NEWS HIGHLIGHTS
Published Studies Related to Ribavirin
Antiviral activity of danoprevir (ITMN-191/RG7227) in combination with pegylated interferon alpha-2a and ribavirin in patients with hepatitis C. [2011.08.15]
BACKGROUND: Current therapy options for patients with chronic hepatitis C virus (HCV) infection genotype 1 are effective in <50%. Danoprevir (ITMN-191/RG7227) is a potent, selective, and orally active inhibitor of the HCV NS3/4A serine protease... CONCLUSIONS: Our study showed substantial antiviral efficacy of danoprevir in combination with pegylated interferon alpha-2a and ribavirin. Exploration of the safety and antiviral efficacy of danoprevir in longer clinical studies is warranted.
High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). [2011.07]
BACKGROUND & AIMS: In patients with chronic hepatitis C who failed to respond to standard therapy, high-dose pegylated interferon (IFN)-alpha and/or ribavirin could induce a stronger antiviral response and prevent treatment failure and HCV resistance when combined with direct-acting antivirals. The influence of genetic determinants in this context remains unknown... CONCLUSIONS: High-dose pegylated IFN-alpha with standard or high doses of ribavirin induces a potent antiviral response in a substantial number of patients who did not respond to standard therapy. The IL-28B genotype is an independent predictor of the antiviral response. High-dose pegylated IFN-alpha in combination with ribavirin and protease inhibitors appears as an attractive option for future study in this population. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Twice-weekly pegylated interferon-alpha-2a and ribavirin results in superior viral kinetics in HIV/hepatitis C virus co-infected patients compared to standard therapy. [2011.06.01]
CONCLUSION: Our results, when confirmed in larger randomized clinical trials, may provide a novel therapeutic approach to improve SVR among HIV/HCV co-infected patients, especially African-American patients.
Ribavirin for patients with Crimean-Congo haemorrhagic fever: a systematic review and meta-analysis. [2011.06]
BACKGROUND: Crimean-Congo haemorrhagic fever (CCHF) is a potentially fatal tick-borne infection. The virus is widely distributed around the world and reports of sporadic cases and outbreaks have recently increased significantly. Some authors have proposed that ribavirin improves survival in CCHF and this view appears to be widely accepted... CONCLUSIONS: Our systematic review and meta-analysis revealed that the available data in the literature are inadequate to support a claim of efficacy of ribavirin in CCHF. We believe a real uncertainty exists over the benefit of ribavirin in the treatment of CCHF, which necessitates the urgent conduct of a randomized placebo-controlled trial.
Coffee consumption is associated with response to peginterferon and ribavirin therapy in patients with chronic hepatitis C. [2011.06]
BACKGROUND & AIMS: High-level coffee consumption has been associated with reduced progression of pre-existing liver diseases and lower risk of hepatocellular carcinoma. However, its relationship with therapy for hepatitis C virus infection has not been evaluated... CONCLUSIONS: High-level consumption of coffee (more than 3 cups per day) is an independent predictor of improved virologic response to peginterferon plus ribavirin in patients with hepatitis C. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
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.
Reports of Suspected Ribavirin Side Effects
Anaemia (335),
Nausea (227),
Fatigue (221),
White Blood Cell Count Decreased (171),
Weight Decreased (153),
Vomiting (150),
Asthenia (147),
Dyspnoea (146),
Rash (125),
Dysgeusia (113), more >>
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