In March 2016, the Australian Government listed new generation, direct-acting antiviral medications for Hepatitis C on the Pharmaceutical Benefits Scheme (PBS). This means that ground breaking medicines are accessible and affordable to all people in Australia living with Hepatitis C who are entitled to medicines under the PBS.
The introduction of such health policy maintains Australia’s world leading status in relation to publicly-funded access to medicines, which ultimately saves lives.
Hepatitis C infection can be life threatening. Such medicines offer many people a good chance of being cured.
What is Hepatitis C?
Hepatitis C is a virus that reproduces by making many copies of itself in liver cells. It does not kill liver cells directly, but the immune response initiated by the presence of the virus in the liver can cause liver inflammation and cell death. It is estimated that 130-150 million people worldwide are chronically infected with hepatitis C. In Australia, it is estimated that 230,470 are living with chronic hepatitis C.
Early studies confirmed that hepatitis C was spread through blood-to-blood contact. A person may have come into contact with the hepatitis C virus as a result of the receipt of a blood transfusion, blood products, or tissues in Australia prior to 1991; tattooing and other forms of skin penetration; sharing drug utensils (including for example syringes, snorting utensils, spoons, or other items); transmission in medical settings (eg. needle-stick injury); mother to child transmission; or may have another cause that is unknown.
What are the new drugs being used to combat Hepatitis C?
The new, direct-acting antiviral medicines that have been made available on the PBS from 1 March 2016 are:
- sofosbuvir + ledipasvir (Harvoni®)
- sofosbuvir (Sovaldi®)
- daclatasvir (Daklinza®)
- ribavirin (Ibavyr®)
The medicines are used independently or in combination with other medicines depending on individual clinical assessment.
For most people (i.e. those carrying the most common Hep C genotypes 1-3), treatment will not require the use of peg-interferon. This is good news as prior treatments were known to have such significant side-effects, and low success rates, that many people have simply not engaged in treatment.
The new treatments have been hailed as ground breaking as they:
- are more effective resulting in a cure for 90-95% of people;
- are taken as tablets only and have very few side effects; and
- can be taken for as little as 8-12 weeks for most people.
Many hope that they will eradicate hepatitis C within 10 to 15 years.
Are the new medicines available for all people with Hepatitis C?
The new DAA medicines are available through the PBS for all people living with hepatitis C over the age of 18 and who have a Medicare Card.
The particular combination of medicines used will depend on a range of individual factors including genotype, prior treatment experience and whether or not the person has already developed cirrhosis (liver scarring).
What about people who currently inject drugs?
There are no restrictions applied to people who inject drugs as they are a priority population for hepatitis C treatment. Whether or not a person currently injects drugs should not be used as criteria for restricting access to the new medicines.
Can people in prison access the new medicines?
Yes, people in prison are a priority population for hepatitis C treatment. The Australian Government has ensured the new medicines will be funded for people in prison.
Are there interferon-free options available for all genotypes?
From 1 March 2016, interferon-free treatment options have been made available for genotypes 1, 2 and 3, which are the most common genotypes of hepatitis found in Australia. (The predominant genotypes are genotype 1 (54%) and genotype 3 (37%) with genotype 2 (around 5%).)
People with genotypes 4, 5 and 6 will still require taking a combination of one of the new medicines in conjunction with pegylated interferon and ribavirin, but for a shorter duration than before.
Other new DAA medicines are currently being considered by the Government for listing on the PBS and we anticipate that more will follow. Hepatitis Australia will provide further information about these and other interferon-free options for genotypes 4, 5 and 6 as it becomes available.
Hepatitis C Genotypes around the world
What do people need to do?
The important thing is that if a person is at risk or knows they have been exposed to the hepatitis C virus they should consult a doctor (usually a GP in the first instance) to:
- undergo blood tests to confirm whether they have active hepatitis C infection,
- undergo tests to determine the hepatitis C genotype (strain),
- undergo an assessment to assess whether cirrhosis (liver scarring) has developed,
- discuss any previous treatments for hepatitis C,
- identify any other illnesses or health complaints,
- discuss any other prescription medications, over-the-counter medications or substances being taken. (This is important to avoid any possible drug interactions.)
The doctor will then discuss a person’s readiness to start treatment and things that may impact on their ability to take the medicine regularly, as prescribed.
Treatment involves taking the medicines for 8 to 24 weeks, depending on genotype, treatment history, and whether there is cirrhosis of the liver. Treatment length may vary dependent upon the combination of medicines used. Some treatments require only 1 to 2 tablets once or twice a day. For some treatment regimens, up to three medicines may be required to be used together. Depending on treatment history and genotype, some people may still need to include an injection (peg-interferon) as well as taking tablets. During treatment, the doctor will need to do blood tests to monitor how a person’s body is responding to the medicines. The doctor will check if the medicine is working effectively against the hepatitis C and that it is not negatively affecting the patient’s overall health.
Can general practitioners (GPs) prescribe treatment for Hepatitis C?
Yes. From 1 March, GPs in Australia can prescribe the new medicines.
Before prescribing any medicines, GPs will be required to collect information and conduct tests (see above) to establish which combination of medicines will be the most effective for the patient. Based on that information, the GP will then consult with a specialist before prescribing the medicine.
It is likely a person will need a couple of appointments before receiving a prescription. In some cases, where there are other significant health factors to consider, the GP may refer the person to a specialist before treatment is commenced.
Can specialists prescribe the new medicines?
Yes, gastroenterologists, hepatologists or infectious diseases physicians experienced in the treatment of chronic hepatitis C will continue to prescribe the new medicines.
These specialists will also provide advice to GPs prescribing the new medicines, so people may consider seeing their GP if this is more convenient for them.
From 1 March 2016, people will only be charged the usual co-payment price they pay for the dispensing fee of each prescription. As these medicines are PBS ‘Authority required’ the doctor can only prescribe one medicine on each prescription. This means a person may be required to pay the dispensing fee for each medicine if they require more than one type.
The dispensing fee for each prescription was $38.30 for general patients and $6.20 for concessional patients on 1 January 2016. This fee is reviewed each year.
Prescriptions will be filled by a local pharmacy or a hospital based pharmacy depending on whether a person is given an s100 (hospital) or s85 (pharmacy) prescription. It has been noted that waiting periods of up to 72 hours may occur in some smaller local pharmacies as they may not immediately stock the medicine. It is expected that this situation should improve over time as more people start accessing treatment.
As well as some initial delays, some prescriptions may only allow a person to collect 4 weeks’ supply of medicine at a time. It will therefore be important to plan ahead so that they do not run out of medicine.
What if treatment is not effective?
For most people it is highly likely the new DAA medicine will be effective. If the new treatment does not work the doctor will refer the person to a specialist for further assessment prior to commencing any further treatment.
Don’t put your health at risk by waiting too long
It’s easy to understand why people might have waited for the new interferon-free treatments to become available. However, now treatment is much simpler and by waiting, people could be putting their health at risk. If a person is 40 years of age or over, they are likely to experience an accelerated rate of liver damage which increases their risk of developing cirrhosis, liver cancer or liver failure. This is called the ‘Liver Danger Zone’. It should also be kept in mind that symptoms of liver disease may not be felt until the liver is significantly scarred.
The current view is that people should not put their health at risk by waiting too long for treatment. They are encouraged to make an appointment with their doctor to have a liver health assessment and treatment discussion at least once a year.
Need further information?
You can talk to your GP, specialist, clinic nurse or call the National Hepatitis Information Line 1800 437 222