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 greater than or equal to 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence greater than or equal to 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.[10]
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%.[10]
About HCV
HCV is a blood-borne infectious disease that affects the liver.[8,9] With an estimated 130-210 million people infected worldwide,[10] and three to four million people newly infected each year, HCV puts a significant burden on patients and society.[11] 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] Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.[13] About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV.[12] The previously accepted standard treatment for HCV is peginterferon alfa combined with ribavirin,[14] however this only clears the virus for 40-50 percent of genotype-1 chronic HCV patients.[14,15]
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 http://www.janssen-emea.com.
References:
1) Sulkowski, M S et al.Ribavirin dose modification in treatment-naive and
previously treated ppatients who received telaprevir combination treatment: no impact
on sustained virologic response in phase 3 studies. Poster presented at the 47th
Annual Meeting of the European Association of Study of the Liver (EASL)2012
2) Copegus(R) Summary of Product Characteristics, updated 2012
3) Jacobson, I et al. Telaprevir for Previously Untreated Hepatitis C Virus
Infection. N Engl J Med. 2011;364:2405-16. (ADVANCE)
4) Sherman, K et al. Response-Guided Telaprevir Combination Treatment for
Hepatitis C Virus Infection. N Engl J Med. 2011;365:1014-24. (ILLUMINATE)
5) Zeuzem,S et al. Telaprevir for Retreatment of HCV Infection. N Engl J Med.
2011;364:2417-28.(REALIZE)
6) Incivo(R) Summary of Product Characteristics, updated 2011
7) 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. Paper presented at the 47th Annual Meeting of
the European Association of Study of the Liver (EASL); 2012
8) 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.
9) Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec
17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#....
10) 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
11) WHO. State of the art of vaccine research and development. Viral Cancers.
Available from http://www.who.int/vaccine_research/docu...).
12) 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.
13) Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert
Review of Vaccines 2008;7(7): 915-923.
14) 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.
15) 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: Daniel De Schryver, +49-173-7689-149
