Janssen has launched Incivo (telaprevir), a new treatment for patients with genotype-1 chronic hepatitis C (hep C), in the UK.
It is estimated that 216,000-466,000 people in the UK are chronically infected with hep C, of which only 80,000 have been diagnosed. Genotype 1 affects the greatest number of patients - around 45% have it and this group is the hardest to treat, says the firm.
Telaprivir, a new direct-acting antiviral (DAA) protease inhibitor (PI), has been launched for use in the treatment of adult patients with genotype-1 chronic hep C in combination with peginterferon alfa and ribavirin (ie, current standard treatment). It is one of a new class of medicines which directly targets the hep C virus, and offers more patients infected with genotype-1 chronic hepatitis C the chance of clearing the virus compared to current standard treatment, it adds.
Clinical trials have shown that a regimen based on telaprevir is more effective than standard treatment in all genotype-1 patient types, including those with advanced liver ideas such as cirrhosis. When added to the standard treatment, telaprevir has been shown to clear the virus in twice as many previously-untreated patients and almost four times as many who had previously relapsed following treatment. Results have also shown that the regimen can halve the total treatment duration to six months in many previously-untreated patients, says Janssen.
The drug's marketing authorisation is based on results from three Phase III clinical trials - ADVANCE, REALIZE and ILLUMINATE - which evaluated its efficacy and safety in combination with peginterferon alfa and ribavirin in more than 2,290 treatment-naive and previously-treated chronic genotype 1 hep C patients. Data from ADVANCE and REALIZE were published in the New England Journal of Medicine (NEJM) on June 23, and data from the ILLUMINATE study were published in the September 15 edition, marking the sixth paper to be published on telaprevir in the NEJM.
"This is an exciting time for people living with chronic genotype-1 hep C. Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50% of chronic genotype-1 hep C patients got rid of the virus," said Professor Graham Foster of Queen Mary's University Hospital in London.
"For many adults with chronic genotype-1 hep C, treatment with a telaprevir-based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment," he added.
Janssen has also launched an online UK Hepatitis C Map, an interactive tool that provides data on prevalence of hep C by locality, details of local support groups, treatment centres and stories from people living with hep C and their friends, family and carers. It is available at www.HelpEveryPersonC.co.uk, which also offers downloadable questionnaires about hep C for people to take to their healthcare professional to aid their discussion about their condition.