FDA Approves First Home Kit to Test for Hepatitis C

WASHINGTON —  The Food and Drug Administration on Thursday approved the first home test kit for hepatitis C, a “silent” virus that is the leading reason for liver transplants in this country.

Hepatitis C, once known as “non-A, non-B” hepatitis, is one of five known hepatitis viruses that attack the liver and is regarded as one of the most insidious because drug treatments don’t always work and there is no vaccine to prevent it.

It is the third most common hepatitis virus in this country, after A and B. Like hepatitis B, it is spread through blood--typically contaminated needles, and, in the past, through transfusions--and, less commonly, through sex.

Hepatitis A is typically transmitted through fecal contamination of food. But C, unlike A and B, poses the most serious problems for individuals because the majority of infections persist for decades, without symptoms, slowly destroying the liver. It can lead to liver failure, deadly liver cancer or the irreversible and potentially fatal scarring of cirrhosis.

About 4 million Americans are infected with hepatitis C in what health officials regard as a hidden epidemic because many don’t even know it. The infection kills about 10,000 Americans annually.

“It usually doesn’t make itself known until the second or third decade of infection, and it’s often found as an aside when doctors are looking for something else,” said Dr. Robert Purcell, a hepatitis expert at the National Institute of Allergy and Infectious Diseases.

The FDA action coincides with a government public education campaign, which began last fall, urging Americans to be tested for the disease, especially if they received blood transfusions before 1992, which marked the beginning of widespread testing of the blood supply.

The kit, which does not require a prescription, adds to the growing list of medical testing that consumers can perform in the privacy of their own homes. In recent years, the agency has approved tests for AIDS, cholesterol, diabetes, drug testing of urine and others.

The kit, Hepatitis C Check, is made by Home Access Health Co. of Hoffman Estates, Ill., and is expected to become available in June for less than $70.

A consumer will use a special lancet to prick their finger, put a few drops of blood on a filter paper and send it to Home Access Health’s laboratories. The lab tests the sample in two different ways, and results are available within four to 10 business days--either anonymously by telephone from an automated system or from a health care counselor.

If the test proves positive, it is important for consumers to contact a doctor, since the results reveal only whether a person has been exposed to hepatitis C, not whether there is a continuing infection. The company will offer a referral to a physician if a consumer requests one.

Some people can contract the virus and overcome it without consequence; most, an estimated 85%, go on to develop a chronic, simmering infection that can be transmitted to others. It is this infection that, over time, can destroy the liver.

This is different from the other two major hepatitis viruses. With A, often spread through tainted food or unsanitary conditions, most individuals become ill but recover with the infection cleared from their bodies. With B, most become ill but can recover, although about 10% will develop a persistent, chronic infection.

There are effective vaccines available for hepatitis A and B but none for C. Developing a vaccine for C has become a formidable challenge for researchers since the virus--like the virus that causes AIDS--mutates frequently, making it difficult to design a vaccine effective against every possible strain.

There are several drugs available to treat hepatitis C, but they don’t work for everyone; many patients require liver transplants, which, essentially, buy time, since the virus almost always comes back to attack the new liver.

Those regarded at highest risk for the infection include people who received blood transfusions or organ transplants before 1992; health care workers who suffered “needle stick” injuries on the job; hemophiliacs who received blood clotting factor before 1987; individuals who have injected illegal drugs and those who have engaged in unprotected sex with someone who is infected with the virus.