Gilead receives NICE recommendation for Harvoni in hepatitis C

Gilead Sciences' ledipasvir-sofosbuvir combination therapy Harvoni has been provisionally recommended as a hepatitis C therapy by the National Institute for Health and Care Excellence (NICE).

The draft guidance from the UK regulator recommends the product for use in the treatment of genotypes 1 and 4 hepatitis C, based on clinical trial data demonstrating its safety and efficacy.

Harvoni is administered orally as a single tablet and works by inhibiting the replication of the hepatitis C virus. It offers numerous benefits over interferon, the current standard of care, which is administered over a long period of time and is associated with several side effects.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: "Ledipasvir-sofosbuvir offers the possibility of a shortened course of treatment – in some cases as little as eight weeks – without the need for combination therapy with interferon."

However, NICE did not recommend Harvoni in combination with ribavirin  for people with genotype 3 chronic hepatitis C, as this was not deemed suitably cost-effective.

Gilead reported clinical trial data last month showing that the drug can also be effective in treating hepatitis C patients co-infected with HIV.