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Phase 2 Results Show INCIVO® (telaprevir), in Combination With Peginterferon Alfa and Ribavirin, is Effective in Treating Patients Co-infected With Genotype-1 Chronic Hepatitis C Virus and HIV

BOSTON, Massachusetts, November 10, 2012 /PRNewswire/ --

-  Study presented at American Association for the Study of Liver Diseases 2012 shows high sustained virological response (SVR) in HCV/HIV co-infected patients receiving INCIVO® (telaprevir)-based regimen -

Janssen Infectious Diseases-Diagnostics BVBA (Janssen) today presented results from a new phase 2 study which shows that an INCIVO® (telaprevir)-based regimen was effective in achieving a sustained virological response at 24 weeks (SVR24) in patients co-infected with both genotype-1 chronic hepatitis C virus (HCV) and HIV (HCV/HIV) compared to patients receiving a placebo with the standard HCV treatment, peginterferon alfa and ribavirin (74 vs. 45 percent).[1]

An estimated 130 to 210 million people are infected with HCV worldwide[2], with HCV/HIV co-infections averaging about 40 percent of HCV patients in Europe.[3]  People co-infected with HCV/HIV have more rapid fibrosis progression and liver disease than patients with HCV alone.[3] Chronic HCV infections can lead to end-stage liver disease, which is a major cause of death in HCV/HIV co-infected patients.[3] Despite the added health consequences of co-infection, only a small proportion of HCV/HIV co-infected patients receive treatment for their hepatitis.[3]

"The new data further demonstrate the potential efficacy and safety of telaprevir when used in combination with peginterferon alfa and ribavirin in HCV/HIV co-infected patients. New effective treatment regimens are particularly important for this patient group due to their high risk of rapidly developing liver complications," said investigator, Kenneth E. Sherman, M.D., of the University of Cincinnati College of Medicine.

The phase 2 study was a two-part randomized, double-blind, placebo-controlled, parallel-group, trial of telaprevir with a standard HCV treatment combination of peginterferon alfa and ribavirin (PR) in previously untreated patients with genotype-1 chronic HCV/HIV co-infection. The study treated a total of 60 HCV/HIV co-infected patients who did or did not receive a concomitant stable antiretroviral therapy (ART) regimen.[1] During the study, no patients receiving a telaprevir-based regimen experienced HIV RNA breakthroughs and their CD4 T-cell count percentage remained unchanged.[1]

The safety and tolerability of a telaprevir-based regimen for treating HCV in HCV/HIV co-infected patients were comparable to that previously observed in HCV mono-infected patients.[1] Adverse events that occurred more frequently (>10 percent difference) in HCV/HIV co-infected patients receiving telaprevir and PR compared to HCV/HIV co-infected patients taking PR alone included pruritus (itchiness), headache, nausea, rash and dizziness.[1]

"Now that ART for people living with HIV has improved so vastly over the years in controlling their HIV, it has become increasingly important to address the consequences of chronic HCV infection in patients co-infected with HCV/HIV. Janssen remains committed to addressing the unmet needs of patients and increasing the availability of new treatment options for patient groups who have been largely underserved until now", said Alessandra Baldini, Medical Affairs Director, Janssen.

The analysis of the data from this study, AASLD Abstract Final ID: 54, will be submitted for peer-review publication.

Additional telaprevir data being presented at AASLD (http://www.aasld.org/lm2012)includes:

  • Non-inferior SVR rates in previously untreated genotype-1 HCV patients receiving a telaprevir-based regimen twice-daily versus every eight hours.[4]    Abstract (Final ID: LB-8)
  • Telaprevir Global Early Access Programme efficacy and safety data regarding treatment among genotype-1 HCV patients with severe fibrosis or compensated cirrhosis.[5]Abstract (Final ID: LB-15)
  • Factors predictive of anemia development in treatment-experienced patients receiving telaprevir plus PR in the REALIZE trial.[6] Abstract (Final ID: 771)
  • Rate of disappearance of telaprevir-resistant variants using clonal and population sequence data from Phase 3 studies.[7] Abstract (Final ID: 756)
  • Evaluation of liver and plasma HCV RNA kinetics and telaprevir levels in genotype-1 HCV patients treated with telaprevir using serial fine needle aspirates.[8]Abstract (Final ID: 215)
  • Deep sequencing of the HCV NS3/4A region confirms low prevalence of telaprevir-resistant variants.[9] Abstract (Final ID: 1091)

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.[10]  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 Infectious Diseases - Diagnostics BVBA, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex Pharmaceuticals (Vertex) and Mitsubishi Tanabe Pharma Corporation (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 containing 2,641 patients who received a telaprevir-based regimen. 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 adverse reactions (incidence ≥ 5.0%) of at least grade 2 in severity were anemia, rash, pruritus, nausea, and diarrhoea during the telaprevir treatment phase, and the most frequently reported adverse reactions (incidence ≥ 1.0%) of at least Grade 3 were anemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.[10]

Rash events were reported in 55% of patients with a telaprevir-based regimen compared to 33% of patients treated with peginterferon alfa and ribavirin only 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 of telaprevir alone in 5.8% of patients and 2.6% of patients discontinued telaprevir combination treatment for rash events compared to none of those receiving peginterferon alfa and ribavirin.[10]

Hemoglobin values of < 10 g/dl were observed in 34% of patients who received telaprevir combination treatment and in 14% of patients who received peginterferon alfa and ribavirin. In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued telaprevir alone due to anemia, and 0.9% of patients discontinued INCIVO® combination treatment due to anemia compared to 0.5% receiving peginterferon alfa and ribavirin.[10]

About HCV

HCV is a blood-borne infectious disease that affects the liver.[11,12] With an estimated 130-210 million people infected worldwide,[2] and three to four million people newly infected each year, HCV puts a significant burden on patients and society.[13] 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 (latest data available).[14] Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.[15] About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV (latest data available).[14]  The previously accepted standard  treatment for HCV was peginterferon alfa combined with ribavirin,[16] however this only cleared the virus for 40-50 percent of genotype-HCV patients.[16,17]

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 develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Infectious Diseases - Diagnostics BVBA is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

References:

  1. Sulkowski MS, Sherman KE, Soriano V, et al. Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: 54).
  2. 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.
  3. WHO EUROPE. Management of Hepatitis C and HIV co-infection - Clinical protocol for the WHO European Region. Available at: http://www.euro.who.int/data/assets/pdf_file/0008/78146/E90840_Chapter_6.pdf. Last accessed September 12, 2012.
  4. Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial: Non-inferiority of twice-daily telaprevir versus administration of every 8 hours in treatment-naïve, genotype 1 HCV infected patients. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: LB-8)
  5. Colombo M et al. Treatment of Hepatitis C Genotype 1 Patients with Severe Fibrosis or Compensated Cirrhosis: The International Telaprevir Early Access Program. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: LB-15)
  6. Zeuzem S, DeMasi R, Baldini A, et al. Factors predictive of anemia development in treatment-experienced patients receiving telaprevir (T;TVR) plus peginterferon/ribavirin (PR) in the REALIZE trial. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: 771).
  7. Sullivan J, De Meyer S, Haseltine E, et al. Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: 756).
  8. Talal A, Dimova R, Zhang E, et al. Evaluation of Liver And Plasma HCV RNA Kinetics And Telaprevir Levels In Genotype 1 HCV Patients Treated With Telaprevir (TVR) Using Serial Fine Needle Aspirates (FNA). 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: 215).
  9. Dierynck I, De Meyer S, Thys K, et al. Deep Sequencing of the HCV NS3/4A Region Confirms Low Prevalence of Telaprevir-resistant Variants Both at Baseline and End of Study. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID: 1091).
  10. Incivo® Summary of Product Characteristics, updated 2011
  11. 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.
  12. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission
  13. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf
  14. 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.
  15. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Review of Vaccines 2008;7(7): 915-923.
  16. 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.
  17. 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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