TREATMENT OF RECENTLY ACQUIRED HEPATITIS C VIRUS INFECTION (ATAHC II) A national study to find the best treatment strategy for people with recently acquired hepatitis C infection.
introduction This information booklet is written for people who have recently (in the last year or two) acquired hepatitis C (commonly known as hep C), and are considering participating in a national study called ATAHC II. What is atahc ii? ATAHC II is an Australian study following and treating people who have recently acquired hepatitis C virus (HCV) infection. The study is run by a team of doctors, nurses and researchers who are experienced in working with people with or at risk of HCV infection. To take part in this study, you must have been recently infected with hep C. This means that: You have had your first positive antibody test for hep C or first positive hepatitis C virus test within the last 6 months And before receiving that test had a negative antibody test for hep C within the last 2 years { Or have had acute hepatitis symptoms (jaundice yellow eyes and skin and raised liver function tests) within the last 12 months 1
The study plans to: enrol and follow up a group of patients with recently acquired HCV to learn more about the disease and outcomes. identify the best treatment strategy for patients with recently acquired HCV infection. find out how common it is to be infected with more than one strain of the virus at a time. find out how common it is to be infected with a strain of virus that is resistant to the new types of drugs that are being developed to treat HCV. find out whether specific genes exist that may influence how an individual s immune system reacts to hepatitis C, either with or without treatment. examine how common reinfection with hepatitis C is after either natural clearance or successful treatment. There are also other aims of the study which will be explained to you by the study doctor. If your doctor thinks you are suitable you will be offered treatment with pegylated interferon with or without ribavirin, depending on your HIV status and how long you had been infected with Hep C for. The length of treatment will be determined by your genotype and your response to treatment and will range from 8 weeks to 48 weeks. You do not have to receive treatment to participate in this study. You will find out more information on treatment in the following sections. What is hep c? a brief overview Hep C is a blood borne virus that causes inflammation of the liver, which can lead to problems such as fatigue, nausea, liver cirrhosis (extensive scarring of the liver) and, in a small number of cases to liver failure and liver cancer. It is estimated that more than 260,000 people in Australia have been infected with hep C; this is about 1% of the entire Australian population. Most people in Australia with hep C got the virus through sharing injecting equipment such as needles, syringes and other injecting equipment while injecting drugs. Others may have contracted it through different ways, or even be unaware as to how they became exposed. If you have concerns as to how you became infected with hepatitis C you should discuss this with your doctor. can i be cured of hep c? The outcomes of hepatitis C infection are varied about one 1 in 4 people exposed to hep C will clear or get rid of the virus without any treatment. This usually happens in the first 6 months of infection. If you do not clear the virus naturally you will develop chronic (long term) infection. You may also clear the virus through HCV treatment. There is evidence that HCV treatment in the early stages of infection significantly improves your chances of clearing the virus. If you clear the virus, either with or without treatment, this means that you no longer have the hepatitis C virus in your body, and you are essentially cured. 2 TreaTmenT of recently acquired HepaTiTis c infection (atahc ii) 3
However, unfortunately this does not mean that you cannot become infected again (re-infected). This is because you may not have any immunity to the virus. So if you are still injecting drugs it is very important that you use a new fit for every hit and clean and unused injecting equipment such as swabs, tourniquets and filters at all times. What are the treatment options in this study? pegylated interferon (or peg-interferon in short) with or without ribavirin. If you and your doctor have decided to start hep C treatment you will receive a weekly injection of Peg-interferon. If you have HIV or have been infected with hep C for longer than 6 months you will also receive tablets called ribavirin which are taken daily. The length of your treatment will be guided by your early response to treatment and will range from 8 weeks to 48 weeks in total. This is called response-guided treatment or individualized therapy. Standard treatment for people with chronic hep C (infected for longer than 6 months) is combination therapy with both Peg-interferon and ribavirin for 24 to 48 weeks depending on genotype (the strain of hep C virus). Patients who have been infected with hep C for less than 6 months and do not have HIV are generally treated with Peg-interferon alone for 24 weeks. used to treat hep C are manufactured and taken in higher doses than what naturally occurs in the body to boost a person s immune system and stop viral growth. Ribavirin is a drug which decreases the ability of the hep C virus to reproduce. The number of tablets you get will depend on the genotype you are infected with and/or your body weight. Why individualized therapy? By individualizing the length of treatment according to early response to treatment patients may have a shortened duration of treatment (as compared to the current standard). This may reduce the length of time patients are exposed to the toxicity the drug(s) and the cost of treatment. What if i don t Want treatment? If you are not suitable for HCV treatment or choose not to receive HCV treatment you can still participate in the study and be followed by the study doctor and nurse at regular intervals for up to 2 years. Interferon is a drug used to treat hep C. For this study, we will be using Peg-interferon which is a newer type of interferon. Interferons are naturally produced by the body in response to infection with a virus. The interferons that are 4 TreaTmenT of recently acquired HepaTiTis c infection (atahc ii) 5
What are the risks and Benefits of participating in this study? risks: There are some risks with treatment, however if you have good support and discuss your concerns with your doctor/ nurse the majority of side effects and risks can be easily managed. Localised reactions to blood taking: Bruising and a slight discomfort. Some people feel a little light-headed when they have blood taken. Side effects to Peg-interferon: Like any medication there are side effects. These range from fatigue, flu like symptoms, headaches, and nausea to depression. You will be closely monitored by your study doctor and nurse while receiving this medication for any signs and symptoms of depression or suicidal thoughts. A questionnaire you fill out at regular intervals during the study will also help to inform your study doctor or nurse. It is important for you to talk to your doctor and nurse if you have developed symptoms of depression and suicidal thoughts so they can arrange appropriate medical consultation and treatment for you. Side effects to ribavirin: You may experience temporary changes in laboratory tests measuring red blood cell counts (anaemia), platelet counts and liver function. Rapid decreases in red blood cell counts may infrequently be associated with shortness of breath and heart symptoms. You may also experience nausea, vomiting and abdominal discomfort. 6 TreaTmenT of recently acquired HepaTiTis c infection (atahc ii) Pregnancy: Like many drugs, Peg-interferon may have a harmful effect on unborn babies. Therefore if you are female and planning to commence Peg-interferon therapy in this study, it is important that you must take precautions to avoid pregnancy. Your doctor will discuss this with you in more detail. If you are of child bearing age and going to receive ribavirin with Peg-interferon then you should avoid becoming pregnant while taking ribavirin and for six months thereafter. This is because ribavirin is known to cause birth defects and harm the foetus following minor exposure of ribavirin concentrated in semen and absorbed through the inner linings of the vagina. If you become pregnant you will have to withdraw from the treatment and your medical progress will be carefully followed. These and other potential side effects of Peg-interferon and ribavirin will be discussed with the study doctor before you decide about whether to commence treatment. Throughout treatment your study doctor will be able to prescribe you the appropriate medicines (including pain killers if necessary) to help you manage the side effects of therapy. All the doctors involved in the study are very experienced in managing hepatitis C therapy and its side effects. Potential higher chance of relapse: Relapse is when the virus comes back again after a period where it was undetectable in your blood. This can happen up to six months after treatment finishes. We cannot predict who might relapse after treatment but it is possible that it might happen more often in patients who receive a shorter duration of treatment than standard. This is one of the questions that this study is trying to answer. Patients who relapse are able to receive re-treatment with Peg-interferon and ribavirin through the government funded S100 scheme. 7
Benefits: You may not benefit directly from this study because it is a trial. However, the information we learn on this study may help other people with HCV in the future. There are some potential benefits: Increasing your knowledge of hep C: Whether or not you decide to take treatment you will be followed regularly over a period of 2 years with regular check-ups. Your overall health and your hep C will be monitored at these check-ups and you will be able to discuss the results with the doctor, as well as general issues around your health and safety. Access to early treatment: Previous studies have shown that taking treatment in the early stages of infection may be more effective than taking treatment at a later stage. It is therefore possible that you may benefit from taking treatment at an early stage. Individualized treatment: While this is a trial, if you decide to receive treatment, the type of treatment and the duration of treatment are tailored to you. This may mean that your treatment duration is shorter than standard hep C treatment if you respond well early or it may mean that your treatment duration is longer than standard hep C treatment if your early test results indicate that you are a slow responder. It is hoped that this strategy will produce an overall better response rate than standard of care treatment but it may not directly benefit you. You may also be exposed to less harmful effects of the hep C treatment if you receive treatment shorter than the standard duration. What are my commitments and rights if i chose to participate in this study? study visits: If you choose to participate in the non-treatment part of the study, then you will need a screening visit and a baseline visit, then 7 more visits (weeks 4, 8, 12, 24, 48, 72, 96) for up to 2 years. At each visit you will have blood taken and will complete some questionnaires (except week 4 and week 8). You will also have a FibroScan assessment which is a painless non-invasive test to measure the condition of your liver. If you start treatment with Peg-interferon with or without ribavirin, you will need a screening and a baseline visit, then depending on your response to treatment and the duration of your treatment, you will return for 10 to 19 visits over the next 2 years. At each visit you will have blood taken. You will complete some questionnaires and have a FibroScan assessment at most of the visits. You CAN withdraw from the study at any time for any reason. If at any time during the study you think that you can t keep participating, then let us know and we ll stop your involvement in the study. There will be support throughout the study to help you stay with the study. All the information that we collect from you, and about you, during the course of the study is completely CONFIDENTIAL. Your study data will be identified using an unique study number and your initials but not your name. All the doctors and researchers in the study are experienced in managing people who have, or may be at risk of hep C, and are nonjudgemental and approachable. 8 TreaTmenT of recently acquired HepaTiTis c infection (atahc ii) 9
What if i don t Get cured after receiving treatment in this study? If you are not cured by either treatment or by clearing hep C naturally, you will go on to develop chronic infection. Most people with a chronic infection remain symptom free for the next 10-20 years or so, after this time, some people will develop some long term liver damage and then cirrhosis (permanent scarring of the liver). A small proportion of people may develop liver failure or cancer. If you received Peg-interferon but do not respond to the treatment, or your hep C comes back after treatment, or you are re-infected with hep C after you have cleared the virus, you will be offered re-treatment with both Peg-interferon and ribavirin for 48 weeks through the S 100 scheme. However, further down the track there may be better and newer treatments for hep C that are developed to help clear and/or manage hepatitis C in people with chronic infection. Participating in this study will not stop you being able to use these treatments. What are the alternatives if i do not Want to participate in this study? Participation in this study is voluntary. If you decided not to participate in this study, you may choose to continue to be seen by your doctor and nurse in the clinic. If you participate in the study and decided to withdraw for any reasons, you can withdraw anytime during the study. It will not affect the care or treatment you receive in the clinic now or in the future. Your doctor and nurse will be able to discuss with you being treated under the current standard if you are suitable or continue to follow your health and disease progress if you prefer not to receive treatment now. If you haven t seen a doctor or nurse about your hepatitis C infection and wish to be seen at a health care facility, the organization/clinic you have received this booklet from will be able to refer you to a health care facility in your area. Who should i contact for more information on this study? The study doctors, nurses and other people will answer your questions before, during and after the study, and provide you with support and advice, particularly throughout the treatment period. The study is being run by the Viral Hepatitis Clinical Research Program, the Kirby Institute (formerly the National Centre in HIV Epidemiology and Clinical Research) in Sydney, and the following are the major clinics participating in the study in Sydney, Melbourne, Brisbane & Adelaide: 10 TreaTmenT of recently acquired HepaTiTis c infection (atahc ii) 11
Sydney St. Vincent s Hospital Kirketon Road Centre Royal Prince Alfred Hospital Nepean Hospital Melbourne The Alfred Hospital St Vincent s Hospital Royal Melbourne Hospital Adelaide Royal Adelaide Hospital Brisbane { Princess Alexandra Hospital The following people can be contacted if you want to discuss any aspect of the study: Barbara Yeung (Project Coordinator): 02 9385 0879 or Dr Gail Matthews (Principal Investigator) 02 9385 0900 In addition the following organisations are useful sources of information and support: Hepatitis NSW (02) 9332 1599 NUAA (NSW Users and AIDS Association Inc.) (02) 8354 7300 ACON (02) 9206 2000 or 1800 063 060 AIVL (Australian Injecting and Illicit Drug Users League) (02) 6279 1610 Hepatitis C Council of VIC (03) 9380 4644 Hepatitis C Council of SA (08) 8362 8443 Hepatitis Council of QLD (07) 3236 0610 Hepatitis WA (08) 9328 8538 12 TreaTmenT of recently acquired HepaTiTis c infection (atahc ii)
version 3, dated 27-7-2011