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NICE gives draft backing to three hepatitis C drugs

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The National Institute for Health and Care Excellence has published draft guidance recommending three different treatment options for some adults with hepatitis C.

NICE has given its draft support for the use of daclatasvir (Daklinza), edipasvir-sofosbuvir (Harvoni) and ombitasvir-paritaprevir-ritonavir (Viekirax) with or without dasabuvir (Exviera) .

Daclatasvir, which is manufactured by Bristol-Myers Squibb, is an oral inhibitor of non-structural protein 5A – a multifunctional protein that is a component of the hepatitis C virus replication complex. It inhibits both viral replication and assembly.

“We are very pleased to recommend not only one, but three new treatment options for chronic hepatitis C”

Carole Longson

The recommended dose of daclatasvir is 60mg once daily. The price is £8,172 per 28 tablet pack.

Ledipasvir-sofosbuvir, manufactured by Gilead Sciences, is recommended in specific treatment durations for hepatitis C genotypes 1, 3 and 4 only, and should not be used in people with genotypes 2, 5 and 6.

The recommended dose is one daily tablet containing a fixed-dose combination of 90mg ledipasvir and 400mg sofosbuvir. It costs £12,993 per 28 tablet pack, excluding VAT.

Ombitasvir-paritaprevir-ritonavir, marketed by Abbvie, is a fixed-dose combination of two direct-acting anti-hepatitis C virus drugs and ritonavir.

The recommended dose is two tablets once daily, taken orally. It costs £10,733 excluding VAT for 28 days’ supply.

Its marketing authorisation recommends specific treatment combinations and durations for genotypes 1 and 4 hepatitis C virus, depending on genotype, subtype and whether or not the person has cirrhosis.



Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, noted that hepatitis C was a “major public health challenge”.

“We are very pleased to recommend not only one, but three new treatment options for chronic hepatitis C,” she said. “This is good news, not just for people with chronic hepatitis C, but also because having more effective treatments for the condition could reduce the spread of the virus.”

She added: “The long duration and potentially unpleasant side-effects of current interferon-based treatments can discourage people with the disease from completing the full course, or even from seeking treatment in the first place.”

Hospital admissions from hepatitis C-related end-stage liver disease and liver cancer continue to rise, according to latest figures highlighted by Public Health England.

The national public health agency yesterday published its latest annual report on hepatitis C cases in the UK.

Although there has been a small drop in deaths in 2013 compared to 2012, PHE said “caution was needed” as overall trends in admissions and deaths had been upwards for more than a decade.

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