HIGH WYCOMBE, England, October 10, 2011 /PRNewswire/ --
- Shortens the Course of Treatment for Many (58%) Treatment Naive Genotype-1 Chronic Hep Cpatients Compared to Current Standard Treatment -
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INCIVO® (telaprevir)*, a new direct acting antiviral (DAA) protease inhibitor (PI), 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 has been launched today in the UK. Telaprevir, one of a new class of medicines which directly targets the hep C virus, now offers more patients infected with genotype 1 chronic hep C the chance of clearing the virus (achieving sustained virologic response, SVR) compared to current standard treatment[2,3].
Clinical trials have shown that a telaprevir based regimen is 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 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<0.0001)[2,3,4]. It also offers the potential to halve the current total treatment duration to six months in many (58%) previously untreated patients[1,2,4].
"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, Queen Mary's University Hospital of 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."
The marketing authorisation for telaprevir is based on results from three phase III clinical trials, ADVANCE, REALIZE and ILLUMINATE[2,3,4] 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 edition of the New England Journal of Medicine (NEJM). Data from the ILLUMINATE study were published in the 15th September edition of the NEJM. This marked the sixth paper to be published on telaprevir in the NEJM[5,6,7].
Speaking on behalf of patients living with hep C, Charles Gore, Chief Executive of the Hepatitis C Trust said,"Hepatitis C can be a devastating disease; however, if treated successfully, patients can avoid life-threatening liver problems such as further liver damage, cirrhosis, liver failure and liver cancer. The arrival of protease inhibitors is the first major treatment advance in more than 10 years and a significant step forward for the hep C community."
In the UK, it is estimated that 216,000 to 466,000 individuals are chronically infected with hep C of which only 80,000 have been diagnosed[8,9]. Chronic hep C poses a public health burden. It is an infectious disease, with often no symptoms, and can lead to severe liver conditions. Of those who develop chronic hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation. Chronic hep C is the most common reason for liver transplants in Europe. 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 outcome.
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 nausea.
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 patients.
In addition to the launch of telaprevir, Janssen, as part of its ongoing commitment to support the hep C community, has launched the first ever online "UK Hepatitis C Map". This interactive map for hep C, available at http://www.HelpEveryPersonC.co.uk, 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. In addition the website offers downloadable questionnaires about hep C which people who have any questions may take to their healthcare professional to aid their discussion about hep C.
* INCIVO® (telaprevir), a direct acting antiviral (DAA) protease inhibitor (PI), 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.
Notes to the Editor:
About Hep C
More information about hep C can be found on http://www.helpeverypersonc.co.uk.
More information about telaprevir is available in the Summary of Product Characteristics (SmPC). Please refer to the product SmPC on http://www.medicines.org.uk.
Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, hep C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).
Driven by our commitment to patients, Janssen develops sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
More information can be found on http://www.janssen.co.uk
- Telaprevir Summary of Product Characteristics 2011.
- Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.
- Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.
- 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.
- McHutchinson et al. Telaprevir for Previously Treated Chronic HCV Infection. Engl J Med. 2010; 362; 1292-1303.
- Hezode et al. Telaprevir and Peginterferon Alfa with or without Ribavirin for Chronic HCV. Engl J Med 2009; 360; 1839-50.
- McHutchinson et al. Telaprevir with Peginterferon Alfa and Ribavirin for Chronic HCV Genotype 1 Infection 2009 N Engl J Med 2009; 360: 1827-38.
- Hepatitis C in the UK: Annual Report2011. London Health Protection Agency, July 2011
- In The Dark: An audit of hospital hepatitis C services across England. The All-Party Parliamentary Hepatology Group, August 2010
- 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
- Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923
SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson