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NICE consults on further draft guidance on the drug sofosbuvir (Sovaldi) for treating hepatitis C

In further draft guidance NICE has recommended sofosbuvir (Sovaldi, Gilead Sciences) as a treatment option for some people with chronic hepatitis C. The positive recommendation follows receipt of additional information about the drug’s cost effectiveness from the manufacturer.

Hepatitis C is a virus that infects the liver. It is spread by contact with infected blood, for instance by using contaminated needles for injecting drugs or sharing razors or toothbrushes. The virus can cause inflammation of, and damage to the liver, preventing it from working properly.

Although 15 to 20% of people infected with the hepatitis C virus naturally clear their infections within 6 months, the remainder develop chronic hepatitis which can be life-long.

Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in England. More than half of people with chronic hepatitis C do not know they are infected because they only have mild symptoms or no symptoms at all for a long period of time.

About 1 in 3 people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue.

A small percentage of people with chronic hepatitis C and cirrhosis also develop liver cancer.

The aims of treatment are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis C virus. Sofosbuvir is an oral antiviral drug used to prevent hepatitis C viral replication in infected cells.

Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Hepatitis C is a major public health challenge. It is difficult to diagnose and each year there are many new infections.

“The problem is made worse because the potential side-effects of current treatments, such as interferon, which often needs to be given for a long period of time, mean that many people with the disease either don’t complete the full course, or are reluctant to seek treatment in the first place.

“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. This could potentially encourage more people to seek treatment.

“Our previous draft guidance concluded that the available evidence showed sofosbuvir to be an effective treatment for chronic hepatitis C in certain patients. However, there were some uncertainties in the evidence base for some subgroups of patients with chronic hepatitis C. The 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.”

Stakeholders are now able to comment on the draft recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee at the next meeting, and following this meeting the next draft guidance will be issued. The closing date for comments on the draft guidance is 5 September 2014.

This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.