Diagnosis and testing
How is HCV spread from one person to another?
Pregnancy and Breast feeding
Counseling
Long-term Consequences of HCV Infection
Management and Treatment of Chronic Hepatitis C
Genotype
Hepatitis C and Healthcare Workers

Diagnosis and testing

What is hepatitis C?
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), which is found in the blood of persons who have this disease. HCV is spread by contact with the blood of an infected person.

What blood tests are available to check for hepatitis C?
There are several blood tests that can be done to determine if you have been infected with HCV. Your doctor may order just one or a combination of these tests. The following are the types of tests your doctor may order and the purpose for each:

Anti-HCV (antibody to HCV)
EIA (enzyme immunoassay)	This test is usually done first. If positive, it should be confirmed
RIBA (recombinant immunoblot assay	A supplemental test used to confirm a positive EIA test
Anti-HCV does not tell whether the infection is new (acute), chronic (long-term) or is no longer present.
Qualitative tests to detect presence or absence of virus (HCV RNA)
Generic polymerase chain reaction (PCR) Amplicor HCV™
Quantitative tests to detect amount (titer) of virus (HCV RNA)
Amplicor HCV Monitor™ Quantiplex HCV RNA (bDNA)

PCR and other tests to directly detect virus are not licensed tests and are only available on a research-basis. A single positive PCR test indicates infection with HCV. A single negative test does not prove that a person is not infected. Virus may be present in the blood and just not found by PCR. Also, a person infected in the past who has recovered may have a negative test. When hepatitis C is suspected and PCR is negative, PCR should be repeated.

Can you have a "false positive" anti-HCV test result?
Yes. A false positive test means the test looks as if it is positive, but it is really negative. This happens more often in persons who have a low risk for the disease for which they are being tested. For example, false positive anti-HCV tests happen more often in persons such as blood donors who are at low risk for hepatitis C. Therefore, it is important to confirm a positive anti-HCV test with a supplemental test as most false positive anti-HCV tests are reported as negative on supplemental testing.

Can you have a "false negative" anti-HCV test result?
Yes. Persons with early infection may not as yet have developed antibody levels high enough that the test can measure. In addition, some persons may lack the (immune) response necessary for the test to work well. In these persons, research-based tests such as PCR may be considered.

How long after exposure to HCV does it take to test positive for anti-HCV?
Anti-HCV can be found in 7 out of 10 persons when symptoms begin and in about 9 out of 10 persons within 3 months after symptoms begin. However, it is important to note that many persons who have hepatitis C have no symptoms.

How long after exposure to HCV does it take to test positive with PCR?
It is possible to find HCV within 1 to 2 weeks after being infected with the virus.

Who should get tested for hepatitis C?

• persons who ever injected illegal drugs, including those who injected once or a few times many years ago

• persons who were treated for clotting problems with a blood product made before 1987 when more advanced methods for manufacturing the products were developed

• persons who were notified that they received blood from a donor who later tested positive for hepatitis C

• persons who received a blood transfusion or solid organ transplant before July 1992 when better testing of blood donors became available

• long-term hemodialysis patients

• persons who have signs or symptoms of liver disease (e.g., abnormal liver enzyme tests)

• healthcare workers after exposures (e.g., needle sticks or splashes to the eye ) to HCV-positive blood on the job

• children born to HCV-positive women

What is the next step if you have a confirmed positive anti-HCV test?
Measure the level of ALT ( alanine aminotransferase, a liver enzyme) in the blood. An elevated ALT indicates inflammation of the liver and you should be checked further for chronic (long-term) liver disease and possible treatment. The evaluation should be done by a healthcare professional familiar with chronic hepatitis C.

Can you have a normal liver enzyme (e.g., ALT) level and still have chronic hepatitis C?
Yes. It is common for persons with chronic hepatitis C to have a liver enzyme level that goes up and down, with periodic returns to normal or near normal. Some persons have a liver enzyme level that is normal for over a year but they still have chronic liver disease. If the liver enzyme level is normal, persons should have their enzyme level re-checked several times over a 6 to 12 month period. If the liver enzyme level remains normal, your doctor may check it less frequently, such as once a year.

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How is HCV spread from one person to another?
How could a person have gotten hepatitis C?
HCV is spread primarily by direct contact with human blood. For example, you may have gotten infected with HCV if:

• you ever injected street drugs, as the needles and/or other drug "works" used to prepare or inject the drug(s) may have had someone else's blood that contained HCV on them.

• you received blood, blood products, or solid organs from a donor whose blood contained HCV.

• you were ever on long-term kidney dialysis as you may have unknowingly shared supplies/equipment that had someone else's blood on them.

• you were ever a healthcare worker and had frequent contact with blood on the job, especially accidental needlesticks.

• your mother had hepatitis C at the time she gave birth to you. During the birth her blood may have gotten into your body.

• you ever had sex with a person infected with HCV.

• you lived with someone who was infected with HCV and shared items such as razors or toothbrushes that might have had his/her blood on them.

Is there any evidence that HCV has been spread during medical or dental procedures done in the United States?
Medical and dental procedures done in most settings in the United States do not pose a risk for the spread of HCV. There have, however, been some reports that HCV has been spread between patients in hemodialysis units where supplies or equipment may have been shared between patients.

Can HCV be spread by sexual activity?
Yes, but this does not occur very often. See section on counseling for more information on hepatitis C and sexual activity.

Can HCV be spread by oral sex?
There is no evidence that HCV has been spread by oral sex. See section on counseling for more information on hepatitis C and sexual activity.

Can HCV be spread within a household?
Yes, but this does not occur very often. If HCV is spread within a household, it is most likely due to direct exposure to the blood of an infected household member.

Since more advanced tests have been developed for use in blood banks, what is the chance now that a person can get HCV infection from transfused blood or blood products?
1 chance out of 100,000, per each transfused unit.


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Pregnancy and Breast feeding

Should pregnant women be routinely tested for anti-HCV?
No. Pregnant women have no greater risk of being infected with HCV then non-pregnant women. If pregnant women have risk factors for hepatitis C, they should be tested for anti-HCV.

What is the risk that HCV infected women will spread HCV to their newborn infants?
About 5 out of every 100 infants born to HCV infected women become infected. This occurs at the time of birth, and there is no treatment that can prevent this from happening. Most infants infected with HCV at the time of birth have no symptoms and do well during childhood. More studies are needed to find out if these children will have problems from the infection as they grow older. There are no licensed treatments or guidelines for the treatment of infants or children infected with HCV. Children with elevated ALT (liver enzyme) levels should be referred for evaluation to a specialist familiar with the management of children with HCV-related disease.

Should a woman with hepatitis C be advised against breast-feeding?
No. There is no evidence that breast-feeding spreads HCV. HCV-positive mothers should consider abstaining from breast-feeding if their nipples are cracked or bleeding.

When should babies born to mothers with hepatitis C be tested to see if they were infected at birth?
Children should not be tested for anti-HCV before 12 months of age as anti-HCV from the mother may last until this age. If testing is desired prior to 12 months of age, PCR could be performed at or after an infant's first well-child visit at age 1-2 months.



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Counseling

How can persons infected with HCV prevent spreading HCV to others?

• Do not donate blood, body organs, other tissue, or semen. (Note from Lyric: Organs MAY be donated to other people who have HepC. A HepC liver in good condition can save a life. Just be sure that everyone involved knows you are HepC positive!)

• Do not share personal items that might have your blood on them, such as toothbrushes, dental appliances, nail-grooming equipment or razors.

• Cover your cuts and skin sores to keep from spreading HCV.

How can a person protect themselves from getting hepatitis C and other diseases spread by contact with human blood?

• Don't ever shoot drugs. If you shoot drugs, stop and get into a treatment program. If you can't stop, never reuse or share syringes, water, or drug works, and get vaccinated against hepatitis A and hepatitis B.

• Do not share toothbrushes, razors, or other personal care articles. They might have blood on them.

• If you are a healthcare worker, always follow routine barrier precautions and safely handle needles and other sharps. Get vaccinated against hepatitis B

• Consider the health risks if you are thinking about getting a tattoo or body piercing: You can get infected if:

  • the tools that are used have someone else's blood on them.

  • the artist or piercer doesn't follow good health practices, such as washing hands and using disposable gloves.

HCV can be spread by sex, but this does not occur very often. If you are having sex, but not with one steady partner:

• You and your partners can get other diseases spread by having sex (e.g., AIDS, hepatitis B, gonorrhea or chlamydia).

• You should use latex condoms correctly and every time.

• You should get vaccinated against hepatitis B.

Should patients with hepatitis C change their sexual practices if they have only one long-term steady sex partner?
No. There is a very low chance of spreading HCV to that partner through sexual activity. If you want to lower the small chance of spreading HCV to your sex partner, you may decide to use barrier precautions such as latex condoms. Ask your doctor about having your sex partner tested.

What can persons with HCV infection do to protect their liver?

• Stop using alcohol.

• See your doctor regularly.

• Don't start any new medicines or use over-the-counter, herbal, and other medicines without a physician's knowledge.

• Get vaccinated against hepatitis A if liver damage is present.

What other information should patients with hepatitis C be aware of?

• HCV is not spread by sneezing, hugging, coughing, food or water, sharing eating utensils or drinking glasses, or casual contact.

• Persons should not be excluded from work, school, play, child-care or other settings on the basis of their HCV infection status.

• Involvement with a support group may help patients cope with hepatitis C.

Should persons with chronic hepatitis C be vaccinated against hepatitis B?
If persons are in risk groups for whom hepatitis B vaccine is recommended, they should be vaccinated. A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination)



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Long-term Consequences of HCV Infection

What are the chances of persons with HCV infection developing long term infection, chronic liver disease, cirrhosis, liver cancer, or dying as a result of hepatitis C?
Of every 100 persons infected with HCV about:

• 85 persons may develop long-term infection,

• 70 persons may develop chronic liver disease,

• 15 persons may develop cirrhosis over a period of 20 to 30 years, and

• 5 persons may die from the consequences of long term infection (liver cancer or cirrhosis).

Do medical conditions outside the liver occur in persons with chronic hepatitis C?
A small percentage of persons with chronic hepatitis C develop medical conditions outside the liver (this is called extrahepatic). These conditions are thought to occur due to the body's natural immune system fighting against itself. Such conditions include: glomerulonephritis, essential mixed cryoglobulinemia, and porphyria cutanea tarda.

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Management and Treatment of Chronic Hepatitis C

When might a specialist (gastroenterologist or hepatologist) be consulted in the management of HCV-infected persons?
A referral to or consultation with a specialist for further evaluation and possible treatment may be considered if a person is anti-HCV positive and has elevated liver enzyme levels. Any physician who manages a person with hepatitis C should be knowledgeable and current on all aspects of the care of a person with hepatitis C.

What is the treatment for chronic hepatitis C?
Antiviral drugs such as interferon used alone or in combination with ribavirin, are approved for the treatment of persons with chronic hepatitis C. Interferon works in 10 to 20 persons out of 100 treated. Interferon combined with ribavirin works (on the viral strain that is mostly found in the U.S.) in about 30-40 persons out of 100. Ribavirin, when used alone, does not work.

What are the side effects of interferon therapy?
Most persons have flu-like symptoms (fever, chills, headache, muscle and joint aches, fast heart rate) early in treatment, but these lessen with continued treatment. Later side effects may include tiredness, hair loss, low blood count, trouble with thinking, moodiness, and depression. Severe side effects are rare (seen in less than 2 out of 100 persons). These include thyroid disease, depression with suicidal thoughts, seizures, acute heart or kidney failure, eye and lung problems, hearing loss, and blood infection. Although rare, deaths have occurred due to liver failure or blood infection, mostly in persons with cirrhosis. An important side effect of interferon is worsening of liver disease with treatment, which can be severe and even fatal. Interferon dosage must be reduced in up to 40 out of 100 persons because of severity of side effects, and treatment must be stopped in up to 15 out of 100 persons. Pregnant women should not be treated with interferon.

What are the side effects of combination (ribavirin + interferon) treatment?
In addition to the side effects due to interferon described above, ribavirin can cause serious anemia (low red blood cell count) and can be a serious problem for persons with conditions that cause anemia, such as kidney failure. In these persons, combination therapy should be avoided or attempts should be made to correct the anemia. Anemia caused by ribavirin can be life-threatening for persons with certain types of heart or blood vessel disease. Ribavirin causes birth defects and pregnancy should be avoided during treatment. Patients and their healthcare providers should carefully review the product manufacturer information prior to treatment.

Can anything be done to reduce symptoms or side effects due to antiviral treatment?
You should report what you are feeling to your doctor. Some side effects may be reduced by giving interferon at night or lowering the dosage of the drug. In addition, flu-like symptoms can be reduced by taking acetaminophen before treatment.

Can children receive interferon therapy for chronic hepatitis C?
Antiviral drugs are not licensed for persons under 18 years of age. Children with hepatitis C should be referred to a children's specialist in liver diseases. You may want to ask your doctor about clinical trials that may be on-going for children.

FOR MORE INFORMATION ON THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C - CLICK HERE FOR THE NIH WEBSITE

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Genotype

What does the term genotype mean?
Genotype refers to the genetic make-up of an organism or a virus. There are at least 6 distinct HCV genotypes identified. Genotype 1 is the most common genotype seen in the United States.

Is it necessary to do genotyping when managing a person with chronic hepatitis C?
Yes, as there are 6 known genotypes and more than 50 subtypes of HCV, and genotype information is helpful in defining the epidemiology of hepatitis C. Knowing the genotype or serotype (genotype-specific antibodies) of HCV is helpful in making recommendations and counseling regarding therapy. Patients with genotypes 2 and 3 are almost three times more likely than patients with genotype 1 to respond to therapy with alpha interferon or the combination of alpha interferon and ribavirin. Furthermore, when using combination therapy, the recommended duration of treatment depends on the genotype. For patients with genotypes 2 and 3, a 24-week course of combination treatment is adequate, whereas for patients with genotype 1, a 48-week course is recommended. For these reasons, testing for HCV genotype is often clinically helpful. Once the genotype is identified, it need not be tested again; genotypes do not change during the course of infection.

Why do most persons remain infected?
Persons infected with HCV mount an antibody response to parts of the virus, but changes in the virus during infection result in changes that are not recognized by preexisting antibodies. This appears to be how the virus establishes and maintains long-lasting infection.

Can persons become infected with different genotypes?
Yes. Because of the ineffective immune response described above, prior infection does not protect against reinfection with the same or different genotypes of the virus. For the same reason, there is no effective pre- or postexposure prophylaxis (i.e, immune globulin) available.


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Hepatitis C and Healthcare Workers

What is the risk for HCV infection from a needle-stick exposure to HCV contaminated blood?
After needle stick or sharps exposure to HCV positive blood , about 2 (1.8%) healthcare workers out of 100 will get infected with HCV (range 0%-10%).

What are the recommendations for follow-up of healthcare workers after exposure to HCV positive blood?
Anti-viral agents (e.g., interferon) or immune globulin should not be used for postexposure prophylaxis.

1. For the source, baseline testing for anti-HCV.

2. For the person exposed to an HCV-positive source, baseline and follow-up testing including
   ­ baseline testing for anti-HCV and ALT activity; and
   ­ follow-up testing for anti-HCV (e.g., at 4-6 months) and ALT activity.  (If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4-6 weeks.)

3. Confirmation by supplemental anti-HCV testing of all anti-HCV results reported as positive by enzyme immunoassay.
   

Should HCV-infected healthcare workers be restricted in their work?
No, there are no recommendations to restrict a healthcare worker who is infected with HCV. The risk of transmission from an infected healthcare worker to a patient appears to be very low. As recommended for all healthcare workers, those who are HCV positive should follow strict aseptic technique and standard precautions, including appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments.