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NICE approves two new drugs for treating chronic hepatitis C

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Two new drug treatments for hepatitis C have been approved for NHS use by the National Institute for Health and Care Excellence.

NICE has recommended sofosbuvir (Sovaldi) and simeprevir (Olysio) as treatment options for some people with chronic hepatitis C.

Sofosbuvir and simeprevir are both oral antiviral drugs used to prevent hepatitis C viral replication in infected cells.

The NICE guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1-6 chronic hepatitis C.

However, there will be a delay before NHS providers must comply with the guidance on sofosbuvir, after a request from NHS England. It will not have to comply with the recommendations until 31 July.

Sofosbuvir, manufactured by Gilead Sciences, is given as one 400mg tablet daily. The duration of treatment is 12 or 24 weeks depending on hepatitis C virus genotype and history of prior treatment with interferon. It costs £11,660.98 per 28-tablet pack of 400mg tablets (excluding VAT).

In contrast, the guidance on simeprevir is not subject to any delay. It recommends the drug’s use, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

Simeprevir, manufactured by Janssen, is a protease inhibitor that inhibits the NS3/4A enzyme, which the hepatitis C virus depends on to replicate. It costs £1,866.50 per pack of 7x150mg tablets (excluding VAT).

“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”

Carole Longson

Meanwhile, NICE noted that more data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who cannot tolerate or are not eligible for treatment with interferon is due to become available soon.

As a result, it said recommendations on that treatment combination would be developed in separate guidance.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “New treatments, like sofosbuvir and simeprevir, can shorten the length of interferon-based therapy and in some situations don’t need to be taken with interferon at all.

“Both drugs can also be given to people who have previously been treated but did not clear the virus, in people whose condition has relapsed, or in people who have become re-infected after treatment,” she said.

“Sofosbuvir and simeprevir could therefore be valuable treatment options for people with chronic hepatitis C. 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.

There are six major genotypes and several subtypes of the hepatitis C virus, the prevalence of each vary geographically.

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

People with genotype 2 hepatitis C generally respond to treatment better than those with genotype 1, 3, 4, 5 or 6.

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