NICE Recommends Gilead’s Harvoni

NICE Recommends Gilead’s HarvoniThe National Institute for Health and Care Excellence (NICE) have announced draft guidelines recommending Gilead’s Harvoni for regulatory approval.

If approved, the combination therapy (ledipasvir-sofosbuvir) will be available to treat NHS patients with hepatitis C in England and Wales.

Specifically, the drug has been recommended for the treatment of adults with genotype 1 or 4 chronic hepatitis C (HCV), but not for those with genotype 3.

At the moment the standard treatment for HCV is interferon-based therapy, but this is often lengthy and linked with significant side effects that could prevent some patients from starting or choosing to complete the treatment.

Harvoni could help address these issues as it involves a once-daily, all-oral, interferon- and ribavirin-free treatment option, and the possibility of a shortened course of treatment, in some cases as reducing the length of the course to as short as eight weeks.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, commented that “this could make it more likely that people will seek treatment for their condition. In turn this could have important benefits, not just for people with chronic hepatitis, but also in reducing transmission of the virus to people without the infection.”

Harvoni was granted European regulatory approval in November as a result of Phase III clinical data showing that the treatment achieved cure rates – sustained virologic response – of 94%-99%.


Industry News