June 24, 2009 In a multi-center trial led by a Saint Louis University researcher, investigators found that a new combination therapy of daily consensus interferon and ribavirin helps some hepatitis C patients who have not responded to previous treatment. The findings, published in the June issue of Hepatology, offer a new option for hepatitis C patients, and may be effective even for those patients with factors that make their condition difficult to treat.
"This represents an important advance for difficult to treat hepatitis C patients who have failed to respond to traditional therapy," said Bruce Bacon, M.D., director of the division of gastroenterology and hepatology at Saint Louis University School of Medicine and co-director of the Saint Louis University Liver Center .
About 4 million people in the U.S. have been infected with hepatitis C; an estimated 10,000 to 12,000 people die from complications each year in this country. Hepatitis C is caused by a virus, transmitted by contact with blood, and may initially be asymptomatic. For patients who develop chronic hepatitis C infection, inflammation of the liver may develop, leading to fibrosis and cirrhosis (scarring of the liver), as well as other complications including liver cancer and death.
For patients with chronic hepatitis C, the prognosis varies. About half fully recover after an initial course of pegylated interferon and ribavirin anti-viral therapy that may last from six months to a year.
The remaining patients, known as non-responders, may improve but the virus is not eliminated. These patients are at greatest risk for worsening, and subsequent treatments have shown limited effectiveness for this group. In addition, those with genotype 1 (a particular genetic variation of the virus), those with high baseline virus levels, those with advanced liver disease and African American patients are all less likely to respond well to treatment.
The study looked at 515 patients at 44 different sites. Patients were given either one of two doses of daily consensus interferon and ribavirin, or no treatment.
For patients with less severe liver damage who had shown some response to initial treatment, the success rate was above 30 percent. The overall results showed that, for patients who had been unresponsive to initial treatment, consensus interferon and ribavirin worked for about 7 percent of patients given the lower dose and about 11 percent of patients given the higher dose of consensus interferon and ribavirin.
"This study shows that select patients who have failed to respond to prior therapy are candidates for retreatment with consensus interferon and ribavirin," Bacon said.
The study was funded by Valeant Pharmaceuticals and 3 Rivers Pharmaceuticals.
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- Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy (DIRECT). Hepatology, June 2009
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