New medicine to fight Hepatitis C now registered

New medicine to fight Hepatitis C now registered

15 December 2016, Merck Sharp & Dohme (New Zealand) Ltd (MSD) today announced ZEPATIER® (elbasvir/grazoprevir) has been registered by Medsafe for the treatment of chronic Hepatitis C – genotype 1, 3* and 4 infection in adults.

Hepatitis C is an infectious liver disease caused by different strains (genotypes) of the Hepatitis C Virus (HCV). Chronic hepatitis C is a major public health burden in New Zealand and affects around 50,000 New Zealanders.1 Of these, 50-60 percent are not aware they have the infection as HCV can remain asymptomatic for decades. 1 Without treatment; patients may go on to develop advanced liver disease with a high risk of liver failure and liver cancer.1

Approximately 1,000 new cases of HCV are diagnosed in New Zealand each year, and the majority have genotype 1 infection.2, 3

In the past year, New Zealand has had two new Hepatitis C medicines funded. PHARMAC has highlighted the potential to eliminate Hepatitis C in New Zealand. 4 This aligns with the World Health Organisation which has declared it wants to eliminate Hepatitis C worldwide by 2030. 5

ZEPATIER belongs to a new group of drugs known as Direct Acting Antivirals (DAAs). DAAS are proven to have the potential to cure the virus in the vast majority of people living with HCV. 2

MSD New Zealand Director, Mr Paul Smith, says, “A Hepatitis C elimination strategy is much needed and I congratulate PHARMAC for making Hepatitis C a priority. The new treatments have very high cure rates and short treatment durations; therefore they have great potential to successfully treat patients and begin to eliminate Hepatitis C. 2 With ZEPATIER, patients benefit from the simplicity of only taking one pill daily. 6

“As a company, we are delighted that ZEPATIER is now registered. The once-daily tablet regimen does not contain interferon and most patients do not require ribavirin. Like other DAAS, ZEPATIER’s short treatment duration (12 weeks for most patients) is a benefit for patients, doctors and other health care professionals involved in their care. 6

“In New Zealand, we have (already) treated approximately 50 patients through ZEPATIER clinical trials.7 Data from global trials, proved ZEPATIER is a powerful treatment option for eligible genotype 1, 3* and 4 patients.

Results showed:

· 95 - 100% of GT1a, GT1b and GT 4 patients achieved cure with 12 weeks of treatment 6,8

· 98% of patients with compensated cirrhosis (early liver disease) achieved cure with 12 weeks of treatment 6

· 93% of genotype 3 patients in combination with sofosbuvir * (with our without cirrhosis) achieved cure within 12 weeks of treatment.” 6

Hepatitis Foundation CEO, Susan Hay, says, “In New Zealand, Hepatitis C is the main reason people require liver transplants. By offering a better chance of a cure, we can reduce the rate of liver cancer and the need for liver transplants.

“HCV infection is now highly curable for many genotypes and all New Zealanders living with HCV should be considered for treatment, as part of an elimination strategy.”

MSD New Zealand Director, Mr Paul Smith, adds, “Although ZEPATIER is now registered, it is not yet funded by PHARMAC. We will continue to work with PHARMAC in order to provide access to ZEPATIER for all appropriate G1, G3 and G4 patients living with HCV.”

ZEPATIER is also registered in Australia, the US, European Union and Canada. 9

For more information or questions about Hepatitis C please contact your GP or the Hepatitis Foundation of New Zealand http://www.hepatitisfoundation.org.nz

-ENDS-

References

* G3 treatment (only in combination with sofosbuvir)

1. Hepatitis Foundation of New Zealand website. Last accessed 15th November 2016

2. Gane, Stedman, Brunton et al, Impact of improved treatment on disease burden of chronic hepatitis C in New Zealand, NZ Medical Journal, 2010-2019/2014/Vol-127

3. Hepatitis Foundation of New Zealand – You have been diagnosed with chronic hepatitis C presentation. From website. Last accessed 15th November 2016

4. News hub 28th July 2016 NZ could wipe out hepatitis C nationwide news story

5. World Health organisation media release, 2 September 2015 World Hepatitis Summit harnesses global momentum to eliminate viral hepatitis

6. New Zealand data sheet ZEPATIER 21 September 2015

7. MSD data on file

8. Eric Lawitz et al Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet 2015, Published online November 11, 20158.

9. MSD Data on file

CONSUMER MPI NZ

ZEPATIER (elbasvir / grazoprevir) 50mg / 100mg tablets
ZEPATIER is a Prescription Only Medicine.
Use: In treatment of chronic (long lasting) hepatitis C infection in adults.

Side Effects: Headache, feeling tired, nausea (feeling sick). You may experience more than one side effect at the same time. You may experience other side effects if your doctor has prescribed this medicine with another medicine called sofosbuvir or ribavirin.

All medicines have risks and benefits. Talk to your doctor to see if ZEPATIER is right for you, a normal doctor’s visit fee may apply. ZEPATIER is an unfunded medicine. Ask your health professional the cost of the medicine and any other medical fees that may apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist, or health professional.

For additional product information, consult the Consumer Medicine Information (CMI), available on request, phone 0800 500 673 or refer to the Medsafe website www.medsafe.govt.nz.

Based on data sheet prepared 1 December 2016.
Supplied by: Merck Sharp & Dohme (New Zealand) Limited, Newmarket, Auckland.

About MSD

For 125 years, MSD has been a global health care leader working to help the world be well. MSD is a trade name of Merck & Co., Inc., Kenilworth, N.J., USA. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships. For more information, visit www.msd.co.nz.

Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. Copyright © 2016 Merck Sharp & Dohme (New Zealand) Pty Limited. Level 3,123 Carlton Gore Road, Newmarket, Auckland. All rights reserved.

INFC-1203125-0000 TAPS Approval NA 8715 First issued December 2016

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