Media Release

MAVIRET® IS THE FIRST PBS LISTED HEPATITIS C TREATMENT AVAILABLE FOR AUSTRALIANS 12 YEARS AND OVER 

* For treatment-naïve,non-cirrhotic patients who have chronic hepatitis C virus (HCV) genotype 1 to 6 infection.

  • About 75,000 Australians have initiated treatment for hepatitis C since 2014  2 however it is estimated 150,000 Australians are still living with the virus  3 .
     

Sydney, 16 September 2020 – AbbVie (NYSE: ABBV) Australia welcomes the Government’s decision to list MAVIRET® (glecaprevir/pibrentasvir) for treatment-naïve, non-cirrhotic patients 12 years and over who have chronic hepatitis C virus (HCV) genotype 1 to 6 infection1 on the Pharmaceutical Benefits Scheme.

This means that most Australian patients with HCV over the age of 12 have been able to be treated with an eight-week, once-daily treatment since the listing on 1 April 2020.2

“As a paediatric gastroenterologist, I see first-hand the effects hepatitis C has on children and families living with this disease,” says gastroenterologist, Professor Winita Hardikar. “Having the option to treat a young person’s HCV when it is diagnosed means that this is one less burden for these children and young people to bear.  Giving them the hope of a cure is a really positive outcome.”

In 2016, the Australian Government endorsed the World Health Organization (WHO) Global Health Sector Strategy on Viral Hepatitis, which recognised hepatitis as a major public health threat and set the overarching goal of elimination of HCV by 2030. Extending direct acting anti-viral (DAA) treatment to adolescents contributes to reducing the burden of HCV in our community and supports Australia’s ongoing efforts to eliminate the virus.4

With MAVIRET® now available, healthcare providers are able to treat eligible patients over the age of 12 who may have been living with this chronic health condition since birth or may have become infected during adolescence.

Chris Stemple, Vice President and General Manager of AbbVie Australia and New Zealand, welcomed the additional listing for MAVIRET® and commended the Government for its ongoing commitment to ensuring Australians have broad access to hepatitis C medicines.

“This is great news for young people who are living with HCV,” he said. “This listing allows health professionals to treat some of our most vulnerable people and potentially help them achieve better long-term health outcomes.

We acknowledge the Government’s ongoing commitment to prioritise the elimination of this virus by 2030 and we are pleased to be part of the solution.”

All medicines have adverse effects and may impact different people in different ways. In clinical trials with MAVIRET®, the most common adverse effects were mild in nature and included feeling tired, headache and nausea.  Refer to the CMI or your doctor or pharmacist for further information about MAVIRET®.

Australians with hepatitis C are encouraged to see their GP for more information and to have their liver health assessed.

PBS Information: MAVIRET is PBS listed for treatment of chronic genotype 1-6 hepatitis C infection in patients 12 years and older. Dual General Schedule and $100[HSD] listing. Authority required. Refer to PBS Schedule for full authority information

INDICATIONS
MAVIRET® is a prescription medicine containing a combination tablet of 100 mg of glecaprevir and 40 mg of pibrentasvir. It is used to treat chronic hepatitis C virus (HCV) infection in patients aged 12 years and older. This medicine belongs to a group of medicines called direct-acting antiviral agents. Ask your doctor if you have any questions about why MAVIRET® has been prescribed for you. Maviret has risks and benefits. You must not take Maviret® if you are allergic to any of the medicines contained in Maviret®, or to any of the inactive ingredients. Do not take it if you have severe liver disease; if you are taking atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyloestradiol-containing medications (for contraception or hormone replacement therapy), rifampicin. Before you use MAVIRET®, tell your doctor if you have or have had liver problems other than hepatitis C infection, hepatitis B infection, a liver transplant. Tell your doctor or pharmacist if you are pregnant, trying to become pregnant or if you are breastfeeding or are planning to breastfeed. Some medicines and Maviret® may interfere with each other, so tell your doctor if you are taking medicines containing any of the following: digoxin, carbamazepine, St John’s wort, darunavir, lopinavir, ritonavir, efavirenz, pravastatin, rosuvastatin, lovastatin, ciclosporin. Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Some of the more common side effects of Maviret® include feeling tired, headache and nausea.

If you have any questions about using MAVIRET, including the risks and benefits, how much to use, how and when to use it, ask your doctor or pharmacist and refer to the Consumer Medicine Information (CMI) by contacting AbbVie Pty Ltd on 1800 043 460 or from the TGA website www.tga.gov.au . Always use MAVIRET according to your doctor’s advice.

Consumer Medicine Information
For a copy of the Consumer Medicine Information for MAVIRET®, please refer to: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-CMI-02054-1

About AbbVie in Australia
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. Our heritage in Australia reaches back more than 75 years and we employ more than 280 people with our therapies currently benefiting more than 32,000 Australians.  For further information please visit http://www.abbvie.com.au.  Follow @abbvie_AU or follow us on Facebook or our LinkedIn page.

REFERENCES

  1. MAVIRET Consumer Information,  Accessed January 2020 https://medicines.org.au/mob/item.cfm?handle=vecmavit&type=cmi&src=Direct
  2. Kirby Institute. Monitoring Hepatitis C Uptake in Australia, June 2019 https://kirby.unsw.edu.au/report/monitoring-hepatitis-c-treatment-uptake-australia-issue-10-june-2019
  3. Hepatitis information: Hepatitis C https://www.hepatitisaustralia.com/Pages/Category/hepatitis-c. Accessed January 2020
  4. Fifth National Hepatitis C Strategy, Commonwealth of Australia, Department of Health, https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-bbvs-1/$File/Hep-C-Fifth-Nat-Strategy-2018-22.pdf Accessed February 2020

For furthur information please contact:

Simone McKay
Red Havas
Thomas Skinner
Red Havas
M: +61(0) 430 551 906 M: +61 (0) 451 147 528


NOTE:

Professor Winita Hardikar AM is gastroenterologist. She completed her medical training and a PhD at Melbourne University, and was a Fulbright scholar at Yale University. 

She has over 25 years’ experience in managing children with liver and bowel disorders.