Simple FactSheet: ribavirin (Copegus, Rebetol, Ribasphere)

ribavirin (Copegus, Rebetol, Ribasphere)
a Simple FactSheet from the AIDS Treatment Data Network

||||| Ribavirin is a drug used to treat hepatitis C infection:

Ribavirin is approved for use in combination with pegylated interferon to treat hepatitis C (HCV) infection. Ribavirin belongs to a class of drugs called nucleoside analogues, which includes some anti-HIV drugs like zidovudine (AZT). Ribavirin works with pegylated interferon to help stop HCV from making new copies of itself, these drugs also help the immune system to kill HCV. Ribavirin used alone does not have any effect on HCV or HIV, but it helps pegylated interferon to be more effective.
There are two brand-name versions of ribavirin: Copegus and Rebetol. There are also generic versions of ribavirin available, including Ribasphere, that are less expensive and equivalent to the branded drugs.

||||| Will this drug work for me?

The main goal of treating hepatitis C is to rid the body of HCV. A viral load test is used to measure the amount of HCV in your blood. If there is no detectable amount of HCV in your blood six months after you have finished a full course of treatment, you have a sustained virological response (SVR). This means that the treatment has worked.
Your body's response to treatment depends on several things, especially what genotype (or strain) of HCV you have. If you have genotype 2 or 3, treatment is more likely to result in an SVR. If you have genotype 1 (which is the most common HCV genotype in the United States), you're less likely to have a SVR. The odds are less in your favor if you are HIV positive, have a very high HCV viral load, or if you have liver cirrhosis.
In addition, clinical trials have shown that HCV treatment is not as effective for African Americans as for Whites. More research is needed to find out why. Treatment also works better if you are younger than 40, have never been treated for HCV before, or have a healthier liver when you start treatment. Nevertheless, HCV treatment could help prevent further liver damage and may help improve liver health, even if the treatment cannot get rid of the virus completely from your body.
Research has shown that it is more effective to treat HCV using a combination of pegylated interferon and ribavirin than treating without ribavirin. For people infected with HCV only, SVR is achieved in about 45-50% with genotype 1, and over 80% with genotype 2 or 3 when treated with the combination. When treating with pegylated interferon alone without ribavirin, SVR is about 15% in genotype 1 and about 35% in genotype 2 or 3. In people co-infected with HIV and HCV, combination treatment results in SVR rates range from 14% to 29% for genotype 1, and 44% to 73% for genotype 2 or 3. Treating with only pegylated interferon without ribavirin is not recommended for those co-infected with HIV and HCV.

||||| Dosage:

Current treatment guidelines from the American Association for the Study of Liver Diseases recommend that people co-infected with HIV and HCV receive combination treatment for 48 weeks for all genotypes. Some doctors are treating co-infected people with genotype 1 for 72 weeks. People with HCV alone and genotype 2 or 3 only need 24 weeks of treatment. Many doctors will advise stopping treatment if your HCV viral load does not drop significantly after the first 12 weeks of treatment.
Ribavirin comes in 200 mg tablets or capsules. The approved dose of ribavirin when used with Pegasys is 1,000-1,200 mg (5-6 tablets) daily, split into a morning dose (2-3 tablets) and an evening dose (3 tablets). The actual dose is based on body weight: people who weigh less than 165 lbs. take 1,000 mg daily, and people who weigh 165 lbs. or more take 1,200 mg daily. People with genotype 2 or 3 only need 800 mg daily, split into a morning dose (2 tablets) and an evening dose (2 tablets), regardless of weight.
The approved dose of ribavirin when used with Peg-Intron is 800 mg (4 tablets) daily, split into a morning and an evening dose. However most doctors would prescribe 1,000-1,200 mg, based on body weight, and expect the approved dose to change when more data is available.
There is no approved dose of ribavirin for HIV and HCV co-infected people. Most major studies for co-infected people have used the 800 mg daily dose, split into a morning and evening dose, to lower the risk of side effects.
The ribavirin dose may be lowered if you're experiencing serious side effects, and ribavirin may be stopped if side effects continue after lowering the dose. People with serious kidney problems may need to take a lower dose of ribavirin.
For children, the recommended dose of ribavirin is also based on body weight, calculated at 15 mg ribavirin per kilogram of body weight. Rebetol is available in liquid form for children.

||||| Side effects:

Hemolytic anemia is the most common side effect of ribavirin. Ribavirin can lower red blood cell counts, causing fatigue and dizziness. People taking ribavirin should have their hemoglobin counts measured to monitor red blood cell counts. Serious drops in hemoglobin levels can be managed by reducing the dose of ribavirin or, if necessary, stopping ribavirin. Anemia can be prevented or treated with erythropoietin (EPO, marketed as Procrit and Aranesp), a red blood cell growth factor.
Ribavirin can also cause nausea, loss of appetite, rash and itching, and cough.

||||| Warnings:

Ribavirin can cause birth defects. Women should avoid pregnancy while taking ribavirin and for at least six months after taking ribavirin. Women taking ribavirin should have a pregnancy test before treatment and every month during treatment, and for six months after treatment. Men with female partners should use birth control while taking ribavirin and for six months afterwards.
Ribavirin can worsen heart problems. If you have a history of heart disease, talk to your doctor about whether you should take ribavirin. Contact your doctor immediately if you have trouble breathing or chest pain while taking ribavirin.
Ribavirin should not be taken with didanosine (Videx) due to the risk of potentially fatal lactic acidosis. Ribavirin may effect levels of zidovudine (AZT, Retrovir) and stavudine (d4T, Zerit) and should be used with care when taking these drugs.

Not all state AIDS Drug Assistance Programs (ADAPs) cover hepatitis C treatment. To find out whether your state ADAP covers ribavirin, see The Access Project.
Hoffman-LaRoche, the maker of Copegus, and Schering-Plough, the maker of Rebetol, each have a patient assistance program for people having problems getting the drug. The number to call is (800) 443-6676 for Copegus and (800) 521-7157 for Rebetol.
For clinical trials of other treatments or experimental drugs to treat HCV, contact the Network.

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Last modified: 8/15/2006
copyright © 2006 The Network
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\|\|\|\|\| Ribavirin is a drug used to treat hepatitis C infection:
Ribavirin is approved for use in combination with pegylated interferon to treat hepatitis C (HCV) infection. Ribavirin belongs to a class of drugs called nucleoside analogues, which includes some anti-HIV drugs like zidovudine (AZT). Ribavirin works with pegylated interferon to help stop HCV from making new copies of itself, these drugs also help the immune system to kill HCV. Ribavirin used alone does not have any effect on HCV or HIV, but it helps pegylated interferon to be more effective. There are two brand-name versions of ribavirin: Copegus and Rebetol. There are also generic versions of ribavirin available, including Ribasphere, that are less expensive and equivalent to the branded drugs.
\|\|\|\|\| Will this drug work for me?
The main goal of treating hepatitis C is to rid the body of HCV. A viral load test is used to measure the amount of HCV in your blood. If there is no detectable amount of HCV in your blood six months after you have finished a full course of treatment, you have a sustained virological response (SVR). This means that the treatment has worked. Your body's response to treatment depends on several things, especially what genotype (or strain) of HCV you have. If you have genotype 2 or 3, treatment is more likely to result in an SVR. If you have genotype 1 (which is the most common HCV genotype in the United States), you're less likely to have a SVR. The odds are less in your favor if you are HIV positive, have a very high HCV viral load, or if you have liver cirrhosis. In addition, clinical trials have shown that HCV treatment is not as effective for African Americans as for Whites. More research is needed to find out why. Treatment also works better if you are younger than 40, have never been treated for HCV before, or have a healthier liver when you start treatment. Nevertheless, HCV treatment could help prevent further liver damage and may help improve liver health, even if the treatment cannot get rid of the virus completely from your body. Research has shown that it is more effective to treat HCV using a combination of pegylated interferon and ribavirin than treating without ribavirin. For people infected with HCV only, SVR is achieved in about 45-50% with genotype 1, and over 80% with genotype 2 or 3 when treated with the combination. When treating with pegylated interferon alone without ribavirin, SVR is about 15% in genotype 1 and about 35% in genotype 2 or 3. In people co-infected with HIV and HCV, combination treatment results in SVR rates range from 14% to 29% for genotype 1, and 44% to 73% for genotype 2 or 3. Treating with only pegylated interferon without ribavirin is not recommended for those co-infected with HIV and HCV.
\|\|\|\|\| Dosage:
Current treatment guidelines from the American Association for the Study of Liver Diseases recommend that people co-infected with HIV and HCV receive combination treatment for 48 weeks for all genotypes. Some doctors are treating co-infected people with genotype 1 for 72 weeks. People with HCV alone and genotype 2 or 3 only need 24 weeks of treatment. Many doctors will advise stopping treatment if your HCV viral load does not drop significantly after the first 12 weeks of treatment. Ribavirin comes in 200 mg tablets or capsules. The approved dose of ribavirin when used with Pegasys is 1,000-1,200 mg (5-6 tablets) daily, split into a morning dose (2-3 tablets) and an evening dose (3 tablets). The actual dose is based on body weight: people who weigh less than 165 lbs. take 1,000 mg daily, and people who weigh 165 lbs. or more take 1,200 mg daily. People with genotype 2 or 3 only need 800 mg daily, split into a morning dose (2 tablets) and an evening dose (2 tablets), regardless of weight. The approved dose of ribavirin when used with Peg-Intron is 800 mg (4 tablets) daily, split into a morning and an evening dose. However most doctors would prescribe 1,000-1,200 mg, based on body weight, and expect the approved dose to change when more data is available. There is no approved dose of ribavirin for HIV and HCV co-infected people. Most major studies for co-infected people have used the 800 mg daily dose, split into a morning and evening dose, to lower the risk of side effects. The ribavirin dose may be lowered if you're experiencing serious side effects, and ribavirin may be stopped if side effects continue after lowering the dose. People with serious kidney problems may need to take a lower dose of ribavirin. For children, the recommended dose of ribavirin is also based on body weight, calculated at 15 mg ribavirin per kilogram of body weight. Rebetol is available in liquid form for children.
\|\|\|\|\| Side effects:
Hemolytic anemia is the most common side effect of ribavirin. Ribavirin can lower red blood cell counts, causing fatigue and dizziness. People taking ribavirin should have their hemoglobin counts measured to monitor red blood cell counts. Serious drops in hemoglobin levels can be managed by reducing the dose of ribavirin or, if necessary, stopping ribavirin. Anemia can be prevented or treated with erythropoietin (EPO, marketed as Procrit and Aranesp), a red blood cell growth factor. Ribavirin can also cause nausea, loss of appetite, rash and itching, and cough.
\|\|\|\|\| Warnings:
Ribavirin can cause birth defects. Women should avoid pregnancy while taking ribavirin and for at least six months after taking ribavirin. Women taking ribavirin should have a pregnancy test before treatment and every month during treatment, and for six months after treatment. Men with female partners should use birth control while taking ribavirin and for six months afterwards. Ribavirin can worsen heart problems. If you have a history of heart disease, talk to your doctor about whether you should take ribavirin. Contact your doctor immediately if you have trouble breathing or chest pain while taking ribavirin. Ribavirin should not be taken with didanosine (Videx) due to the risk of potentially fatal lactic acidosis. Ribavirin may effect levels of zidovudine (AZT, Retrovir) and stavudine (d4T, Zerit) and should be used with care when taking these drugs. Not all state AIDS Drug Assistance Programs (ADAPs) cover hepatitis C treatment. To find out whether your state ADAP covers ribavirin, see The Access Project. Hoffman-LaRoche, the maker of Copegus, and Schering-Plough, the maker of Rebetol, each have a patient assistance program for people having problems getting the drug. The number to call is (800) 443-6676 for Copegus and (800) 521-7157 for Rebetol. For clinical trials of other treatments or experimental drugs to treat HCV, contact the Network.