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Title: Sustained Response to Anti-Hepatitis C Virus Drugs Results in Cure in Virtually All Cases: Presented at EASL

"Sustained Response to Anti-Hepatitis C Virus Drugs Results in Cure in Virtually All Cases: Presented at EASL"

By Jill Stein BARCELONA, SPAIN -- April 16, 2007 -- More than 99% of patients infected with hepatitis C virus (HCV) who achieve a sustained virological response (SVR) have an outcome that may be considered a cure, according to data presented here at the 42[^nd Annual Meeting of the European Association for the Study of the Liver (EASL).

Lead investigator Mark G. Swain, MD, professor of medicine, University of Calgary, Calgary, Canada, said that only 8 of 997 patients who achieved an SVR later developed re-infection.

Dr. Swain and colleagues reviewed the long-term outcomes from nine studies and identified patients who had achieved a SVR after treatment with alpha peginterferon alfa-2a (40 KD) (Pegasys(R)) as monotherapy or in combination with ribavirin (Copegus(R)).

"I tell my patients who have had a sustained virological response that they can go home and get on with their lives," Dr. Swain said in a presentation on April 12^th. "I tell them that there is less than a 0.5% chance that the disease will ever return."

The study included three trials in which patients were treated with monotherapy and six trials in which the combination treatment was used. The combination therapy is now considered the treatment standard, and as many as 66% of HCV patients who take their antiviral medication as prescribed -- usually for 48 weeks -- are able to achieve the SVR.

A SVR was defined as an undetectable viral load in the blood six months following cessation of treatment.

Dr. Swain noted that statistical analyses on this study were not performed. "We were looking for an absolute number," he said. "There was no comparator group."

Of patients who achieved a SVR, 163 patients who had HCV monoinfection were treated with peginterferon alfa-2a alone; 741 patients with HCV monoinfection were treated with peginterferon alfa-2a plus ribavirin in combination; 93 patients co-infected with HIV and HCV were treated with either monotherapy or combination therapy.

"We found that a sustained virological response is a sustained virological response whether it occurs in an immunosuppressed patient due to disease such as HIV or in a patient who has undergone transplantation and requires immunosuppressive drugs," Dr. Swain said. "There was no falloff in response."

Because of the study's methodology, it will be impossible to determine if patients indeed relapsed or were re-infected, he added.

The study was supported by Roche.

[Presentation title: Durable Sustained Virological Response After Treatment With Peginterferon a-2a (PEGYSUS) or in Combination With Ribavarin (COPEGUS): 5-Year Follow-Up and the Criteria of a Cure. Abstract Number 1]

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