Simple FactSheet: pegylated interferon (Pegasys, PEG-Intron)

pegylated interferon (Pegasys, PEG-Intron)
a Simple FactSheet from the AIDS Treatment Data Network

||||| Pegylated interferon is a drug used to treat infection of the hepatitis C virus:

Pegylated interferon is a man-made form of interferon, a chemical naturally produced in the body to fight viruses. Interferon helps to stop the hepatitis C virus (HCV) from making new copies of itself. It also helps the immune system to kill HCV. Pegylated interferon is made with special add-on parts that help the drug stay in the body longer. It is injected once a week, while interferon that is not pegylated needs to be injected three times a week.
There are two brands of pegylated interferon: Pegasys and PEG-Intron. There are slight differences between the drugs, but both brands seem to work equally well and do not have major differences in side effects. Both are used in combination with ribavirin to treat Hepatitis C virus (HCV) infection. If left untreated, HCV infection can lead to serious liver disease and death over time.

||||| 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.
Pegylated interferon is administered by injection under the skin (subcutaneous).
Pegasys comes in pre-filled syringes that need to be refrigerated. The usual dose of Pegasys is 180 µg, taken once a week. The dose may be lowered if you're experiencing serious side effects, although lower doses may be less effective. Pegasys has not been approved for use in children.
PEG-Intron comes in a pre-filled pen that contains powder and sterile water; pushing down on the pen mixes them together. The pens need to be refrigerated. The dose of PEG-Intron depends on weight-1.5 µg per kilogram (range: 50 - 150 µg total), taken once a week. The dose may be lowered if you're experiencing serious side effects, although lower doses may be less effective. PEG-Intron has not been approved for use in children.

||||| Side effects:

Side effects cause many people to stop HCV treatment. Side effects may be more severe for people co-infected with HIV and HCV. Before starting treatment, talk to people who have been through it, educate yourself, and make sure you ask family and friends for support.
Flu-like symptoms such as fever, chills, headache, muscle ache, and fatigue are common side effects of treatment. Other symptoms are fatigue or extreme tiredness. Nausea and loss of appetite are also common. The flu-like symptoms are usually the worst right after taking the weekly injection; some people schedule their injection for a time each week when they know they'll be able to rest and take it easy afterwards. Some of these symptoms can be reduced by taking pain relief drugs an hour or two before each injection. Drinking lots of water is necessary.
Depression and related symptoms, such as anxiety, irritability, insomnia, and mental confusion, are common during treatment. This is especially true in people with a history of depression. People may also experience mental confusion, and difficulty with concentration and memory. While less common, other psychiatric side effects include aggressive behavior, psychosis, hallucinations, and mania; a few cases of suicide have been reported. People considering HCV treatment should receive a psychiatric evaluation before starting, and be closely monitored during treatment. Some doctors prescribe an antidepressant before starting treatment to prevent depression. If depression occurs during treatment, options include antidepressants, reducing the dose of pegylated interferon, or discontinuing treatment.
Pegylated interferon can also reduce levels of white blood cells. People with HIV generally see their overall CD4 T cell count decrease temporarily during interferon treatment, although the CD4 T cell count usually returns to baseline after treatment. Some people taking pegylated interferon develop neutropenia (reduced levels of neutrophils, a type of white blood cell). Neutropenia can put people at risk for developing other infections. If neutropenia occurs during treatment, options include shots of Neupogen (filgrastim), a growth factor to boost neutrophil levels, reducing the dose of pegylated interferon, or discontinuing treatment.
Pegylated interferon can also cause thrombocytopenia (reduced levels of platelets, a type of cell that helps blood to clot). If thrombocytopenia occurs during treatment, options include reducing the dose of pegylated interferon or, in severe cases, stopping treatment.
Colitis (inflammation of the colon) and pancreatitis (inflammation of the pancreas) may occur in some people. If these serious conditions appear, treatment should be stopped. Heart and thyroid problems, some lung disorders, and autoimmune diseases have also been reported. Pegylated interferon can worsen these conditions in people who already have them before treatment.
Other side effects can include vision problems, itching, hair loss, and injection site reactions (soreness or swelling at the site of injection). It is also important to be aware of the potential side effects of ribavirin.

||||| Warnings:

Research has shown that pegylated interferon should not be used by people with the following conditions: 1) decompensated cirrhosis; 2) autoimmune hepatitis; 3) major, uncontrolled depression; 4) kidney, lung or heart transplants; or 5) known hypersensitivity (allergic reaction) to pegylated interferon components. Pegylated interferon should be used with caution, preferably by a specialist, in people with heart and thyroid problems, pulmonary disorders, and autoimmune diseases.
Since pegylated interferon requires injection, some former drug injectors and people in recovery may feel uncomfortable or triggered by using needles, especially since some of the side effects can feel like heroin withdrawal symptoms. Get support and consider asking if a doctor, a nurse, or your care-giver can give you the injections.
Pegylated interferon can increase blood levels of theophylline, an asthma medication. If you are taking theophylline and pegylated interferon, your doctor should monitor blood levels of theophylline and may adjust the dose.

Pegylated interferon is expensive, and many state AIDS Drug Assistance Programs (ADAPs) do not cover hepatitis C treatment or place limits or restrictions on who can receive it. To find out whether your state ADAP covers pegylated interferon, see The Access Project.
Hoffman-LaRoche, the maker of Pegasys, and Schering-Plough, the maker of PEG-Intron, each have a patient assistance program for people having problems getting the drug. The number to call is (800) 443-6676 for Pegasys and (800) 521-7157 for PEG-Intron.
For clinical trials of other treatments or experimental drugs to treat HCV, contact the Network.

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Last modified: 8/15/2006
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\|\|\|\|\| Pegylated interferon is a drug used to treat infection of the hepatitis C virus:
Pegylated interferon is a man-made form of interferon, a chemical naturally produced in the body to fight viruses. Interferon helps to stop the hepatitis C virus (HCV) from making new copies of itself. It also helps the immune system to kill HCV. Pegylated interferon is made with special add-on parts that help the drug stay in the body longer. It is injected once a week, while interferon that is not pegylated needs to be injected three times a week. There are two brands of pegylated interferon: Pegasys and PEG-Intron. There are slight differences between the drugs, but both brands seem to work equally well and do not have major differences in side effects. Both are used in combination with ribavirin to treat Hepatitis C virus (HCV) infection. If left untreated, HCV infection can lead to serious liver disease and death over time.
\|\|\|\|\| 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. Pegylated interferon is administered by injection under the skin (subcutaneous). Pegasys comes in pre-filled syringes that need to be refrigerated. The usual dose of Pegasys is 180 µg, taken once a week. The dose may be lowered if you're experiencing serious side effects, although lower doses may be less effective. Pegasys has not been approved for use in children. PEG-Intron comes in a pre-filled pen that contains powder and sterile water; pushing down on the pen mixes them together. The pens need to be refrigerated. The dose of PEG-Intron depends on weight-1.5 µg per kilogram (range: 50 - 150 µg total), taken once a week. The dose may be lowered if you're experiencing serious side effects, although lower doses may be less effective. PEG-Intron has not been approved for use in children.
\|\|\|\|\| Side effects:
Side effects cause many people to stop HCV treatment. Side effects may be more severe for people co-infected with HIV and HCV. Before starting treatment, talk to people who have been through it, educate yourself, and make sure you ask family and friends for support. Flu-like symptoms such as fever, chills, headache, muscle ache, and fatigue are common side effects of treatment. Other symptoms are fatigue or extreme tiredness. Nausea and loss of appetite are also common. The flu-like symptoms are usually the worst right after taking the weekly injection; some people schedule their injection for a time each week when they know they'll be able to rest and take it easy afterwards. Some of these symptoms can be reduced by taking pain relief drugs an hour or two before each injection. Drinking lots of water is necessary. Depression and related symptoms, such as anxiety, irritability, insomnia, and mental confusion, are common during treatment. This is especially true in people with a history of depression. People may also experience mental confusion, and difficulty with concentration and memory. While less common, other psychiatric side effects include aggressive behavior, psychosis, hallucinations, and mania; a few cases of suicide have been reported. People considering HCV treatment should receive a psychiatric evaluation before starting, and be closely monitored during treatment. Some doctors prescribe an antidepressant before starting treatment to prevent depression. If depression occurs during treatment, options include antidepressants, reducing the dose of pegylated interferon, or discontinuing treatment. Pegylated interferon can also reduce levels of white blood cells. People with HIV generally see their overall CD4 T cell count decrease temporarily during interferon treatment, although the CD4 T cell count usually returns to baseline after treatment. Some people taking pegylated interferon develop neutropenia (reduced levels of neutrophils, a type of white blood cell). Neutropenia can put people at risk for developing other infections. If neutropenia occurs during treatment, options include shots of Neupogen (filgrastim), a growth factor to boost neutrophil levels, reducing the dose of pegylated interferon, or discontinuing treatment. Pegylated interferon can also cause thrombocytopenia (reduced levels of platelets, a type of cell that helps blood to clot). If thrombocytopenia occurs during treatment, options include reducing the dose of pegylated interferon or, in severe cases, stopping treatment. Colitis (inflammation of the colon) and pancreatitis (inflammation of the pancreas) may occur in some people. If these serious conditions appear, treatment should be stopped. Heart and thyroid problems, some lung disorders, and autoimmune diseases have also been reported. Pegylated interferon can worsen these conditions in people who already have them before treatment. Other side effects can include vision problems, itching, hair loss, and injection site reactions (soreness or swelling at the site of injection). It is also important to be aware of the potential side effects of ribavirin.
\|\|\|\|\| Warnings:
Research has shown that pegylated interferon should not be used by people with the following conditions: 1) decompensated cirrhosis; 2) autoimmune hepatitis; 3) major, uncontrolled depression; 4) kidney, lung or heart transplants; or 5) known hypersensitivity (allergic reaction) to pegylated interferon components. Pegylated interferon should be used with caution, preferably by a specialist, in people with heart and thyroid problems, pulmonary disorders, and autoimmune diseases. Since pegylated interferon requires injection, some former drug injectors and people in recovery may feel uncomfortable or triggered by using needles, especially since some of the side effects can feel like heroin withdrawal symptoms. Get support and consider asking if a doctor, a nurse, or your care-giver can give you the injections. Pegylated interferon can increase blood levels of theophylline, an asthma medication. If you are taking theophylline and pegylated interferon, your doctor should monitor blood levels of theophylline and may adjust the dose. Pegylated interferon is expensive, and many state AIDS Drug Assistance Programs (ADAPs) do not cover hepatitis C treatment or place limits or restrictions on who can receive it. To find out whether your state ADAP covers pegylated interferon, see The Access Project. Hoffman-LaRoche, the maker of Pegasys, and Schering-Plough, the maker of PEG-Intron, each have a patient assistance program for people having problems getting the drug. The number to call is (800) 443-6676 for Pegasys and (800) 521-7157 for PEG-Intron. For clinical trials of other treatments or experimental drugs to treat HCV, contact the Network.