MONDAY, SEPTEMBER 26, 2016

Boehringer Ingelheim's hepatitis C antiviral shows promise in Phase III study

Boehringer Ingelheim, a German pharmaceutical company, announced on Monday that its second-generation protease inhibitor was effective in a Phase III trial against mutant variants of the hepatitis C virus.

When used in conjunction with pegylated interferon and ribavirin, faldaprevir was effective even in the presence of naturally-occurring mutant variations of HCV. The presence of the mutated virus was found to have no effect on the chances of viral cure in genotype-1 infected hepatitis C patients.

"These data are encouraging as they demonstrate that HCV genotype-1 infected patients irrespective of the presence of the common HCV Q80K variant may benefit from faldaprevir," Christoph Sarrazin, the professor of medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, said. "In some parts of the world the Q80K mutation is present in almost 50 percent of genotype-1a infected patients who will potentially require additional screening prior to using some HCV protease inhibitors. With faldaprevir's efficacy against HCV Q80K, physicians should be able to avoid screening for this mutation prior to treatment of genotype-1a infected patients."

HCV's NS3/4A protease is needed for viral replication, making it a key target for direct acting antiviral treatments like faldaprevir. Faldaprevir is the core component of Boehringer Ingelheim's investigational hepatitis C pipeline. The company is currently studying the antiviral with and without interferon.

Boehringer Ingelheim presented the data from the study last week during the HEP DART 2013 conference in Big Island, Hawaii