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Pegasys Study Authors Conclude that Patients Successfully Treated for Hepatitis C Can be Considered ''Cured''; Mitch Shiffman says 'you can cure HCV', Eugene Schiff says 'get treated'.
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Reported by Jules Levin
DDW, May 22, 2007, Washington DC
The findings were to be presented Monday at the 38th annual Digestive Disease Week conference, in Washington, D.C. (They were presented first at EASL last month).
"This paper strongly suggests, for the first time, that hepatitis C is a curable disease," said lead researcher Dr. Mitchell Shiffman, a professor at Virginia Commonwealth University School of Medicine and chief of hepatology and medical director of the school's Liver Transplant Program. "After treatment, 99.6 percent of the patients remained virus undetectable for over five years," he added.
"This is the first long-term study that confirms what we believed for many years that these individuals are truly cured of hepatitis C," Shiffman said.
Most people who have hepatitis C don't know they have it, Shiffman said. "Of those who have been diagnosed, only about 25 percent have received treatment, because of the side effects of treatment," he said. "The reason why you should treat it is because you can cure hepatitis C, and we finally have the data to definitively document it."
Dr. Eugene Schiff, chief of the division of hepatology and professor of medicine at the University of Miami Miller School of Medicine, agrees that most cases of hepatitis C can be cured.
"In contrast to hepatitis B or HIV, this virus can be totally eradicated and cured," he said.
But, many patients find the side effects of treatment off-putting. Those side effects can include fever and chills, Shiff said. "You feel pretty lousy. After treatment starts, you feel worse the day after your shot, but it tapers off over the course of the week," he said. "Along with that anxiety, irritability and depression can develop. And we are quick to use antidepressants to allow these people to stay on the medication."
Additional side effects include a drop in the production of white blood cells and anemia. Often patients are giving additional drugs to combat these conditions, Shiff said.
Treatments can go on for as many as 72 weeks, depending on the reaction to therapy Shiff said. "Some people are reluctant to get treatment, because they heard that the treatment isn't so pleasant," he said. "But they should come out and get treatment."
Schiff noted that new antiviral drugs to treat hepatitis C are being tested. "It is hoped that these new antivirals will be more effective and have less severe side effects and may even be used without peginterferon alfa-2a or ribavirin," he said.
WASHINGTON--(BUSINESS WIRE)--May 21, 2007 - Results from a new study, presented at the 38th annual Digestive Disease Week (DDW) conference, showed that more than 99 percent of patients with chronic hepatitis C virus (HCV) infection who were treated successfully with PEGASYS(R) (peginterferon alfa-2a) had no detectable virus up to seven years later - validating the use of the word "cured" to describe these patients, according to study authors. Currently, the best indicator of treatment success is a sustained viral response (SVR), defined as undetectable hepatitis C virus in the blood six months after the end of treatment. The results announced today are from a long-term follow-up study to determine whether the virus re-emerges in patients who achieve an SVR. (Studies show that, overall, about half of patients with hepatitis C monoinfection can achieve an SVR with PEGASYS and ribavirin treatment, the current standard of care.)
"The results announced today are encouraging because it is rare in the treatment of life-threatening viral diseases that can we tell patients they have the chance for a cure," said Dr. Mitchell L. Shiffman, Professor of Medicine, Chief of Hepatology and Medical Director of the Liver Transplant Program, Virginia Commonwealth University Medical Center, and study author. "But in hepatitis C today, we are able to help some patients achieve an outcome that effectively enables them to put their disease behind them."
About the Study (Abstract ID #444)
This study monitored 997 patients (either mono-infected with chronic HCV or co-infected HCV and HIV) who achieved an SVR following treatment with PEGASYS monotherapy or combination therapy with PEGASYS and ribavirin. Serum levels of HCV were monitored on an annual basis for an average of 4.1 years (range 0.4 to 7 years) following successful treatment. Of the 997 patients, 989 (greater than 99 percent) maintained undetectable levels of HCV; the remaining eight patients tested positive for HCV, at an average of two years following the completion of treatment. The study found that these eight patients exhibited no consistency in age, gender or HCV genotype, and it has not been determined if these patients experienced a relapse or if they were re-infected with HCV.
"We at Roche are proud to be able to offer some hepatitis C patients the prospect of such a positive outcome with our currently-available therapies, but we also recognize the urgent need to further improve response rates," said Tom Klein, Vice President, Hepatology, Roche. "In addition to ongoing research with PEGASYS, Roche has the most comprehensive pipeline in the area, with four compounds currently in human development that target the virus in a number of different ways. The development of R1626 and partnerships with InterMune, Maxygen and Pharmasset, all underscore our long-term commitment to finding effective new therapies with the goal of successfully treating more patients with chronic hepatitis C."
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