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Highest Sustained Virologic Response in Treatment of Hepatitis C Ever Reported in a Prospective Study

Source: Rush-Presbyterian-St. Luke's Medical Center, 04/18/2002

A combination treatment of Pegasys (peginterferon alfa-2a 40kd) a pegylated interferon, with ribavirin, an orally active anti-viral medication, has shown some of the most effective treatment rates yet for individuals with hepatitis C. The combination treatment yielded a 61 percent sustained virologic response (SVR), the highest SVR ever reported in a prospective trial for a pegylated interferon using an intent-to-treat (ITT) analysis, according to Dr. Donald Jensen at Rush-Presbyterian-St. Luke's Medical Center.

SVR refers to a patient's continued undetectable serum hepatitis C (HCV) RNA levels six months after discontinuation of treatment. Results of a recently completed phase III study of the investigational hepatitis C therapy were presented today at the European Association for the Study of Liver (EASL) annual meeting in Madrid, Spain.

The study also revealed strong evidence that, to achieve optimal results, treatment regimens should be based on hepatitis C virus genotype, rather than on the traditional, weight-based methodology.

Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis and liver cancer. It is also the primary reason for liver transplantation in the United States. An estimated 2.7 million Americans are chronically infected with the virus, with about 35,000 new infections reported each year.

"These results are unprecedented," explained Jensen, a U.S. investigator in the trial and director of Hepatology at Rush-Presbyterian St. Luke's Medical Center, Chicago. "Physicians can confidently expect that when Pegasys is available they can prescribe it for the most appropriate length and dose of combination treatment based on a patient's genotype and achieve optimal results." Rush-Presbyterian St. Luke's Medical Center was one of 29 U.S. trial locations.

The study also found a 51 percent SVR, the highest ever achieved, for patients with genotype 1, the most difficult to treat and most prevalent genotype in North America. There are six different strains, or genotypes of hepatitis C. About 70 percent of American patients with hepatitis C exhibit genotype 1.

The study showed that patients with HCV genotype 1 require 48 weeks of Pegasys treatment with the standard dose (daily 1000mg/1200mg) of ribavirin in order to achieve the optimal outcome.

A 78 percent SVR, previously only achieved in genotype non -1 patients treated for 48 weeks, was achieved with only 24 weeks of therapy and a low daily 800 mg dose of ribavirin.

"These data are very important because we know that for certain patients, we can use a lower dose of therapy and cut the treatment duration by half without sacrificing efficacy. Potentially, this can spare some patients nearly six months of unnecessary treatment," said Jensen.

The randomized, multi-center study had a total of 99 sites around the world and included 1,284 patients stratified by genotype into one of four treatment groups:
PEGASYS 180 micrograms (µg) weekly (qw) + ribavirin 800 milligrams (mg) daily (qd) for 24 weeks
PEGASYS 180 µg qw + ribavirin 1000-1200 mg qd for 24 weeks
PEGASYS 180 µg qw + ribavirin 800 mg qd for 48 weeks
PEGASYS 180 µg qw + ribavirin 1000-1200 mg qd for 48 weeks

In this study, the adverse events were similar to previous reported trials and included flu-like symptoms, fatigue and depression.

Pegasys is a new generation hepatitis C therapy manufactured by Hoffmann-La Roche and is awaiting FDA approval. A polyethylene glycol (PEG) strand attached to the interferon molecule keeps the drug active in the bloodstream longer and at a more constant level than standard interferons. Hepatitis C virus is transmitted through body fluids, primarily blood or blood products, and by sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people infected with hepatitis C are unaware of it because it may take years for symptoms to develop. Hepatitis C chronically infects an estimated 170 million people worldwide (three percent of the world's population), with as many as 180,000 new cases occurring each year. It is estimated that less than 30 percent of all cases are diagnosed.

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