Hepatitis C: Treating the Disease

by Food and Drug Administration (FDA)

(Page 2 of 3)

Doctors may prescribe Rebetron, a Schering product that combines interferon with the antiviral drug ribavirin. Approved last June for patients who have relapsed after interferon therapy and expanded in December to include patients never treated with interferon, this combination therapy appears to suppress blood levels of HCV more effectively than a first or repeat course of interferon alone. In clinical trials, about 45 percent of relapsed patients treated with the combination sustained reduced HCV levels for six months after discontinuing therapy, compared with 5 percent of relapsed patients who were retreated with interferon alone. These results were reinforced by a study published last Nov. 19 in the New England Journal of Medicine showing the combination to be significantly more effective in suppressing HCV levels.

"We've learned from research in other viral diseases that combination therapies rather than [a single drug] may offer the best potential for effective treatment," says John Hutchison, M.D., medical director of liver transplantation at Scripps Clinic and Research Foundation.

Bill Ruttman, 44, a Lansdale, Pa., hepatitis C patient, has taken the combination treatment since last October. As a result, his HCV levels have dropped to undetectable levels, and his once-elevated liver enzyme levels have "normalized," which he says is good news because for now, he feels the disease has been slowed down. "I'm extremely happy in that regard," he says.

Ruttman's successful therapy has come at a price, however, because of Rebetron's side effects. He suffers from extreme fatigue and has to nap often during the day, and he sleeps restlessly at night. He also has bouts of depression and is currently unable to work. His side effects are typical of those experienced by patients taking interferon alone as well as the combination therapy.

Because side effects can be serious, patients should be closely monitored by their doctors. Ribavirin can cause anemia, and interferon is associated with both psychosis and suicidal behavior, though the latter occurs in 1 to 2 percent of patients. Both interferon and ribavirin present significant potential risks for pregnant women, including possible fetal death or malformations. Female patients and female partners of male patients must not become pregnant while receiving this therapy and for six months after completing therapy.

Some patients who take interferon or the combination complain of flu-like side effects such as fever, chills and body aches. Many side effects, such as muscle aches and low-grade fever, can be managed. Some side effects may be reduced by giving the drug at night or lowering the dosage. Side effects are often more severe during the first few weeks of treatment, especially after the first injection.

Patient Elaine Moreland says her interferon therapy caused "just about every one of the [side effects] listed in the drug handout sheets — severe muscle cramps, hair loss, nervousness, heart palpitations, fatigue, sweating, headaches, and blurry vision." Ultimately, she says, treatment was stopped because it wasn't working. Because of the potential side effects, she is holding off on further therapy in the hope that improved treatments may soon be available. "I'm waiting to see what comes down the pike unless signs start to point to serious progression of my disease."

Currently, chronic hepatitis C patients who do not respond to therapy have few options. In many, cirrhosis or other damage will eventually cause the liver to stop functioning. In these cases, a liver transplant is the only recourse. However, even new livers often become infected with the virus. But because HCV usually progresses slowly, says Jay Hoofnagle, many transplant recipients can live normal lives for many years despite the infection.

On the Horizon

A major focus of hepatitis C research is development of a cell culture through which scientists can study HCV outside the human body. By understanding how the virus replicates and how it injures cells, researchers may be able to develop ways to control the virus as well as drugs to block it.

Several drugs currently under study show some promise as future treatments for the disease. They include thymosin, amantadine, and other forms of interferon.

"What we really need, of course, is a vaccine against this disease," Surgeon General David Satcher, M.D., told a congressional committee last year. "However, we cannot underestimate the complexity of this task, particularly because of the rapid rate at which the virus mutates." Researchers at the National Institute of Allergy and Infectious Diseases say a vaccine is likely 10 years away.

One research hurdle was cleared in 1997 when NIAID scientists and FDA researcher Stephen Feinstone, M.D., independently cloned an infectious hepatitis C virus. NIAID director Anthony Fauci, M.D., says the work "will enable scientists to better understand the factors and mechanisms that determine whether the virus is cleared from the body or produces a chronic infection."

Another obstacle to research progress is the need for more funding. Though hepatitis C has taken a back seat in recent years to appropriations for many other more visible public health problems such as AIDS, the situation is improving. Direct funding for hepatitis C research at the National Institutes of Health was $25.3 million in 1997, but has increased to over $34 million in 1999. Private efforts have bolstered funding as well. For example, country music entertainer Naomi Judd, herself a hepatitis C patient who was forced to retire in 1991, started the Naomi Judd Research Fund to help find a cure for the disease. Through the fund, she has helped the American Liver Foundation raise over a million dollars.

Meanwhile, federal and private groups are escalating efforts to educate primary care physicians and the public about the disease. And through the Internet and local support groups, hepatitis C sufferers are finding what patient Bill Ruttman calls "a community."

As for those just diagnosed with the disease, patient Elaine Moreland has this advice: "Try to find a good doctor who is knowledgeable about HCV. Become active in your own medical treatment. Read all you can about the disease. Above all, try to keep a positive attitude and know you're not alone in the fight."

About the Author

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