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Hepatitis C treatment to help curb Australia’s silent epidemic TGA approves VICTRELIS™ (boceprevir)
Sydney, 1 February 2012 - The Australian Therapeutic Goods Administration (TGA) has approved VICTRELIS for the treatment of chronic hepatitis C, genotype 1 , the most common form of the condition affecting 55% of all sufferers. The approval of VICTRELIS provides another option in the treatment of hepatitis C, a condition that has been without another treatment option in more than 10 years.
Chronic hepatitis C is a major public health burden in Australia and affects around 220,0002 Australians, with 10,000 new cases reported annually. Without other treatment options and appropriate intervention, estimates of new cases stand at approximately 500,000 by 2020. If left untreated, hepatitis C can cause serious liver disease including cirrhosis, liver cancer and even mortality.
According to Professor Geoff McCaughan, Head of the Liver Immunobiology Program, Centenary Research Institute and Director, AW Morrow Gastroenterology and Liver Centre, in Sydney, “In the last 10 years there has been little development in the availability of treatments for hepatitis C and a significant proportion of patients fail to respond to current standard of care. VICTRELIS is an approved treatment that works directly on the hepatitis C virus and prevents it from replicating and therefore reproducing.
VICTRELIS, a direct acting anti-viral agent (DAA) is used in combination with the current standard of care peginterferon alfa and ribavirin.1 VICTRELIS, a protease inhibitor, interferes with an enzyme involved in the replication of the hepatitis C enzyme.
Unfortunately, hepatitis C is a silent disease where there is very little awareness of the condition and patients often present late with severe complications. Hepatitis C is a huge burden for individuals and is still very heavily stigmatised, and having another new treatment option marks progress in the management of patients with the disease,” added Professor McCaughan
The safety of VICTRELIS was evaluated in a clinical trial program involving more than 1,500 people. ,
About VICTRELIS (boceprevir)
VICTRELIS belongs to a class of medicines called HCV protease inhibitors.
VICTRELIS is indicated for the treatment of chronic hepatitis C genotype 1 infection, in a combination regimen with peginterferon alpha and ribavirin, in adults (18 years and older) with compensated liver disease who are previously untreated or who have failed previous therapy.
Contraindications: VICTRELIS in combination with peginterferon alpha and ribavirin is not able to be taken by patients who are allergic to boceprevir or any of the ingredients listed in the Consumer Medicine Information. VICTRELIS is also not suitable for patients with certain other past or present illness including serious liver problems other than chronic hepatitis C, autoimmune hepatitis (caused by the immune system attacking the liver) or any other problem with your immune system, patients with hereditary disorders including galactose intolerance (the inability to absorb galactose), lapp lactase deficiency (the inability to digest milk and milk products), glucose-galactose malabsorption (the inability to absorb glucose and galactose).
Precautions: VICTRELIS must not be used alone. Other warnings include anaemia, neutropenia (condition causing low white blood cells), use in patients with rare hereditary disorders, pregnancy, breastfeeding, those under the age of 18 years, elderly people ≥ 65 years of age.
Interactions: VICTRELIS should not be taken together with medicines that are metabolised primarily by an enzyme pathway in the liver called cytochrome P450 (e.g some oral contraceptives and cholesterol lowering medications).
Side effects: The most common side effects reported in clinical studies include: fatigue, anaemia, nausea, headache and dysgeusia (taste disturbance).
For more information about VICTRELIS please see the Consumer Medicine Information (CMI) available at: www.msd-australia.com.au/products
PBS Information: VICTRELIS is not listed on the PBS
Please review the Product Information before prescribing.
Full Product Information is available on request from Merck Sharp & Dohme (Australia) Pty Limited
Note to editor: Professor McCaughan has served on advisory boards for MSD and other pharmaceutical companies. He is also involved in clinical trials supported by MSD and other pharmaceutical companies.
Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 4, 66 Waterloo Road, North Ryde NSW 2113
INFC-1009780-0043 First issued January 2012
References
1 Victrelis Product Information. January 2012.
2 Hepatitis Australia. www.hepatitisaustralia.com Last accessed 14 December 2011
3 Razali K, Amin J, Gore GJ & Law MG 2009, HCV Projections Working Group, ‘Modeling and calibration of
the HCV epidemic in Australia. Statistical Methods in Medical Research. 18(3), pp. 253-270
4 National Centre in HCV Social Research, 2003. Research Reportback Forum and Hepatitis C Health
Promotion Plan Discussion, University of New South Wales.
5 World Hepatitis Alliance. What is Viral Hepatitis?
Available via http://worldhepatitisalliance.org/AboutViralHepatitis/What_is_Viral_Hepatitis.aspx.
Last accessed 5 Dec 2011.
6 B.R. Bacon et al. Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection.
N Engl J Med 2011;364:1207-17.
7 F. Poordad et al. Boceprevir for Untreated Chronic HCV Genotype 1 Infection.
N Engl J Med 2011;364:1195-206.