A experimental drug made by Roche (RHHBY ) combined with an antiviral medication has proven to be the most effective treatment so far for hepatitis C, according to researchers at Rush-Presbyterian-St. Luke's Medical Center in Chicago. This combination therapy could cut treatment time in half, to 24 weeks from the usual 48, for many patients, the researchers say.
The current standard of treatment for hepatitis C, a blood-borne infectious disease of the liver, involves injections of the human protein interferon three times a week in combination with ribavirin, an antiviral pill. Only about half of patients respond to the treatment, however, and the interferon can cause side effects so severe that one in seven patients must discontinue the regime.
A research team led by Dr. Donald Jensen, director of hepatology at Rush-Presbyterian, tested the experimental Roche drug Pegasys -- a less intense, longer-acting form of interferon which is injected only once a week -- in combination with ribavirin in 1,294 patients at 99 sites around the world. They found that 61% of the patients were disease-free six months after the end of treatment. "These results are clearly superior to anything we have seen before," Jensen told a news conference on Apr. 18. In addition, he said, the treatment was well-tolerated overall.
The trial was unusual in that it also divided the patients into six categories, depending on the type of hepatitis C pathogen they were infected with. Patients with Type 1, the most prevalent in the U.S. and the most difficult to treat, had a 51% response rate -- the highest ever achieved, says Jensen. These patients reacted best when given the two drugs for 48 weeks.
Patients with the other types of hepatitis C, however, had a 78% response rate after only 24 weeks of therapy and a lower dose of ribavirin. Jensen said the survey shows that the best treatment might be determined based on an analysis on the type of hepatitis C virus the patient is carrying.
An estimated 170 million people worldwide are infected with hepatitis C, and about 2.7 million of those are in the U.S. Less than one-third of those infected have been diagnosed, however. It's a leading cause of liver cancer and cirrhosis, and often goes undetected until a patient develops liver disease.
Roche has filed with the Food & Drug Administration for approval for Pegasys and expects the drug to be cleared for marketing by yearend. A similar long-acting interferon, PegIntron from Schering (SGP ), was approved by the FDA in August, 2001. Jensen says the two drugs have not been tested in a head-to-head comparison, so he could not say which might be more effective.
By Catherine Arnst in New York
Edited by Douglas Harbrecht