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Ribavirin

Ribavirin

Description

Biochem/physiol Actions

Antiviral agent. Its metabolite, ribavirin 5′-phosphate, is an inhibitor of inosine monophosphate (IMP) dehydrogenase. Used to inhibit purine (GTP pools) biosynthesis at the level of inosine monophosphate (IMP) dehydrogenase and as a precursor to the di- and tri-phosphates which inhibit viral RNA-dependent RNA polymerases.

Antiviral agent used against a wide variety of human viral infections, in particular, chronic hepatitis C, HIV, and adenovirus. Its metabolite, ribavirin 5′-phosphate, is an inhibitor of inosine monophosphate (IMP) dehydrogenase, but many other mechanisms of action are also supported with experimental evidence.

WARNINGS AND PRECAUTIONS

Pregnancy Category X (5.1, 8.1, 8.3)

Birth defects and fetal death with ribavirin: Patients must have a negative pregnancy test prior to therapy; use at least 2 forms of contraception and undergo monthly pregnancy tests.

Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:

Monotherapy with ribavirin is not permitted.

Hemolytic anemia may occur with a significant initial drop in hemoglobin.

Pancreatitis.

Pulmonary infiltrates or pulmonary function impairment.

New or worsening ophthalmologic disorders.

Severe decreases in neutrophil and platelet counts, and hematologic, endocrine (e.g., TSH), and hepatic abnormalities.

Dental/periodontal disorders reported with combination therapy.

Concomitant administration of azathioprine.

Weight loss and growth inhibition reported during combination therapy in pediatric patients. Long-term growth inhibition (height) reported in some patients.

Side effects from RBV:

Talk with your health care provider about possible side effects and how they will be managed. Some people develop anemia (low red blood cell count) from RBV, usually within the first few weeks of treatment. It is important to have blood tests before and during RBV treatment to check for anemia and other side effects. Anemia is usually treated by lowering RBV dose.

When RBV was used without interferon in clinical trials, side effects included: aching muscles, anxiety, back pain, colds, constipation, coughing, diarrhea, dizziness, fever, headaches, insomnia, irregular periods, irritability, itchy skin, nausea, night sweats, rash, stomach pain and swelling, stuffy nose, tiredness, vomiting, and weakness.

WHO SHOULD TAKE IFN/RBV?

The combination of IFN and RBV is the only therapy currently approved by the FDA to treat HCV. People who test positive for HCV might spontaneously (without medications) clear HCV. If they don’t, they should begin treatment with IFN/RBV within 12 weeks of infection.

HCV is more serious in people who also are infected with HIV. This is called “coinfection.” See fact sheet 507 for more information on HCV/HIV coinfection.

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