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Hep C drug clears next hurdle towards NICE approval

A treatment for people with chronic hepatitis C has been given draft approval for use in the NHS, after the drug’s manufacturer agreed to reduce the price.

Sofosbuvir (Sovaldi) is an oral antiviral drug used to prevent hepatitis C viral replication in infected cells.

In draft guidance, published today, the National Institute for Health and Care Excellence recommended it as a treatment option for some people with chronic hepatitis C.

“We are pleased to be able to provisionally recommend sofosbuvir as a clinically and cost effective treatment for some people with chronic hepatitis C”

Carole Longson

The positive recommendation follows receipt of additional information about the drug’s cost effectiveness from the manufacturer, said NICE.

The draft guidance states that sofosbuvir, in combination with peginterferon alfa and ribavirin, should be an option for treating genotype 1 chronic hepatitis C in adults.

Meanwhile, sofosbuvir, in combination with peginterferon and ribavirin, is recommended as an option for treating genotype 3 chronic hepatitis C in adults with cirrhosis.

For treating genotype 3 chronic hepatitis C in adults without cirrhosis, the drug is recommended as an option in combination with peginterferon alfa and ribavirin – but only if the patient has had treatment for hepatitis C before.

However, sofosbuvir, in combination with peginterferon alfa and ribavirin, is not recommended for treating genotype 4, 5 and 6 chronic hepatitis C in adults.

The duration of treatment is 12 or 24 weeks depending on the patient’s hepatitis C virus genotype and history of prior treatment with interferon. The recommended dose is one 400mg tablet daily.

The cost of sofosbuvir is £11,660.98 per 28-tablet pack of 400mg tablets. The cost of a 12-week course of treatment is £34,982.94 and a 24-week course is £69,965.88.

The drug is manufactured by Gilead Sciences.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said the potential side effects of current drugs, such as interferon, which often needed to be given for a long period of time, meant patients often failed to complete the full course of treatment.

Professor Carole Longson

Carole Longson

“New treatments, like sofosbuvir, can shorten the duration of interferon-based therapy and in some cases don’t need to be taken with interferon at all,” she said. “This could potentially encourage more people to seek treatment.”

Professor Longson added that NICE had previously had some uncertainties about the effectiveness of the drug for some subgroups of hepatitis C patients.

“The [NICE appraisal] committee has considered the additional evidence it requested from the manufacturer and we are pleased to be able to provisionally recommend sofosbuvir as a clinically and cost effective treatment for some people with chronic hepatitis C,” she said.

Stakeholders are now able to comment on the draft recommendations which are available for public consultation. The closing date for comments on the draft guidance is 5 September 2014.

Figures from 2012 suggest around 160,000 people are chronically infected with the hepatitis C virus in England. About one in three will eventually develop liver cirrhosis.

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