High Wycombe, UK, 25th April 2012: Janssen is pleased to announce that the National Institute for Health and Clinical Excellence (NICE) has today issued technology appraisal guidance (TAG) to the National Health Service (NHS) in England and Wales which recommends the full unrestricted use of INCIVO® (telaprevir)* in combination with peginterferon alfa and ribavirin as an option for the treatment of genotype 1 chronic hepatitis C (hep C) in adults with compensated liver disease who are previously untreated or in whom previous treatment failed1.
The TAG states that the availability of telaprevir, one of a new class of medicines which directly targets the hep C virus, “represents a cost-effective use of NHS resources” and is “clinically more effective than peginterferon alfa and ribavirin [current standard treatment] alone in inducing a sustained virological response [clearing the virus] in previously untreated and previously treated patients” 1.
Commenting on the TAG, Professor Graham Foster, Professor of Hepatology, Barts and the London School of Medicine and Dentistry, said: "For too many years I have watched many patients with genotype-1 hepatitis C face treatment with a limited chance of success. I am therefore delighted that new, more effective drugs have recently been launched and I welcome the publication of this positive NICE guidance for telaprevir. This means that clinicians will be able to prescribe these new treatments on the NHS which significantly increases these patients' chances of clearing the virus and offers some patients a shorter treatment duration. The next step is to ensure that appropriate patients are prescribed the new treatments so that they can have a better chance of clearing the virus."
Telaprevir offers many (58% of) previously untreated patients and an even greater number (66%) of patients that are relapsers, defined as those patients whose hep C becomes undetectable during treatment but then returns once treatment stops, the potential to halve their treatment duration to six months. The Committee agreed that this was “particularly important for patients and that telaprevir could therefore be considered a major development”1,2,3,4.
Speaking on behalf of patients, Charles Gore, Chief Executive of the Hepatitis C Trust said, "People living with genotype-1 hepatitis C who have perhaps been delaying starting treatment, or who have lost hope after their previous treatment had failed them, can now be offered cost effective treatments that offer them a much better chance of clearing the virus than ever before. This is really great news and I look forward to direct acting anti-virals being made available to all patients on the NHS as soon as possible."
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 diagnosed7,8. Hep C is often dubbed a ‘silent killer’ as symptoms may go unnoticed for many years, before eventually leading to severe liver conditions such as cirrhosis (deterioration of the liver) and liver cancer which may require liver transplantation9. Chronic hep C is the most common reason for liver transplants in Europe.10
When NICE recommends a medicine or treatment**, the NHS must usually ensure it is available to those people it could help, within three months of the final guidance being issued.1,6
The ADVANCE, ILLUMINATE and REALIZE clinical trials, which NICE based their recommendation on, shows 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 (i.e. deterioration of the liver). Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for genotype-1 chronic hep C cleared the virus in about 50% of patients, leaving the other 50% without a successful outcome following 12 months of treatment9. 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.
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 (reduced red blood cell count), rash, pruritus (itchy skin), nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence = 1.0%) were anaemia, rash, thrombocytopenia (reduced platelet count in the blood), lymphopenia (reduced white blood cell count), pruritus and nausea5. 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 patients5.* 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.
More information about the implications of NICE technology appraisal guidance may be found in ‘NICE technology appraisals – a guide for patients’ developed by Janssen in conjunction with the Hepatitis C Trust: http://www.hepctrust.org.uk/News_Resources/news/2012/March/NICE+technology+appraisals+a+guide+for+patients
1.TA252: Telaprevir for the treatment of genotype-1 chronic hepatitis C, April 2012
2.Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.
3.Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.
4.McHutchinson et al. Telaprevir for Previously Treated Chronic HCV Infection. Engl J Med. 2010; 362; 1292-1303
5.Telaprevir Summary of Product Characteristics 2012.
6.NHS Constitution, http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_113613, accessed on 6th March 2012
7.Hepatitis C in the UK: Annual Report 2011. London Health Protection Agency, July 2011
8.In the Dark: An audit of hospital hepatitis C services across England. The All-Party Parliamentary Hepatology Group, August 2010.
9.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.
10.Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923
Last updated on: 25/04/2012