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NICE gives backing to hepatitis C drug in latest draft guidance

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The National Institute for Health and Care Excellence has provisionally recommended ledipasvir-sofosbuvir (Harvoni) as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C.

The marketing authorisation for ledipasvir-sofosbuvir recommends treatment for hepatitis C genotypes 1, 3 – in combination with ribavirin – and 4.

Genotypes 1 and 3 hepatitis C account for the majority of chronic hepatitis C cases in England (46% and 43%, respectively). Genotype 4 hepatitis C accounts for around 4% of cases.

“Ledipasvir-sofosbuvir is a valuable new therapy for treating chronic hepatitis C”

Carole Longson

Ledipasvir-sofosbuvir, manufactured by Gilead, is administered orally as a single tablet – with or without ribavirin – and works by inhibiting the replication of the hepatitis C virus. It prevents hepatitis C virus replication by inhibiting the NS5A and NS5B proteins.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said ledipasvir-sofosbuvir could prove to be a “valuable new therapy” for treating chronic hepatitis C.

“The current mainstay of treatment for hepatitis C is interferon-based therapy,” she said. “This often has to be given over a long period of time and is associated with significant side effects that increase the risk that some people may choose to discontinue treatment, or not seek it in the first place.

“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. This could make it more likely that people will seek treatment for their condition,” she said.

NICE also considered ledipasvir-sofosbuvir in combination with ribavirin for people with genotype 3 chronic hepatitis C. But, based on the evidence presented, it concluded that this could not be considered a cost-effective use of NHS resources.

A consultation on the draft guidance will close on 23 March 2015, which will be followed by a further draft version of the guidelines before they are finally approved.

Last week, NICE gave final approval to two other new oral drug for treating hepatitis C – sofosbuvir (Sovaldi) and simeprevir (Olysio) – for use in the NHS.

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