UK NICE consults on draft guidance for hepatitis C drug Olysio

In draft guidance published today UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Olysio (simeprevir) as a treatment option for some people with chronic hepatitis C.

The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin as an option for treating genotype 1 chronic hepatitis C in adults. Just last month,  NICE issued draft guidance recommending US biotech firm Gilead Sciences' (Nasdaq: GILD) Sovaldi (sofosbuvir) as a treatment option for some people with chronic hepatitis C.

Patient population in England

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.

Simeprevir has a marketing authorization for treating two forms of hepatitis C, genotype 1 and genotype 4. Genotype 1 hepatitis C is the most common type of chronic hepatitis C in England, accounting for around 46% of cases. Genotype 4 hepatitis C accounts for around 4% of cases.

Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “Chronic hepatitis C can have a significant impact on a person’s quality of life, particularly if it progresses to the cirrhosis stages. One of the main challenges in treating hepatitis C is ensuring that people take the drugs they are prescribed. However, current treatment regimens, particularly interferon-based therapy, often have to be given over a long period of time and are associated with significant side effects that increase the likelihood that people may discontinue treatment, or not seek it in the first place.”

Prof Longson continued: “Simeprevir, like sofosbuvir which NICE provisionally recommended last month as an option for some patients, offers the possibility of a shortened course of interferon-based therapy. This could make it more likely that people will seek treatment for their condition. In turn this could have important benefits, not just for people with chronic hepatitis, but also in reducing transmission of the virus to people without the infection.”