Factsheet: Treatments for hepatitis C Direct Acting Antivirals (DAAs)

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1 Factsheet: Treatments for hepatitis C Direct Acting Antivirals (DAAs) For more information about anything in this factsheet, phone the Hepatitis Infoline on or go to 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. Introduction 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 This factsheet relates to these hepatitis C treatment combinations: Harvoni (sofosbuvir/ledipasvir) two drugs combined in one pill, taken daily Sovaldi and Daklinza (sofosbuvir and daclatasvir) separate pills, taken daily Sovaldi and Ibavyr (sofosbuvir and ribavirin) separate pills, taken daily 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 March 2016 Pharmaceutical Benefits Advisory Committee will be considering Fepatier (grazoprevir + elbasvir), which is suited to genotype 4. Genotype 4 is relatively rare in the Australian context (less than 5%). This will fill the gap in relation to interferon free treatment options and no treatment will require weekly injections. Success rates of the new treatments Sofosbuvir/ledipasvir Around 95% of people (with genotype 1) achieved cure in Phase 3 studies (see Defining cure, below, for an explanation of cure ). Sofosbuvir and daclatasvir Around 95% of people (with genotypes 1 or 3 and no cirrhosis) achieved cure in Phase 3 studies. People with genotype 3 and cirrhosis have lower (although still relatively high) cure rates and will require longer duration or addition of ribavirin. Sofosbuvir and ribavirin Around 93% of people (with genotype 2) achieved cure in Phase 3 studies. 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.

2 Treatments and genotypes Hepatitis C genotype 1 sofosbuvir/ledipasvir sofosbuvir and daclatasvir Hepatitis C genotype 2 sofosbuvir and ribavirin Hepatitis C genotype 3 sofosbuvir and daclatasvir People with genotypes 4 or 6 remain limited to sofosbuvir taken with pegylated interferon and ribavirin treatment (85% cure rate). Other drug combinations are approved and available but those mentioned above are the ones with best response and tolerability. Treatment durations 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 to 16 weeks for people with genotype 3 and cirrhosis. 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. 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).

3 Treatment contraindications There are some drug-drug interaction issues, including amiodarone (an antiarrhythmic medication used to treat ventricular tachycardia or ventricular fibrillation) however, most issues will be able to be handled with change of accompanying medications, or through careful monitoring. Pregnancy must be strictly avoided when either the potential father or mother are being 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. 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 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 for information. The Federal Government has also agreed to fund the new treatments for prisoners (see below). Treatment access The Federal Government has said that General Practitioners (GPs) will be able to prescribe these medicines in consultation with a specialist. Initially, this will be much the same as for current treatments: doctors and specialists working at hospital liver clinics and some specially trained GPs (doctors). There will be an expanded approach to prescribing these hepatitis C drugs under the more relaxed S85 program (for GPs) as well as the current drugs S100 program (for specialist liver clinics and prisons). This will expand access to treatment for the foreseeable future, including in rural and regional areas. See Victoria S100 Prescribers for trained GPs. This list will be updated as training is rolled out throughout 2016 and beyond. Treatment could also be coordinated in consultation with a specialist via Telehealth (Telemedicine is currently funded by Medicare). See for a listing of specialist liver/hepatitis clinics across Victoria. For more information about the above directories, or to have one of our workers do a search, people can call the Hepatitis Infoline on It should be noted that initially, many GP s may be unfamiliar with the new treatment regime and will continue to refer patients to specialist services, similarly, community pharmacists may take some time to have familiarity with the new medicines. If seeking support, it is advised to be persistent and patient during the transition phase to the S85 prescribing model.

4 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. People with cirrhosis will be referred for specialist care and treatment. People with cirrhosis require long term monitoring for complications including liver cancer. See for a listing of Fibroscan availability across Victoria. (Treatment protocols are currently in development and once they are confirmed, the information in this factsheet will be amended.) Treatment protocols are currently dependent on: The hepatitis C genotype; and the patient s cirrhotic status (non-cirrhotic or cirrhotic). The treating doctor needs to be able to provide evidence of a chronic hepatitis C infection (Antibody or PCR test results). Filling of prescriptions If a person s prescription is written as an S.100 HSD public hospital item (HSD PUB) it will need to be dispensed in a public hospital pharmacy. If the script is written as an S.100 HSD private hospital item (HSD PTE) it can be dispensed in a private hospital pharmacy or community pharmacy. If the script is written as a S.85 General Schedule streamlined approval (by a GP) it can be dispensed at a community pharmacy. At this stage, we are unsure of whether community pharmacies will have the capacity to carry stocks of the DAA medicines, or whether they will order them in. For more information, please call the Hepatitis Infoline on Treatment costs Once the PBS listing takes effect on 1 March 2016, people will be charged only the usual monthly co-payment paid for a prescription. This is currently $38.30 per month for general patients and $6.20 per month for concessional patients. Treatment monitoring and follow up Treating doctors will probably use a PCR viral load test at week 4 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 visit while on treatment (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.)

5 Defining cure 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 (including 6-monthly Fibroscan examinations). 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 Victoria jails The Federal Government has agreed to fund the new treatments for prisoners under the current S100 scheme. On this basis, Victorian adult prisoners will have access to the new DAA treatments for hep C after 1 March 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 Royal Children s Hospital at Parkville ( ). The information in this factsheet will be amended as new information emerges. To talk about anything in this factsheet, in Victoria phone the Hepatitis Infoline on or go to This factsheet was developed by Hepatitis Victoria based on a factsheet produced by Hepatitis NSW. Last updated 17 February 2016