NEWS HIGHLIGHTS
Published Studies Related to Copegus (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 Copegus (Ribavirin)
Peg-Ifn Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED) [Completed]
The objective is to compare the safety and efficacy of the following three treatment regimens
in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)
PEG-Intron 1. 5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2)
PEG-Intron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3)
PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection. [Active, not recruiting]
This 2 arm study will compare the efficacy and safety of treatment with Pegasys (180
micrograms sc weekly) plus Copegus (800mg po daily) and PEGASYS (180 micrograms sc weekly)
plus Copegus (1000-1200mg po daily) in interferon-naive patients with CHC genotype 1
co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be
followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months,
and the target sample size is 100-500 individuals.
A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection. [Active, not recruiting]
This 7 arm study will determine the optimal treatment combination, based on efficacy and
safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7
treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV
polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or
180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24
weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus
1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus
PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks,
those achieving a rapid virological response (RVR) will stop all medication, and non-RVR
patients will remain on triple combination for an additional 24 weeks. Group 7 will receive
SOC for 48 weeks. There will be a 24 week period of treatment-free follow-up for all
treatment groups. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.
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).
Ribavirin for Hemorrhagic Fever With Renal Syndrome in Germany [Not yet recruiting]
This is a treatment protocol using IND Ribavirin-there is no control group. Hemorrhagic
Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically
infected rodent hosts. HFRS is present throughout Europe and caused mainly by Puumala and
Dobrava viruses. Treatment consists mainly of supportive care with careful attention to
control of blood pressure and fluid balance and/or dialysis. Early initiation of IND
Intravenous Ribavirin has been shown to be an effective treatment for HFRS and may prevent
the need for dialysis. It is important to initiate therapy based on a diagnosis consistent
with HFRS and a history that makes exposure likely. This study will monitor the clinical
events that occur with HFRS as well as the safety and efficacy of Ribavirin.
Reports of Suspected Copegus (Ribavirin) Side Effects
Anaemia (233),
Pyrexia (105),
Thrombocytopenia (88),
Asthenia (74),
Pancytopenia (73),
Nausea (70),
Pneumonia (68),
White Blood Cell Count Decreased (67),
Fatigue (63),
Vomiting (62), more >>
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