Treatment Decisions: Entire Lesson

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 biggest 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.

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 which increase the chance an SVR (sustained virological response) are continuing to be developed and some are anticipated to be FDA approved as early as 2011 . Many patients with hepatitis C can defer treatment until these newer drugs are available, in order to have the highest likelihood of achieving an SVR when they do undergo treatment.

Watchful waiting and lifestyle changes for hepatitis C are aimed at doing 3 things:

• stopping or slowing down the damage to your liver
• keeping you feeling well and helping you to feel better
• monitoring the natural course of the liver before deciding if treatment is necessary

Good candidates for watchful waiting are:

• patients with mild liver disease in whom treatment is not needed at the current time
• patients in whom pegylated interferon and ribavirin could be particularly too risky in terms of side effects. For example, patients with serious heart, lung, kidney disease or cancer may have these medical issues as much more active and antiviral HCV treatment would be too risky
• patients who are ready for treatment but would potentially benefit from waiting until new drugs are available.

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 such as alcohol or tobacco, because reducing further damage to your liver is crucial
• attaining or maintaining a healthy BMI
• minimizing risk of steatosis with good control of diabetes and lipids

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

1. remove (or clear) all the hepatitis C virus from your body permanently
2. stop or slow down the damage to your liver
3. reduce the risk of advancing liver to cirrhosis

Complete and permanent clearing of 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:

• slow down the scarring and 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
• control the effect of hepatitis C in other organ systems, such as kidney and skin

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

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

• have a liver biopsy that showed damage (usually a moderate amount of fibrosis or more)
• are motivated to undergo treatment
• are willing to comply with the necessary steps and tests and visits for treatment
• were very recently (acutely) infected with hepatitis C, within the past 6 months
• are coinfected with HIV or hepatitis B

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.

There are two main types of treatment regimens for hepatitis C:

• Dual therapy: pegylated interferon and ribavirin
• Triple therapy: pegylated interferon and ribavirin PLUS either boceprevir or telaprevir

You will be given a treatment regimen based in large part on your genotype. Genotype refers to the "strain" of hepatitis C virus that a person has. There are six genotypes. In the United States, genotype 1 is the most common, followed by genotype 2 and 3.

• People with genotype 1 generally are given triple therapy.
• People with genotype 2 and 3 are given dual therapy.

Interferon

Interferon is a medicine that helps your body's immune system to attack infected liver cells and to protect healthy liver cells from new infection. Pegylated interferon is taken by injection once a week.

Ribavirin

Ribavirin is a medicine that can fight certain viruses, though, by itself, it does not work against hepatitis C. It is taken in pill form and in combination with pegylated interferon.

Boceprevir and telaprevir

Telaprevir and boceprevir are anti-viral drugs. They work directly on the hepatitis C virus itself to stop it from replicating. These drugs cannot be used together, and they each must be taken in combination with pegylated interferon and ribavirin.

How long the treatment lasts depends not only on your genotype but on the severity of your liver disease, and how you respond to the treatment along the way. Dual therapy, for genotypes 2 and 3, generally lasts for 24 weeks.Triple therapy for genotype 1 can last from 36 to 48 weeks.

If the treatment is not working, or if you have too many side effects, your provider may stop treatment as early as 4 weeks. Treatment may also be stopped if you aren't following your treatment regimen, as directed--such as not showing up for doctor visits, or not taking your medications on time.

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 for more information.)

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.

In patients who complete drug therapy, the virus is cleared from the blood (an SVR) about 45% of the time if the patient is genotype 1 and about 65%-75% of the time if the patient is genotype 2 or 3.

Other factors can change how likely it is that treatment is successful.

Being HIV-HCV coinfected lowers the chance of treatment success. Having more advanced fibrosis or cirrhosis lowers the chance of treatment success. Having a low viral load prior to treatment increases the chance of treatment success. These are a few of many potential factors which can make it more or less likely that treatment will result in an SVR.

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

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?

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.

Risk of birth defects

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.

The drugs boceprevir and telaprevir stop hormonal birth control from working, including:

• Birth control pills
• Vaginal rings
• Uterine implants
• Depo-Provera injections

If you start taking the drugs boceprevir and telaprevir to treat your hepatitis C, you must use 2 effective forms of "non-hormonal" birth control, one for you and one for your partner. For example: a barrier method (condoms or diaphragms) plus spermicidal jelly. 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.

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 virological 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. Studies have shown that patients who achieve an SVR almost always have the virus undetectable (absent) for years, for as long as the studies have followed them.

• Rapid Virological Response
  

  At 4 weeks into treatment if the virus is undetectable or has dropped 2 logs then this is a Rapid Virological Response. It is very likely that if a patient has an RVR that they will also have an SVR.

• Early Virological Response
  

  At 12 weeks into treatment if the virus is undetectable or has dropped 2 logs then this is an Early Virological Response. It is very likely that if a patient has an RVR that they will also have an SVR

• End of Treatment Response
  

  At the end of treatment (usually 24 or 48 weeks depending on planned course) if the virus is undetectable then this is a End of Treatment Virological Response. After the End of Treatment response, treatment is stopped and virus is measured for the next 6 months for any evidence of relapse.

Relapse

The treatment worked to achieve no detectable virus while the medications were present, but after the drugs were stopped, the virus was found again in the bloodstream.. 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 by 24 weeks and if it was continued did not clear the virus by 48 weeks.

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.

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.
• Practice 2 forms of birth control while on ribavirin, and continue to use birth control for 6 months after the last dose of ribavirin before trying to conceive a child.
• Practice 2 forms of "non-hormonal" birth control while on boceprevir or telaprevir, and continue to use birth control for 6 months after the last dose of ribavirin before trying to conceive a child.
• 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.

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.

• 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.

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.

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, continue watchful waiting, and potentially be retreated when new drugs become available.

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.

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.

Treatment Decisions

• Hepatitis C Medications: A Review and Update for Patients
  An overview of hepatitis C treatment, including information on the most recently approved drugs.
• Centers for Disease Control and Prevention: Viral Hepatitis
  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.

Treatment Guides

• Triple Therapy Workbooks
  Detailed workbooks to guide patients through their treatment course with triple therapy--pegylated interferon, ribavirin and either boceprevir or telaprevir.
• Taking Your Hepatitis C Triple Therapy
  One-page printable handouts for patients who are taking boceprevir or telaprevir--with tips on how and when to take the medications, and what to do if you miss a dose.

Clinical Trials

• 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.

Treatment Side Effects

• Managing Side Effects of Hepatitis C Treatment
  A 33-page booklet that describes ways to help manage the more common side effects of interferon treatment
• Side Effects Chart
  A one-page printable sheet of tips for coping with common side effects of hepatitis C treatment.

Challenges When in Drug/Alcohol Recovery

• Alcoholics Anonymous
  A.A. World Services, Inc.
  P.O. Box 459
  New York, NY 10163
  (212) 870-3400
• Narcotics Anonymous
  World Service Office in Los Angeles
  P.O. Box 9999
  Van Nuys, CA 91409
  (818) 773-9999