The National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance recommending Janssen Cilag's Incivo (telaprevir), in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.
The final guidance recommends the drug as an option for the treatment of such patients who are previously untreated or in whom previous treatment with peginteron alfa and ribavirin has failed, including people whose condition has relapsed, partially responded or did not respond.
Commenting on the draft recommendations, Meindert Boysen, programme director for technology appraisals at NICE, pointed out that chronic hepatitis C can have a significant impact on quality of life, particularly if it progresses to the fibrosis and 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,” he added.
NICE says its independent appraisal committee had heard that the current treatment regimen for chronic hepatitis C is often lengthy and that the side effects of treatment themselves can have a significant impact on daily life.
"The significant improvement in sustained virological response rates seen with telaprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone, and its potential for shortening the treatment time from the full 48-week course needed for a virological response, therefore represents a major benefit for people with chronic hepatitis C," said Mr Boysen.
NICE is “pleased to be able to recommend teleprevir as a cost-effective use of NHS resources" alongside the final draft guidance also issued this month for Merck Sharp & Dohme's Victrelis (boceprevir), he added.
This latter final draft also recommends Victrelis, in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.
Graham Foster, professor of hepatology at Barts and the London School of Medicine and Dentistry, welcomed NICE’s positive recommendation for Incivo’s clinical and cost-effectiveness. "We have approved new treatments which significantly increase these patients' chances of clearing the virus and offers some patients a shorter treatment duration. We must now ensure that patients are in a position to access the new antiviral treatments which offer them a very good chance of clearing the virus,” said Prof Foster.
- 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 is the most resistant to treatment. Poor diagnosis and 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, says NICE.