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VA National Clinical Public Health Programs — Hepatitis C

www.hepatitis.va.gov

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Treatment Decisions

Do you need to start drug therapy immediately?

Not necessarily. Your doctor may recommend certain lifestyle changes (such as following a healthy diet and avoiding alcohol) and "watchful waiting," instead of starting drug treatment immediately.

Two of the big decisions you and your doctor will need to make are whether you should start drug treatment and, if so, when to start it.

Talking with other important people in your life--such as your family members and close friends--also can be helpful during the decision-making process.

What is watchful waiting?

Watchful waiting doesn't mean that you will be doing nothing. Instead, it means that you and your doctor will carefully monitor the progression of your hepatitis C, keeping treatment with currently available medications in mind as an option. Newer medications, possibly with fewer side effects, continue to be developed. Many patients with hepatitis C can wait until these better drugs are available, some of which should be on the market by 2010.

Watchful waiting and lifestyle changes for hepatitis C are aimed at doing 2 things:

  • stopping or slowing down the damage to your liver
  • making you feel better

Good candidates for watchful waiting are patients with mild liver disease and patients in whom interferon and ribavirin could be particularly dangerous. This includes patients with serious heart, lung, or kidney disease; psychiatric disease; or cancer, or patients who are older than 75.

Watchful waiting involves the following:

  • having liver enzyme blood tests once or twice a year
  • having a liver biopsy every 3 to 5 years
  • going to regular doctor appointments
  • following your doctor's lifestyle recommendations, because reducing further damage to your liver is crucial

What are the benefits of treatment?

If you and your doctor decide that you should begin taking medicines for your hepatitis C, the drugs are intended to do 3 things:

  • remove (or clear) all the hepatitis C virus from your body
  • stop or slow down the damage to your liver
  • make you feel better

Clearing the hepatitis C virus from the blood does not happen in all patients. If this does not happen, there are still some ways that treatment can help you.

The treatment can:

  • decrease the amount of damage to your liver
  • lower the amount of hepatitis C virus in your blood
  • improve your overall well-being and quality of life
  • lower your alanine aminotransferase (ALT) liver enzyme level

Drug treatments are not right for everyone. Only you and your doctor can decide if a certain treatment is right for you.

Who should consider treatment?

Only patients with hepatitis C in their blood (chronic hepatitis C infection) are considered for therapy. In general, doctors suggest treatment if you:

  • have high liver enzyme levels, especially ALT levels
  • have a liver biopsy that showed damage (inflammation, and particularly fibrosis)
  • have not used alcohol or other drugs for at least 6 months

If you want to start treatment for hepatitis C, speak with your VA doctor. It is a good idea to talk about any concerns you have before you start treatment. You and your doctor will decide if treatment is right for you and which medicines might work.

What treatments are effective?

Before your doctor can prescribe a treatment for hepatitis C, it has to be approved for that purpose by the U.S. Food and Drug Administration (FDA). Several treatments for hepatitis C already have been approved by the FDA:

  • long-acting (pegylated) interferon combined with another drug called ribavirin (combination therapy)
  • long-acting (pegylated) interferon by itself
  • short-acting (standard) interferon with ribavirin

You can read more about interferon and ribavirin in the next few pages.

Interferon

Interferon is a protein that your body naturally makes to fight infections. People with hepatitis C can inject extra interferon into their bodies to help fight the virus. Interferon can be given only as a shot.

There are 2 types of interferon used to treat hepatitis C:

  • long-acting (pegylated) interferon, given as 1 shot a week
  • short-acting (standard) interferon, given as 3 shots a week

Pegylated (or once a week) interferon is a newer form. As of 2002, pegylated interferon was shown to be at least slightly more effective than standard interferon in most patients. For this reason, it is the main form of interferon used today.

Another advantage for patients is that they only have to get 1 shot a week of pegylated interferon, instead of 3 shots a week with standard interferon.

Standard (or 3 times a week) interferon is being used less and less. Each shot of standard interferon contains 3 million units of the drug. Because of the way drugs are measured, 3 million units sounds like a lot more medicine than it actually is.

Ribavirin

Ribavirin is a medicine that fights certain viruses. It comes in a capsule that you can swallow. Ribavirin by itself doesn't work in treating hepatitis C. It has to be combined with interferon to be effective.

Combination therapy

If you take ribavirin and interferon together, then both medicines work much better. This is called combination therapy, and it is currently the recommended treatment for hepatitis C.

Treatment success varies a lot from person to person. Depending on specific factors, patients have anywhere from a 20% to an 80% chance of having hepatitis C removed from their bodies.

How long does treatment last?

Treatment time varies. In general, standard combination therapy lasts between 24 and 48 weeks, with 6 months of follow-up after treatment has ended. If a patient is treated in a clinical trial, treatment duration may be adjusted.

Sometimes, if the treatment is not working or if you have too many side effects, your doctor may stop your treatment early.

What are the side effects?

Almost all medicines have side effects, including medicines for hepatitis C. Side effects vary a lot from person to person. Most patients on hepatitis C treatment have side effects, such as fatigue and flulike symptoms. Some side effects go away and some of them last the whole time you are on treatment. (See the Side Effects Guide (http://www.hepatitis.va.gov/treat-05-00) for more information.)

Can you work while on treatment?

Some patients keep a normal work schedule while they are on treatment. Others may have to cut down their work hours or stop working altogether. The side effects are different for every patient, so it is hard to say how much hepatitis C treatment will affect your work schedule.

Here are some work-related factors to consider before starting treatment:

  • If your job is busier or more stressful during certain times of the year (for example, during the holidays), ask your doctor about beginning treatment at the start of a less busy period.
  • You also might ask your employer about the possibility of lessening the number of hours you work or going on short-term medical disability leave. This is in case the drug therapy makes you feel worse than you expect and you need to take some time off.
  • Learn about your rights in the workplace. The Americans with Disabilities Act (ADA) says that employers can't discriminate because of a person's disability (such as a physical illness). Depending upon your situation, the ADA may apply.

How successful is treatment?

In patients who complete drug therapy, the virus is cleared from the blood between 20-80% of the time, depending on a number of factors (see next page). In most patients, the chances of clearing the virus are in the 40-50% range.

What factors can affect outcomes?

Not everyone will have the same results from hepatitis C treatment. The following are some things that can affect how the treatment works:

FactorEffects
Viral genotype (the type of hepatitis C virus you have)Not all hepatitis C viruses are the same. We know of 6 different types--called genotypes--for hepatitis C. Some of them respond to treatment better than others. For genotype 1, the virus generally is removed in 30-50% of patients. For genotypes 2 or 3, the virus usually is removed in 65-80% of patients.
Viral loadThis is the amount of virus in your blood. If you have lower levels of virus in your blood when you start treatment, you may have a better chance of getting rid of the virus. (Note: A high viral load does not necessarily mean you have worse liver damage.)
IronIf you have less iron in your blood or in your liver cells, your treatment may work better. Iron levels can be checked with a blood test or a liver biopsy.
GenderHepatitis C treatment works slightly better for women than for men.
Ongoing use of alcoholStudies have found that patients who continue to drink alcohol regularly during treatment have lower rates of clearing the virus.
EthnicityStudies in the United States have shown that African American patients have lower rates of clearing the virus than do Caucasian patients, though the reasons are not apparent. Other ethnic groups have not been studied as well, but there may be other differences in response rates among ethnic groups.
Length of infection You may have a better chance of clearing the virus from your body if you haven't been infected with the hepatitis C virus for very long.
Adherence (taking medications as prescribed)Adherence to prescribed medications can be challenging but is a very important part of making sure the treatment works. Studies have shown that patients who receive adequate doses of interferon and ribavirin have much higher rates of clearing the virus.
ObesityA number of studies have shown that patients who are overweight have lower rates of clearing the virus. If you are overweight, losing some weight prior to treatment may make the medications more effective.

Deciding on a treatment plan

If you are ready to start drug therapy, talk with your VA health care provider about which treatment plan is right for you.

Many things need to be considered before you begin treatment. Your doctor will need to know more about the amount of the virus in your blood (viral load) and the type of hepatitis C virus (genotype) that you have.

Here are some questions that you should discuss with your doctor:

  • Do I need to start treatment?
  • What is my genotype and how can it affect my treatment outcome?
  • What is my viral load and how can it affect my treatment outcome?
  • What kind of treatment should I receive?
  • How long will treatment last?
  • Do I have any other conditions that will complicate treatment?
  • Should I be tested for hepatitis A and B?
  • Do I need a liver biopsy?
  • What medications should I avoid while I am on treatment?
  • What precautions do I need to take while I am on treatment?
  • How often will I have doctor appointments?
  • What tests will I need to take?
  • How will treatment affect my daily life? Will treatment affect my ability to work?
  • What side effects will I have?
  • Are there any long-term risks from treatment?

What do you need to know about the treatment?

Your treatment time may vary.

If you are on standard hepatitis C treatments, you will take them for 24 or 48 weeks. If you have too many side effects, or if the drugs don't seem to work for you, your doctor may suggest that you stop early. After you finish taking the drugs, your doctor usually will follow your progress for 6 months.

If you are in a clinical trial, you may take the medicine for only a month or for more than a year. It depends on the kind of clinical trial and what type of medicine you are taking.

You will have frequent lab tests while you are being treated with the medications.

These lab tests are done to make sure that the drugs are safe for you and also to find out if the treatment is working.

Your doctor will give you instructions.

Your VA doctor will give you instructions before you start treatment. It is important that you follow these instructions carefully, and that you understand the risks and side effects of the drugs.

For example, ribavirin can cause serious birth defects, and you or your partner should not become pregnant while taking it.

If you start taking ribavirin to treat your hepatitis C, you must use 2 effective forms of birth control, one for you and one for your partner.

An example is a condom for the man, and a diaphragm or birth control pill for the woman. You must keep using this type of birth control during the whole time you are on combination treatment and for 6 months after your last dose.

What are the different responses to treatment?

Patients who have never taken medications to treat their hepatitis C are called "treatment naïve."

For patients who have taken medications, there are 2 main types of response to treatment:

Sustained response

This means that the treatment worked while you were taking the medicine and continued to work even after you stopped taking it. Sustained virological response (SVR) means no virus is present in the blood 6 months after the medications have been stopped. Generally, the virus remains absent long-term.

Incomplete response

This means that the treatment did not clear the virus. Two types of incomplete responses are:

Relapse (or transient response)

The treatment worked while the medications were present, but not afterward. The medicine and your immune system were able to clear the virus for a time, but could not do so completely. When you stopped taking the medicine, the hepatitis C virus came back.

Nonresponse

The treatment did not remove (or clear) the virus from your blood during treatment.

What tests will your doctor run?

Laboratory tests help keep tabs on your health during treatment. You will have frequent lab tests while you are being treated.

Here are 2 lab tests that can be done to give some information about whether the treatment is working:

ALT level (Alanine aminotransferase)

This test measures the amount (or level) of an enzyme called ALT that is made in liver cells. If liver cells are damaged or die, ALT leaks into the bloodstream. One goal of treatment is to bring high levels of ALT back to normal.

If the treatment is working, ALT levels often come down to normal. If the ALT level decreases quickly in the treatment process, this is a positive factor in the response to treatment.

Viral load (hepatitis C virus ribonucleic acid level or hepatitis C RNA level)

This test measures the amount of hepatitis C virus in your blood. Treatment for hepatitis C is aimed at reducing the viral load, and specifically at making it negative (undetectable). "Undetectable" means that no virus is currently present in your blood. Your doctor will check your viral load at different times during treatment. Studies have shown that if the amount of hepatitis C virus in your blood after 12 weeks of being on medications falls by 100-fold (eg, 1 million international units of virus goes down to 10,000 international units), the chance that the hepatitis C virus will be gone once you have finished your therapy goes up.

In addition to the ALT level and viral load tests, your doctor will look at your complete blood count (CBC). This includes your white blood cells, which may be affected by interferon treatment. If the level of your white blood cells drops below a certain point, your doctor may change your interferon dose. A CBC also measures your red blood cells, which may be affected by ribavirin. If your red blood cell and hemoglobin levels drop below a certain point, your doctor may change your ribavirin dose.

For more information, see Understanding Lab Tests (http://www.hepatitis.va.gov/diag-tests-00) .

What can you do to help the treatment work best?

Here are some things you can do to make sure that your hepatitis C treatment works best:

  • Always follow your health care providers' advice, particularly the instructions on taking your medicine.
  • Take good care of yourself. Eat well, drink 8 to 10 glasses of water each day, and try to get a full night's sleep.
  • Learn about the hepatitis C medications you are taking. This includes special risks and warnings, such as the need to practice 2 forms of birth control while on ribavirin, even after treatment has finished.
  • Keep all your appointments with your doctor. If you have to cancel an appointment, call your doctor and schedule a new one as soon as possible.
  • Write down your doctor's name and phone number. Carry this information with you at all times.
  • Write the names and amounts of the medicines you are taking. Carry this information with you at all times.
  • Check with your doctor before starting new medicines. This includes vitamins, supplements, herbal remedies, prescription drugs, or other over-the-counter drugs.

What if the virus was cleared from your blood?

Here are some things to consider after you've finished treatment, and the virus was cleared from your blood:

  • Ask for liver function tests every 6 months or every year.
  • Ask your doctor about a viral load test if your liver tests become abnormal.

It is likely that the hepatitis C virus is no longer in your blood. Data suggest that you will stay virus free indefinitely.

Ten years is about the longest length of time that people have been followed after clearing the virus with interferon. The good news is that no data suggest that late relapse occurs.

  • Try to keep yourself healthy by:
    • eating well
    • not drinking alcohol or using drugs
    • getting plenty of rest
    • staying active and exercising
  • Keep your appointments with your doctor and get regular checkups.

Will you stay negative?

If your viral test was negative 6 months after the end of treatment, will you stay negative? Doctors prefer not to call this a "cure," but if treatment is successful, it is felt that health risks from hepatitis C can be reduced dramatically.

Treatment for hepatitis C hasn't been available for very long, so doctors are just starting to understand the long-term effects.

What if the virus is still in your blood?

If you have finished your treatment, and it did not clear the hepatitis C virus from your blood, you may want to take a break for a while or you may want to try another drug soon.

Your decision will depend on several things, such as the results of your liver function tests and biopsy. Some people with less severe liver damage decide to wait until better treatments become available. Other people decide to try new drugs right away.

Keep in mind that, even if the treatment didn't get rid of the virus, it likely has improved the overall health of your liver.

Here are some things to consider after you've finished treatment, and the virus wasn't cleared from your blood:

  • Talk with your doctor about other treatments.
  • Ask for liver function tests every 6 months or every year.
  • Think about having a liver biopsy every few years to check your liver's health.
  • Ask about new clinical trials for hepatitis C treatments.
  • Talk with your doctor about tests for liver cancer if you have scarring of the liver (cirrhosis).
  • Try to keep yourself healthy by:
    • eating well
    • not drinking alcohol or using drugs
    • getting plenty of rest
    • staying active and exercising
  • Keep your appointments with your doctor and get regular check-ups.

Summary

Everyone has a different experience with hepatitis C treatments. Side effects are different for everyone, and doctors can never predict how well a drug will work for a certain person.

It always helps to know as much as you can and to keep yourself healthy by eating well, getting plenty of rest, and not using alcohol or drugs that can damage your liver.

At all stages (before, during, and after treatment), talk with your health care provider to learn as much as possible about your disease and your treatment. Your doctor will give you advice after you finish treatment. You must understand that the risks and side effects of treatment may last even after you have finished treatment.

With support from your family, friends, and a doctor that you trust, you can have a better treatment experience.

If you have tried a treatment that didn't work, don't be discouraged. Every day, new and better treatments are becoming available as we learn more about hepatitis C.

Resources

  • ClinicalTrials.gov
    (http://www.clinicaltrials.gov/)
    ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone numbers for more details.
  • Centers for Disease Control and Prevention: Viral Hepatitis
    (http://www.cdc.gov/ncidod/diseases/hepatitis/index.htm)
    Information on all types of viral hepatitis from the CDC's National Center for Infectious Diseases. Site features related CDC guidelines and recommendations as well as training materials, slide sets, fact sheets, and key CDC hepatitis documents.