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Using PEGASYS
Test Results and What They Mean During your treatment, your healthcare team will perform a variety of tests to monitor your condition and the health of your liver. Read and ask questions about your lab tests until you understand their significance. Remember that sometimes the exact "number" is not as important as a comparison of values across several weeks or months. Use your Calendar as a convenient place to record the results of your lab tests. Only you can see this information, and it can help you track your results over time.

Virus Detection Tests

These tests look for the presence of the hepatitis C virus, or viral load, in the blood or body tissue. If the virus is detected, it means you have hepatitis C.

One thing doctors look for when comparing virus detection tests is sensitivity (how capable the test is of finding the hepatitis C virus in your body). A highly sensitive test provides a more accurate result because it's capable of detecting low levels of hepatitis C virus that a less-sensitive test might miss.

The most sensitive virus detection test is called a PCR (polymerase chain reaction) test. In the case of the hepatitis C virus, the PCR works by taking a sample of the blood and amplifying genetic material associated with the virus millions of times.

While there are several PCR tests available through local laboratories, AMPLICOR® is the name of the first PCR test approved by the U.S. Food and Drug Administration (FDA) for the detection of hepatitis C. (No test is FDA-approved for measuring how much of the virus is present in blood.) Other, non-approved hepatitis C virus detection tests may be used as well, especially in clinical trials. Your doctor can help you understand the meaning of your PCR test results.

Liver Function Tests

Liver function tests (LFTs) are the most commonly used way to check for liver problems. These blood tests look for chemicals in the body that are produced when the liver does its various jobs.

  • ALT (alanine aminotransferase)—ALT is an enzyme that is normally found in the liver cells and in the blood. When liver cells become damaged, they leak into the bloodstream, causing levels of liver enzymes to be raised. An increase in ALT levels can indicate acute liver damage. However, a single ALT test will not reveal the severity of liver damage. Many people with chronic hepatitis C have normal ALT levels, so this test is not considered a completely accurate marker of disease progression.

    Other liver enzymes that may be measured by blood tests include AST (aspartate aminotrasferase), GGT (gamma-glutamyl transferase), and alkaline phosphatase.
  • Bilirubin—When red blood cells complete their life cycle and break down naturally, they produce bilirubin, a yellow pigment that's passed on to the liver and excreted in the bile. Most of the time, the body produces as many red blood cells as it breaks down. However, if the red blood cells break down more rapidly or if liver function becomes impaired, bilirubin levels in the blood rise. In patients with hepatitis, bilirubin levels tend to fluctuate. A prolonged persistent rise in bilirubin for a patient with chronic hepatitis C usually indicates severe liver dysfunction.
  • Albumin—Albumin is a protein manufactured by the liver. A decrease in albumin may reflect a reduction in the liver's ability to synthesize this protein, and a significant sustained decrease in this protein may mean poor liver function. However, decreases in albumin levels may also occur for reasons not related to the liver. Your doctor will take this into account when interpreting test results.
  • Prothrombin time—This test measures blood clotting ability. When the liver is damaged, it may fail to produce blood clotting factors.
  • Complete blood count—A complete blood count analysis can be used to help detect liver scarring. If the liver becomes scarred, blood may back up into the spleen. This causes the spleen to enlarge and to trap blood elements, removing them from circulation and lowering blood counts.

Liver Biopsy

In order to track the progression of the disease, your doctor may perform a liver biopsy every 3 to 5 years. This is a procedure in which a tiny sample of tissue from the liver is removed and examined in a laboratory. A liver biopsy is an essential tool in monitoring hepatitis C—in fact it is the best way to measure the extent of liver damage. Liver biopsies are also important in ruling out any other forms of liver disease.

Today, liver biopsies are performed as outpatient procedures. General anesthesia is not necessary. Patients receive local anesthesia at the area where the needle will be inserted (usually the right side of the rib cage). Although the test itself only takes a few minutes—with the actual biopsy being done in seconds—you may be monitored at the testing facility for several hours.

Patients often describe the sensation they experience during the test as a feeling of strong pressure on the spot where the tissue is removed. About 10% of patients experience mild to moderate pain at the biopsy site. You may feel tired after the test, so it is a good idea to schedule some rest time after having a biopsy. You should speak to your doctor about the specific details and risks of liver biopsy.

The degree of liver damage measured from a liver biopsy is scored in stages:

  • Stage I—In the earliest stage of liver damage, the liver is inflamed (immune cells called lymphocytes are present), but scarring has not yet occurred. There is little damage to the liver at this point.
  • Stage II—In this early stage of liver damage, the liver is inflamed and mild scarring (fibrosis) has begun to form.
  • Stage III—In this stage, scar tissue from one area of the liver bridges (connects) to scar tissue from other areas, leading to advanced fibrosis.
  • Stage IV—In this advanced stage of liver damage, cirrhosis (advanced scarring) has occurred. At this point, the degree of damage to the liver is more serious.

With respect to the liver, the goals of therapy for hepatitis C are to delay or stop disease progression by:

  • Delaying the progression of scarring
  • Preventing cirrhosis
  • Preventing liver cancer

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Safety Information

What is PEGASYS?

PEGASYS is a medicine used to treat some adults who have hepatitis C and signs of liver damage. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.

PEGASYS® (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).

What is COPEGUS?

COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the virus. Do not take COPEGUS by itself.

COPEGUS® (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm your DNA and possibly cause cancer (see medication guide for more information and warnings).

Who should not take PEGASYS and COPEGUS?

Do not take PEGASYS alone or with COPEGUS if:

  • You are pregnant or your partner is pregnant
  • You or your partner plans to get pregnant during therapy or within 6 months after treatment ends
  • You are breastfeeding
  • You have hepatitis caused by your immune system (autoimmune hepatitis)
  • You have unstable or severe liver disease before or during treatment
  • You are allergic to alpha interferons or any of the ingredients in PEGASYS and COPEGUS
  • You have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major)

What if I am pregnant or thinking about having a baby?

If you are a woman who could get pregnant, you must take pregnancy tests before, during and for 6 months after treatment ends to make sure you are not pregnant.

During treatment and for 6 months after treatment, female and male patients must:

  • Use two forms of birth control (one being a condom with spermicide)
  • Tell your doctor right away if you or your partner becomes pregnant. You or
    your doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214

What medication should I avoid when I am taking PEGASYS and COPEGUS?

You should not take didanosine with COPEGUS. Talk to your doctor about all medications that you are taking.

What are the possible side effects?

The most common side effects of PEGASYS and COPEGUS are:

  • Flu-like symptoms (including fever, chills, muscle aches, joint pain, headaches)
  • Tiredness
  • Upset stomach (like nausea, taste changes, diarrhea)
  • Blood sugar problems (may lead to diabetes)
  • Skin problems (like rash, dry or itchy skin, redness and swelling at injection site)
  • Hair loss (temporary)
  • Trouble sleeping

The most serious side effects of PEGASYS and COPEGUS are:

  • Risks to pregnancies
  • Mental health problems (such as irritability, depression, anxiety, aggressiveness, trouble with drug addiction or overdose, thoughts about suicide, suicide attempts, suicide and thoughts about homicide)
  • Blood problems (like a drop in blood cells leading to increased risk for infections, bleeding and/or heart or circulatory problems)
  • Infections (which sometimes cause death)
  • Lung problems (like trouble breathing, pneumonia)
  • Eye problems (like blurred vision, loss of vision)
  • Autoimmune problems (such as psoriasis, thyroid problems)
  • Heart problems (including chest pain and, rarely, a heart attack)
  • Liver problems (rarely, liver function worsens). Patients with both the hepatitis C virus and HIV can have an increased chance of having liver failure during PEGASYS treatment. Change in a blood test that measures liver inflammation occurs more often in patients with hepatitis B. If you have a rise in this blood test you may need to be watched more closely with additional blood tests.

Tell your doctor immediately if you think you or your partner may be pregnant or if any of these symptoms occur.

This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.

Please see the medication guides and complete product information for PEGASYS and COPEGUS.

 

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