Clinical

Novel antiviral agent shows efficacy in hepatitis C virus infection

Last Updated: 2007-05-25 16:29:11 -0400 (Reuters Health)

By Martha Kerr

WASHINGTON, DC (Reuters Health) - An antiviral agent, in a new class, significantly decreases HCV viral loads when given in combination with peg-interferon alfa-2b and ribavirin, according to a study reported this week at Digestive Disease Week.

Dr. Kelly D. Kaita, of the University of Manitoba, reported results of a phase 2 study of 57 chronic HCV-infected patients refractory to previous anti-HCV agents. The study drug was celgosivir, described as "a potent inhibitor of alpha-glucosidase-1, a host enzyme required for viral assembly and release."

Patients were randomized to either celgosivir 400 mg a day plus peg-interferon and ribavirin, celgosivir 400 mg plus peg-interferon alone or placebo plus peg-interferon and ribavirin daily for 12 weeks.

Ribavirin and peg-interferon alfa-2b doses were calculated according to standard weight-based algorithms.

Median HCV RNA levels were 6 log10 at baseline. Patients with a history of nonresponse to previous therapy had a reduction of 1.2 log10 in HCV RNA and 0.4 log10 for those with a previous partial response.

Early viral response was achieved by 33% of patients on triple therapy and by 10% of patients on any two-drug regimen.

"This study is the first demonstration that celgosivir in combination with peg-interferon alfa-2b and ribavirin results in a clinically significant decrease in HCV viral loads in patients highly resistant to current standard treatment," Dr. Kaita told meeting attendees.