Research Fuels Hope for Hard-to-Treat Hepatitis C Patients

The outlook for patients with hepatitis C continues to improve as results from a clinical trial led by a Saint Louis University researcher found that the drug boceprevir helped cure hard-to-treat patients. The findings were reported at the 61st annual meeting of the American Association for the Study of Liver Diseases earlier in November.

Bruce R. Bacon, MD, professor of internal medicine at Saint Louis University School of Medicine and co-principal investigator of the HCV RESPOND-2 study, studied the protease inhibitor, boceprevir, and found that it significantly increased the number of patients whose blood had undetectable levels of the virus.

"These findings are especially significant for patients who dont respond to initial treatment," says Bacon. "When the hepatitis C virus is not eliminated, debilitating fatigue and more serious problems can follow."

Hepatitis C is caused by a virus that is transmitted by contact with blood. The infection may initially be asymptomatic, but 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.

The prognosis varies for patients with chronic hepatitis C. With the current standard therapy, about half fully recover after an initial course of peginterferon and ribavirin antiviral therapy that may last from six months to a year. The remaining patients, known as non-responders, may improve with initial treatment but the virus is not eliminated, or may not respond to treatment at all.

For this group, the only current option is to retreat patients with the same or similar drugs, which increases the likelihood of severe treatment side effects. In addition, researchers have found that the success of treatment depends on the major strain, or genotype, of hepatitis C that a patient has.

The HCV RESPOND-2 study looked at 403 patients with chronic hepatitis C infections with genotype one, the most difficult strain of the virus to treat, who still had significant levels of the virus after being treated with peginterferon and ribavirin, the standard hepatitis C treatment.

"These results are very exciting," Bacon says. "In this study, boceprevir helped cure significantly more patients in 24 weeks of therapy than did treatment with peginterferon and ribavirin alone."

A second study, HCV SPRINT-2, examined patients with hepatitis C with genotype one who had not yet been treated with the standard treatment. They, too, responded well to the drug.

Bacon calls the progress made in treating hepatitis C remarkable. "Weve gone from the discovery of the virus in 1989 to where we are now, 22 years later, when we have the ability to cure a large majority of those with hepatitis C," Bacon says. "Its a true success story. Drugs like boceprevir are going to revolutionize care of those with hepatitis C."

The clinical trial was funded by Merck, which expects to begin seeking FDA approval this year.