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24 Week Incivo® (Telaprevir)-Based Regimen Effective For Majority Of Previously Untreated Genotype-1 Chronic HCV Patients
24 Week Incivo® (Telaprevir)-Based Regimen Effective For Majority Of Previously Untreated Genotype-1 Chronic HCV Patients
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ILLUMINATE Phase 3 Study Published In New England Journal Of Medicine

Beerse, Belgium (September 15, 2011) – Data from ILLUMINATE, a Phase 3 clinical trial investigating response guided therapy with INCIVO® (telaprevir) in combination with peginterferon and ribavirin (PR), in previously untreated patients with genotype-1 chronic hepatitis C (HCV), will be published today in the New England Journal of Medicine (NEJM).[1] The results of the study showed that a 24-week telaprevir-based regimen was non-inferior to a 48-week telaprevir-based regimen in patients who achieved an extended rapid virologic response (eRVR) or undetectable viral load (undetectable HCV RNA) at weeks 4 and 12 of treatment.[1] The majority of patients in the study (65 percent) achieved eRVR on a telaprevir-based regimen.

“These data support response guided therapy with telaprevir in previously untreated genotype-1 HCV patients, which has the potential to halve current standard treatment duration for the majority of patients treated with telaprevir” says Professor Kenneth Sherman, M.D., Ph.D., Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and telaprevir trial investigator. “Currently patients must endure a long course of treatment (typically 48 weeks) with peginterferon and ribavirin, which cures less than half of them.[2] This long treatment duration can lead to poor treatment adherence and subsequent treatment failure.[3,4,5]The potential to halve treatment duration, without compromising efficacy, could lead to better treatment outcomes for patients.”

All patients who completed the study received a 12-week course of telaprevir in combination with PR, followed by treatment with PR alone, for a total treatment duration of either 24- or 48- weeks.

. The results show that of patients who achieved eRVR, 92 percent achieved SVR or a cure, when randomized to a 24-week total treatment duration (T12PR24), compared to 88 percent who were randomized to a 48 week total treatment duration (T12PR48).[1] Patients who did not achieve eRVR were separately assigned to total treatment duration of 48-weeks (non-eRVR, T12PR48). Of these, 64 percent achieved SVR.[1] Overall, the results show 72 percent of patients achieved SVR.[1] Of patients who prematurely discontinued treatment prior to randomization, 23 percent achieved SVR.

Adverse events were consistent with other telaprevir studies, with 9 percent of patients having serious adverse events; anemia was the most common serious adverse event, reported in 2 percent of patients.[1] Other adverse events included fatigue, pruritus, nausea, headache and rash. During the telaprevir treatment phase 7 percent of all patients discontinued all study drugs, with 1 percent and 1 percent attributable to rash and anemia respectively.[1]

“This sixth NEJM publication marks the latest study in a robust, extensive clinical trial programme for telaprevir.[6,7,8,9,10]  These trials highlight the potential benefit telaprevir can bring to patients with genotype-1 chronic HCV.” said Isabelle Lonjon-Domanec, Global Medical Affairs Leader, Janssen. “The Janssen Companies are dedicated to continuing to improve treatment outcomes for HCV patients as currently there are an estimated 170 million people infected with HCV worldwide, and three to four million people newly infected each year.”[4]

These data along with those from ADVANCE and REALIZE, published in NEJM June 2011, formed the basis of a European Marketing Authorisation application for telaprevir.[8,10] Telaprevir received accelerated review by the Committee for Medicinal Products for Human Use (CHMP) which issued a positive opinion on 22 July 2011 for the indication of treatment of genotype-1 chronic HCV in adults with compensated liver disease (including cirrhosis) in previously untreated patients or patients who have been previously treated with peginterferon alfa alone or in combination with ribavirin.

About Telaprevir
Telaprevir was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and by Health Canada in August 2011. Telaprevir is marketed in the U.S. by Vertex under the brand name INCIVEK™. Following marketing authorization approvals, telaprevir is marketed in the EU and other territories under the brand name INCIVO® by Janssen companies.

About the ILLUMINATE study[1]
ILLUMINATE was an open-label, randomized (1:1), Phase 3 non-inferiority trial.  The primary endpoint of the study was to assess non-inferiority of a 24-week versus 48-week telaprevir-based regimen among patients who achieved eRVR (undetectable HCV RNA at weeks 4 and 12). 540 patients were enrolled in this study to receive 12 weeks of telaprevir in combination with peginterferon and ribavirin. Virologic response was assessed in patients at weeks 4 and 12. Patients who achieved eRVR and remained on treatment at week 20 ( n=322), were randomized to complete treatment with PR at either 12 or 36 weeks (total treatment duration 24 or 48 weeks respectively).Patients who did not achieve eRVR (n=118) received an additional 36 weeks of PR (total treatment duration 48 weeks). 100 patients discontinued treatment before randomization.

About HCV
HCV is a blood-borne infectious disease that affects the liver.[2,11] With an estimated 170 million people infected worldwide, and three to four million people newly infected each year.[4]  Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases, about one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV.[12]The previously accepted standard of treatment for HCV is peginterferon combined with ribavirin,[6] however this only cures 40-50 percent of genotype 1 patients.[13]

HCV puts a significant burden on patients and society. 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.[12] Most of the DALYs (95%) were accumulated by patients in preventable disease stages.[12]

About Tibotec
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company’s main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.

About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology , immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.

Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.

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

Contacts:
Daniel De Schryver
Mobile: + 32 (473) 99 93 90

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References

1. Sherman et al.  Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration, N Engl J Med. 2011;365.

2. Simin M et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.

3. Manns MP. Et al. Treating viral hepatitis c: efficacy, side effects and complications. Gut. 2006;55: 1350-1359.

4. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923.

5. Ghany MG et al. Diagnosis, Management, and Treatment of Hepatitis C:  An Update. AASLD guidelines; 2009.

6. 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.

7. Hezode et al. Telaprevir and Peginterferon with or without Ribavirin for Chronic HCV Engl J Med 2009;360;1839-50.

8. Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.

9. McHutchinson et al. Telaprevir with Peginterferon and Ribavirin for Chronic HCV Genotype 1 Infection 2009 N Engl J Med 2009;360:1827-38.

10. Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011;364; 25.

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.  Nikolai Mühlberger 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

13. 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.

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