WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
COPEGUS (ribavirin) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with COPEGUS [see Warnings and Precautions, Adverse Reactions, and Dosage and Administration].
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin, including COPEGUS, is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post treatment follow-up period [see Contraindications (4), Warnings and Precautions, and Use in Specific Populations].
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COPEGUS SUMMARY
COPEGUS, the Hoffmann-La Roche brand name for ribavirin, is a nucleoside analogue with antiviral activity.
COPEGUS in combination with PEGASYS (peginterferon alfa-2a) is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
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NEWS HIGHLIGHTS
Published Studies Related to Copegus (Ribavirin)
The combination of MK-5172, peginterferon, and ribavirin is effective in
treatment-naive patients with hepatitis C virus genotype 1 infection without
cirrhosis. [2014]
without cirrhosis... CONCLUSIONS: Once-daily MK-5172 (100 mg) with PR for 24 or 48 weeks was highly
[Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth
disease]. [Article in Chinese] [2014]
with hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol can be effectively and safely used for treating
[Effects of ribavirin aerosol on viral exclusion of patients with hand-foot-mouth
disease]. [Article in Chinese] [2014]
treatment of hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol has multiple advantages of lower dose, quicker
Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese
patients infected with hepatitis C genotype 1. [2014]
infection... CONCLUSIONS: Daclatasvir combined with alfa-2a/ribavirin in treatment-naive
A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for
HCV genotype 1 infection. [2014]
infection... CONCLUSIONS: Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin
Clinical Trials Related to Copegus (Ribavirin)
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance. [Completed]
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or
without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients
with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to
receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body
weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg
daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day +
pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years,
and the target sample size is 100-500 individuals.
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471) [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) PegIntron 1. 5 µg/kg/wk in combination with weight based REBETOL (800-1400
mg/day); (2) PegIntron 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.
Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin [Terminated]
To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy
with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC)
virus infection genotype 2 or 3 who responded during (i. e. had HCV-RNA <50 IU/mL at the end
of previous therapy), but relapsed after (i. e. had detectable HCV-RNA after the end of prior
treatment) previous therapy with pegylated interferon and ribavirin given for at least 12
weeks and at most 24 weeks.
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C [Completed]
The purpose of this study is to evaluate the safety and efficacy of
nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens
compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C
genotype 4. The study will also evaluate the effect of the studied treatment regimens on
end of treatment virologic response, ALT normalization and safety parameters.
In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia [Recruiting]
The standard treatment of chronic hepatitis C infection is pegylated interferon alpha
combined with ribavirin. Anaemia is a common complication occurring in up to 30% of
subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose
reductions, reducing the likelihood of sustained viral response. Recent data shows that
interferon alpha may increase hepcidin (a key iron regulator) production, resulting in
impaired iron availability for production of red blood cells. In this study, we will
evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon
containing regimes. If hepcidin plays a role in interferon-induced anaemia, cheap and
readily available oral hepcidin inhibitors could be trialled to potentially reduce the
impact of interferon alpha induced anaemia.
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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Page last updated: 2015-08-10
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