Hepatitis C: An Individual Disease

by Food and Drug Administration (FDA)

(Page 4 of 4)

In July 2001, the FDA approved two tests that do indicate if an infection is active. These similar tests, made by Roche Molecular Systems, Inc., of Pleasanton, Calif., are the Amplicor HCV Test, v2.0 and the Cobas Amplicor HCV Test, v2.0. Both are approved for people who have evidence of liver disease and antibody evidence of HCV infection and who are suspected to be actively infected with HCV. The tests detect HCV RNA, indicating that the virus is replicating and therefore active. Either the Amplicor or the Cobas Amplicor test may be used as a follow-up to an EIA positive test result, a RIBA positive result, or an EIA positive and a RIBA inconclusive result.

The FDA has also approved an over-the-counter home test system, called Hepatitis C Check. Made by Home Access Health Corp. of Hoffman Estates, Ill., the product allows a person to take a sample of blood at home and mail it to a designated laboratory for analysis with EIA and, when appropriate, RIBA testing. The results are available anonymously by phone through a unique identification number.

A liver biopsy to examine tissue from the liver is not necessary for diagnosing HCV infection. "However, a biopsy is the only accurate way to check the severity and stage of liver disease," says the NIDDK's Seeff.

Hepatitis C patients — whether they decide to get treated or not — should be monitored regularly by their doctors. Patients not in treatment should have a blood test approximately every six months to check liver functioning. A baseline liver biopsy is recommended to establish the severity of HCV infection, and the biopsy should be repeated in three to five years. Patients on treatment will have additional and more frequent tests.

There is no vaccine for hepatitis C, but there are vaccines for hepatitis A and B. The CDC recommends these vaccines, particularly the hepatitis A vaccine, for HCV-positive individuals. Becoming infected with hepatitis A virus can be life threatening for someone with HCV infection. In May 2001, the FDA approved a combined hepatitis A and B vaccine called Twinrix, marketed by SmithKline Beecham Pharmaceuticals in Philadelphia.

An Individual Disease

"The progression of disease varies from person to person," says the NIDDK's Hoofnagle. "Therapies are getting better, and some people have time to wait."

Afraid they were running out of time, Gamache and Buchanan sought interferon treatment. For Gamache, it didn't work, but Buchanan remains "clear" (shows no detectable virus in the blood). Clark is waiting, hoping she won't need interferon treatment or that something better will come along. She is due for a liver biopsy this year. Ultimately, the decision to get treated or not for HCV infection is up to the individual and his or her health-care provider.

"We insist people be educated about their treatment options and the risks involved," says Clark, who runs a support group with Buchanan to help people with hepatitis learn more about their disease. The support group also helps them deal with feelings of isolation, contamination, and fear. "It can be very scary," says Clark. "It puts you face to face with your own mortality and gives you a whole different perspective on life."

Gamache, who also joined a support group and volunteers at a hepatitis clinic, recommends leading a healthy lifestyle and keeping a positive attitude. "Anything you can do to help yourself, empower yourself, helps get rid of the sense of hopelessness," he says. "It doesn't have to be a death sentence."

Hepatitis C Study

Researchers are conducting a large study to try to prevent the development of cirrhosis and liver cancer in people with chronic hepatitis C. Called Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C), the four-year study is being conducted at 10 research centers nationwide and involves more than 1,300 participants.

The goal is to learn whether long-term pegylated interferon plus ribavirin treatment will decrease liver damage over time in people with advanced fibrosis or cirrhosis who didn't respond to prior treatment. Pegylated interferon is a, longer-acting form of interferon than conventional interferons.

You May Be at Risk for Hepatitis C if you have:

• had a blood transfusion before 1992 (when screening blood for HCV antibodies started)
• shared needles for IV drug use (even if you injected drugs just once, many years ago)
• shared straws for inhaling cocaine
• had body (including ear) piercing and tattoos with unsterile equipment
• had hemodialysis (used a kidney machine)
• had frequent exposure to blood products (have hemophilia, or had chronic renal failure, cancer requiring chemotherapy, or an organ transplant)
• had a needle-sticking accident (mainly a risk for health-care workers)
• used an infected person's toothbrush, razor or other item that may have blood on it
• engaged in high-risk sexual behavior, such as having multiple partners or failing to use condoms.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.