June 20, 2014

HCV Drug Out of the Running - Faldaprevir

Infectious Disease

Published: Jun 20, 2014

By Michael Smith, North American Correspondent, MedPage Today

The German pharmaceutical giant Boehringer Ingelheim is stopping development of faldaprevir, its hepatitis C virus (HCV) drug.

In a statement, the company said HCV treatment has "significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world."

As a result, the company said, "there is no longer an unmet medical need" for faldaprevir, an inhibitor of the HCV protease enzyme that was intended to be used with pegylated interferon and ribavirin.

The drug yielded good results in clinical trials, and it was a gentler therapy than similar combinations currently on the market. But given the development of all-oral regimens that do not use interferon, faldaprevir was increasingly regarded as a dead end.

In 2013, Peter Ferenci, MD, of the Medical University of Vienna, told MedPage Today the drug's development began in a clinical context in which its competitors were two other protease inhibitors -- telaprevir (Incivek) and boceprevir (Victrelis).

Both are approved, in combination with interferon and ribavirin, but they have been associated with serious and sometimes dangerous adverse events. Both, for instance, cause significant anemia, and telaprevir has been associated with a life-threatening rash that in at least two cases led to death.

Ferenci said the gentler side effect profile of faldaprevir, combined with more convenient dosing, might let the drug find a market while the interferon-free regimens are still being worked out.

But other investigators told MedPage Today that, even if it were approved, they would only use it for the most serious cases; patients with less severe disease could wait for an interferon-free treatment regimen.


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