INCIVO ® (Telaprevir) in Combination With Peginterferon Alfa and Ribavirin is Cost-effective for Both Treatment-naïve and Experienced Patients With Chronic Genotype-1 Hepatitis C Virus

BEERSE, Belgium, April 4, 2012 /PRNewswire/ --

Not Intended for US Journalists

-  Analysis to be presented at European Association for the Study of the Liver (EASL) 2012 shows clinical and cost-effectiveness regardless of IL28B subtype -

Janssen Pharmaceutica NV (Janssen) will present a cost-effectiveness analysis for INCIVO(telaprevir) at the 47^th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona.  The analysis demonstrates that the addition of telaprevir to peginterferon alfa and ribavirin (PR) is cost-effective for both treatment-naïve and experienced patients with genotype-1 chronic hepatitis C virus (HCV), regardless of IL28B subtype.¹ The analysis considers cost-effectiveness in terms of incremental cost per quality adjusted life year (QALY) gained from the perspective of the NHS in England and Wales.¹

The analysis showed that the improved clinical outcomes from the addition of telaprevir to PR for the treatment of genotype-1 chronic HCV infection result in an Incremental Cost Effectiveness Ratio (ICER)^1,2 of £13,553 for treatment-naïve patients and an average of £8,688 for treatment-experienced patients.¹ The ICER is different depending on the characteristics of treatment-experienced patients, but for all groups, regardless of IL28B subtype, telaprevir was shown to be cost-effective according to the threshold of £20,000-£30,000 per quality adjusted life year (QALY),which is a measurement of the impact of a treatment on patient quality of life. ^1,3 Health authorities generally view a treatment to be cost-effective if it does not cost more than £20,000-£30,000 per QALY.^1,3

Alessandra Baldini, EMEA Medical Affairs Director, Janssen said: "INCIVO has demonstrated a significant improvement in sustained virologic response (SVR) rates for genotype-1 chronic HCV compared to standard treatment with pegylated interferon and ribavirin, including for those patients who were considered difficult to treat. The analysis shows that the clinical benefits and improved outcomes provide a cost-effective long-term benefit for patients with genotype-1 chronic HCV infection."

Data from Phase 3 clinical trials showed that telaprevir in combination with PR demonstrated significant improvements in SVR, compared with PR alone, for both previously untreated genotype-1 chronic HCV patients and those who had failed previous treatment.^4,5

"The cost-effectiveness of new direct-acting antivirals for HCV is an important consideration for national health authorities when assessing the benefit of making these treatments available for patients." said Charles Gore, President of the World Hepatitis Alliance. "The availability of direct acting antivirals like telaprevir has been a huge step forward in the fight against chronic HCV infection, giving more patients than ever the hope of clearing the virus from their bodies.  We know that the long-term consequences of HCV can be devastating for both patients and health systems, so it is encouraging to see that these treatments are cost-effective in the long term."

An estimated 130-210 million people are infected with HCV worldwide⁶, and the virus has been described as a 'timebomb' by the World Health Organization due to low diagnosis and treatment rates and long-term consequences of HCV infection such as liver cirrhosis and liver cancer.⁶ Despite the availability of treatment options, as few as 3.5% of people with HCV are currently receiving treatment in Europe.⁷

1. Additional telaprevir data to be presented at EASL will include:
2. Retrospective sub-analyses from ADVANCE, ILLUMINATE and REALIZE studies in treatment naïve and previously untreated patients with genotype-1 chronic HCV showing that SVR rates for patients receiving telaprevir in combination with PR were not substantially affected by a ribavirin dose reduction⁸

About INCIVO®

INCIVO® (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic HCV in adult patients with compensated liver disease (including cirrhosis) who are treatment naïve, and who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.⁹  INCIVO is a small molecule, selective inhibitor of the HCV serine protease, and a member of the new class of medicine for the treatment of genotype-1 chronic HCV, direct acting antivirals (DAAs).  Unlike previous treatments, DAAs act directly on viral enzymes and prevent the virus from replicating.  INCIVO was approved by the European Commission on 19 September 2011.  

Telaprevir was developed by Janssen-Virco BVBA, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex and Mitsubishi Tanabe Pharma. Janssen has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK^TM.  Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries where it is being marketed as TELAVIC®.

Important Safety Information

Please see full Summary of Product Characteristics or visit http://www.emea.europa.eu for more details.

The overall safety profile of telaprevir is based on the Phase 2/3 clinical development programme. In clinical trials, the incidence of adverse events of at least moderate intensity was higher in the telaprevir group than in the placebo group (both groups receiving peginterferon alfa and ribavirin). 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.⁹

Rash events were reported in 55% of patients with a telaprevir based regimen and more than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir combination treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients and led to discontinuation in 2.8%.⁹

About HCV

HCV is a blood-borne infectious disease that affects the liver.^10,11With an estimated 130-210 million people infected worldwide,⁶ and three to four million people newly infected each year, HCV puts a significant burden on patients and society.¹² Estimations indicate that HCV caused more than 86,000 deaths and 1.2 million disability-adjusted life-years (DALYs) in the WHO European region in 2002.¹³ Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.¹⁴ About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV.¹³   The previously accepted standard  treatment for HCV is peginterferon alfa combined with ribavirin,¹⁵ however this only clears the virus for 40-50 percent of genotype-1 chronic HCV patients.^15,16

About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.

More information can be found at www.janssen-emea.com.

References:

1. Curtis S, Cure S, Gavart S, et al. The cost-effectiveness of telaprevir (TVR) in combination with pegylated interferon-alfa and ribavirin (PR) for the treatment of genotype 1 chronic hepatitis c patients. Poster presented at the 47th Annual Meeting of the European Association of Study of the Liver (EASL); 2012
2. Phillips C, What is Cost-effectiveness? Health Economics. Available via URL http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/Cost-effect.pdf
3. NICE, Measuring effectiveness and cost effectiveness: the QALY. Available via URL: http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp
4. Zeuzem, S et al. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011;364:2417-28.(REALIZE)
5. Jacobson, I et al. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011;364:2405-16. (ADVANCE)
6. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011; 55: 245-264
7. Lettmeier B, Mühlberger N, Schwarzer R et al. Market uptake of new antiviral drugs for the treatment of hepatitis C. Journal of Hepatology 2008;49:528-536.
8. Sulkowski, M S et al. Ribavirin dose modification in treatment-naïve and previously treated ppatients who received telaprevir combination treatment: no impact on sustained virologic response in phase 3 studies. Presented at EASL 2012
9. Incivo® Summary of Product Characteristics, updated 2011
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11. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission.
12. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).
13. Mühlberger, N et al. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health. 2009; 9(34):1-14.
14. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Review of Vaccines 2008;7(7): 915-923.
15. McHutchison, J et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361:580-93.
16. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from:  http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus.