Hep C Community News Summer 04
Issue 25
Jargon
Buster
Page 7
Co-infection Trials Page 9
Anaemia Drug Helpful with HCV The Birth of a New Medicine Page 14
Hepatitis C Community News
Page 11
Contents Council Info
3
Articles Of Interest
4
4 The Parade Norwood. SA 5067 Ph. (08) 8362 8443 SA Regional Callers 1800 021 133
Yarnin’ Up Hep C
5
Breastfeeding, it helps
6
Jargon Buster
7
Cerebral Dysfunction
8
Non-waged membership -— $5.50 Waged membership -——– $16.50 Organisational membership — $55
Co-infection Trials
9
Impaired QOL
10
Anaemia Drug Helpful
11
Personals
12
Inspirations
13
Birth of a Medicine
14
Legal Issues
15
Additional Services
16
(GST inclusive) You can request a zero-cost membership Donations do not attract GST
Postal Address Hep C Community News PO Box 782 Kent Town SA 5071 PH. (08) 8362 8443 Fax. (08) 8362 8559 Email: admin@hepccouncilsa.asn.au Web site: www.hepccouncilsa.asn.au
Do you enjoy reading the Hep C Community Newsletter but always want to read more? Check out the Hepatitis C Council of NSW "Hep C Review" online at http://www.hepatitisc.org.au/reviews/reviews.htm
We welcome contributions from Council members and the general public. Views expressed in this newsletter are not necessarily those of the Hepatitis C Council of S.A. Inc. Information contained in this newsletter is not intended to take the place of medical advice given by your doctor or specialist. 2
Hepatitis C Community News
Issue 25
Under new Management
A
ll the staff here at the Hep C council would like to take this opportunity to welcome to you our new manager. Now before you wander off with an intense feeling of déjà vu, yes we have had a few. In our defense though, when someone moves on to other pastures we need to place another in the seat solely in an acting capacity until a replacement can be found. Having said that, we really only have been through two managers of recent times, with Dan now being our third. To date we have all now had a chance to have a chat with him, and the general consensus would be that he seems to already have a good grasp on the various needs of this type of organisation, and resources available to them. This probably stems from his experience with the AIDS council of NSW. We are glad he has come onboard and look forward to some positive movement in the direction of assisting the Hep C affected community. His experience places him in a position of high expectations from us, but no pressure mate… :) Welcome Dan.
Message from Dan Gallant It’s a great honour to be appointed as the manager of the Hepatitis C Council of SA and join the dedicated members, staff and volunteers who make up the team. Having been in the position for less than a month I am aware that I come to you at an important time in the Council’s history. Now in its tenth year the Council is in a position to reflect on past achievements and future directions as the hepatitis C epidemic in SA is better understood. The contributions that the staff, volunteers and community have made to the development of “South Australian Response to Hepatitis C Strategic Directions 2004-2008” are well timed in this anniversary year and will provide us with a framework on which we can embark on our own strategic planning. Born in Canada, I come to South Australia via Sydney where I managed the clinical services at the AIDS Council of NSW. With over fifteen years in healthcare as both a clinician and project manager, I am passionate about the integral role that community based organisations play in primary health care through the provision of information, education, and advocacy for all South Australians living with, or at risk of, Hepatitis C. These are exciting times to be part of the Council and I encourage you to find a way to participate with us in making sure that your voice in the epidemic is heard. Yours sincerely Dan Gallant
Hepatitis C Community News
Issue 25
3
Insulin resistance, chronic hepatitis C and fibrosis progression Hepatitis C virus may induce insulin resistance irrespective of the severity of liver disease, find researchers in the Dec. issue of Gastroenterology. Chronic hepatitis C virus infection is associated with an increased prevalence of type 2 diabetes. In this study, researchers from Australia assessed whether virus-induced insulin resistance was a mechanism for fibrogenesis in chronic hepatitis C virus infection. The team evaluated 250 hepatitis C virus-infected subjects, they examined the relationship between histological findings, and anthropometric and biochemical data, including insulin resistance. Insulin resistance was determined by the homeostasis model assessment (HOMA-IR). The team also compared fasting serum insulin, C peptide, and HOMA-IR levels in 121 hepatitis C virus patients with stage 0 or 1 hepatic fibrosis and 137 healthy volunteers. Insulin resistance was an independent predictor of the degree of fibrosis. The researchers found that hepatitis C virusinfected subjects with stage 0 or 1 hepatic fibrosis had higher levels of insulin, C peptide, and HOMA-IR than the controls. In the 250 hepatitis C virus patients, viral genotype and portal inflammation were univariate predictors of HOMA-IR. Using multiple linear regression analysis, the team identified BMI, previous failed antiviral treatment, portal inflammatory grade, and genotype 3 status as independent predictors of HOMA-IR Patients with genotype 3 had significantly lower HOMA-IR than other genotypes. The team also found that HOMA-IR was an independent predictor for the degree of fibrosis, as well as the rate of fibrosis progression. Dr Jason Hui's team concluded, "Hepatitis C virus may induce insulin resistance irrespective of the severity of liver disease, and this effect seems to be genotype specific". "Further, our findings support the hypothesis that insulin resistance may contribute to fibrotic progression in chronic hepatitis C virus infection".
Efficacy of Early Re-treatment with Interferon Beta for Relapse in Patients with Genotype Ib Chronic Hepatitis C Nomura H, Sou S, Nagahama T, Hayashi J, Kashiwagi S, Ishibashi H. Interferon (IFN) retreatment for hepatitis C virus (HCV) relapsers has been effective under some conditions. Japanese researchers conducted a randomised, controlled trial of IFN beta retreatment for HCV relapsers after failure of IFN alfa. 43 patients who had relapse of HCV after 24 weeks IFN alfa monotherapy received IFN beta 6MIU therapy. The 43 patients were randomly assigned to two groups: *Group A started retreatment within 4 weeks after relapse; and *Group B started retreatment 24 weeks or more after relapse. Results Nine patients showed sustained virological response (SVR) to the retreatment. All of these patients were in a low viral load subgroup. The SVR rate in Group A (8/22, 36%) was significantly higher than in Group B (1/21, 5%) (P=0.0128). Among patients with lower viral load, the SVR rate in Group A (8/10, 80%) was also significantly higher than in Group B (1/8, 13%) (P=0.0076). The authors conclude, “Re-treatment with IFN beta is effective for patients with HCV low viral load, and the sooner after the relapse the retreatment is started, the better the clinical results will be.� Department of Internal Medicine, Shin-Kokura Hospital, 1-3-1 Kanada, Kokurakitaku, KitaKyushu, Japan. 03/03/04 Reference H Nomura and others. Efficacy of Early Retreatment with Interferon Beta for Relapse in Patients with genotype Ib chronic hepatitis C. Hepatology Research 28(1): 36-40. January 2004. Abridged with thanks via... hivandhepatitis.com
Abridged with thanks via HEPV_L email list.
4
Hepatitis C Community News
Issue 25
Yarnin’ Up Hep C New education resources for Indigenous communities. Two written resources designed to encourage conversations in Indigenous communities about Hep C and Hep C prevention have recently been produced in S.A. The Commonwealth Government funded this through our State HIV and HCV Programs Unit and many local communities and organisations participated in their development, including the Hep C Council.
Community Leaflet The first resource is a small leaflet meant for the metro area. It gives basic information about Hep C and how to avoid infection and has been designed to fit in wallets and back pockets.
Education Booklet The second resource is a booklet for use by trained workers who are in a situation where they can talk with a person in more detail to answer questions and elaborate on the issues specific to them. There are 4 sections in the booklet: 1. 2. 3. 4.
What is Hep C? How is Hep C transmitted? Treatment and Care Getting Support in Metro. Adelaide
Each section has an introduction followed by a question and answer ‘wheel’ that you can turn in order to find answers to commonly asked questions. Many South Australian Aboriginal organisations have been sent free copies from the first print run. The Hep C Council has copies of both these resources, however the Education Booklet may only be viewed at this stage due to a limited number of copies. You can go to the cope website to see them at www.cope.edu.au and click on documents at the top right of the page. Or to find out more contact Jen Hamer Relationships Australia SA (8245 8100).
Hepatitis C Community News
Issue 25
5
Breastmilk Positives Breastmilk defends babies against viruses Elusive proof that mothers give their babies an immune response to viral illnesses through breast milk - even when the mother isn't sick herself - has been found by an Australian researcher. The work, part of the doctoral thesis by Dani-Louise Bryan of the Paediatrics and Child Health department of Flinders University in Adelaide, found that mothers produce antibodies in breast milk if they are exposed to pathogens their babies encounter, regardless of whether they display any symptoms of disease.
Although the research found a link, more work needs to be done to understand what the immune cells are doing in the infant once they have been passed through the milk. ABC News in Science 12/06/2003 Abridged from www.abc.net.au/science/news/ stories/s877755.htm
Article first appeared in “The Hep C Review�, Edition 42, Sept 2003, page 29. Reprinted with Thanks.
"What we were looking at was whether exposure to a viral antigen causes a feedback response in the mother to the infant being ill," Bryan told ABC Science Online. The research concentrated on a common virus in childhood, RSV (respiratory syncytial virus). "It is one of the most common respiratory pathogens of infancy, and the majority of infants will be infected with it in their first 12 months of life," said Bryan. "In a significant proportion of those, it develops into a very severe bronchiolitis which requires hospitalisation." The research targeted the mothers of hospitalised infants, requesting breast milk from them. They then compared it to the milk of healthy mothers in the general community, looking at a number of different factors in their milk. All the babies in the study were exclusively breastfed. In the breast milk of mothers with sick babies, Bryan found a four- to five-fold increase in the total number of white blood cells - which help protect against viral and bacterial infections compared to the healthy control mothers.
AMAZING, INDEED Aoccdrnig to a rscheearch at Cmabrigde Uinervtisy, it deosn't mttaer in waht oredr the ltteers in a wrod are, the olny iprmoetnt tihng is taht the frist and lsat ltteer be at the rghit pclae. The rset can be a total mses and you can sitll raed it wouthit porbelm.Tihs is bcuseae the huamn mnid deos not raed ervey lteter by istlef, but the wrod as a wlohe. Amzanig huh?
"Obviously, there is some type of feedback in the mums being exposed to the virus," said Bryan. "The mum didn't need to be suffering from the virus, but the feedback is still strong enough that the milk was changing to help the baby."
6
Hepatitis C Community News
Issue 25
Jargon Buster Some medical terminology used these days can be beyond your average practitioner let alone the poor old layman, so this little section has been added to assist with some of the terms and words that may appear in this newsletter, and various journals, from time to time. If you have seen a term or word that you would like clarified, please let us know and we will do our best to clear the air for everyone. Titer [Fr, titre, to make a standard] 1. the normality of a solution or substance, determined by titration to find the equivalence of two reactants. 2. the extent to which an antibody can be diluted before losing it’s power to react with a specific antigen. 3. the highest dilution of a serum that causes clumping of bacteria. Also spelled titre. Prophylaxis [Gk, prophylax, advance guard] Prevention of or protection against disease, often involving the use of a biologic, chemical, or mechanical agent to destroy or prevent the entry of infectious organisms. Cutaneous [L, cutis, skin] Pertaining to the skin.
Impetiginous Lesions – Impetigo [L, impetus, an attack] A streptococcal, staphylococcal, or combined infection of the skin beginning as focal erythema and progressing to pruritic vesicles, erosions, and honey-coloured crusts. Lesions usually form on the face and spread locally. The disorder is highly contagious through contact with the discharge from the lesions. Nosocomial [Gk, nosokomeian, hospital] Pertaining to a hospital. Viraemia / Viremia [L, virus + Gk, haima, blood] The presence of viruses in the blood. Qualitative [L, quails] Pertaining to the quality, value, or nature of something.
Subcutaneous [L, sub + cutis, skin] Beneath the skin. Percutaneous [L, per + cutis, skin] Performed through the skin, such as biopsy; aspiration of fluid from a space below the skin using a needle, catheter, and syringe; or instillation of a fluid in a cavity or space by similar means. Hepatic [Gk, hepar, liver] Pertaining to the liver.
Qualitative analysis [L, quails, what kind; Gk, analysis a loosening] 1. (in chemistry) the study of a sample of material to determine what chemical substances are present. 2. (in research) the analysis and interpretation of data that cannot be analysed by statistical methods. Quantitative [L, quantus, how much] Capable of being measured.
Horizontal Transmission The spread of an infectious agent from one person or group to another, usually through contact with contaminated material, such as sputum or faeces. Sputum [L, spittle] Material coughed up from the lungs and expectorated through the mouth. It contains mucus, cellular debris, or micro-organisms, and it also may contain blood or pus.
Quantitative analysis [L, quantum, how much; Gk, analysis, a loosening] 1. (in chemistry) the determination of the amounts of constituents in a sample of material. Kinds of quantitative analysis include gravimetric analysis, volumetric analysis, and spectrophotometric analysis. 2. (in research) the use of statistical methods to analyse data.
Hepatitis C Community News
Issue 25
7
Cerebral dysfunction in chronic hepatitis C infection
HCV/HIV coinfection:
A number of studies have reported an association between chronic hepatitis C (HCV) infection and significant impairments in health-related quality of life (QOL), which are independent of the severity of liver disease.
Tracy Swan, Treatment Action Group
There are numerous reports documenting the prevalence of symptoms such as fatigue and depression in chronic HCV infection, which may in part account for the reductions in quality of life. Although there are a large number of potential explanations for these symptoms, including depression and anxiety associated with the diagnosis of HCV infection or substance abuse, there has been recent interest in the possibility of a biological effect of HCV infection on cerebral function. There is emerging evidence of mild, but significant neurocognitive impairment in HCV infection, which cannot be attributed to substance abuse, coexistent depression or hepatic encephalopathy. In vivo magnetic resonance spectroscopy and neurophysiological studies have suggested that a biological mechanism may underlie these cognitive findings. The recent detection of HCV genetic sequences in post mortem brain tissue raises the intriguing possibility that HCV infection of the central nervous system may be related to the reported neuropsychological symptoms and cognitive impairment. Abridged with thanks via the HEPV_L email list.
International recommendations published
Tracy Swan is the Coinfection Project Director for the New York-based Treatment Action Group. The HCV-HIV International Panel, a group of medical experts in HIV and HCV, has released new recommendations for the care of HIV/HCV co-infected patients. The panel has updated its 2002 recommendations to include new information on both viruses and their treatment. The new recommendations are framed around nine questions addressing current controversies about the natural history of HIV in co-infected persons, the use of liver biopsy, HCV treatment and side effect management, antiretroviral hepatotoxicity and liver transplantation. Since HCV genotypes 1 and 4 do not respond as well to treatment as genotypes 2 and 3, those with HCV-1 and HCV-4 may prefer to delay therapy until more effective drugs become available. The panel recommends a liver biopsy for these individuals. HCV therapy may be delayed in genotypes 1 and 4 if no fibrosis is present. For those with minimal fibrosis who do not want HCV treatment, the panel recommends repeat biopsies every two to three years. Although HIV accelerates HCV disease progression, the effect of HCV on HIV disease progression is unclear. Although some studies suggest that HCV co-infection may accelerate HIV disease progression, other large clinical and epidemiological studies have not identified HCV co-infection as a co-factor for HIV disease progression. Given what is known about the natural history of HCV in HIV-positive persons, the panel takes an aggressive stance on HCV treatment. References Soriano V et al. Care of patients with hepatitis C and HIV co-infection. AIDS 18: 1 —12, 2004. Abridged with thanks via‌ aidsmap.com
8
Hepatitis C Community News
Issue 25
Co-infection Trials Worldwide, approximately 30% of people infected with human immunodeficiency virus (HIV) also have hepatitis C (HCV) and in these patients, liver disease progresses more rapidly to cirrhosis, end stage liver disease and hepatocellular carcinoma (liver cancer). Liver disease is now the leading cause of death in patients with HIV.
Methods: We randomised 868 HIV/HCV coinfected subjects in 19 countries to 48 weeks of treatment with interferon-α-2a (IFN) 3-MIU 3 times a week plus 800 mg/day ribavirin (RBV), peginterferon-α-2a (40 kD) 180 µg weekly (PEGASYS) plus placebo, or PEGASYS 180 µg weekly plus 800 mg/day RBV.
Typically, patients infected with the hepatitis C virus experience damage to their liver over a long period of time: 20% of those with chronic HCV develop cirrhosis, although this may not be detected until up to 20 years after infection. HIV/HCV co-infection however, accelerates the progression of disease in the liver.
Eligible subjects were HCV RNA and HCV antibody positive, had compensated liver disease, a CD4+ count >100 cells/mL, and stable HIV disease, with or without antiretroviral therapy (ART). The primary endpoint, sustained virological response, was defined as HCV RNA <50 IU/mL at the end of 24 weeks of treatmentfree follow-up (week 72), determined by the COBAS AMPLICOR HCV Test v 2.0.
Co-infected patients progress to cirrhosis twice as quickly. Hepatocellular carcinoma (liver cancer) also appears to occur at a younger age and after a shorter duration of HCV infection in co-infected individuals. The study APRICOT (AIDS PEGASYS Ribavirin International CO-infection Trial) is the largest and only multinational study evaluating the efficacy and safety of pegylated interferon combination therapy in people co-infected with HIV-HCV. Scope of the Trial Patients were recruited for the study from 95 centres in 19 countries including Australia: ♦Argentina ♦Australia ♦Austria ♦Belgium ♦Brazil ♦Canada ♦Denmark
♦France ♦Germany ♦Italy ♦Mexico ♦Netherlands ♦Norway ♦Portugal
♦Spain ♦Sweden ♦Switzerland ♦UK ♦US
Centres in Australia included: • • • • •
Fremantle Hospital, Perth Albion Street Medical Centre, Sydney Royal Brisbane Hospital, Brisbane Royal Melbourne Hospital, Melbourne St. Vincent’s Medical Centre, Sydney
With the large pool of patients studied (868), APRICOT has undoubtedly provided robust evidence and guidance on the appropriate management of this much understudied patient population.
A total of 860 subjects received study drugs. Final week-72 results are presented in the table below. IFN/RBV HCV Virological Outcome (A) (%) (n = 285)
PEGASYS/ PEGASYS/ placebo RBV (B)
(C)
(n = 286)
(n = 289)
End-oftreatment
41 (14%)
95 (33%)
143 (49%)
Sustained virological response Overall
33 (12%)
58 (20%)
116 (40%)
Conclusions: The combination of PEGASYS + RBV produced significantly higher sustained virological response rates than conventional IFN + RBV in HCV/HIV co-infection (40% vs 12%, p <0.0001). In addition to this landmark study which will provide solid guidance to physicians treating coinfected patients, 30 local clinical trials with Pegasys® or Pegasys®RBVTM combination therapy are currently ongoing in patients with HIV/HCV co-infection. There are 20 countries involved in this program, including the US, Australia, France, Spain, Germany and Italy, which plan to enrol about 4,000 patients and in fact, already half of them have been recruited. Abridged with thanks via Edelman Health.
Hepatitis C Community News
Issue 25
9
Patients with Chronic Hepatitis C and Normal ALT Levels Show Impaired Quality of Life But Significantly Lower Liver Inflammation and Fibrosis Progression Compared to Patients with Elevated ALT A significant proportion of the patients chronically infected with the hepatitis C virus (HCV) have persistently normal serum ALT levels. Previous studies suggested a lower risk for these patients to progress to liver cirrhosis and its sequelae. Comprehensive data on the quality of life in these patients are currently not available. In the present study, 45 patients with chronic hepatitis C and persistently normal aminotransferases, defined by normal serum ALT levels on at least three occasions during a 6 months period, 70 patients with chronic hepatitis C and elevated aminotransferases and 50 healthy subjects without any evidence of a chronic disease were enrolled. Patients with chronic hepatitis C and persistently normal ALT levels and healthy subjects were matched regarding age and gender. For patients with chronic hepatitis C several biochemical (e. g. ALT, AST, ferritine) and virological tests (e. g. HCV RNA serum concentration, HCV genotype) were performed. In 27/45 patients with persistently normal ALT levels and in 68/70 patients with elevated ALT levels liver inflammation and fibrosis were histologically evaluated by the HAI scoring system. Emotional and psychological states were measured by a German adapted and validated “Profile of Mood States scale,” which measures 4 factor scores for depression, fatigue, vigour, and anger. Furthermore, quality of life was assessed by the “Everyday Life” questionnaire (EDLQ), a German validated questionnaire related to the SF36 Health Survey. Statistical significance was assessed by Fisher exact test and Mann-Whitney U test. Study Results In patients with chronic hepatitis C and persistently normal ALT levels duration of infection was significantly longer than in patients with chronic hepatitis C and elevated ALT levels (176.9 vs. 131.2 months; p=.016). However, the portion of male patients (36% vs. 66%; p=.001) and the number of patients with hepatitis B infection in the past (27 vs. 51%; p=.01) were significantly lower in the group of patients with persistently normal ALT levels. Liver histology showed significantly less inflammation (3.88 vs. 4.89; p<.02) in patients with persistently normal ALT levels compared with those with elevated ALT levels.
10
Calculation of the liver fibrosis progression rate per year as the ratio between the liver fibrosis stage and the estimated duration of infection in years revealed a significant lower fibrosis progression rate for patients with persistently normal ALT levels (0.2 vs. 0.5; p=.002). However, current stage of liver fibrosis was similar in both groups. In patients with persistently normal ALT levels the “Profile of Mood States scale” showed a reduction in quality of life in all 4 items compared with the matched control group with significant differences for depression (p=.006) and anger (p=.007). In the EDLQ significant differences were also found for the items body (p=.04), relationship to partner (p=.01), self-confidence (p=.04), and zest for life (p=.01) between patients with chronic hepatitis C and persistently normal ALT levels and healthy subjects. No significant differences were observed for any item in POMS or EDLQ between patients with chronic hepatitis C and persistently normal ALT levels and patients with elevated ALT levels and chronic hepatitis C. Conclusions Patients with chronic hepatitis C and persistently normal ALT levels show significantly lower liver inflammation and fibrosis progression rate per year compared with patients with elevated ALT levels. Quality of life assessments show a significant impairment of health-related quality of life in patients with chronic hepatitis C compared with healthy controls, however, no differences between chronically HCV-infected patients with persistently normal or elevated aminotransferase levels. 10/27/03 Reference M von Wagner and others. IMPAIRED QUALITY OF LIFE IN PATIENTS WITH CHRONIC HEPATITIS C AND PERSISTENTLY NORMAL AMINOTRANSFERASE LEVELS. Abstract 606 (poster). 54th AASLD. October 24-28, 2003. Boston, MA. Abridged with thanks via... hivandhepatitis.com
Hepatitis C Community News
Issue 25
Anaemia drug helpful in patients with hepatitis C NEW YORK (Reuters Health) The red blood cell-boosting drug erythropoietin improves haemoglobin levels in patients with anaemia caused by the drugs used to treat hepatitis C. The hepatitis C virus can cause permanent liver damage, cancer, or even death. Early symptoms include fatigue, which can progress to the yellow staining of the skin called jaundice and swelling of the abdomen. People can get the virus through any exposure to infected blood, including intravenous drug use, body piercing, tattooing, unbandaged cuts or poorly sterilised medical equipment and blood transfusions.
"Based on the results of this study," the authors conclude, "epoetin alfa seems to be promising for the treatment of anaemia in HCV-infected patients receiving ribavirin/interferon combination therapy. Further research is warranted to investigate the potential impact of epoetin alfa therapy on outcomes, including quality of life and sustained viral response." SOURCE: American Journal of Gastroenterology, November 2003. Abridged with thanks via the HEPV_L email list.
Standard treatment for hepatitis C infection includes the immune system protein interferon alfa in combination with the antiviral agent ribavirin, both of which are associated with decreased haemoglobin levels, Dr. Douglas T. Dieterich and his associates note in the American Journal of Gastroenterology. When anaemia results, ribavirin doses are usually reduced to levels that are likely to be less effective in controlling the hepatitis C virus. Dieterich, from Mount Sinai School of Medicine, New York, and colleagues evaluated the efficacy of once-weekly doses of epoetin alfa in alleviating anaemia and minimizing ribavirin dose reductions in 64 anaemic, HCV-infected patients. After 16 weeks, patients assigned to epoetin alfa treatment had higher mean haemoglobin levels than did patients assigned to standard care, the authors report. Moreover, 83 percent of patients receiving epoetin alfa maintained daily ribavirin doses of 800 mg or more, compared with only 54 percent of patients receiving standard care. Improvements in quality of life measures were greater in the epoetin alfa treatment group than in the standard care group, the investigators report, and epoetin alfa treatment was well tolerated.
Hepatitis C Community News
Issue 25
11
Personals MY HEP C SINCE 1993
I
will never forget how scared I was when being told that I have Hepatitis C. Back in 1993 doctors didn’t know much compared to now. It was only because of one and a half bottles of Jim Beam that I felt pain around my liver area, so I went to see a GP to find out what was wrong. The GP sent me to go and get a blood test, when I got my results back, and told “you have Hepatitis C Wayne” I was shocked. It was the scariest time of my life to date. As I was worried about people close to me and around me that I would pass it on. Thank the Lord that wasn’t the case, but at that time I didn’t know anything about Hepatitis C, and we all know the unknown can scare the hell out of people. Later on with my first specialist we worked out that I caught Hep C from sharing a needle when I was younger. I didn’t know not to share back then. Hopefully one day there will be an add campaign like the government has done for HIV in the eighties. Since having my Hep-C I have lost a beautiful lady years ago, she left because a G.P. told her that you could get Hepatitis C from kissing someone. It was probably my fault for not letting her know up front. It’s a catch 22 situations if you tell someone you have Hep C up front because if they don’t know anything about Hepatitis C it scares the hell out of them. Now more is known about this disease called Hepatitis C. You would think all GP’s would be up to date, but still some GP’s are giving misleading information about Hepatitis C. Hopefully soon they will all get the information right for the general public.
they are afraid of Hepatitis C. It is just that the general public don’t know anything about the virus, and why would they. I hope in the future it changes and people with Hepatitis aren’t treated in such an alienating way. Discrimination hurts! I made some choices when I had no information (education) about blood borne viruses that I would not make today. At one of my job’s in the past I let the 12 blokes I worked with know that I had Hepatitis C. Management rang the Hepatitis C Council and got two educators from the Council out to let everyone know the In’s and Out’s about the virus. Out of 12 blokes 11 were happy to work with me. Only one person was still worried, but you can’t educate some people. I wish everyone that’s got Hepatitis C knew of the Hepatitis C Council’s around Australia. I know once I found out about the Hepatitis C Council of SA and went there I have learnt a lot about my virus. The Hep C Council has helped me so much. The Council not only provides education about the virus they also provide courses for volunteers and also have meditation classes on Tuesday nights in house. I go to the meditation classes every week and I find them so relaxing. They are great. The Council is the best place for information. Thanks to all the staff at the Hepatitis C Council for helping me out since I found them, they have helped me more than they will ever know. Yours sincerely, W.R. Warden
In the past at work it has been a catch 22 situation about letting people know or not know about being Hepatitis C positive. Some people are scared to work with me, but I can understand why
12
Hepatitis C Community News
Issue 25
Inspirations WHO AM I ? Don’t judge me on first impressions. Don’t form opinions on what you see. I have many faces and layers, covering the true heart of me. I smile when I am unhappy. I laugh while inside fall the tears. There is a brave mask I pull on, when beneath it I tremble with fear. I look busy and manic and active, with my body just aching for sleep. And yes, I dress in contentment, while inside my heart gently weeps. Sometimes I appear to be peaceful, while within me a storm starts to rage. If you think I am nice just be careful, of what’s lurking behind a locked cage. I will make jokes about things that matter, while my heart just aches to speak out, And though I might seem bold and assured, inside I am riddled with doubt. I make fun of myself in good humour, because I’m scared what another might see; There are failings and faults all around – let me be the first to point fingers at me. When I’m loud it is because I’m longing, for some quietness to draw me in. When I speak too much or too quickly, my resolve has worn a bit thin. If you peel away layer upon layer, and search for the heart that’s inside, if you slowly take time to go deeper, you’ll find a sincere source of pride. For beneath all the acting and nonsense, under the faces, facades and the lies, Is a real person who longs to be loved, to be seen, to be heard, recognized. There is a soul that is holding the wisdom, and the knowledge of all that is real, There is love and light and compassion, there is truth in these things I feel. I would love to just be myself, but I’ve hidden so long I’ve forgot, Which layer represents who I am, and whether it is me, or is not. I sometimes don the clothes of a sinner, when too afraid of the robes of the saint, Then the whore and the hippy and gypsy mix the colours that I myself paint. I play at the hero and the housewife, I’m the hypocrite, and philosopher too, These are some of the many guises, that I wear when I stand before you. I spend time soul-searching as a woman, finding joy as a mother and child, Yet can still revel in the crone’s wisdom, or be the pagan untamed and wild. I celebrate my role as the nurturer, echoing the calling of true mother earth, Being the lover is my greatest moment, as my heart reflects my own self worth. I am the victim, warrior, artist, seeker of spiritual freedom and wealth. But nowhere is the play acting stronger than when I try to examine myself. But please, don’t let this all fool you. Don’t let this enigma drive you away. If you take the time to look deeply, such faith will be rewarded both ways. I will cry if you hurt or reject me. If you cut me, I surely will bleed. For inside me is a place full of feelings, of questions, of longings, of need. And I am no different to you. You must know in your depths, how I feel. I seek the oneness of home and belonging. My humanness is all that is real. Such mystery might fool myself and others, but reality is at home in my soul; Beneath the surface compassion lies waiting, in the me that is perfect and whole. © Wendy Slee.
Hepatitis C Community News
Issue 25
13
The Birth of a new Medicine Once a compound has been identified as a potential drug candidate, it goes through an exacting, rigorous process to prove that the new drug is both safe and effective. There are a number of steps involved in researching and developing a new medicine. Drug target selection Researchers study the biology of a disease to understand the biological processes, or biochemical pathways, that may be altered in a disease state.
Gene function/target association By finding the identifying specific genes linked to disease states, new drug targets can be identified by looking for gene sequence associations with disease-causing proteins.
Linking a target to a potential new medicine Once a target has been selected, researchers begin to test or screen compounds to find those that bind to the target and affect its function in the desired way.
Finding the best potential medicine for further development To identify an optimal single drug candidate, each promising compound is further tested for its biological, physical and chemical properties. Tests also check it can be made in large quantities and can be formulated into a dosage form, such as a tablet or capsule.
Pre-clinical testing Pre-clinical research is conducted under four categories: 1: safety evaluation/ dose selection. 2: genetic toxicity studies. 3: design of clinical trials. 4: manufacturing of sufficient quantities for clinical trials.
Testing the hypothesis Early clinical trials and non-clinical studies test, refine and prove the hypothesis of how the drug will act in people. Phase Ϊ clinical trials on 20 to 80 healthy volunteers gather safety and pharmacology data for the drug. Phase Π clinical trials on 100-300 volunteers with the target disease, establish dosage, efficacy and safety.
Making the product As part of the eventual transfer to fullscale manufacturing, the first trial batches are made at manufacturing sites. The best large-scale manufacturing methods are identified, tested and validated at this stage.
Phase Ш trials and beyond Phase Ш clinical trials are conducted to confirm safety and efficacy and to provide regulatory data. Typically, they involve between 600 and 3,000 people and can take three years or more to complete. They also generate evidence to support claims concerning efficacy, safety and so on.
File and launch The research data is then submitted to regulatory agencies around the world - to apply for government licences to market the product for a particular medical condition.
14
Hepatitis C Community News
Issue 25
Did you know it is illegal to take PBS medicine overseas unless it is for your personal use or the use of someone travelling with you?
If you’re planning a trip overseas, organising your medicine is one of the most important things you can do. If you take a prescription medicine regularly, it is important that you take this medicine with you so that you remain in good health while you are away. It is also important that you are aware of the legal requirements associated with carrying or sending PBS medicine overseas.
Legal Issues
•
Carrying or sending PBS medicine overseas that is not for your personal use or the personal use of someone travelling with you is illegal. People who are found to be dealing with a PBS medicine in a way other than which it was meant risk a fine of up to $5000 and/or two years imprisonment. There are also restrictions on the amount of PBS medicine you can carry or send overseas. Giving PBS medicine to family or friends that has not been prescribed for them, is not only against the law, but may endanger their health. It can be dangerous to take medicine that is past its use-by date or medicine that has not been prescribed for you.
Taking PBS medicine overseas When planning to travel overseas with PBS medicine for your personal use or the personal use of someone travelling with you, it is important that you: • talk to your doctor and discuss the medicine you will need to take with you; • contact the embassy of the country you are visiting to ensure the medicine is legal there; • carry a letter from your doctor detailing what the medicine is, how much you will be taking, and stating that it is for your own personal use; and • leave the medicine in its original packaging so it is clearly labelled with your name and dosage instructions.
• •
enclose a letter from your doctor in the package outlining the details of the medicine, why you are sending it and stating that it is for your personal use; leave the medicine in its original packaging so it is clearly labelled with your name and dosage instructions; and attach to their parcel a completed Customs declaration available from any post office, disclosing that the package contains prescription medicine that is for personal use.
Information about PBS medicines you need to provide Customs may detain any medicine they suspect is being illegally exported. It is therefore in your best interest to provide documentation explaining what the medicine is, how much you are carrying or sending, and that it is for your personal use. If you are unable to get the letter from your doctor, HIC's Medicine Export Declaration may be sufficient to satisfy Customs that the medicine is for your personal use. People found to be illegally diverting PBS medicine overseas may be prosecuted.
More information For more information about carrying or sending PBS medicine overseas, call HIC’s Overseas Drug Diversion information line 1800 500 147.
Sending PBS medicine overseas When planning to send PBS medicine overseas before you travel, for your personal use or for the personal use of someone who will be travelling with you, it is important that you: • talk to your doctor and discuss the medicine you will need to send; • contact the embassy of the country to which you are sending the medicine to ensure it is legal there; Hepatitis C Community News
Issue 25
15
Hepatitis C Council of SA
C-Clearly
Phone the Hep C Council for confidential information and support about hep C, as well as free written information. The Hep C Council also runs information and support sessions. Phone to find out about upcoming sessions. 4 The Parade, Norwood. Phone: 8362 8443 or 1800 02 11 33 (SA Regional Callers) Email: admin@hepccouncilsa.asn.au Web: www.hepccouncilsa.asn.au
C-Clearly helps to coordinate the health care of people living with hepatitis C and people who may be at increased risk of infection with hepatitis C. CClearly can help you find a â&#x20AC;&#x153;userfriendlyâ&#x20AC;? GP as well as access to a psychologist and a dietician. Phone: 8410 0466 or 0428 428 027 Email: William@careandprevention.org
MOSAIC Project
The Adelaide Dental Hospital is a specially funded clinic for people with hep C who also have a Health Care Card to receive priority dental care. Some research on dental health is carried out at the clinic, however it is up to you if you choose to participate.
Free and confidential counselling for people with hepatitis C. Daytime and evening appointments are available. Phone: 8245 8100 and ask for MOSAIC
Adelaide Dental Hospital
Phone the Hepatitis C Council for a referral on 8362 8443
PEACE (Personal Education and Community
Empowerment) A Multicultural Program
PEACE provides support, education, information and referral services for culturally and linguistically diverse communities affected, or at risk of infection of hepatitis C and/or HIV. Phone: 8223 3433
SAVIVE (SA Voice for IV Education) SAVIVE provides peer-based support, information and user education. SAVIVE is a Clean Needle Program outlet 64 Fullarton Road, Norwood. Phone: 8362 9299 Email: savive@camtech.net.au
Streetlink Streetlink is a service for people aged 12-25 years who are homeless or at risk of being homeless. Through Streetlink you can access information about hep C prevention as well as free medical and counselling services for you or your children. 1st floor, 27 Gresham St, Adelaide. Phone: 8231 4844 Email: streetlink@ucwadel.org.au
[CNP] Locations for statewide Clean Needle Programs Contact
ADIS [Alcohol &Drug Information Service] Phone 1 300 131 340
16
Hepatitis C Community News
Issue 25