Hepatitis C: To Treat or Not to Treat, Diagnosis and Vaccination

by Food and Drug Administration (FDA)

(Page 3 of 4)

To Treat or Not to Treat

"If we had a treatment that was safe, good, and not unpleasant, we should treat everybody," says Seeff. Unfortunately, the length of treatment required, the low rate of success, and the current treatments' side effects — the severity of which is unpredictable from patient to patient — don't warrant treating everybody.

Treatment decisions should not be based on symptoms, says DI Bisceglie. "Patient symptoms are a very unrelated guide to the severity of hepatitis C. Someone can be feeling very well and have severe hepatitis on a liver biopsy. Some patients have very profound symptoms, such as fatigue, but HCV is trivial in severity based on blood tests and a liver biopsy."

The NIH and CDC recommend treating people with HCV infection who are at greatest risk for progression to cirrhosis. These include individuals with four characteristics:

• a positive test for antibodies to HCV (meaning they were, or still are, infected with HCV),
• persistently elevated blood levels of a liver enzyme called alanine aminotransferase (ALT),
• a positive test for HCV RNA (ribonucleic acid), which detects virus in the blood, and
• a liver biopsy that shows either advanced fibrosis or moderate degrees of inflammation and necrosis (death of living tissue).

For those with less severe liver damage, indications for treatment are less clear.

"Patients, along with their physicians, need to carefully evaluate the stage of their disease and other risk factors before deciding whether or not to undergo treatment with interferon-based therapies," says the FDA's Schwieterman.

After discussing the pros and cons of interferon treatment with her doctor, Helen Clark of Minnetonka, Minn., decided against it. Clark had acquired the virus in 1970 during treatment for a severe form of dysentery she contracted in Cozumel, Mexico. Following 18 life-saving blood transfusions, Clark continued to feel ill for years, but doctors could find nothing wrong. They dismissed her symptoms, telling her she was tired because she was a busy mother, or she was menopausal. Some said that it was "all in her head" and that she should see a psychiatrist. Finally, in 1997, a doctor diagnosed her with hepatitis C.

Clark has genotype 1 (the most resistant to treatment) and a high "viral load." Her liver biopsy did not show any fibrosis after 27 years of infection. So Clark decided she could live with the disease if she could do something about her fatigue and other debilitating symptoms. "Now I pace myself, take naps, and find ways to remove stress from my life."

Clark avoids red meat, which she claims gives her liver pains after eating. "And I haven't had a drop of alcohol since diagnosis," she says. Alcohol is toxic to the liver and can advance the progression to cirrhosis. Clark also attributes her decrease in symptoms to some alternative therapies, including acupuncture.

Along with experiencing symptoms of the virus, individuals with HCV infection often experience discrimination, says Clark. "People think you're an alcoholic or drug addict. And they're afraid of you — there's such a misconception about the infectiousness."

HCV is not spread through coughing, kissing, hugging, or casual contact. It is spread only by contact with blood and possibly other body fluids.

People with HCV infection should cover any open wounds, and be careful not to share personal care items such as toothbrushes, razors, and nail files.

It's possible to get the virus through unprotected sex with an infected partner. However, studies — which have focused mainly on long-term monogamous couples — have shown that transmission through sexual contact is rare.

There is a 5 percent risk that an HCV-positive mother can give the virus to her unborn child. There is no evidence that HCV is transmitted from mother to child through breastfeeding.

Diagnosis and Vaccination

DI Bisceglie encourages everyone at risk — not just those with symptoms — to be tested for HCV. (See "You May Be at Risk for Hepatitis C".) The FDA has approved two types of test for HCV. One type, the enzyme immunoassay (EIA) test (also called enzyme-linked immunosorbent assay, or ELISA) is usually the first laboratory test used to determine if someone is infected with HCV. The EIA detects antibodies to the virus in a person's blood.

The EIA is not always accurate — it may show an infection when there really isn't one. So if the EIA test result is positive, an additional, more expensive test is used to make sure the person really is infected with HCV. Until recently, the only FDA-approved second test was the recombinant immunoblot assay, RIBA, made by Chiron Corporation, Emeryville, Calif. The EIA and RIBA tests may detect HCV infection, but do not tell if the infection is active or inactive.

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.