New direct acting antiviral treatment drugs were listed on the Pharmaceutical Benefits Scheme (PBS) on 1 March 2016. This factsheet relates primarily to these hepatitis C treatment combinations (in no particular order):
- Harvoni (sofosbuvir/ledipasvir) two drugs combined in one pill, taken once per day
- Sovaldi and Daklinza (sofosbuvir and daclatasvir) in 1 pill of each, taken once per day
- Sovaldi and Ibavyr (sofosbuvir and ribavirin) in 3 or more separate pills, taken daily
- VIEKIRA PAK (paritaprevir/ritonavir/ombitasvir and dasabuvir) in 4 separate pills, taken daily.
- VIEKIRA PAK plus ribavirin (paritaprevir/ritonavir/ombitasvir and dasabuvir and ribavirin) in 6 or more pills taken per day.
- Zepatier (elbasvir and grazoprevir) two drugs combined in one pill, taken once per day
- Zepatier (elbasvir and grazoprevir) and ribavirin, in two or more pills taken per day.
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.
Success rates of the new treatments
Genotype 1: sofosbuvir/ledipasvir; sofosbuvir and daclatasvir; VIEKIRA PAK (with or without ribavirin); or elbasvir/grazoprevir (with or without ribavirin), achieve cure rates in excess of 95-97%, depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotype 2: sofosbuvir and ribavirin achieves cure rates of around 95% depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotype 3: sofosbuvir and daclatasvir (with or without ribavirin) achieves cure rates of around 95% depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotype 4: elbasvir/grazoprevir (with or without ribavirin), achieve cure rates in excess of 95-97%, depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotype 6: People with genotype 6 remain limited to sofosbuvir taken with pegylated interferon and ribavirin treatment. They enjoy a greater than 90% chance of cure.
The above cure rates relate to people’s hepatitis C genotype and treatment history. Treating doctors will advise which treatment options are suitable for individual people.
Treatments and genotypes
- If you have hep C genotype 1a or 1b, you might be offered (in no particular order): Harvoni (on its own), or Sovaldi plus Daklinza (taken together), or Zepatier (own its own or with ribavirin).
- If you have hep C genotype 1a, you might be offered VIEKIRA PAK plus ribavirin (taken together)
- If you have hep C genotype 1b, you might be offered VIEKIRA PAK.
- If you have hep C genotype 2, you are offered Sovaldi plus Ibavyr (taken together).
- If you have hep C genotype 3, you are offered Sovaldi plus Daklinza (taken together, with or without ribavirin).
- If you have hep C genotype 4, you are offered Zepatier (on its own or with ribavirin).
- If you have hep C genotype 6, you remain limited to Sovaldi taken with pegylated interferon injections plus ribavirin pills.
Other drug combinations are approved and available but those mentioned above are the ones with best response and tolerability.
= 8 weeks for people with no prior treatment, no cirrhosis and viral load less than 6 million IU/mL
= 12 weeks for people with no prior treatment, no cirrhosis and viral load more than 6 million IU/mL
= 12 weeks for people with no prior treatment and cirrhosis
= 24 weeks for people with prior treatment and cirrhosis
Sofosbuvir and daclatasvir
= 12 weeks (although likely longer for people with cirrhosis)
= 24 weeks for people with genotype 3 and cirrhosis
Sofosbuvir and daclatasvir plus ribavirin
= 12 weeks for people with genotype 1 and cirrhosis
= 12 weeks for people with genotype 3 and cirrhosis
Sofosbuvir and ribavirin
= 12 weeks for people with genotype 2
= 12 weeks for people with genotype 1b, no cirrhosis
= 12 weeks for people with genotype 1b, compensated cirrhosis
VIEKIRA PAK plus ribavirin
= 12 weeks for people with genotype 1a, no cirrhosis
= 12 weeks for people with genotype 1a, with cirrhosis
= 24 weeks for people with genotype 1a, cirrhosis and prior null response to treatment
Elbasvir and grazoprevir
= 12 weeks for people with genotype 1 or 4, with no prior treatment, or with prior treatment relapse
Elbasvir and grazoprevir plus ribavirin
= 16 weeks for people with genotype 1a or 4, who experienced prior treatment failure.
There are a range of different treatment regimens. People are offered treatment on the basis of their genotype, level of liver damage and treatment history.
Are new treatments taken with ribavirin or interferon injections?
Several of the new treatments, listed above, are sometimes taken with ribavirin. Importantly, all the new treatments are taken as tablets (pills) and none involve interferon injections.
(Treatment for people with genotype 6, involves sofosbuvir taken with pegylated interferon injections and ribavirin tablets. A new interferon-free treatment will become available later in 2017).
Treatment side effects
Sofosbuvir/ledipasvir is well tolerated with only minor side effects.
Sofosbuvir and daclatasvir are well tolerated with only minor side effects.
Sofosbuvir and ribavirin are well tolerated (the most common adverse events of ribavirin are anaemia, fatigue, headache, skin irritation and insomnia).
VIEKIRA PAK is well tolerated with only minor side effects. When taken with ribavirin, it is well tolerated but may be associated with anaemia, fatigue, headache, skin irritation and insomnia.
Elbasvir and grazoprevir is well tolerated with only minor side effects. When taken with ribavirin, it is well tolerated but may be associated with anaemia, fatigue, headache, skin irritation and insomnia.
Sofosbuvir/peginterferon/ribavirin combination treatment involves side effects including fatigue, headache, throwing up, sleep problems, itching and crawling of the skin, and anaemia (low blood platelets). Pregnancy must be strictly avoided by both men and women (during treatment and for 24 weeks after). This is because ribavirin has been shown to cause birth defects.
There are some drug-to-drug interaction issues (for example, with the drug amiodarone which is used for heart problems) but most issues will be adequately handled with changing accompanying medications, or choice of hepatitis C medication, or through careful monitoring.
VIEKIRA PAK includes ritonovir which can lead to significant drug-drug interactions. All medications should be checked before prescribing with any hepatitis C medications.
Pregnancy must be strictly avoided by both men and women treated with Ibavyr (ribavirin) in any of the previously mentioned treatment combinations (during treatment and for 24 weeks after). Pregnancy must also be avoided with Daklinza (during treatment and for 5 weeks after). Talk to your doctor about treatment with Harvoni in pregnancy. It is recommended that treatment is not taken while breastfeeding.
Your doctor or specialist will advise which treatments would be suitable (or not suitable) for you, depending on your past and present medical conditions and any other medications you are taking.
Does treatment interfere with other drugs?
Sometimes one medicine that a person takes interferes with other medicines, or with recreational drugs (including alcohol). A useful website that lists all these interactions is based at University of Liverpool (UK). Of course, it is really important to talk about these issues with your treatment doctor or nurses.
No treatment restrictions
All Australian adults who have been diagnosed with chronic hepatitis C (genotypes 1, 2, 3 and 4) and who hold a Medicare Card are eligible to access the new DAA treatments, regardless of their stage of disease.
There are no restrictions applied for people who inject drugs. If people are denied access or experience limited access to treatment and believe it is because of their status as a person who injects drugs, they can call either the Hepatitis Infoline on 1800 803 990 or the NSW Users and AIDS Association on 02 8354 7300 for information.
The new treatments are also available for prisoners (see far below).
The new medicines are available through Medicare (PBS) to all adults who hold a Medicare Card.
Doctors and specialists working at hospital liver clinics can provide the new treatments.
GPs and other doctors experienced in the treatment of hepatitis C can also provide the new treatments. This expands access to treatment, especially if you live in a rural area.
See www.hep.org.au/services-directory/ for a listing of GP across NSW. This list is updated on a regular basis.
Sofosbuvir/peginterferon/ribavirin combination treatment remains available via liver clinics and specialists.
Preparing for treatment
People with hepatitis C have an initial GP or specialist assessment. This involves full blood testing and assessment of fibrosis stage, via Fibroscan or APRI test. People with cirrhosis are referred for specialist care and treatment. People with cirrhosis require long term monitoring for complications including liver cancer. See www.hep.org.au/services-directory/ for a listing of Fibroscan availability across NSW.
It is important that all people are tested for the presence of hepatitis B prior to starting hepatitis C medications. This is because some people with hepatitis B have had increased activity of hepatitis B during treatment which may require special attention.
Filling of prescriptions
Scripts are usually filled for a month at a time. S100 scripts are written as public hospital items and need to be dispensed in the public hospital pharmacy. Hospital pharmacies will usually be able to fill scripts on the day.
The new S85 (General Schedule streamlined approval) scripts are written by GPs or specialists and are dispensed at community pharmacies. Community pharmacies don’t usually have the capacity to carry stocks of the DAA medicines, but will be able to order them in – usually within 72 hours.
It is important to remind the community pharmacy to order in the next month’s supply of medications about a week before the medications are due to be collected.
Hepatitis C treatment drugs can also be ordered from online pharmacies. While this might not be as secure as customers picking up their treatment drugs from a local pharmacy, it will be very helpful for people who live in parts of NSW with no pharmacies that fill these scripts.
Consumers are required to
- fill in their details online
- phone the pharmacy
- post the prescription to the address provided on the website.
The pharmacy must first receive the prescription. Once they receive the script, they will place the order for the medicine, which may arrive within 1-2 days and then the medicine is delivered through Australia Post.
Try the following online pharmacies…
If the treatment drugs don’t appear in their ‘search’ option, people should call the online pharmacy. They can take orders over the phone (generally, a medicine doesn’t go live on their site until it’s ordered previously). Further, online pharmacies prefer to receive a call about the script beforehand so they can explain to the consumer the process.
People are charged only the usual monthly co-payment paid for a prescription. This is currently $38.80 per month for general patients and $6.30 per month for concessional patients.
Treatment monitoring and follow up
Viral load is not checked while people are on treatment as the result does not affect the treatment duration. Only liver enzymes, kidney function and full blood count are checked at week 4 of treatment.
If ribavirin is required in the treatment, then most people will have blood tests every month of treatment.
Some hospital clinics may use different monitoring protocols based on whether or not people have other illnesses and the complexity and severity of their hepatitis C disease.
All people will require a PCR viral detection test 12 weeks after treatment finishes to check if they are cured.
“Cure” or “SVR” (Sustained Virological Response) means that someone has cleared hepatitis C virus from their body. If someone has a PCR viral detection 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.
Treatment inside NSW jails
The Federal Government has agreed to fund the new treatments for prisoners under the current S100 scheme. On this basis, NSW adult prisoners will have access to the new DAA treatments for hep C after 1 March 2016.
People with hep C in NSW jails will be assessed and treatment delivered under Justice Health and Forensic Mental Health Network’s (JH&FMHN) Nurse-Led Model of Care.
There are 31 JH&FMHN Health Centres across NSW and most will be able to initiate and manage the new hep C treatments. To talk about accessing treatment while you are in custody, prisoners should first talk to the Health Centre Nurse.
For more information about hep C including treatment, please call the Hepatitis Infoline by dialling 3 on the Common Calls list. This is a free service.
Children and treatment
The PBS listing of new direct acting antivirals (1 March 2016) is for Australian adults only. Children with hepatitis C should be seen and assessed by a paediatrician experienced in viral hepatitis. To find out more about monitoring and treating hepatitis C in children, contact the gastroenterology unit at The Children’s Hospital at Westmead (02 9845 3989).
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.
To talk about anything in this factsheet, in NSW phone the Hepatitis Infoline on 1800 803 990
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.
Last updated 27 Jan 2017