Oct. 13, 2000 -- There are very few therapeutic options available to patients with chronic hepatitis C virus infection, but over the last two-and-a-half years LeighAnn Vogel has tried just about all of them.
She first went on the antiviral agent interferon for four months. When tests showed the drug was not working, her doctors added ribavirin, the only other drug approved for treatment of the disease, to the mix. After a year of unsuccessful combination treatment, the 44-year-old Fillmore, Calif., woman went back on interferon alone, but this time she was given large doses of the drug every day.
During the various treatments Vogel lost 45 lb, her hair started to fall out, and she was so tired she couldn't even climb the stairs in her home without stopping to rest. With the daily interferon treatments, she says, the therapy turned out to be worse than the disease. Her blood cell counts dropped dramatically and she could barely function before her doctor took her off the drug.
"Because the therapies weren't working, there were many times when I questioned whether it was worth it. But I'm only 44. I'm not ready to die yet, and I am terrified of the idea of a liver transplant," she tells WebMD. "If I didn't try therapy, I'd be doing nothing, and in my mind that is the same as letting the virus win."
Unfortunately, Vogel's experience is common among hepatitis C virus patients who receive drug treatment. In previously untreated patients, only 20% of patients treated with interferon for a year achieve sustained viral remissions, in which the virus is completely cleared from the blood. About 40% treated with interferon plus ribavirin, which is now the standard therapy for hepatitis C virus, achieve sustained remissions.
But an Italian study that included the hardest to treat hepatitis C patients suggests that a combination approach to therapy, in which a third antiviral agent known as amantadine is added to the interferon/ribavirin regimen, may offer hope to patients like Vogel. Amantadine is also commonly used to fight the flu and to treat Parkinson's disease, and now it appears it might help fight hepatitis C. The three-drug regimen was found to prompt sustained responses in almost half of the study patients who did not respond to initial therapy with interferon alone.
"I think this study shows that treatment with several antiviral agents given simultaneously is a good approach," study author Stephano Brillanti, MD, of Italy's University of Bologna, tells WebMD. "The lessons we learned from treating HIV will serve us well in the treatment of hepatitis C. We are learning that the best options in difficult to treat patients is a cocktail approach, like that used to treat AIDS."
It is estimated that four million people in the United States are chronically infected with hepatitis C, and as many as 70% will develop liver disease caused by the virus. Worldwide, some 170 million people are infected with hepatitis C. Infection can lead to cirrhosis, liver cancer, and liver failure and is the most common reason for liver transplants in the U.S. today.
Because symptoms do not generally develop until a decade or more after infection, many people who have chronic hepatitis C don't realize it.
In the study reported by Brillanti and colleagues, 40 patients were treated with the triple-drug therapy containing amantadine, and 20 patients received the interferon and ribavirin combination only. The patients received therapy for one year.
Almost half of the patients treated with the triple-drug therapy had sustained responses to treatment six months after its completion, compared with just 5% of patients treated with the interferon and ribavirin combo alone. At one year after the end of therapy, almost 40% of the responding patients given the three-drug regimen had not relapsed, Brillanti says.
The Italian researchers are now testing the three-drug regimen in a group of 500 patients who failed initial therapy with the interferon and ribavirin combination. They published the results of this study in the Sept. issue of the journal, Hepatology.
"We were very skeptical before we saw how well this worked, but we now believe amantadine may act synergistically with interferon and ribavirin. We aren't exactly sure how, but we think it is very exciting."
Eugene R. Schiff, MD, of the University of Miami (Fla.) Center for Liver Disease, says he remains skeptical about the usefulness of the three-drug combination therapy, although he quickly adds that he hopes the Italian findings are confirmed. His center is currently using the regimen in some patients, as are others around the U.S., and he says more data will certainly be available within a year. Schiff, a spokesman for the American Association for the Study of Liver Disease, reviewed the study for WebMD.
Despite past disappointments, Vogel says she is still willing to try new therapies in an effort to keep her disease from progressing. She has enrolled in a University of Southern California study evaluating a novel form of interferon known as PEGASYS given with ribavirin.
She remains optimistic but says she is also angry that there are so few treatment options for patients with chronic hepatitis C.
"We are really at the point where HIV was 15 years ago," she says. "We are just beginning and there is not much out there. This is an epidemic, but the government doesn't seem to understand that there are more people with hepatitis C than there are with AIDS. We need the same kind of effort to find new therapies." -->