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Hepatitis C: Treatments Helps Some
by Food and Drug Administration (FDA)

Elaine Moreland knew she wasn't imagining the symptoms. Fatigue, migraines, nausea, memory loss, anxiety, and dizziness all were wreaking havoc in her life. Yet doctor after doctor could find nothing wrong with her. Some said she was depressed. Others blamed hypochondria.

Finally, in 1992, after suffering for several years, she went to another doctor in tears. "I told him that I was not leaving his office until he found something," she says. Through extensive testing, he did. Moreland, then 32, had hepatitis C.

The nation's most common blood-borne infection, hepatitis C is estimated to affect some 4 million Americans in its chronic form. Eventually, as many as 70 percent of them will develop liver disease, according to the national Centers for Disease Control and Prevention.

In congressional testimony last year, former Surgeon General C. Everett Koop, M.D., called hepatitis C "a disease these millions will carry for a decade or more — possibly spreading to others — while it develops into a serious threat to their health."

Hepatitis C is one of five currently identified viruses — hepatitis A, B, C, D, and E — all of which can attack and damage the liver. Widely viewed as one of the most serious of the five, the hepatitis C virus (HCV) is spread primarily through contact with infected blood and can cause cirrhosis (irreversible and potentially fatal liver scarring), liver cancer, or liver failure. Hepatitis C is the major reason for liver transplants in the United States, accounting for 1,000 of the procedures annually. The disease is responsible for between 8,000 and 10,000 deaths yearly.

Some estimates say the number of HCV-infected people may be four times the number of those infected with the AIDS virus. "One of the main differences is that hepatitis C doesn't kill as quickly as AIDS," says Jay Hoofnagle, M.D., director of digestive diseases and nutrition at the National Institute of Diabetes and Digestive and Kidney Diseases.

Presently, there is no vaccine or other means of preventing hepatitis C infection. HCV exists in many different forms, called genotypes, confounding researchers in their quest to develop a vaccine effective for all variations. Also, HCV mutates frequently within infected patients, so even if an effective vaccine is developed, it could be rendered useless by a new strain of mutant virus.

Once HCV is contracted, treatment or the body's defenses can cure a small portion of patients. In most others, however, HCV's frequent mutations allow it to evade the immune system, defeating attempts to develop a cure. Some treatments are available, but they don't work for all patients. The most recent is one that combines a genetically engineered biological drug (interferon) with the drug ribavirin.

Who Is at Risk?

High-risk activities for acquiring hepatitis C include:

  • injecting illegal drugs — this risk exists even if the drug abuse only lasted for a short time or occurred many years ago
  • receiving organs from donors whose blood contained HCV
  • getting pricked with a needle that has infected blood on it — mainly a risk for health-care workers
  • frequently being exposed to blood products such as those used to treat hemophilia or chronic kidney failure
  • "snorting" cocaine using shared equipment
  • getting a tattoo or body piercing with nonsterile instruments that were used on someone infected with HCV
  • using an infected person's toothbrush, razor, or anything else that may have blood on it
  • engaging in high-risk sexual behavior, such as having multiple partners or failing to use condoms.

In the recent past, people receiving blood transfusions were a main risk group for HCV infections. That is because before 1990, there was no way to reliably screen the blood supply for the virus, so many were unwittingly infected. At the time, the risk of HCV infection was about 1 in 200 units of blood, says CDC. In May 1990, the Food and Drug Administration licensed an enzyme immunoassay (EIA) test for HCV, which indicates the presence of HCV antibodies in blood samples. But this test had a high rate of false positives (see "Identifying Recipients of Contaminated Blood."). Two years later, the agency approved a more sensitive and reliable EIA test, which has helped lower the odds of contracting hepatitis C from donated blood to 1 in 100,000 units. In February, FDA approved an improved test for confirming positive results from screening tests.

Acquiring HCV through sex between monogamous partners has not been conclusively demonstrated and appears to be rare. Studies have shown that less than 5 percent of spouses of patients with chronic hepatitis C become infected. But some of these studies include data from countries where hepatitis C is common in the general population. Likewise, transmission of HCV from infected mother to infant also is rare and results in infection of the infant in only about 5 percent of cases. There is no evidence that breast-feeding spreads HCV.

In about 10 percent of acute hepatitis C cases and 30 percent of chronic cases, the source of the infection cannot be identified. These "sporadic" infections, says the National Institute of Diabetes and Digestive and Kidney Diseases, are likely caused by infection through contamination of cuts, wounds or medical injections with the blood or body fluids of infected persons. Also, some infected patients may not provide truthful information about potential exposure, especially regarding past drug abuse. Further, some health experts say there may be an as-yet unknown pathway for the virus. Most experts agree, however, that HCV cannot be acquired through casual contact with an infected person such as shaking hands, hugging, or even kissing. It also is not spread by sneezing, coughing, or sharing eating utensils or drinking glasses.

Treating the Disease

Some patients learn they have hepatitis C through a routine physical or when they donate blood and a blood test shows elevated liver enzymes. Others have symptoms (see "Hepatitis C: Types and Symptoms."). Further testing for HCV antibodies using the EIA test and a supplemental test such as the "Western blot" or HCV-RNA detection can positively identify the infection. A liver biopsy shows disease manifested by damage already done to the liver.

Once diagnosed, CDC recommends the following:

  • Stop using alcohol.
  • See a doctor regularly.
  • Don't start any new medicines or use over-the-counter, herbal, or other drugs without consulting with a doctor.
  • Get vaccinated against hepatitis A, a food- and water-borne virus, if liver damage is present.

One of the only approved treatments for chronic hepatitis C, especially for patients with consistently elevated liver enzymes or mild-to-moderate liver damage, is the biological drug interferon alpha, marketed as Intron A by Schering Corp. and Roferon-A by Roche Laboratories Inc. Amgen Inc. also has an approved drug derived from interferon alpha called Infergen. Hepatitis C patients must inject interferon themselves, usually three times a week. In about 25 percent of patients, the drug has a pronounced effect, reducing HCV to very low levels in the blood. However, if the drug is ineffective after three months, doctors probably will discontinue it.

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About the Author

www.fda.gov
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.

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