Hep C News

NEW TREATMENTS ON PBS

From 1 May 2016 another new Direct Acting Antiviral (DAA) hepatitis C treatment has become available on the Pharmaceutical Benefits Schedule (PBS):

• Viekira Pak® (ombitasvir, paritaprevir, ritonavir, dasabuvir – tablets with or without ribavirin) for the treatment of hepatitis C genotype 1

This is a welcome addition to the other new hepatitis C treatments that were listed on the PBS in March 2016.

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

Another DAA combination treatment Zepatier® (grazoprevir/elbasvir) will be going before the Pharmaceutical Benefits Advisory Committee (PBAC) for approval in July 2016. HFA will be making a submission to PBAC about this treatment.

Zepatier has completed trials in people with HIV/HCV co-infection and in a cohort of people with bleeding disorders. The co-infection trials showed high success rates.(1) The results of the trials with people with bleeding disorders were released at the EASL International Liver Conference in April 2016: 93% of the cohort achieved a virologic cure; and the treatment demonstrated good safety, few side effects, and did not affect bleeding disorder-related bleeding or management of the underlying bleeding disorder.(2)

WHAT IS SPECIAL ABOUT THESE NEW TREATMENTS?

The new treatments have revolutionised hepatitis C care. They have high cure rates – more than 90% across the entire hep C population:

• Genotypes 1-3 – oral treatment with tablets; no interferon injections
• Shorter treatment courses – usually 8, 12, or 24 weeks
• Fewer and usually only minor side-effects
• People with cirrhosis still have relatively high cure rates but need specialist and individualised care and monitoring.

Many thousands of Australians have started the new treatments since 1 March – we hear from Hepatitis Australia that more people were on treatment in March 2016 than for the entire year in 2014.

WHAT IF YOU HAVE A BLEEDING DISORDER?

HFA has had initial discussions with the Australian Haemophilia Centre Directors’ Organisation (AHCDO) and hepatitis and HIV/HCV co-infection specialists:

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 about 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
• Be proactive with your appointments. There are a lot of people waiting for hep C treatment. If you have an appointment, make sure you keep it if at all possible. If you need to change it, contact your clinic in advance so they can reschedule you and put someone else in your place. And follow up with them if you haven’t heard back from them
• 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.

For more information, visit the HFA website page on the new hep C treatments.

WORLD HEPATITIS DAY

World Hepatitis Day will be marked globally on 28 July 2016.

In 2016 the Australian World Hepatitis Day campaign will focus on promoting the new treatments.

As a Partner in the national World Hepatitis Day Campaign, HFA is working with Hepatitis Australia and State and Territory Foundations on the annual national awareness campaign and is committed to making a difference on hepatitis C in Australia.

As part of this campaign, HFA and the team from Haemophilia Foundation Victoria are developing a short YouTube video about the new treatments for people with bleeding disorders. Watch out for the new video which is soon to be released – a Q & A interview with Dr Joe Sasadeusz, an HCV/HIV co-infection specialist in Melbourne with a long history of working with people with bleeding disorders and HFA.

For more information about World Hepatitis Day, visit the Hepatitis Australia website.

REFERENCES

1.Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV 2015;2(8):e319–e327. doi:10.1016/S2352-3018(15)00114-9

2.Hezode C, Colombo M, Spengler U, et al. C-EDGE IBLD: Efficacy and safety of elbasvir/grazoprevir in patients with chronic hepatitis c virus infection and inherited blood disorders. Presentation at The International Liver Congress™, EASL – European Association for the Study of the Liver, Barcelona, Spain, 13-17 April 2016.