NICE has issued final guidance recommending boceprevir and telaprevir, in combination with peginterferon alfa and ribavirin, as options for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.
Hepatitis C is a blood-borne virus that predominantly infects the cells of the liver. Transmission is by contact with infected blood primarily as a result of exposure through the skin to contaminated blood (for example, through intravenous drug use). The virus can cause inflammation of, and sometimes significant damage to, the liver and affect the ability of the liver to perform its many, varied and essential functions. Hepatits C infections can be categorised into 2 stages: firstly an acute infection (the first 6 months following initial infection) and secondly a chronic infection.
Figures from 2009 suggest that around 146,000 people were chronically infected with the hepatitis C virus. Genotype 1 is the most common subtype of hepatitis C in England and Wales - affecting 40-50% of people with hepatitis - and the most resistant to treatment. Poor diagnosis rates, low compliance rates and a high annual incidence of new infection mean that chronic hepatitis C presents a major public health challenge, despite the availability of treatments that provide the opportunity to address this challenge.
The primary 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. Current NICE guidance recommends pegylated interferon and ribavirin combination therapy for people with genotype 1 chronic hepatitis C.
Administered orally, boceprevir and telaprevir inhibit the activity of the NS3/4A serine protease. Activity of this protease is essential for viral replication and may be partially responsible for the ability of the hepatitis C virusto evade clearance by the host immune system. The guidance for boceprevir recommends the drug as an option for the treatment of people with genotype 1 chronic hepatitis C, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or in whom previous treatment has failed.
The guidance for telaprevir recommends the drug as an option for the treatment of genotype 1 chronic hepatitis C, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease who are previously untreated or in whom previous treatment with peginterferon alfa alone or in combination with ribavirin has failed, including people whose condition has relapsed, partially responded or did not respond.
Commenting on the final recommendations, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Chronic hepatitis C can have a significant impact on a person's quality of life, particularly if it progresses to the cirrhosis stages. Fear of transmitting the disease is also a concern, particularly for women of child-bearing age for whom there is a risk of transmitting the disease to their unborn child. In the past, patients have declined treatment because the perceived chance of a sustained virological response with peginterferon alfa plus ribavirin was too low for them to accept the associated side effects.
"The significant improvement in sustained virological response rates seen with boceprevir plus peginterferon alfa and ribavirin, and telaprevir plus peginterferon alfa and ribavirin, compared to peginterferon alfa and ribavirin alone represents a major benefit for people with chronic hepatitis C. The Committee also acknowledged the significant public health impact that a sustained virological response can have in reducing transmission of the hepatitis C virus to uninfected people. We are pleased to be able to recommend boceprevir and telaprevir as a cost-effective use of NHS resources."
