Scottish Medicines Consortium approves INCIVO® (telaprevir), a new treatment for genotype-1 chronic hepatitis C, for use within NHS Scotland1
Janssen PharmaceuticalPosted on:23 Dec 11
High Wycombe, 12th December 2011 – Today the Scottish Medicines Consortium (SMC) has recommended that INCIVO® (telaprevir)* should be made available for the treatment of genotype-1 chronic hepatitis C (hep C), in combination with peginterferon alfa and ribavirin (i.e. current standard treatment), in adults in Scotland who have not previously had treatment and adult patients for whom treatment has previously failed1.
Telaprevir, a new direct acting antiviral (DAA) protease inhibitor (PI), one of a new class of medicines which directly targets the Hep C virus, now offers significantly more patients infected with genotype 1 chronic hep C in Scotland the chance of clearing the virus (achieving sustained virologic response, SVR)2,3,4 compared to current standard treatment.
“I welcome the news that telaprevir can now be prescribed for patients living with chronic genotype-1 hep C in Scotland. 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 Dr John F Dillon, Consultant Hepatologist and Gastroenterologist, University of Dundee Ninewells Hospital. “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.”
In Scotland, it is estimated that 50,000 individuals are infected with hep C5. Hep C is a significant public health threat. It is highly infectious, often has no symptoms and can lead to fatal liver conditions. Of those who develop hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation6. Hep C is the most common reason for liver transplants in Europe7. A model, developed in Scotland, which looks at transmission rates for hep C has shown that effective treatment of the disease, assuming a 62.5% SVR rate, could reduce the onward transmission of the virus and its occurrence in the community. Taking this into account it could be expected that effective treatment of hep C with a treatment regimen that achieves a higher SVR rate will, in the longer term, reduce the risk of transmission among the population and lower the burden of hep C on NHS Scotland8. The standard treatment for hep C, peginterferon alfa and ribavirin, is successful in only about 50% of patients with genotype 1, leaving the other 50% without a successful treatment outcome6.
Clinical trials have shown that a telaprevir based regimen is significantly more effective than standard treatment in all genotype-1 patient types, including those with advanced liver disease such as cirrhosis. The addition of telaprevir cleared the Hep C virus in almost twice as many previously untreated patients (79% vs. 46%, p<0.0001) and almost four times as many who had previously relapsed following treatment (84% vs. 22%, p<0.001)3,4,9. It also offers the potential to halve the current total treatment duration to just six months in many (58%) previously untreated patients and prior treatment relapsers2,3,9.
The marketing authorisation for telaprevir was based on results from three phase III clinical trials, ADVANCE, REALIZE and ILLUMINATE3,4,9 which evaluated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin in more than 2,290 treatment-naïve and previously-treated chronic genotype 1 hep C patients. Data from ADVANCE and REALIZE were published in the 23rd June 2011 edition of the New England Journal of Medicine (NEJM). Data from the ILLUMINATE study were published in the 15th September 2011 edition of the NEJM. This marked the sixth paper to be published on telaprevir in the NEJM10,11,12.
The overall safety and tolerability profile of telaprevir is based on the phase II and III clinical development programme. The most frequently reported moderate adverse reactions (incidence = 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence = 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea2.Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients2.
* INCIVO® (telaprevir), a direct acting antiviral protease inhibitor, was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceutical Companies of Johnson & Johnson, and the company responsible for marketing telaprevir in Europe.
1.The Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home), accessed December 2011
2.Telaprevir Summary of Product Characteristics 2011
3.Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.
4.Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.
5.Hepatitis C Action Plan for Scotland Phase II May 2008-March 2011
6.TA200: Peginterferon Alfa and Ribavirin for the treatment of chronic hepatitis C. Part review of NICE technology appraisal guidance 75 and 106. Issued September 2010
7.Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923
8.Martin NK, Vickerman P, Foster GR, Hutchinson SJ, Goldberg DJ, Hickman M. Can antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user populations? A modeling analysis of its prevention utility. J Hepatol 2011 Jun;54(6):1137-44
9.Sherman et al. Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration, N Engl J Med. 2011: 365; 1014-24.
10.McHutchinson et al. Telaprevir for Previously Treated Chronic HCV Infection. Engl J Med. 2010; 362; 1292-1303.
11.Hezode et al. Telaprevir and Peginterferon Alfa with or without Ribavirin for Chronic HCV. Engl J Med 2009; 360; 1839-50.
12.McHutchinson et al. Telaprevir with Peginterferon Alfa and Ribavirin for Chronic HCV Genotype 1 Infection 2009 N Engl J Med 2009; 360: 1827-38.
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