON (MedPage Today) -- In patients with advanced liver disease related to hepatitis C, a course of pegylated interferon and ribavirin (Rebetol) before liver transplant may help them avoid recurrence of infection, a researcher said here.
SCYNEXIS' SCY-635 Demonstrates Positive Antiviral Activity In Combination With Approved And Investigational Anti-HCV Agents
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.04]
Drug discovery company SCYNEXIS, Inc. presented positive data from an in vitro study evaluating the antiviral activity of SCY-635 in combination with approved and investigational non-nucleoside polymerase inhibitors, nucleoside polymerase inhibitors, protease inhibitors, ribavirin and interferon alpha 2b. SCY-635 exhibited additive to synergistic antiviral activity when combined with each of the six compounds tested and all combinations exhibited greater-than-anticipated antiviral activity.
Bristol-Myers Squibb And ZymoGenetics Present Final Phase 1b Results For PEG-Interferon Lambda In Hepatitis C
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.03]
Bristol-Myers Squibb Company (NYSE: BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) today presented final results from a Phase 1b clinical trial of PEG-Interferon lambda administered with ribavirin in relapsed and treatment-naïve hepatitis C virus (HCV) patients. The poster included data on 56 patients in the study. Antiviral activity was observed at all dose levels tested.
Published Studies Related to Ribavirin
A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naive patients with chronic hepatitis C: ViSER1 results. [2009.09]
Pegylated interferon (peg-IFN) and ribavirin (RBV) are effective in eradicating the hepatitis C virus in more than half of patients. However, anemia arising from RBV-induced hemolysis can prompt dose reductions and lower sustained virologic response (SVR) rates... These results suggest fixed-dose VRD given 600 mg BID is insufficient to treat patients with chronic hepatitis C; a weight-based dosing trial of viramidine is currently under way.
Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. [2009.08.06]
BACKGROUND: Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared... CONCLUSIONS: In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials.gov number, NCT00081770.) 2009 Massachusetts Medical Society
Predictability of sustained virological response to pegylated interferon alpha-2b Plus ribavirin therapy by week-8 viral response in HIV-positive patients with chronic hepatitis C virus infection. [2009.07]
Chronic hepatitis C is frequent and aggressive in HIV-positive patients. Identification of early predictors of response to anti-HCV therapy is needed for a lower rate of response and higher discontinuations, compared to HCV mono-infected subjects...
Effect of dietary purines on the pharmacokinetics of orally administered ribavirin. [2009.06]
Ribavirin is found to be absorbed in the intestine through the human concentrative nucleoside transporter 2 (hCNT2). Cellular uptake of ribavirin was strongly inhibited by purine nucleoside in an in vitro study...
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.
Clinical Trials Related to Ribavirin
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.
PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy [Completed]
HRN-003 STUDY SYNOPSIS
OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin
among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.
OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using
PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice
daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by
mouth twice daily for 48 weeks.
STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have
previously failed to achieve a sustained virologic response following interferon alfa or
interferon alfa-2b plus ribavirin therapy.
DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron
weight-adjusted dose (1. 5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth
twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if
weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for
48 weeks.
EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study
medication doses will be obtained.
SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity
of adverse experiences and progression of disease, as measured by HCV viral load.
STUDY DESIGN
This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability
polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of
chronic hepatitis C virus infection in patients who have previously failed to achieve a
sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin
therapy. Patients will be stratified according to their response to the previous course of
therapy (i. e. non-reponse or relapse virologic pattern
This is a multi-center, randomized, open-label clinical trial that will involve approximately
25 sites with an anticipated enrollment of 600 patients over a six-month period.
Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1. 5
mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks
OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by
subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.
- Group A: PEGIntron weight -adjusted dose (1. 5 mg/kg) by subcutaneous injection weekly
+ ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).
- Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80
KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an
additional 48 weeks (Total therapy x 48 weeks).
Trial of Peg-Interferon Plus Epoetin-Alfa for Treatment of Chronic Hepatitis C Virus Infection [Completed]
The purpose of this study is to determine if the use of epoetin-alpha will allow patients
with chronic hepatitis C virus infection to be treated with higher doses of
peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and
raising sustained virologic response.
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy [Completed]
This 4 arm study is designed for patients with CHC who have not responded to peginterferon
alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening
the duration of treatment, as well as including an initial 12-week period of high-dose
PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS
(180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment
is 1-2 years and the target sample size is 500+ individuals.
Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders [Terminated]
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to
increase sustained virological response (SVR) rates in HCV non-responders to a standard
interferon/ribavirin combination.
Patients with hepatitis C virus infection were eligible if they had failed to respond to a
single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was
defined as persistent HCV RNA in the serum during the last month of treatment.
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and
amantadine or a placebo for 48 weeks.
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