No 193 March 2016

Hep C news

WHAT’S NEW

New hep C treatments available on the PBS from 1 March 2016

  • Very successful and few side effects
  • Mostly interferon-free – just tablets
  • For people with cirrhosis and previously unsuccessful treatment too
  • Don’t wait – make an appointment now with your hepatitis or HIV clinic!
  • And talk to your Haemophilia Centre too

NEW HEP C TREATMENTS AVAILABLE

Very welcome news for our community arrived just before Christmas: on 20 December 2015 Australian Minister for Health Sussan Ley announced that new breakthrough hepatitis C treatments will be available on the PBS from 1 March 2016.

The new hepatitis C medicines are:

  • sofosbuvir with ledipasvir (Harvoni®)
  • sofosbuvir (Sovaldi®)
  • daclatasvir (Daklinza®)
  • ribavirin (Ibavyr®).

“This is fantastic news for people with bleeding disorders and hepatitis C,” said Gavin Finkelstein, President of Haemophilia Foundation Australia. “They have been waiting so long for access to treatment to cure their hepatitis C. Many have seen their liver disease progressing and were despairing. This decision by the Government will change people’s lives and we would like to congratulate Minister Ley for seeing the process through to make these treatments available and affordable to all Australians with hepatitis C.”

Most of these treatments can be taken orally as tablets, with the most common course of treatment being as short as 12 weeks.

“This combination of breakthrough cures has a success rate of more than 90 per cent across the entire hep C patient population and is faster and has fewer side effects than anything currently available,” said Minister Ley.

Listing the new medicines on the PBS will mean that people with hepatitis C will only pay up to the normal PBS co-payment for these treatments: currently $6.20 for concessional patients and $38.30 for general patients each time the medicines are dispensed by the pharmacy.

“HFA will continue to work with expert health professionals and health services to make sure that people with bleeding disorders can access treatment when needed in a timely manner,” noted Gavin Finkelstein. “For our community members, the message about being proactive with your hepatitis C care is even more important now: look after your liver health, make sure you have had your liver health checked and talk to your hepatitis or HIV clinic about your treatment options.”

WHAT NEXT?

It is a very exciting time for hepatitis C, and with more developments likely in the future.

What’s different about these treatments?
These new treatments provide very successful cure rates for nearly all genotypes. However, the treatment combinations and the length of treatment will be very individual. They will depend on factors such as the person’s genotype, whether they have had unsuccessful treatment before, whether they have cirrhosis, and other issues.

For example, although most people may be able to have interferon-free treatments, some may need to have a combination treatment with ribavirin. Others, including those with genotype 4 and 6, may need to have a combination treatment with sofosbuvir and pegylated interferon and ribavirin. Some may need 12 weeks of treatment; others may need 24 weeks.

More detailed medical treatment protocols are in the process of being developed by hepatitis and infectious diseases specialists. These will define the tests required, when they should be administered, the different treatment regimens, and what the treating doctor needs to consider and monitor. Until these protocols are released and implemented, this may vary among the specialist clinics. In any case, some people may need to be managed and monitored more closely than others because of their particular health issues or complications.

Who will be able to prescribe treatment?
As with the previous hepatitis C treatments, gastroenterologists, hepatologists and infectious diseases specialists experienced in treating hepatitis C are able to prescribe the new treatments.

A major new step is that processes are being set up for general practitioners (GPs) to prescribe hepatitis C treatments in the future as well. This will include a national medical education program and may take some time to establish across Australia. While most people with bleeding disorders will attend their specialist hepatitis or infectious diseases clinic for hepatitis C treatment, this may be of interest to some people who have difficulty accessing specialist clinics; for example, in regional areas. We will keep you updated on progress.

Under the PBS listing, the treating doctor will need to have information on:

  • the patient’s HCV genotype
  • whether they have cirrhosis or not, eg through a fibroscan test
  • and evidence that they have chronic hepatitis C infection, eg if positive HCV antibody and HCV RNA PCR tests are documented in their medical record
What if you have a bleeding disorder?

This situation is new and how it will work best for people with bleeding disorders needs to be looked at in more detail and understood.

HFA has had initial discussions with the Australian Haemophilia Centre Directors’ Organisation (AHCDO) and hepatitis and HIV/HCV co-infection specialists. In the immediate future, the best course of action for people with bleeding disorders and hepatitis C is to make an appointment with their hepatitis/liver clinic - or, if they have HIV/HCV co-infection, their HIV or infectious diseases physician - and discuss their treatment options so that they can have a treatment regimen tailored to their particular health and situation. It is important also to touch base with their Haemophilia Centre to discuss referrals and make sure their Centre stays in the loop.

Treatments in the pipeline

Other treatments are also in the process of coming before the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the PBS:

  • Viekira Pak® (for genotype 1) has been approved and is completing the process for listing on the PBS
  • Zepatier® (elbasvir/grazoprevir) was to go before PBAC in March 2016, but this has been postponed by the pharmaceutical company producing it. Zepatier has had high success rates in people who have had unsuccessful treatment and in people who are HIV/HCV co-infected. It is also being trialled in people with bleeding disorders. HFA is likely to make a submission in support of Zepatier when it comes before PBAC.

Clinical trials of other new hepatitis C treatments are continuing and we hope to see more highly successful treatments coming before PBAC in the next couple of years.

WHAT CAN YOU DO NOW IF YOU HAVE HEPATITIS C?

In the meantime - if you have hepatitis C and a bleeding disorder, remember that you would need to have a recent liver health assessment before you could be considered for treatment. Don’t wait; if you haven’t already, make your appointment now!

  • Don’t know where to start? Ask your Haemophilia Centre for a referral
  • Do you have hepatitis C? Make an appointment with your hepatitis or liver clinic to discuss your treatment options
  • Do you have HCV/HIV co-infection? Talk to your HIV or infectious diseases specialist about the new treatments. There may be some HIV drug interactions to take into account as well as other factors, and they will work out the best treatment regime for you.
  • Do you have more advanced liver disease/cirrhosis? Talk to your hepatitis or HIV specialist about liaising with your Haemophilia Centre in case of complications
  • Not ready for treatment? Make sure you still have your liver health checked regularly and stay in touch with your hepatitis clinic about what’s new
  • And for comprehensive care, talk to your Haemophilia Centre first and let your Centre know about your liver test results or how your treatment is going to make sure they stay in the loop.
FURTHER READING

Read Minister Ley’s Press Release Read the PBS factsheet on the new hep C treatmentsUpdates are also available on the Hepatitis Australia website

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Date last reviewed: 15 March 2016