Positive draft guidance for hep C drug Sovaldi from UK’s NICE

In further draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended US biotech firm Gilead Sciences' (Nasdaq: GILD) Sovaldi (sofosbuvir) 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. Sovaldi’s pricing - dubbed the $1,000 per day pill in the USA – has come under criticism and is  being investigated by US lawmakers. In the first six months on the market the drug generated sales of $5.8 billion.

Although 15% to 20% of people infected with the hepatitis C virus naturally clear their infections within six 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 one in three 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.

Gilead will work with NICE on treatment availability