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. New direct acting antiviral treatment drugs have been listed on the Pharmaceutical Benefits Scheme (PBS) on 1 March and 1 May 2016.
This factsheet relates to these hepatitis C treatment combinations:
- 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.
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; or VIEKIRA PAK® (with or without ribavirin) all achieve cure rates in excess of 90-95%, depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotype 2: sofosbuvir and ribavirin achieves cure rates of around 90-95% depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotype 3: sofosbuvir and daclatasvir achieves cure rates of around 95% depending on pre-treatment variables such as the presence of cirrhosis, prior therapy, etc.
Genotypes 4-6: People with genotypes 4 or 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
Hep C genotype 1 = sofosbuvir/ledipasvir
sofosbuvir and daclatasvir
VIEKIRA PAK®-ribavirin pack
Hep C genotype 2 = sofosbuvir and ribavirin
Hep C genotype 3 = sofosbuvir and daclatasvir
People with genotypes 4 or 6 remain limited to sofosbuvir taken with pegylated interferon and ribavirin treatment.
Other drug combinations are approved and available but those mentioned above are the ones with best response and tolerability.
Treatment regimens (also see above)
sofosbuvir/ledipasvir = 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 ribavirin = 12 weeks for people with genotype 2
sofosbuvir and daclatasvir and ribavirin = 12 weeks for people with genotype 1 and cirrhosis.
VIEKIRA PAK® = 12 weeks for people with genotype 1b, no cirrhosis
= 12 weeks for people with genotype 1b, compensated cirrhosis
VIEKIRA PAK® plus ribavirin pack = 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
There are a range of different treatment regimens. People will be offered treatment on the basis of their genotype, level of liver damage and treatment history.
Are new treatments taken with ribavirin or interferon injections?
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. VIEKIRA PAK may be taken with ribavirin for people with genotype 1a.
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.)
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.
Sofosbuvir involves 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.
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 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/VIEKIRA PAK 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.
No treatment restrictions
All Australian adults who have been diagnosed with chronic hepatitis C (genotypes 1, 2 and 3) and who hold a Medicare Card will be eligible to access the new all-oral DAA treatments, regardless of their stage of disease.
There will be 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 Federal Government has also agreed to fund the new treatments for prisoners (see far below).
General Practitioners (GPs) are able to prescribe the new DAA medicines. This is done in consultation with a specialist. Once the GP has assessed their patient, the GP contacts a specialist to discuss the patient’s treatment options. The specialist advises on which patients should be referred to specialist care and treatment. Generally, those patients with cirrhosis or other complications are referred for specialist care and treatment (patients with cirrhosis require long term monitoring for complications including liver cancer).
There are two treatment pathways for prescribing the DAA drugs: under the more relaxed S85 program (allowing GPs to prescribe) as well as the current drugs S100 program (specialists, liver clinics and NSW prisons).
The S85 program is also available to specialists and liver clinics. It will expand access to treatment, including in rural and regional areas. Initially, though, most new DAA treatment will be delivered via specialists and doctors, supported by specialist nurses, who work at hospital liver clinics.
See http://www.ashm.org.au/HCV/hcv-prescriber-list for trained GPs. This list will be updated as training is rolled out throughout 2016 and beyond.
See www.hep.org.au/services-directory/ for a listing of specialist liver/hepatitis clinics across NSW. The directory also features GPs who have shown an interest in hepatitis C. This list will also be updated on a regular basis.
For more information about the above directories, or to have one of our workers do a search, people can call the Hepatitis Infoline on 1800 803 990.
Preparing for treatment
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® or APRI test. People with cirrhosis will be 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.
For patients without access to fibroscan, other non-invasive methods for assessing severity of liver damage, for example, the APRI (AST to Platelet Ratio Index) test.
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 will probably not 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.
For more information, please call the Hepatitis Infoline on 1800 803 990.
The new 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.
These medications are available on the PBS and people will be charged only the usual monthly pharmacy co-payment paid for a prescription. This is currently $38.30 per month for general patients and $6.20 per month for concessional patients, per script.
Currently, the NSW Ministry of Health will pay the S100 co-payment costs but not the S85 co-payment costs.
Treatment monitoring and follow up
The Australian Consensus Statement recommends that the virus 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 load 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 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 immediately after being cured. 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 now have access to the new DAA treatments for hep C.
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 listings of new direct acting antivirals (2016) have been 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.
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 1 May 2016