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Microsoft word - 120117 victrelis consumer media release - final cert

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 11, the most common form
of the condition affecting 55% of all sufferers.2 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.3 Without other treatment options and
appropriate intervention, estimates of new cases stand at approximately 500,000 by 2020.4 If left
untreated, hepatitis C can cause serious liver disease including cirrhosis, liver cancer and even
mortality.5
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.1
“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.6,7
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.1
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). 1 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. 1 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).1 Side effects: The most common side effects reported in clinical studies include: fatigue, anaemia, nausea, headache and dysgeusia (taste disturbance).6,7 For more information about VICTRELIS please see the Consumer Medicine Information (CMI) available at: http://www.msd-australia.com.au/products/ – Ends –
Interviews available with Professor Geoff McCaughan
Issued by Cube on behalf of MSD. For further information please contact:-
Claire Pope
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 and Dohme (Australia) Pty Limited VICTRELIS Minimum PI

VICTRELIS (boceprevir). Indication:
Treatment of chronic hepatitis C genotype 1 infection, in a
combination regimen with peginterferon alpha and ribavirin, in adult patients with compensated liver disease
who are previously untreated or who have failed previous therapy. Contraindications: hypersensitivity to the
active substance or any of its excipients; autoimmune hepatitis; hepatic decompensation [Child-Pugh score > 6 (class B and C)]; co-administration with medicines highly dependent on CYP3A4/5 [including: orally administered midazolam, triazolam, amiodarone, cisapride, alfuzosin, sildenafil or tadalafil when used for the treatment of pulmonary arterial hypertension, ergot derivatives (dihydroergotamine, ergotamine)]; pregnancy, male partners of pregnant women (use contraception including at least 6 months after treatment conclusion). Precautions: must be administered in combination with peginterferon alpha and ribavirin; dose reduction of
VICTRELIS is not recommended; anaemia (monitor); neutropenia (monitor); HCV protease monotherapy; rare hereditary disorders; potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, phenytoin); drospirenone-containing medications (alternative contraceptives should be considered); simvastatin co-administration; patients < 18 years; elderly; pregnancy; lactation; medicines metabolized primarily by CYP3A4/5; medicines known to prolong QT interval (amiodarone, quinidine, methadone, pentamidine and some neuroleptics); potential for a drug interaction with sensitive substrates of p-glycoprotein (e.g., digoxin). Adverse Reactions: Fatigue; anaemia; nausea; dysgeusia; neutropenia; diarrhoea; vomiting; dry mouth;
fatigue; chills; pyrexia; influenza like illness; irritability; asthenia; pain; weight decreased; decreased appetite; myalgia; arthralgia; headache; dizziness; insomnia; depression; anxiety; cough; dyspnea; dyspnea
exertional; alopecia; pruritus; dry skin; rash. Dose: Initiate therapy with peginterferon alpha and ribavirin for 4
weeks. Add VICTRELIS 800mg three times a day with food to peginterferon alpha and ribavirin regimen at
treatment week 5. VICTRELIS must be administered in combination with peginterferon alpha and ribavirin.
Duration of treatment with VICTRELIS, peginterferon alpha and ribavirin combination is up to 44 weeks. See
full PI for full therapy duration details.
Based on TGA approved Product Information dated 22 December 2011.
See full Product Information for complete details. Please review the Product Information before prescribing.
Full Product Information is available on request from Merck Sharp and Dohme
(Australia) Pty Limited.
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.
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

Source: http://www.hepatologyassociation.com.au/images/stories/pdf/Victrelis_Consumer_media_release_-_FINAL2.pdf

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