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(R) 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_.... 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-naive,
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(R) 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#...
13) WHO. State of the art of vaccine research and development. Viral Cancers.
Available from http://www.who.int/vaccine_research/docu...
14) Muehlberger, 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/Dr...
CONTACT: MEDIA CONTACT: Ronan Collins, +44(0)7876-257-746
