Sept 20, 2001 -- Doctors are still using the word "cure" around the new combination therapy for hepatitis C infection. Results of the first major clinical trial of the combination are being published in the Sept. 22 issue of the medical journal The Lancet, but doctors already call it the treatment of choice.
The new combination treatment has to be taken for close to a year and it does have some severe side effects, such as anemia, fatigue, depression, and flu-like symptoms. But it promises to knock out the virus in more than half of infected people -- and to prevent or delay liver disease in many others.
"This will be the new standard of care for hepatitis C," study leader Michael P. Manns, MD, tells WebMD. "In 54% of the patients, we find that their [blood] is free of the virus six months after treatment. This we call 'sustained virologic response' or SVR. It means cures. The treatment is eradicating the virus."
Manns leads the departments of gastroenterology and hepatology at the Medical University of Hannover, Germany.
There are several different strains of the hepatitis C virus, or HCV for short. Unfortunately, the most common strain in the U.S. -- called genotype 1 -- is the hardest to treat. Perhaps the most exciting thing about the new study is that more than 40% of people with genotype 1 HCV had an excellent response to the new combination.
Study participant Kay Fox was infected with the genotype 1 version of the virus. But now doctors can no longer detect the virus in her blood. "Nobody could be more thrilled than I am," the 51-year-old Missouri resident tells WebMD.
HCV was discovered only a decade ago. Researchers soon found that a manmade version of a natural virus-fighting substance -- interferon or IFN -- slowed the virus down. Then they found that an existing drug -- ribavirin -- made interferon work better. Now two drug companies have created a new form of interferon that works even better when given along with ribavirin.
The new interferons are called "pegylated" or "PEG" versions of the older drug. These versions allow the drug to stay in the body much longer. Instead of the frequent injections needed for standard interferon, someone with HCV needs only one shot a week of the PEG interferons. But the drugs aren't easy to take; both PEG interferon and ribavirin cause serious side effects.
To lessen the chance that patients would get severe anemia, Manns' study used a relatively low dose of ribavirin. After analyzing the results, the researchers noticed that the people who weighed the least did much better than heavier people. It turned out that pound for pound, they were getting a higher dose of ribavirin. When dosage is adjusted for weight, the study suggests that the overall success rate of the combination treatment can be higher than 60%.
Hepatitis C expert Curt H. Hagedorn, MD, of Atlanta's Emory University, reviewed Manns' study for WebMD. "It does look like this weight adjustment is really important -- it can boost the response rate," he says. "We are adjusting the ribavirin dosage according to the weight of the individual patient."
Doctors still are learning how best to use the new drugs. Patients infected with the easier-to-treat HCV genotypes 2 and 3 are much more likely to respond to the combination treatment, and they need only 24 weeks of the treatment. On the other hand, it is important to identify which people are not going to respond to treatment to spare them the expense and side effects of an expensive and difficult therapy. Hagedorn says that doctors are getting much better at this.
Even for those who do respond, the treatment is tough.
"I got real nauseated. I was tired. I didn't have any reserve energy -- I couldn't even climb a flight of stairs without being exhausted," Fox says of her 48-week treatment. "But when you know there is a chance for a cure, it is worth it. If I had to do it over again, I'd do it. Now I am back at full steam."