Joan Bennett Nayeri leads a support group for people with hepatitis C. (Bill O'Leary/TWP)

By Sally Squires
Washington Post Staff Writer
Tuesday, April 7, 1998; Page Z12

The letters are scheduled to arrive in early summer, warning thousands of people who received blood transfusions before June 1992 that they may have been given something else: hepatitis C.

This common viral infection attacks the liver and is the leading cause of liver transplants in the United States. Estimates are that 4 million Americans have the illness, according to the latest National Health and Nutrition Examination Survey. About 85 percent of those infected develop chronic liver disease that often leads to severe scarring of the liver and eventually to liver failure.

Hepatitis C can be spread through contact with infected blood, and until 1992 there was no sure test available to detect this tiny virus in blood transfusions or blood byproducts. Since then, good screening tests have made the U.S. blood supply virtually free of hepatitis C. The risk of contracting the infection from a transfusion has dropped from 1 in every 100 pints of blood transfused in the late 1960s to 1 in 100,000 today, according to the federal Centers for Disease Control and Prevention, which calculates that the incidence of hepatitis C has declined by more than 80 percent since the 1980s. "It is a very small risk," said Miriam Alter, chief of the epidemiology section at the CDC's Hepatitis Branch.

Options for Those Who Test Positive People who receive a look-back letter face several simple lab tests to determine if they have hepatitis C. If the results prove positive, people infected have a number of options. Here is what a panel of experts, convened by the National Institutes of Health, concluded last year: Confirm a positive blood test with additional lab tests to rule out inaccurate results. Blood tests look for evidence of active virus and monitor liver enzyme levels -- one way to gauge how much viral activity is occurring in the liver. If results show normal levels of liver enzymes and no active virus in the blood, doctors may simply take a wait and see approach, testing the patient again in another six to 12 months. But if active virus is present or liver enzyme levels are abnormal, many doctors recommend a liver biopsy. During the biopsy, a tiny amount of liver is removed by a needle and analyzed to grade the severity of the infection and to measure how much damage the liver has sustained. If the biopsy shows little damage, many doctors recommend simply monitoring the patient regularly with blood tests. But if there is extensive liver damage, treatment with alpha interferon may be prescribed. Alpha interferon is the only medication approved for use in hepatitis C infections in the United States. But the drug is expensive and has many side effects. It is not advised for people who have normal liver enzyme levels or those who have other health problems, such as rheumatoid arthritis, severe depression or other psychiatric disorders. Nor is it recommended for people who are abusing alcohol or drugs, or those who have an immune system that is suppressed, such as someone who has had an organ transplant. The drug is given by injection three times a week. During interferon treatment, doctors regularly draw blood to test for virus levels and liver enzymes levels. If neither has become normal within three months, then treatment is halted since it is unlikely to be effective. If virus levels and liver enzyme levels drop, then interferon treatment can be continued for 12 months. Enzyme testing is repeated at two-to-six-month intervals; tests for evidence of the virus are performed every six months. If there is no evidence of virus and if liver enzymes remain normal for six months, the chance for long-term recovery is excellent. Relapses have rarely been reported. Source: The National Institute of Diabetes and Digestive and Kidney Diseases.

But the rub is that the disease remains dormant for decades. "We know that many Americans infected with hepatitis C are unaware they have the disease," U.S. Surgeon General David Satcher testified last month before the House Subcommittee on Human Resources.

Not only do these people fail to get treatment, but they may engage in risky behavior, such as drinking alcohol, which can accelerate liver damage. They also don't know to take precautions to help prevent the spread of the disease to others, such as making sure their blood does not come in contact with other people.

For this reason, Congress directed Health and Human Services (HSS) Secretary Donna Shalala to undertake a massive "look-back" program aimed at notifying the estimated 1 million people who are at risk because they received blood transfusions before June 1992 from people who have since tested positive for hepatitis C. The first phase of the program targets 300,000 Americans, those who will begin receiving letters this summer.

"This first group will get a letter saying, 'You have received a transfusion from someone who has subsequently developed hepatitis C,' " said Eric Goosby, director of the HHS office on HIV-AIDS policy, which staffs the blood safety committee for HHS. " 'We do not know what your status is, but there is a small chance that you could be positive." The letters will direct patients to notify their physicians or to contact public health doctors for testing and follow-up treatment.

Patient advocate groups consider the move long overdue. "I'm really angry that they waited so long for this look-back," said Joan Bennett Nayeri of Alexandria, who traced her infection with hepatitis C to a 1982 blood transfusion and who has two sons with the disease. " . . . Common sense says that if you had educated the public and had the people screened that you could have headed off this epidemic."

But many in the medical profession believe there was reason to wait. Few treatments are available for those infected, and some public health officials worry that the look-back will terrify some patients. Most people with hepatitis C have no symptoms. Testing "pulls in people who had no idea that anything was wrong," said Leonard Seeff, chief of gastroenterology and hepatology at the Veterans Affairs Hospital in the District and a senior scientist for hepatitis research at the National Institutes of Health. "It causes enormous anxiety."

Treatment of hepatitis C is changing so fast that many doctors are ill-equipped to answer questions about the disease, one reason that public health officials are working with consumer groups and professional organizations to bring physicians up to speed. "Lots of doctors don't know what to do, and lots of doctors are misinformed," Seeff said.

Testing also poses a difficult medical question: what to do for those who prove positive.

Drug treatment is available for patients with chronic and active infections, but it has its own drawbacks. "It is expensive, has a lot of side effects and is effective in only 20 percent of people," said Jay H. Hoofnagle, head of the Digestive Diseases and Nutrition Division at the National Institute of Diabetes and Digestive and Kidney Diseases.

"Many people go through their whole life with a mild infection," Hoofnagle said. "But it's hard to tell who will do well and who will not. That is the conundrum."

A Silent Threat

Hepatitis C is "a grave threat to our society," Surgeon General Satcher said. It afflicts 170 million people worldwide. In the United States, about 28,000 new cases are diagnosed annually, according to the CDC, a figure that adds up to 4 million chronic cases, or nearly 2 percent of the American population.

The virus is part of a family of microbes -- hepatitis A to E -- that all cause inflammation of the liver, the organ responsible for filtering and breaking down waste products in the blood. If inflammation reaches a certain critical point, the liver can no longer do its job. Bilirubin -- a blood protein -- then accumulates in the blood and tissue, turning the skin and the eyeballs a yellowish hue. This condition is called jaundice and it is the symptom most people think of when they think of hepatitis.

In hepatitis C, jaundice is a very late symptom, one that may or may not occur. It signals severe, irreversible liver damage that can lead to liver failure or to liver cancer.

Of those who are infected with the virus, 15 to 20 percent fight off the infection naturally and suffer no residual effects. The majority of patients, however, develop long-term complications of varying severity, despite the fact that many people do not even know they are infected because they don't have symptoms until many years after the virus has begun its attack on the liver. "The average patient has been infected for 16 years by the time they get their diagnosis," Hoofnagle said.

The infection can wax and wane through the years. Most people experience only vague symptoms, such as feeling tired. Routine blood tests "may reveal slightly higher than normal liver enzymes, but nothing that would definitively point to hepatitis," said Leslye Johnson, chief of NIDDK's Enteric and Hepatic Diseases Branch. There is little to suggest the liver damage that may be occurring.

Only when the virus has destroyed a significant portion of the liver do many sufferers learn that they have the disease. Hepatitis C accounts for more than two-thirds of the chronic cases of hepatitis seen in the United States, and for a third of cirrhosis, end-stage liver disease and liver cancer. Between 8,000 to 10,000 people die annually from this disease, which costs an estimated $600 million to treat per year.

"It is important to recognize that the number of individuals with this infection in the United States is extremely large," Alter said. "Most of them do not know that they have it."

Last July, Susan Chanin, 40, of Germantown, underwent routine, blood tests before having foot surgery. The results showed some elevated liver enzymes. Her anesthesiologist, who wanted to be sure that her liver could process the anesthesia during the operation, insisted that she have a hepatitis test. It proved positive for hepatitis C.

"It was very much a surprise," said Chanin, who otherwise felt well. She traced the infection to a blood product that she had been given in 1980 after surgery for Hodgkin's disease. "I asked the doctor, 'What does this mean? Is it something that is life-threatening?' And he said, 'Well, it can be.' "

Chanin's husband and two of her daughters, who were born after she received the blood product, were also tested. Sexual transmission between spouses is rare, occurring in less than 5 percent of couples with one infected partner, according to the CDC. Transmission from mother to child is also extremely uncommon. Only about 5 percent of infants born to infected women develop the disease, according to the CDC.

But Chanin's luck wasn't good. Her youngest daughter, Dylan, 5, tested positive for the disease. "I pretty much fell apart," Chanin said. "It was awful."

Had she known she was at risk, Chanin said that she would been tested earlier for hepatitis C. "I want to get the word out," she said. "There are people like me who are walking around with this disease and have no idea because they have no symptoms."

Advice for People With Hepatitis C People who are infected with hepatitis C need to take special precautions to prevent complications and to reduce the risk of spreading the disease to others. Here is what public health officials recommend: Do not donate blood, semen or tissues. Avoid sharing razors, toothbrushes or other items that might be contaminated with blood. Avoid alcohol use. Abstinence is recommended to protect the liver from further damage. Sexual transmission is unlikely. Less than 5 percent of partners of infected people develop the disease. You may, however, choose to modify your behavior or use condoms or other barriers. Your sexual partner should be tested for hepatitis C. Get vaccinated against hepatitis A and B since infection with hepatitis C does not convey protection against other forms of hepatitis, which could compound liver damage. Visit your doctor every six to 12 months to check for symptoms and signs of liver disease. Lab tests should be performed to measure liver enzyme levels and to look for evidence of active virus in the blood. Check with your doctor before taking any medications. Even some nonprescription drugs, such as acetaminophen, can harm the liver, particularly in those who already have liver damage. Don't avoid normal social and work contact. Hugging, kissing, shaking hands, eating and preparing food is safe. Source: National Institute of Diabetes and Digestive and Kidney Diseases

More Accurate Tests

Better diagnostic tests and improved treatment are two of the factors driving the look-back effort. The hepatitis C virus is present at such low concentrations that researchers have not been able to find it even with the most powerful electron scanning microscope. No one has ever been able to culture the tiny microbe in the laboratory.

To diagnose hepatitis C infection, doctors rely on a blood test that detects the presence in the blood of antibodies manufactured by the immune system against the virus. These show that infection has occurred.

Since the test can sometimes cross-react with other proteins in the blood, producing a false positive result, most positive results need to be confirmed by other methods. Additional tests are performed to identify the type of hepatitis C virus present and to measure liver enzymes, a gauge of the disease's current activity level.

Besides people who came in contact with infected blood, others at high risk for hepatitis C include health care workers who suffer needlestick accidents and people who use illicit intravenous drugs.

"This drug is so easily spread by use of contaminated drug equipment that there are many people in the United States who used drugs only recreationally many years ago who may be infected," the CDC's Alter said. "Anyone who has injected street drugs at any time in the past, even if only once, should consider themselves at risk and get tested."

Intranasal use of cocaine also heightens the risk of hepatitis C infection because of the high likelihood of breaking blood vessels in the nasal passages.

Kidney dialysis increases the risk of infection too, as do medical conditions such as hemophilia that require repeated exposure to blood products.

Shortly after taking her monthly dose of gamma globulin for a rare, genetic immune deficiency problem, Gina Pollichino, 41, of Northport, N.Y., suddenly became very ill in February 1994. Jaundice followed and she became very weak. Doctors diagnosed hepatitis C and traced the infection to a tainted batch of gamma globulin.

Wher her condition continued to worsen, doctors prescribed alpha interferon, an antiviral drug that is the only approved therapy available in the United States for hepatitis C.

Pollichino knew when she began the treatment that it might not work. Her particular strain of virus was known to be fairly immune to alpha interferon and treatment is only effective in about 20 percent of cases. She considered those factors against the fact that she was relatively young, thin, female and had had the disease for just a short period of time -- all factors that weighed in her favor.

Three times a week for nearly a year, Pollichino injected herself with alpha interferon and suffered from its many side effects, including migraines, anemia and depression. Her asthma worsened and she developed a new condition: an autoimmune disorder called systemic lupus erythematosus.

The drug failed to work. "I'm still glad that I had the opportunity to fight the virus," she said. "Even though I got lupus from it, I didn't want to look back and say, why didn't I try it?"

When treatment is unsuccessful and the liver begins to fail, the only option left is a liver transplant. Bob Volck, 51, of Manassas, took interferon for six months before developing severe anemia, which forced him to abandon the drug. In 1995, 13 years after being diagnosed, Volck's liver enzymes began to rise. Volck received a new liver in December at Inova-Fairfax Hospital.

"Even though I got the liver transplant, the hepatitis C virus is still in my system," Volck said. "Until they can come up with a way of getting a vaccine or a new treatment, I can only minimize my risk."

Sometimes, the disease just mysteriously improves. After Chanin and her daughter Dylan were diagnosed with hepatitis C, they each underwent a liver biopsy to determine the extent of their disease. Results showed that Dylan had only minor damage to her liver. The infection appeared to be inactive and not progressing.

Chanin's test results, by comparison, showed severe liver damage and fibrosis, but no scarring. She was eager to get into a clinical trial that combined alpha interferon with ribavirin, an experimental drug that has proved effective in treating hepatitis C in previous studies. But before she could get into the trial, Chanin's doctor told her that she didn't need the treatment any longer. Her liver enzymes had suddenly returned to normal. They have remained normal for the past three months, a sign that the infection has become inactive.

Therein lies the dilemma for researchers and physicians as more people learn from the look-back that they are infected with hepatitis C. "Many people may go their entire lives without being affected by it," said the CDC's Alter. "But some will develop the disease. If we can intervene and prevent the severe consequences from occurring, that would be an ideal outcome for the individuals who are infected."

Resources
Information on hepatitis C is available from:

Centers for Disease Control and Prevention, telephone: 888-4HEPCDC (888-443-7232).

National Digestive Diseases Information Clearinghouse, 2 Information Way, Bethesda, MD 20892-3570. Phone: 301-654-3810; fax: 301-907-8906. E-mail: nddic@aerie.com

American Liver Foundation, 1425 Pompton Avenue, Cedar Grove, NJ 07009-1000. Phone: 800-513-9748.

Hepatitis Foundation International, 30 Sunrise Terrace, Cedar Grove, NJ 07009-1423. Phone: 800-891-0707.