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Ribavirin tablets monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS).
The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin (see WARNINGS, 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. Ribavirin therapy 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 posttreatment follow-up period (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Information for Patients, and Pregnancy: Category X).
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RIBAVIRIN SUMMARY
Ribavirin tablet is a nucleoside analogue with antiviral activity.
Ribavirin tablets in combination with peginterferon alfa-2a are 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) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).
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NEWS HIGHLIGHTS
Published Studies Related to 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 Ribavirin
Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma [Active, not recruiting]
Human papillomavirus (HPV-16) is an important factor in the development of many tonsil
and/or base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer
by itself, it appears to contribute to the development of tonsil and/or base of tongue
cancer in many patients. It is likely that treatment for many patients with tonsil and/or
base of tongue cancer could be improved if effective therapy to control HPV-16 is developed.
The investigators in this study want to learn if ribavirin shows evidence of activity
against HPV-16.
Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as
part of the standard treatment for Hepatitis C. Laboratory experiments suggest that
ribavirin might also be useful in the treatment of head and neck cancers. However, ribavirin
has not yet been tested against head and neck cancer in patients. The purpose of this study
is to find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in
patients.
The main purpose of this study is to see if ribavirin changes the expression of certain
proteins related to HPV infection in the tumor. The study will also find out if ribavirin
changes how the tumor appears in a PET/CT scan (positron emission tomography/computed
tomography scan).
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.
Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients [Completed]
The results of antiviral therapy in patients with recurrent hepatitis C after liver
transplantation are lower than standard. Ribavirin has immune-modulating effects and seems
to be crucial to optimize viral treatment. The aim of this multicenter controlled study is
to examine the effect of Ribavirin pre-treatment preceding the combination therapy with
peginterferon plus ribavirin on the sustained virological response.
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV [Completed]
Primary Objectives:
1. To determine whether aerosolized ribavirin is effective when given at an intermittent
dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection
(URI) and whether it can prevent progression to pneumonia.
2. To determine the effect of this regimen on persistence of viral shedding.
Treatment With Ribavirin for Patients With Metastatic Breast Cancer [Terminated]
The purpose of this study is to learn whether oral Ribavirin is safe and effective in
treating patients with metastatic breast cancer, that have high levels of eIF4E.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Ribavirin has an overall score of 10. The effectiveness score is 10 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Ribavirin review by 48 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Hepatitis C |
| Dosage & duration: | | 1200 (dosage frequency: three times a day) for the period of Still recieving dosages |
| Other conditions: | | None |
| Other drugs taken: | | Pegasis-interferon | | |
Reported Results |
| Benefits: | | I am in my 5th week of treatment, and my liver enzymes did come down to normal, but I will see Dr. on 12th to find out if viral load came down. |
| Side effects: | | Some days are better than others.Muscle aches, basically all the flu virus symtoms, plus afeww more. |
| Comments: | | I take the ribavirin three times a day ,which equals 1200 MG. I also,give my self a sub-cu shot with the interferon, in either the right or left stomach or thigh muscles, this can bring on the chills extreme fatigue, and some other side effects it really sucks. |
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Page last updated: 2015-08-10
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