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Sofosbuvir: hep C drug gets draft recommendation from NICE for most patients

Hepatitis C drug Sofosbuvir has recieved a draft recommendation from the National Institute for Health and Care Excellence (NICE) for most patients.

NICE which evaluates the cost effectiveness of new treatments for use on the NHS, has provisionally approved the drug after being given additional information from manufacturers Gilead.

The Hepatitis C Trust Chief Executive says this "takes us one step closer to making the elimination of hepatitis C a realistic possibility by improving both cure rates and tolerability."

NICE says it is now planning to recommend the drug’s use, in combination with peginterferon alfa and ribavirin for treating: genotype 1 chronic hepatitis C in adults; genotype 3 chronic hepatitis C in adults with cirrhosis; and genotype 3 chronic hepatitis C in adults without cirrhosis only if they have had treatment for hepatitis C before.

It does not recommend Sovaldi (sofosbuvir) in combination with peginterferon alfa and ribavirin for treating genotype 4, 5 and 6 chronic hepatitis C in adults.

In combination with ribavirin alone, NICE plans to recommend’s Sovaldi’s use as an option for treating: genotype 2 chronic hepatitis C in adults, only if they have not had treatment for chronic hepatitis C before and are intolerant to or ineligible for interferon therapy, or if they have had treatment for chronic hepatitis C before, regardless of interferon eligibility; and for treating genotype 3 chronic hepatitis C only in adults with cirrhosis.

It does not plan to recommend Sovaldi, in combination with ribavirin alone, for treating adults with genotype 1, 4, 5 and 6 chronic hepatitis C.

Charles Gore added: "We are delighted that most patients will have access to this new treatment, although we are equally disappointed that a small group of patients will not benefit. With many other new drugs in the pipeline we ask NICE to find room in its crowded work programme to assess them as early as possible to ensure all patients have the opportunity to get cured of this cancer-causing virus.”

Gilead Sciences’ UK general manager, Stelios Karagiannoglou, said the company is “pleased that, following a very complex assessment, NICE has recognised the clinical and economic benefit of treatment with sofosbuvir and have determined it is a valuable use of NHS resources for the majority of hepatitis C patients.”

Sofosbuvir also goes by the brand name Sovaldi.

Thank you to the Pharma Times for their support with this piece.