The overall safety profile of telaprevir is based on the Phase II/III clinical development programme containing 3,441 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 greater than or equal to 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 greater than or equal to 1.0%) of at least Grade 3 were anemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.[7] INCIVO(R) prescribing information includes special warnings and pre-cautions for use with regards to rash including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and Stevens - Johnson syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), where INCIVO, peginterferon alfa and ribavirin should be immediately and permanently discontinued and a specialist in dermatology consulted.[7] In cases of mild and moderate rash discontinuation of INCIVO(R) is not always required and patients are advised to consult with a healthcare professional. In cases of severe rash immediate discontinuation of INCIVO(R) is required and consultation with a specialist in dermatology is recommended.[7]
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 patientsand 2.6% of patients discontinued telaprevir combination treatment for rash events compared to none of those receiving peginterferon alfa and ribavirin.[7]
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.[7]
About HCV
Hepatitis C (HCV) is a contagious liver disease which is spread through blood-to-blood contact and is usually symptomless at the outset.[8] With an estimated 150 million people infected worldwide,[9] and three to four million people newly infected each year, HCV puts a significant burden on patients and society.[10] Estimations indicate that HCV kills more than 350,000 people worldwide per year, accounting for approximately 1% of deaths worldwide.[9] It is the world's primary cause of cirrhosis and liver cancer[11] with an estimated 20-30% of patients developing liver cirrhosis[12] and a further 7% developing liver cancer.[13] The estimated annual cost of HCV (medical and work loss) is more than $1 billion in the U.S. alone.[14]
About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, 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. Please visit http://www.janssenrnd.com for more information.
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References:
1) Sievert W et al. Adherence with Telaprevir BID vs. Q8h Dosing in
Treatment Naive HCV-infected Patients: Results from the Phase III OPTIMIZE Study. J
Hepatol 2013; 58(Suppl 1): S373.
2) 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).
3) Horsmans Y, Brown Jr. RS, Buti M, et al. Safety and efficacy of twice daily
versus every 8 hour telaprevir with peginterferon/ribavirin (PR) in patients with
cirrhosis. 2013. European Association for the Study of the Liver (EASL) Abstract 862.
4) Casey L C, Lee W M. Hepatitis C Virus Therapy Update 2013. Curr Opin
Gastroenterol. 2013;29(3):243-249.
5) Janssen data on file.
6) Sherman K, et al. Duration of Initial Telaprevir Treatment for HCV Infection:
A phase 3 study of treatment duration. N Engl J Med. 2011;365:1014-24.
7) INCIVO(R) Summary of Product Characteristics updated 2013.
8) Centers for Disease Control and Prevention. Hepatitis C FAQs. Available at:
http://www.cdc.gov/hepatitis/C/cFAQ.htm#... (last accessed May 2013).
9) World Health Organization. Hepatitis C Fact Sheet. Available at:
http://www.who.int/mediacentre/factsheet... (last accessed May
2013).
10) WHO. State of the art of vaccine research and development. Viral Cancers.
Available at: http://www.who.int/vaccine_research/docu...
(last accessed May 2013).
11) Rosen HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med.
2011 Jun 23;364(25):2429-38.
12) Hep C Trust: Overview of Stages. Available at:
http://www.hepctrust.org.uk/Hepatitis_C_...
(last accessed May 2013).
13) Blachier M, Leleu H, Peck-Radosavljevic M, et al. The Burden of liver
disease in Europe: A review of available epidemiological data. European Association
for the Study of the Liver 2013.
14) El Khoury A, Klimack W, Wallace C, et al. Economic burden of hepatitis
C-associated diseases in the United States. J Viral Hep. 2012 March;19:153-160
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