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This factsheet is abridged and adapted from the original published by Hepatitis NSW on 9 February 2016. It is reprinted with permission.
For more information about anything in this factsheet, if you are in NSW, phone the NSW Hepatitis Infoline on 1800 803 990 or go to www.hep.org.au
If you are in other states, phone the National Hepatitis Information Line on 1800 437 222.
The information in this factsheet will be amended as new information emerges. In particular, the administrative details concerning prescription arrangements for GPs and other doctors still need to be established. New treatment consensus guidelines also are being developed. The purpose of this factsheet is to provide as much information about the new treatments as is currently known.
This year, 2016, is a particularly exciting time for the treatment opportunities for all people in Australia living with hepatitis C. It has been announced that new direct acting antiviral treatment drugs will be listed on the Pharmaceutical Benefits Scheme (PBS) on 1 March 2016.
This factsheet relates to these hepatitis C treatment combinations:
Other new drugs for treating hepatitis C are currently in different stages of development and/or approval. Over time, these new drugs will also likely be PBS listed and funded, and this factsheet will be amended accordingly.
The above cure rates relate to people’s hepatitis C genotype and treatment history. They are from Phase 3 clinical trials (researching efficacy in large study groups) and therefore may not apply to reallife populations). Treating doctors will advise which treatment options are suitable for individual people.
People with genotypes 4 or 6 remain limited to sofosbuvir taken with pegylated interferon and ribavirin treatment (greater than 90% cure rate).
Other drug combinations are approved and available but those mentioned above are the ones with best response and tolerability.
sofosbuvir/ledipasvir:
sofosbuvir and daclatasvir:
sofosbuvir and ribavirin:
sofosbuvir and daclatasvir and ribavirin:
As listed above, sofosbuvir is sometimes taken with ribavirin. Also, sofosbuvir and daclatasvir may additionally be taken with ribavirin for those people who have genotype 3 and cirrhosis.
Importantly, all the new treatments are taken as tablets (pills) and none involve interferon injections.
(Treatment for people with genotypes 4 or 6 involves sofosbuvir taken with pegylated interferon injections and ribavirin tablets.)
There are some drug-drug interaction issues, including amiodarone (an antiarrhythmic medication used to treat ventricular tachycardia or ventricular fibrillation), but most issues will be able to be handled with change of accompanying medications, or through careful monitoring.
Pregnancy must be strictly avoided by both men and women treated with ribavirin in any of the treatment combinations (during treatment and for 24 weeks after). Pregnancy must also be avoided with daclatasvir (during treatment and for 5 weeks after). People should be advised to talk to their doctor or specialist about treatment with sofosbuvir/ledipasvir in pregnancy.
Treating doctors or specialists will advise which treatments would be suitable (or not suitable) for patients, depending on their past and present medical conditions and any other medications they are taking.
People with hepatitis C will have an initial GP or specialist assessment. This will involve full blood testing and likely assessment of their fibrosis stage, via Fibroscan®. People with cirrhosis will be referred for specialist care and treatment. People with cirrhosis require long term monitoring for complications including liver cancer.
(Treatment protocols are currently in development and once they are confirmed, the information in this factsheet will be amended.)
Treating doctors will probably use a week 4 PCR viral load test to assess treatment adherence as opposed to speed of viral load decline. By week 4, nearly all people are likely to be <1,000 viral load and generally <100 viral load, if they are taking the medication as prescribed.
Some hospital clinics may use different protocols based on whether or not people have other illnesses and the complexity of their hepatitis C disease.
People with no complicating factors may need to have only one on-treatment visit (generally at week 4). This would typically involve blood testing at week 4 for Full Blood Count, Urea & Electrolytes Test, Liver Function and PCR viral load (mentioned above). Some people will require more intensive monitoring/follow-up.
All people will require a PCR viral load test 12 weeks after treatment finishes to check if they are cured.
(Treatment protocols are currently in development and once they are confirmed, the information in this factsheet will be amended.)
“Cure” or “SVR” (Sustained Virological Response) means that someone has cleared hepatitis C virus from their body. If someone has a PCR viral load test which shows undetectable (no virus) at 12 weeks after treatment finished they are considered to be cured.
If hepatitis C has caused significant liver damage, clearing the virus (cure) might not mean that someone is healthy again all of a sudden. In particular, if someone has cirrhosis, they still need specialist care and monitoring. People with cirrhosis still have a potential risk of developing liver cancer, even after being cured of hepatitis C.
People should talk to their treating doctor about what “cure” should mean for them.
This factsheet was developed by Hepatitis NSW. It was reviewed by the Hepatitis NSW Medical and Research Advisory Panel with special input from Prof Gregory Dore and A/Prof Simone Strasser.
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