HepatitisWA Newsletter (Dec 2012) by HepatitisWA

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contents Banishing the Monster A Personal Perspective.......................................................................... 4 Wayne Thacker’s fight with hepatitis C and the battle of treatment.

Going Viral* Viral Hepatitis News...................................................................................................................... 6

“Hep C drug delay will spur more transplants”; “Hep C patients benefit from regular psychiatric screening” and “Boost needed in fight against hepatitis”.

The Hep C Treatment Race*...................................................................................................................................... 8

Gilead Sciences Inc. may have an edge on rivals developing new hepatitis C drugs for a potential $20 billion market.

“PlayTheBloodRule.com” Feature................................................................................................................. 10 HepatitisWA’s campaign targeted to youth and beyond, adopted by the Perth Redbacks basketball league.

A View From the Inside A Personal Perspective........................................................................13 Alex Hepburn’s recollection of sharing needles in prison.

Promoting Healthier Lifestyles for Better Treatment Outcomes...............14 WASUA’s Domain (WA Substance User’s Association).

Breaking the Syringe Economy: Prison Union Fights ACT Plan*.................1 6

ACT’s Prison Workers Union fight against proposed needle exchange program at the Alexander Maconochie Centre.

GI-13020 TarmogebR Generates Antigen-specific T Cell Responses in Key Preclinical Studies* Press Release............................................................................................18 GlobeImmune, Inc, announced that GI-13020, an investigational therapeutic vaccine designed for the treatment of chronic hepatitis B virus infection, demonstrated immunogenicity in two preclinical studies. HEPATITISWA Newsletter // Dec 2012

GOING VIRAL A ROUND-UP OF ARTICLES ON VIRAL HEPATITIS

Hep C drug delay will spur more transplants The federal government’s delay in listing two potentially lifesaving, hepatitis C treatments on the PBS will mean more people undergoing expensive liver transplants and mounting health costs, health campaigners have warned. Hepatitis Australia has been calling for cabinet to approve listing the drugs, boceprevir and telaprevir, since they were cleared for efficacy and cost effectiveness by the Pharmaceutical Benefits Advisory Committee (PBAC) earlier this year.

Hepatitis Australia CEO Helen Tyrrell said she would seek an urgent meeting with Ms Plibersek. She said the government was “concerned about expenditure at this time” but the cost of not treating hepatitis C early was four times the cost of treating it so “from an economic perspective there’s an imperative to make these drugs available”.

BY BRYON KAYE Nov 09, 2012 for Medical Observer, National.

Hep C patients benefit from regular psychiatric screening

REGULAR psychiatric screening has been Under a controversial temporary deal struck recommended for patients with chronic between the Commonwealth and Medicines hepatitis C following research into the Australia, all new products clearing by the PBAC prevalence of anxiety and depression. are put straight on the PBS, but those expected to cost more than $10 million a year,including the two A study of nearly 400 such patients attending the Royal Adelaide Hospital liver clinic from hepatitis C drugs, must first be cleared by cabinet. 2006 to 2010 found probable prevalence rates of 41% for anxiety and 27% for depression, Despite PBAC approval and a petition of more which were higher than the community norms. than 1000 names from Hepatitis Australia, Health Minister Tanya Plibersek last month Younger patients in particular experienced listed a raft of new products to be PBS increased anxiety, the researchers found. listed, which did not include either drug. Flinders University executive director of health sciences, Professor Michael Kidd, said many GPs were treating patients with hepatitis C “who have been waiting for these new drugs to become available who would be disappointed that there’s a continuing delay in having access through the PBS”. 6

Around 10,000 new hepatitis C notifications are recorded in Australia each year and up to one in five patients with acute infection goes on to develop cirrhosis and end-stage liver disease. Depression and anxiety were commonly induced by the antiviral therapies, the authors said.

HEPATITISWA Newsletter // Dec 2012

Disclaimer: The news articles and excerpts displayed in the HepatitisWA Newsletter remain the copyright of the original authors and news publications.

“The elevated rate of anxiety and depression have significant clinical implications, as these and other psychological co-morbidities can adversely impact on antiviral treatment outcomes, and increase reported physical symptomatology.” the authors concluded.

Dr Edward Gane, deputy director of the New Zealand Liver Transplant Unit, said liver cancer was a “terrible disease. This is one of the few cancers where cancer mortality exceeds cancer incidence because the average survival rate is less than one year after diagnosis.”

“Publicly funded healthcare rebate schemes need to be expanded to allow treating specialists to refer patients for psychological care, which is at present only reimbursed when patients are referred by a GP.

Despite the development of new drugs to treat hepatitis, fewer than 2 per cent of people with hepatitis C and fewer than 3 per cent with hepatitis B are receiving treatment.

Dr Benjamin Cowie, a physician with the Victorian “Evidence has shown that anti-depressants are Infectious Diseases Service and an organiser effective in treating antiviral treatmentof the conference, said he would like more induced depression. resources to be used in the fight against hepatitis. “This demonstrates the need for regular psychiatric screening and, where necessary, subsequent referral for mental health treatment.” they wrote.

BY NEIL BRAMWELL Oct 25, 2012 for Australia Psychiatry 2012.

“Boost needed” in fight against hepatitis

Cowie said he would like to see “reasonable treatment targets” of 5 per cent for hepatitis C sufferers and 10 per cent for hepatitis B sufferers being achieved. “That’s what we’re calling on based on our experience and knowledge of the rapidly rising burden of viral hepatitis and attributable liver cancer in our countries,” Cowie said.

One of the most successful treatments for liver Doctors at the 8th Australasian Conference on cancer was liver transplantation. However, Viral Hepatitis have called on the Government the annual number of liver cancer cases was and health officials to boost efforts to combat 10 times the number of annual transplants. hepatitis. “There’s a lack of community knowledge of viral hepatitis, the fact that it is associated with More than 500,000 people in New liver cancer and the fact that treatments are Zealand and Australia are believed to available,” he said. have chronic hepatitis B or C infections. “Instead of intervening at a time when it is cost They may have no symptoms, but without effective to do so, we’re left with trying to do liver treatment the infections can progress to liver transplants and emergency responses where we cancer or liver failure, which is one of the two could be acting to prevent it in the first instance. fastest-increasing causes of cancer deaths in © FAIRFAX NZ NEWS Australasia, largely due to the increase in hepatitis. Sept 10, 2012 Abridged from stuff.co.nz. tinyurl.com/ boost-needed-against-hepatitis

NEEDLE & SYRINGE

ORIENTATION & TRAINING PACKAGE

NSP Online Orientation and Training Package for NSP Staff and Pharmacy Workers The Sexual Health and Blood-borne Virus Program, in collaboration with the Workforce Development Branch of the Drug and Alcohol Office (DAO), have developed two Online NSP Orientation and Training Packages for NSP staff and for pharmacy workers. Online training for NSP staff This training aims to enhance the knowledge, confidence and skills of health workers who deliver NSP services and is available via the following link: www.dao.health.wa.gov.au/nsp The training can be undertaken for people new to working in the area of NSP, as a refresher for those who already work in NSP and/or have attended the NSP Coordinator training in the past, or for anyone who is interested in learning about NSP.

The activity has been accredited by the Australian Pharmacy Council for 1.5 hours and 3.0 Group 2 PCD upon successful completion of the assessment. These credits are suitable for inclusion in an individual pharmacistâ&#x20AC;&#x2122;s CPD plan. Assessment Following completion of all of the modules there is a final assessment for each of the training packages, which includes 20 questions, with a pass mark of 75%. A certificate of completion will be provided once the assessment has been passed. CD-ROM A copy of the online programs are available on CD-ROM for anybody who has difficulty accessing the internet. To obtain a copy of the CD-ROM, please contact us.

The entire program takes approximately 3 hours to complete and consists of ten stand-alone modules which can be done at your own pace, with the ability to stop and start at any time. There are a series of questions at the end of each module with a final assessment on completion of the program. For registered nurses involved in providing NSP services, this online learning program has been endorsed by Royal College of Nursing, Australia. Completion attracts 3 RCNA Continuing Nurse Education (CNE) points. Online NSP training for pharmacies This training aims to enhance the capacity of pharmacy staff to assist customers purchasing injecting equipment and is available via the following link: www.dao.health.wa.gov.au/nsppharmacy The program is shorter than the training package for NSP staff and contains eight stand-alone modules with learning objectives, activities, questions and a reference list. The duration of each module varies; however the total program duration is approximately one and a half hours (participants do not have to complete this at once and can return to the course as and when they are able to). 12

HEPATITISWA Newsletter // Dec 2012

If you would like more information regarding the online program, please contact the BBV Team on (08) 9388 4841 or by email at NSP@health.wa.gov.au

A PERSONAL PERSPECTIVE

INSIDE

One of the rawest recollections I can remember was pacing up and down the wing after lockdown and being stopped and told to keep a watch for the guards, by one of the inmates. I remember anxiously leaning against the wall just outside the cell and hearing a bunch of swearing from inside. I turned my head to find a group of up to ten men, no older than 25 all sharing the same syringe. The screams had come from one of the boys, whose arm was trickling blood. The needle on the syringe was that short, it must have been cut down at least a half dozen times so it could be repeatedly used to inject. I know this isn’t an isolated incident... Unfortunately needle sharing is a huge problem in prisons and until you can see the extent of it first hand, no one seems too bothered about doing something to help. The reality is, if your are injecting you’re leaving yourself open to hepatitis. For many of the young men I got to know while doing time, the shock felt when the cell door closes or the anxiety felt walking out to the oval for the first time is all the persuasion needed to ask for the easy way out drugs can give you in there.

Despite the attempts from the prison guards to halt the flow of drugs entering jails, the truth is, drugs will always have a place and will always find a way in. I know this from experience. I saw a lot of things happen while I was locked up and now that I’m out I truly want to help.

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For me, it is clear that by removing the dirty needle and supplying an alternative, the number of hepatitis infections would reduce increasingly.

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A view from THE

If you ask around for a clean needle the response you will get is “How much you willing to pay?” While it is possible for clean needles to be smuggled in, most don’t have the money and are desperate enough to share or make their own from whatever they can find. I would strongly support a needle exchange program being accessible to the inmates. Hepatitis is far too serious to ignore. The revolving door has many inmates pass through it, so why not cut off the beast’s head and offer such a program? For many it is only a short stay inside, maybe a few months and what these prisoners don’t consider is that they are entering a high risk environment.

BY ALEX HEPBURN HEPATITISWA Newsletter // Dec 2012

PROMOTING HEALTHIER LIFESTYLES FOR BETTER TREATMENT OUTCOMES

t seems that within the intravenous drug using community there is a deeply entrenched opinion that Hepatitis C treatment is horrific and extremely difficult to undertake. For many people within this group, the view point that treatment is not worth doing has slowly emerged. It always seems that the worst of news is always reported and the positive stories about the experiences of treatment go unmentioned. With the current treatment of hepatitis C, the side effects can be difficult to manage and have in some cases been extremely severe such that treatment has been ceased before due time. For those having trouble in coping with their treatment, it is of the utmost importance that along with ongoing medical treatment, that it is accompanied with the proper support. Ideally, family and friends along with partners can help support through such a period. If there is no immediate support from family and friends, a health professional then becomes a key to this person’s ability to understand what is going to make their treatment less aggressive and a much more comfortable experience. Attitude, diet, exercise and other pre-existing medical issues all contribute towards the experience of Hepatitis C treatment. Eating a balanced diet, keeping a healthy body weight and abstaining or minimising your alcohol intake are all things that can have a positive impact on the health of your liver.

So during treatment it is imperative that all measures are taken so that there is as little stress on the liver as possible. Diet plays a substantial role in maintaining liver health. Carrying extra abdominal fat (fat around your stomach, also known as a beer gut) can increase your risk of an unhealthy liver as well as other serious long term conditions, like heart disease and diabetes. Fatty liver and diabetes can also increase liver damage and decrease treatment success. So exercise and diet become important factors to remember in treatment. Exercise doesn’t have to be working out 3 hours a day. Walking each day and getting plenty of fresh air can contribute greatly to your health, as well as reducing your stress levels. A diet that comprises fresh fruit and vegetables is essential for liver and body health. Often a good diet is more a case of cutting out what is bad in our diet. Don’t eat fried foods! Fast foods such as fried chips, deep fried chicken, fish or meats are very unhealthy for our liver. Food loaded with sugar, such as sweet biscuits, cakes and lollies, contribute to overweight and the development of diabetes. And don’t forget all that sugar in cool drinks and mixed alcoholic mixes, such as the “alcopops” and the “bundys and coke”! Cut these foods down in your diet and you will be surprised at the effect on your weight and the improvement in your overall feelings of well being. Alcohol is definitely “out” for those with liver disease or for those in treatment. The use of alcohol on a regular basis will cause damage to even a healthy liver. Cirrhosis, diabetes, weight gain and cancer are all side effects of regular, daily alcohol intake. Remember that the recommended daily intake for those with a healthy liver is only 2 standard alcohol drinks a day. And what is a standard drink? Certainly not a King Brown or a pint at the pub! For those with liver disease and in treatment, no alcohol is recommended as it accelerates damage to our liver and reduces better treatment outcomes. Our attitude to treatment and our confidence in managing the challenges that treatment may bring are also essential in completing a treatment program. Staying the course of treatment when side effects such as fatigue, depression, low mood or nausea kick in can be very difficult.

HEPATITISWA Newsletter // Dec 2012

Other countries, including Germany, Spain and Switzerland, already have NSPs in their prisons. Bresnan says these are examples of how these initiatives can work. “All the evidence from overseas, from every single prison where they have NSPs, has been that they increase safety for prison staff,” she told Crikey. The CPSU isn’t Labor’s only problem. Should the Liberal opposition win on October 20, a situation ANU academic John Warhurst considers not unlikely, they have promised there will be no NSP for Canberra. A request for comment from the Liberals did not elicit a response. There are other less altruistic reasons for introducing a needle exchange program. The Canadian government is being sued by former inmate Steven Simons, who contracted hepatitis C while serving time in one of their jails. He’s alleging the government ignored multiple calls for an NSP program. In one statement he vividly describes the situation inside the jails: “I would see people passing one homemade needle around and sharpening it with matchbooks. The needle would be dirty and held together with hot glue.” To date three inmates have been infected with hepatitis C in Canberra prisons, the most recent in 2011. Some claim the motivation for the proposed ACT trial was concerned the government could suffer the same fate as their Canadian counterpart. Bresnan agrees somewhat, but adds the territory also has a human rights obligation. “When you’re incarcerated that’s your punishment, but you should have access to the same sorts of services that people would in the community. That’s what a human rights compliant prison is meant to do,” she said.

The outcome of the trial has national implications. Drug reform lobby groups say other state governments are watching the ACT very closely. Although none have trialled a similar program, the issue is certainly not off the table. In Tasmania the Corrections Minister is State Greens leader Nick McKim, who has said he will be keeping an eye on the outcome in Canberra. Bresnan says there has been much discussion of a trial program in Tasmania and it could be the next state to take the leap. Hepatitis Victoria CEO, Melanie Eagle says while there has been no mention of a trial, people inside the Department of Justice have told her they will be keeping a close eye on the ACT. As for NSW, in 2011 then-opposition leader Barry O’Farrell proposed a similar program in the run-up to the election; once in government he decided not to go ahead. This was partly due to pressure from the state’s public service union, who recently demanded further assurances that O’Farrell won’t follow the ACT’s lead. Despite this, Hepatitis NSW executive officer, Stuart Loveday isn’t giving up: “[We] have been advocating for a needle exchange program for many years and we will increase our advocacy following the decision taken by the ACT government.”

BY BEN WESTCOTT October 18, 2012 for Crikey. tinyurl.com/breaking-the-syringe-economy HEPATITISWA Newsletter // Dec 2012

PRESS RELEASE

GI-13020 TarmogebR for the

Treatment of Chronic Hepatitis B Generates Antigen-specific T Cell Responses in Key Preclinical Studies

lobeImmune, Inc. today announced that GI-13020, an investigational therapeutic vaccine designed using the company’s proprietary TarmogenR product platform for the treatment of chronic hepatitis B virus (HBV) infection, demonstrated immunogenicity in two preclinical studies. GI-13020, which is being developed in collaboration with Gilead Sciences, Inc., was found to activate antigen-specific CD4 and CD8 T cells, including those that respond to the HBV X, S and Core antigens, which are critical for the development of hepatitis B disease. This data will be presented today at The Liver Meeting 2012 in Boston. A poster by Guo et al. will include data demonstrating antigen-specific T cell responses generated in mice immunized with GI-13020. In addition, the data will show that GI-13020 significantly protected mice from tumors engineered to express HBV antigens. In a second poster by Kemmler et al., Tarmogens elicited HBV-specific T cell responses ex vivo in samples collected from healthy individuals and donors with chronic HBV. Further analyses showed that the Tarmogens were able to elicit functional immune responses in a clinically relevant model. “Chronic HBV infection, which is characterized by inadequate and dysfunctional T cell responses against HBV antigens, can be effectively suppressed with long term antiviral therapy. However, there is a significant opportunity to improve permanent cure rates,” said David Apelian,

M.D., Ph.D., Senior Vice President, Research & Development, and Chief Medical Officer of GlobeImmune. “We believe that administration of GI-13020 in patients whose disease is under virologic control with a direct acting antiviral agent may have the potential to increase hepatitis B surface antigen seroconversion rates, thus potentially allowing discontinuation of antiviral treatment.” HBV infection is the most common chronic viral hepatitis infection in the world. Approximately 350 million people worldwide are chroniccarriers of HBV, of whom more than 620,000 die from liver-related disease annually. In the United States, chronic HBV infection affects up to two million people. Current treatment for HBV includes oral antiviral therapy with once-daily medicines to suppress virus replication. About GlobeImmune GlobeImmune is a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines, which stimulate predominately antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. For additional information, please visit the company’s website at www.globeimmune.com.

HEPATITISWA Newsletter // Dec 2012

Source: GlobeImmune, Inc via Thomson Reuters ONE, Nov 10, 2012. http://tinyurl.com/GI-13020-TarmogenR HepatitisWA is not responsible for the content in this press release.