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

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1 Factsheet: New 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 is amended as new information emerges. 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. New direct acting antiviral treatment drugs have been listed on the Pharmaceutical Benefits Scheme (PBS) as of March, with additional listing on the 1st May 2016 and it is anticipated that other medicines will be added as they are approved. 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 Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets, with or without ribavirin (taken twice daily)) three drugs combined in one pill, two taken in morning and one dasabuvir pill taken twice daily in the morning and evening. 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. Zepatier (grazoprevir + elbasvir), has been approved by PBAC and is awaiting a decision regarding a listing on the pharmaceutical benefits scheme. Zepatier has had high success rates in people who have had unsuccessful prior treatment and in people who are HIV/HCV co-infected. It is also being trialled in people with bleeding disorders. It is also suited to genotype 4 which is relatively rare in the Australian context (less than 5%). Other treatments currently being considered include: Sofosbuvir (400mg) + velpatasvir (100mg) Epclusa Ledipasvir (90mg) + sofosbuvir (400mg) Harvoni Paritaprevir (75mg) + ritonavir (50mg) + ombitasvir (12.5mg) Technivie This is significant as it heralds the first pan-genotypic, interferon-free regimens for hepatitis C. Epclusa is a new treatment for genotypes 1-6 and Harvoni is seeking approval for other genotypes. Technivie is for the treatment of genotype 4. If successfully approved, Interferon treatments will soon be a thing of the past. 1

2 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 ). 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. Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin. High rates of cure for both genotype 1a and 1b, 95% with compensated cirrhosis and 97% without cirrhosis. Some patient groups require ribavirin. 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 real life populations). Treating doctors will advise which treatment options are suitable for individual people. For more information about anything in this factsheet, phone the Hepatitis Infoline on or visit Treatments and genotypes Hepatitis C genotype 1 Sofosbuvir/ledipasvir Ombitasvir, paritaprevir, ritonavir and dasabuvir (with or without ribavirin) Hepatitis C genotype 2 Sofosbuvir and ribavirin Hepatitis C genotype 3 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. 2

3 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 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 and ribavirin 12 to 16 weeks for people with genotype 3 and cirrhosis. Ombitasvir, paritaprevir, ritonavir and dasabuvir 12 weeks for genotypes 1a and 1b 24 weeks for genotype 1a with compensated cirrhosis who have had a previous null response to interferon and ribavirin *Ribavirin is included in cirrhotic genotype 1 and non-cirrhotic genotype 1a infected patients Are new treatments taken with ribavirin or interferon injections? Ribavirin may be prescribed with many of the combinations listed above if there is evidence of cirrhosis or previous treatment has failed. Weekly Interferon injections may be required in combination with direct acting antiviral therapy for genotypes 4, 5 or 6 which are quite uncommon in the Australian population and is occasionally used for genotype 3. New oral treatments for genotypes 4 6 are currently being developed, this will reduce the reliance on Interferon treatments. See: Hepatitis C Virus Infection Consensus Statement Working Group. Australian recommendations for the management of hepatitis C virus infection: a consensus statement Melbourne: Gastroenterological Society of Australia, Further information. 3

4 Treatment side effects Sofosbuvir/ledipasvir is well tolerated with only minor side effects. 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). Ombitasvir, paritaprevir, ritonavir and dasabuvir, is well tolerated with most side effects being mild in nature. Side effects associated with ribavirin include pruritus, insomnia & anaemia. 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. It is important that you discuss with your clinician any prescribed or alternative medicines that are being taken. 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). Talk to a 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 being taken. 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. Some contraindications in the new DAAs due to co-medications, co-morbidities, co-infections may prevent a patient being able to take a new therapy 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 the Hepatitis Infoline on for information. The Federal Government has also agreed to fund the new treatments for prisoners (see below). 4

5 Treatment access General Practitioners (GPs) are able to prescribe these medicines in consultation with a specialist. Training for general practitioners is available from the Australasian society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM). Some GP s will be reluctant to manage patients until they have received professional development and will continue to refer to specialists as they did with previous treatments. Prescribing may be done under the S85 program for general practitioners as well as the S100 program for hospitals, specialist liver clinics and prisons. This will expand access to treatment. See Victoria S100 Prescribers for trained GPs. This list will be updated as training is rolled out throughout 2016 and beyond. Treatment can 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. 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. Other diagnostic tests can be used if Fibroscan is not available. (Treatment protocols are available at Treatment protocols are currently dependent on: The hepatitis C genotype; and the patient s cirrhotic status (non-cirrhotic or cirrhotic) as well as any previous treatment history. The treating doctor needs to be able to provide evidence of a chronic hepatitis C infection by Antibody or PCR test results. 5

6 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. Community pharmacies may have to order medicines before being able to fill prescriptions. There have been reports of delays of several days. This is an important consideration when filling repeats, so ensure you have a discussion with your pharmacist about ensuring continuity of supply. If you are having difficulty finding a pharmacist to fill your prescription, call the Hepatitis Infoline on Treatment costs Each prescription will cost $38.30 per month for general patients and $6.20 per month for concessional patients. Depending on your course of treatment, this may be between one and three prescriptions per month, for a period ranging from two to six months. Treatment monitoring and follow up Treating doctors often use a PCR viral load test at week 4 to assess treatment adherence. By week four, nearly all people are likely to experience a significant decrease in the amount of virus present in the body 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 four 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. 6

7 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 currently have access to the new DAA treatments for hep C. Children and treatment The PBS listing of direct acting antivirals 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 is amended as new information emerges. To talk about anything in this factsheet, in Victoria phone the Hepatitis Infoline on or go to Last updated October