Valeant hepatitis C drug fails to meet trial endpoint

Valeant’s investigational hepatitis C treatment, Viramidine, has failed to meet one of its primary endpoints in a recent phase III clinical trial, in which the drug was compared with ribavirin.

The drug failed to meet its non-inferiority efficacy endpoint on an intent-to-treat basis, with Viramidine users demonstrating a 40 per cent sustained viral response, in comparison to 55 per cent for ribavirin users.

However, the study confirmed the safety benefits of the drug, with a significantly lower number of Viramidine patients experiencing anaemia compared to those receiving ribavirin.

Timothy C Tyson, Valeant’s president and chief executive officer, said that despite Viramidine’s failure to meet its non-inferiority endpoints, the drug still demonstrates “meaningful clinical efficacy” and that higher doses could be as effective as ribavirin.

He stated: “These analyses, coupled with feedback from the medical community that there will continue to be a strong need for ribavirin or ribavirin analogues in the treatment of hepatitis C, indicate that further clinical testing is prudent.”

Ribavirin is an antiviral treatment that was discovered in the 1970s by ICN Pharmaceuticals, which later became Valeant. It was licensed to companies like Schering-Plough and Roche until its patents expired two years ago, meaning generic equivalents are now available from manufacturers such as Teva Pharmaceutical Industries.