Ms Stephanie Mikac
Committee Secretary
Standing Committee on Health
PO Box 6021
Parliament House
Canberra ACT 2600

Standing Committee on Health Inquiry into Hepatitis C in Australia

Dear Ms Mikac

The Standing Committee’s Inquiry into Hepatitis C in Australia is welcomed by Hepatitis ACT, affected communities in the ACT, and stakeholders with an interest in public health.

I make this submission on behalf of Hepatitis ACT, its members, and communities of interest. Our membership is composed of people living with or at elevated risk of hepatitis C, people who are in custody, carers and family members of affected people, academics, community workers, and health professionals. As an organisational member of Hepatitis Australia, we also endorse Hepatitis Australia’s submission to this Inquiry.

Hepatitis ACT is the Australian Capital Territory’s community hepatitis organisation. We are funded by ACT Health to deliver a comprehensive range of hepatitis-related information/education, health promotion, training, support, prevention, advocacy and representation, and referral services. A priority setting for our service delivery is the Alexander Maconochie Centre – the ACT’s prison.

The attached submission is structured to provide an ACT community perspective on the Inquiry’s Terms of Reference. It concentrates where possible on our experience in the ACT and defers to those better placed to present a national picture.

I would be delighted to assist if further information about our submission is required.

Yours sincerely
John Didlick
Executive Officer
26 February 2015

Hepatitis ACT Submission to the Inquiry into Hepatitis C in Australia

Prevalence rates
Hepatitis ACT estimates there are ~4,000 people living with hepatitis C in the ACT. This estimation extrapolates the national rate, and takes account of ACT treatment rates that are well below the national average. The Alexander Maconochie Centre – the ACT’s prison – has very high rates of hepatitis C and ongoing but under-notified in-prison transmission.

Hepatitis C testing
The Kirby Institute estimated there were 90 hepatitis C incident cases (i.e. newly acquired infections) in 2013 in the ACT, whereas ACT hepatitis C incident notifications (i.e. newly acquired infections diagnosed) totalled just 14. The gulf between estimated incident cases and notified incident cases illustrates the inadequacy of testing for hepatitis C in the ACT, especially within communities of people at greatest risk. This disparity is also reflected nationally with an estimated 5,400 incident cases but only 407 incident notifications in 2013.1

Rapid testing, especially if targeted for the most vulnerable communities, has the potential to increase the quantum of testing and reduce the extent of undiagnosed infection. As has been demonstrated by the HIV sector, rapid testing can encourage a person to undergo testing when that person might not ordinarily take up the opportunity.

In addition to rapid testing, dry blood spot testing (because of its advantages for people with poor venous access – especially vein damage due to injecting drug use) has the potential to increase testing and reduce the extent of undiagnosed infection in populations of people who inject drugs.2 This will require additional TGA approval.

Early testing, and therefore earlier diagnosis, can help reduce the transmission of hepatitis C. When people are aware of their status, taking steps to minimise the risk of onward transmission can become more important. Diagnosis should also allow an affected person to seek treatment. With current approaches to treatment however, there exists a culture of not treating hepatitis C. Whilst that culture exists, affected people will have low expectations of treatment and cure, and there will remain a perceived futility in increasing diagnoses whilst access to treatment is rare.

Hepatitis C treatment
Nationally, just 1% of people living with hepatitis C are treated annually. Although ACT data are not released by ACT Health, Hepatitis ACT understands the ACT treatment rate to be lower than the national rate. Both reflect an appalling situation, unprecedented in every respect.

Hepatitis ACT supports the treatment target in the national strategy3 -to increase by 50% each year the number of people undergoing treatment. In order to achieve this goal, broad access to new direct acting antiviral medicines should be approved without further delay. Whilst access to new medicines is critical, so too is expanding access to treatment through different models of care. These strategies are linked, as it is only with access to new directing acting antivirals that new models of care will be broadly adopted.

Many hepatitis C experts speak of “the warehousing effect”, whereby antiviral treatment for the vast majority of affected people is postponed. This occurs for a number of reasons and has a similar effect to a “holding pattern” facilitated by air traffic control. In this case the holding pattern is composed of thousands and thousands of Australians – with a safe landing unavailable to most. This is unsafe and unacceptable.

The warehousing effect and rumoured restrictions in access to new direct acting antiviral medicines both create a perverse situation whereby a person with advanced liver disease may receive treatment whilst another person in earlier stages of liver disease may not. In other words, a person may qualify to receive medicines that can prevent serious liver disease only when they have serious liver disease. At the risk of using excessive metaphors, this is the ambulance at the bottom of the cliff rather than the fence at the top.

Preventing new hepatitis C infections
Much is known about strategies to prevent new hepatitis C infections. Experience has taught us that a suite of strategies is required including disease awareness at the community level, prevention education, testing and diagnosis, antiviral treatment, regulation of exposure prone procedures (both clinical and body art) and blood products, and primary prevention through the Needle and Syringe Program.

According to the National Centre in HIV Epidemiology and Clinical Research4 the Australian Government’s investment of $243 million in community needle and syringe programs had by 2009 prevented an estimated 96,667 cases of hepatitis C and 32,050 cases of HIV. Some $1.28 billion dollars in direct health care costs were averted and, when patient/client costs and productivity was included, the value of the NSP was estimated to be $5.85 billion. In other words every dollar invested returned $27 in cost savings. Importantly, the report found significant benefits would be attained with expanded distribution of sterile equipment.

Given the indisputable prevention benefits of community needle and syringe programs, it is an unfortunate failing to-date that regulated access to sterile equipment is not available in Australian prisons. Despite community submissions urging otherwise, the new National Blood Borne Virus and Sexually Transmissible Infections Strategies failed to retain the policy support of previous strategies for prison based needle and syringe programs. A strong evidence base demonstrates that regulated prison-based needle and syringe exchange programs make prisons safer and healthier. For example after ten years with a needle and syringe program at Pereiro de Aguiar prison in Spain, the prevalence of hepatitis C in that prison had decreased from 40% to 26% and HIV from 21% to 8.5%.5

Regulated prison NSPs reduce blood borne virus transmission, reduce overdose deaths, help create better relationships between staff and detainees, lead to an increase in assessment and treatment of drug related problems, and are not associated with increased drug use or drug supply. Regulated prison needle and syringe programs reduce the risk of needle stick injuries and have been associated with zero incidents of regulated equipment being used as a weapon.67

Professor Neal Blewett – former Federal Health Minister, key architect of Medicare and the Australian Needle and Syringe Program – said on 20 March 2013 “Why should young people, put in prison, in addition to the penalties they pay, also have the punishment of a blood borne viral disease because of the problem with clean needles?” When people are incarcerated for drug related crimes in a prison with access to drugs and shared needles, it is hardly surprising that many will continue to inject.

This is the case in the Alexander Maconochie Centre where, as with all prisons, detainees have access to illicit drugs and to injecting equipment. Theirs currently is the very worst model of a needle and syringe program as it is unregulated, circulates a limited supply of unsterile equipment, and fails to connect its ”clients” with health professionals. Despite the best efforts of Corrective Services’ supply reduction strategies, detainees continue to access and inject illicit substances. They also continue to transmit and contract hepatitis C.

Educators from Hepatitis ACT have built rapport over time with detainees and Corrections staff. We have had many frank discussions about drug use in the prison, access to injecting equipment, and attitudes towards a regulated prison-based needle and syringe program. Contrary to claims made publicly by opponents of an NSP in the prison, the overwhelming majority of detainees we have spoken with at the Alexander Maconochie Centre are supportive of regulated access to sterile injecting equipment. Similarly, we have found that reports of 100% Corrections Officer opposition are exaggerated.

No submission on blood borne virus prevention would be complete without consideration of the potential health and societal benefits of drug law reform. Many of the harms and costs associated with illicit drugs are caused or perpetuated by their illegality rather than their psychoactive effects.8 The harms of illicit drug use include hepatitis C, and the unintended consequences of a policy of prohibition include increasing the transmission of blood borne viruses and increasing the associated stigma and discrimination. Decriminalising homosexuality was a critical element of Australia’s “World’s best response to HIV/AIDS” as it helped reduce stigma, discrimination and the spread of disease. Drug law reform promises similar benefits.

Reducing stigma
Stigma associated with hepatitis C occurs because of a number of factors, among them societal attitudes to drug use and to prisoners. Another important contributor is the way in which hepatitis C is characterised and invisibilised. These help create a fear of identification, stigma and discrimination which keeps people silent and also stops people from seeking help. It follows then that actual stigma and discrimination reinforce that fear and reinforce the safety of silence and anonymity.

Inequity and discrimination in healthcare, in policy settings, in research, and in surveillance reporting creates a whole new level of injustice. When people living with hepatitis cannot see themselves in key reports because they and their conditions are diminished and discounted, this is a phenomenon some call “invisibilisation” – to make invisible, to marginalise so as to erase the presence of. To borrow from HIV discourse “If you can remove us from the public discourse, you can render us powerless.”

Invisibilisation of hepatitis occurs when vested interests, power, and sometimes
ignorance seek to or allow hepatitis to be hidden or diminished. It is discrimination. There are many examples of the invisibilisation of hepatitis both in national and jurisdictional settings. They include the absence of various Health Ministers’ media releases on World Hepatitis Day, the focus on incident notification data as a way of comparing epidemics and determining priority, and a priority focus on HIV in national BBV/STI strategies and investment despite its much smaller prevalence and burden.

Invisibilisation, stigma and discrimination create the conditions necessary for 233,000 hepatitis C affected people and their families to remain silent. Only through invisibilisation, stigma and discrimination will they continue to accept one per cent per annum treatment rates and restrictions and delays in access to life saving medicines. This Federal Inquiry is very welcome as the status quo diminishes the focus and relative priority placed on hepatitis C and more importantly upon those who live with it.

In addition to the awareness limiting effects of the invisibilisation of hepatitis C, the broader community remains largely unware of the extent and impacts of the hepatitis C epidemic. Unfortunately, because hepatitis C is a highly stigmatised condition often dismissed as affecting “the other”, the media and the public discourse becomes easily fascinated with far less serious topics such as hepatitis A and frozen berries. Only with secure funding and appropriate resourcing can the national hepatitis organisation – Hepatitis Australia – continue and expand its important work at a national level raising awareness, increasing knowledge and focus, and supporting the state and territory hepatitis organisations to fulfil their missions at the jurisdictional level.

Contacts
Thank you for the opportunity to make this submission on behalf of our members and communities of interest in the ACT. If we can assist further, please contact John Didlick, Executive Officer Hepatitis ACT on executive@hepatitisACT.com.au

or

(02) 6230 6344.

 

1 The Kirby Institute. HIV, viral hepatitis and sexually transmissible infections in Australia Annual Surveillance
Report 2014. The Kirby Institute, UNSW, Sydney
2 J M Tait, Brian P Stephens, Paul G McIntyre, Morgan Evans, John F Dillon. Frontline Gastroenterol. 2013;4(4):255-262.
3 Fourth National Hepatitis Strategy 2014-2017. 2014. Commonwealth of Australia: Canberra.
4 Return on Investment 2: Evaluating the cost effectiveness of needle and syringe programs in Australia 2009. National Centre in HIV Epidemiology and Clinical Research
5 Rev Esp Sanid Penit. 2012;14(1):3-11. Evaluation of needle exchange program at Pereiro de Aguiar prison
(Ourense, Spain): ten years of experience
6 McDonald, D. (2005) The Proposed Needle and Syringe Program at the Alexander Maconochie Centre, Canberra’s New Prison – An information paper on the evidence underlying the proposal. Canberra
7 Moore, M (2011) Balancing Access and Safety: Meeting the challenge of blood borne viruses in prison. Public Health Association of Australia. Canberra
8 McDonald, D 2011, A background paper for an Australia 21 Roundtable, Sydney, 2012, addressing the question ‘What are the likely costs and benefits of a change in Australia’s current policy on illicit drugs?’, Australia 21, Canberra

Recommended ACT Priorities for Action: HCV

1. Advocate for and support timely and broad-based access to newly developed and proven HCV treatments through the PBS

2. Increase by 50% each year the number of people undergoing treatment for HCV, including through shared care models

3. Reduce the incidence of new HCV infections by 50% by increasing access to education and prevention strategies, including expanding access to sterile injecting equipment in community and correctional settings

4. Improve collection, analysis, reporting, and publication of viral hepatitis treatment and surveillance data in the ACT

5. Increase the number of people living with viral hepatitis accessing high quality and regular liver check-ups

BBV prevalence & notifications

Prevalence	Hepatitis C	Hepatitis B	HIV
Globally	170 million	350 million	35 million
Australia	230,000	225,000	26,800
ACT	4,000	3,603	300

 

ACT notifications of all BBVs have increased

Notification	Hepatitis C	Hepatitis B	HIV
2012	147	106	17
2013	184	111	24

 

Recommendation 1. Advocate for and support timely and broad-based access to newly developed and proven HCV treatments through the PBS

• Without new DAAs, the National HCV Strategy treatment targets cannot be met.
• 230% increase in liver related deaths by 2030 without significant change in rates of HCV treatment.

–530 HCV deaths in 2013 -> 1,700 in 2030.

• Current treatments are comparatively poorly tolerated and inefficacious; unsafe for those with advanced disease.
• PLWHCV and clinicians are all waiting for better medicines (the ‘warehouse effect’)
• New better DAAs are already in use in other countries.

Recommendation 2. Increase by 50% each year the number of people undergoing treatment for HCV, including through shared care models

• HCV treatment rates are incredibly low.

–Nationally about 1% PLWHCV treated annually.
–In the ACT, TCH commenced treatment for 223 PLWHCV between April 2004 – March 2012 at an average of 28 PLWHCV treated each year.

• Fastest growing cause of cancer mortality in Australia is liver cancer.
• Tertiary clinic as sole treatment providers is unsustainable.
• If available, new DAAs will enable primary care physicians (GPs; AOD; prisons; AMSs) to more easily expand access to HCV treatment.
• National HCV Strategy treatment target as per Recommendation 2.

Recommendation 3. Reduce the incidence of new HCV infections by 50% by increasing access to education and prevention strategies, including expanding access to sterile injecting equipment in community and correctional settings

• ACT estimated 2013 HCV incidence = 90.
• ACT notified 2012 HCV incident cases = 15.
• Testing deficiencies with most vulnerable groups
• ACT NSP coverage estimated to be ~57%.
• AMC sterile NSP coverage nearly 0%.
• National HCV incidence for PWID has increased from 5.4 to 13.0 per 100 person years (from 2009 to 2013).
• National Strategy incidence target = 50% reduction

Recommendation 4. Improve collection, analysis, reporting, and publication of viral hepatitis treatment and surveillance data in the ACT

• ACT tertiary hepatitis treatment data is parlous, unreliable, and remains unavailable.
• Community, patients, stakeholders and others have no way of knowing the extent and efficacy of ACT hepatitis treatment (or unmet need).
• ACT and national reporting diminishes the focus on hepatitis and the priority placed on PLWVH.
• ~800 PLWHCV in the ACT remain undiagnosed

–??   ~1,800 PLWHBV.

Recommendation 5. Increase the number of people living with viral hepatitis accessing high quality and regular liver check-ups

• Regular liver monitoring of PLWVH can track liver health and help prevent or detect early any serious changes in the liver.
• In lieu of treatment, this is cancer prevention.

–1% PLWHCV treated annually (less in ACT)
–5% PLWHCV receiving antivirals (4.6% in the ACT)

• Cirrhotics, even if successfully treated, require ongoing liver monitoring due to ongoing risk of liver cancer.
• If treatment remains restricted, monitoring of those unable to access treatment is critical.

References

• ACT Chief Health Officers Report 2014
• 2014 Annual Surveillance Report (Kirby Institute)
• Australasian Society for Infectious Diseases (ASID) submission to Federal Parliamentary Inquiry into Hepatitis C.
• Hepatitis ACT submission to The ACT Response.
• Hepatitis Report Card (Hepatitis Australia).
• Hep B Mapping Project Report by Medicare Local (ASHM, VIDRL)
• Kirby Institute submission to Federal Parliamentary Inquiry into Hepatitis C.
• TCH Liver Clinic article ‘Influence of psychiatric diagnosis on treatment uptake…’ (authors: Wu, Shadbolt, Teoh, Blunn, Chiturri, Kaye, Farrell and others).
• The Hepatitis Equity Report: Champions and Challenges (Hepatitis Australia).
• UNAIDS 2014 HIV/AIDS Factsheet

 

 

 

Article from EpochTimes “http://www.epochtimes.com/b5/15/3/19/n4390974.htm”

「甲肝莓果」恐慌後 澳洲專家談肝炎預防

【大紀元2015年03月19日訊】（大紀元記者張美馨、夏墨竹堪培拉報導）上個月澳洲爆發一連串與中國大陸進口的冷凍莓果有關的甲型肝炎病例後，除了要加強食品監管檢驗，強化食品標示法之外，在澳洲的華人朋友如何認識肝炎，預防肝炎也是一個重要的話題。在澳大利亞，大約有20萬人患有乙型肝炎，大約百分之五十的乙肝病毒攜帶者都不知道自己感染了病毒。堪培拉估計有3600位乙肝病毒攜帶者，其中大約1300位是在中國出生的。

在澳洲，引起肝炎最常見的病毒是甲型肝炎病毒、乙型肝炎病毒以及丙型肝炎病毒。這些病毒都不同，它們唯一共有的特點就是會影響肝臟。堪培拉Interchange General Practice主治醫生蘇德明醫師（Dr. Tuckmeng Soo）對記者表示：「甲肝症狀一開始的時候會發燒、疲勞、胃口不好、噁心，過了幾天，病情嚴重下去，小便會發黃，皮膚和眼白也會變黃。甲型肝炎主要是通過受感染的食物或飲水來傳染，例如受感染的冷凍莓果等。甲型肝炎有疫苗可以預

關於甲型肝炎，堪培拉社區肝炎中心（Hepatitis ACT）執行長官John Didlick先生對記者表示：「在澳洲，患甲肝的病人不多。這種病通常在發展中國家比較常見。據我們所知，堪培拉只有一位因為吃了冷凍梅子患上甲肝的病人。我們認為乙肝和丙肝其實比甲肝還要嚴重的多。甲肝是比較好治療的。但是若是已經有了乙肝，甲肝就會比較難治。所以，患有乙肝或丙肝的病人建議接種甲肝疫苗。」

談到乙型肝炎，蘇德明醫師表示：「在澳大利亞，大約有20萬人患有乙肝病，有一半的人不知道自己感染了乙肝病毒，因為他們沒有看過醫生來驗血。在東亞、東南亞、東北亞，差不多十分之一的人有乙肝。澳洲本來沒有很多乙肝病例，但是因為亞洲移民很多，還有很多人沒有做過乙肝檢查。在堪培拉，大約有3600人患有乙肝，很多人來自中國、台灣、越南、馬來西亞等。」

乙肝在中國尤為普遍，中國約有10%的人口被乙肝病毒侵擾。為甚麼亞洲有如此龐大的乙肝病毒感染人群呢？John Didlick先生表示：「世界上乙肝最嚴重的地方都是因為疫苗接種計劃不夠有效而造成的。所以，並不是這些國家的人和我們的生活方式不同而引起肝炎的發病率，只是這些國家的保健服務和免疫規劃不普及。中國的免疫規劃現在有所改善。通過國家的免疫規劃，部份五歲以下的兒童只有百分之一攜帶乙肝病毒。這個計劃防止了16-20萬乙肝病例。但是，因為這個計劃只限於部份五歲以下的兒童，中國國內還有很多沒有接種疫苗的人。」

乙肝病毒攜帶者往往沒有任何癥狀表現，所以很多人雖然攜帶了乙肝病毒，自己卻並不知道。John Didlick先生說：「慢性乙肝就是終身患上了乙肝的病人。這個病通常都沒有病症。所以有很多乙肝病毒攜帶者都不知道他們其實生病了。」

乙肝會致人死亡嗎？蘇德明醫師表示：「乙肝病毒攜帶者一般沒有甚麼感覺，等到他們的肝硬化了，才會覺察到。乙肝病人如果沒有吃藥治療，大約十分之一的病人會從乙肝變為肝硬化，甚至肝癌。」

丙肝也是嚴重的病情。在中國大約有4000萬丙肝病毒攜帶者。John Didlick先生表示：「乙肝和丙肝都是嚴重的疾病。兩種病都會影響肝臟的功能。如果不進行醫治，有可能會致命的。去年，在澳大利亞，乙肝和丙肝導致多於1000人死亡。但是，好消息就是我們已經有又安全又有效的治療方法。這些治療方法都會防止嚴重的肝臟疾病。乙肝和丙肝都是可以用藥治療的，而且這個藥又安全又有效。」

蘇德明醫師建議：「如果你的家人有患肝癌的，你最好檢查一下你是否有乙肝。建議去看你的家庭醫生來驗血。如果查出來你有乙肝，你的家人也需要去做檢查。家庭醫生也會幫你看你需不需要去看專科來治療。如果檢查後沒有感染乙肝，可以跟你的家庭醫生談一談，需不需要接種乙肝疫苗。」

「接種疫苗可以預防甲肝和乙肝，但是目前還沒有研製出相應的丙肝疫苗。」John Didlick先生說，「估計堪培拉有3600位乙肝病毒攜帶者，其中大約1300位是在中國出生的。澳洲大約百分之五十的乙肝病毒攜帶者都不知道他們感染了乙肝病毒。所以據這些統計，我們可以推測堪培拉大約有1800位乙肝病毒攜帶者還不知道自己的病情。而這1800位中，大約500-600位是在中國出生的。所以為了華裔朋友們的健康，我建議大家進行正確的血液篩檢，接種甲肝和乙肝疫苗。如果您是在中國出生的，最好能和自己的家庭醫生談談。」

關於乙肝和丙肝的傳播途徑，John Didlick表示：「乙肝和丙肝都是病毒性肝炎。兩種病都是要通過被感染的血的接觸傳染。乙肝也可以通過不安全的性交傳染。乙肝最重要的防止方法就是接種疫苗。大家都可以在家庭醫生診所通過三次注射，終身免疫肝炎。在澳洲，待產的孕婦都會進行乙肝的血液檢查。醫生會幫忙護理乙肝孕婦的病情。」

Hepatitis ACT是堪培拉社區肝炎中心。中心沒有醫生或護士，但是可以提供信息、教育、支持、轉診和宣傳。網址是www.hepatitisact.com.au，乙肝和丙肝的資料已在網上繙譯成中文。聯繫電話：(02)62306344，堪培拉Interchange General Practice蘇德明醫師聯繫電話：(02)62475742。

肝炎小常識

慢性乙型肝炎與您的健康

如果您患有慢性乙型肝炎，因為肝臟可能隨時受損，您必須至少一年看一次醫生。醫生會給您最好的建議，告訴您如何照顧自己以及保護您的肝臟。醫生也會告訴您是否需要服用藥物，並且在必要時轉介您到肝臟專科醫生。大部份患有慢性乙型肝炎的人都生活健康而且不用為乙型肝炎服用藥物。

幫助保護您的肝臟：
• 少喝或不喝酒
• 飲食均衡，避免過量脂肪攝取
• 維持健康體重
• 戒煙或少抽煙
• 規律運動
• 調解您的壓力，尋求幫助以及適量休息
• 接種甲型肝炎疫苗來保護您免於感染另一種可導致更嚴重肝臟疾病的肝炎病毒。

沒有「健康攜帶者」這回事

慢性乙型肝炎是複雜的疾病，它隨著時間改變，有些時期並不會對肝臟造成損壞。以前，在渡過這時期的患者有時被稱作「健康攜帶者」。然而，慢性乙型肝炎可在您渾然不知的情況下產生變化，您就有可能受到肝臟損壞的危險。我們如今知道，沒有」健康攜帶者」這回事。只有透過定期肝臟檢查才能知道慢性乙型肝炎對您的肝臟造成甚麼影響。即使您以前被稱作「健康攜帶者」，您仍然需要去看醫生，一年至少做一次檢查。

您不會從以下感染乙型肝炎：
• 咳嗽
• 擁抱
• 昆蟲咬傷
• 共享浴室以及廁所設施
• 共享廚具以及餐具
• 游泳池游泳

餵食母乳是安全的，特別是如果嬰兒已經接種疫苗預防乙型肝炎。

乙型肝炎篩檢

並非所有的血液篩檢都可顯示您是否患有乙型肝炎。您的醫生必須進行特定的血液篩檢來確定您是否感染。該篩檢可以顯示您是否患有慢性乙型肝炎或者您是否已經產生乙型肝炎的抗體。您需要詢問醫生您必須進行甚麼篩檢來確定您是否患有乙型肝炎。您移民至澳洲所需的健康檢查並不包括乙型肝炎篩檢。

如果您患有慢性乙型肝炎，您的醫生可能會進行更多檢查來確定您的肝臟是否已經受損以及您是否需要服用藥物。您的醫生可以解釋每一項篩檢，以及篩檢的目的是甚麼。

您應該去做乙型肝炎篩檢，如果您：
• 出生或曾居住在乙型肝炎普遍的國家，或是沒有免費乙型肝炎疫苗給嬰兒或孩童的國家。
• 父母或家庭成員患有乙型肝炎、肝病或肝癌。
• 曾有患乙型肝炎的性伴侶，或者跟患有慢性乙型肝炎的人居住。
• 曾在發展中的國家輸血、接受醫療或治牙療程。
• 曾參與涉及血液的文化習俗，例如刺青等等。

**
責任編輯：李熔石

 

MDP 952
Department of Health
GPO Box 9848
CANBERRA ACT 2601

HEPATITIS ACT SUBMISSION MARCH 2015 PBAC CONSIDERATION OF NEW HEPATITIS C MEDICINES
Thank you for the opportunity to provide this submission in support of March 2015 Pharmaceutical Benefits Advisory Committee (PBAC) consideration of new hepatitis C medicines. This submission relates to the following treatments:

•  Asunaprevir
• Daclatasvir
• Ledipasvir and sofosbuvir
• Sofosbuvir
• Ribavirin and sofosbuvir

By way of summary, Hepatitis ACT strongly recommends PBAC approves these new hepatitis C medicines for access under the PBS. In addition, Hepatitis ACT urges that no restrictions be imposed that might deny access to best available treatments for any person living with hepatitis C.

Hepatitis ACT is Canberra’s community hepatitis organisation. We are an independent membership-based not-for-profit organisation funded by ACT Health to provide a comprehensive range of hepatitis services. These include information and education, support, prevention, wellbeing, referral, advocacy, and health promotion programs.

Approximately 4,000 Canberrans are chronically affected by hepatitis C. Our membership base and our work with others affected informs our advocacy and representation efforts, and as such we can confidently represent the best interests of affected communities. As you would know, advocacy and representation is critical when dealing with highly stigmatised conditions affecting often marginalised people.

If it is helpful to contact Hepatitis ACT about this submission, please direct any questions to John Didlick at executive (at) hepatitisACT.com.au or (02) 6230 6344. Thank you for considering the health and wellbeing of people living with hepatitis C.

Yours sincerely
John Didlick Executive Officer

11 February 2015

Medicine to which this submission relates	Asunaprevir (Sunvepra) Daclatasvir (Daklinza)  Ledipasvir + sofosbuvir (Harvoni)  Sofosbuvir (Sovaldi)  Ribavirin (Ibavyr)
Date of PBAC Meeting	March 2015
Submitted by (organisation)	Hepatitis ACT
Email	executive (at) hepatitisACT.com.au
Phone number	(02) 6230 6344
Street Address	36 David St
Suburb	Turner
State	ACT
Postcode	2612
Postal Address	PO Box 6259 O’Connor ACT 2602

Q1. What treatment (if any) are you using now?

There is an estimated 230,000 people in Australia living with chronic hepatitis C. In the ACT that number is approximately 4,000. Nationally less than 2% of the affected population is treated annually. That figure is lower in the ACT and is understood to average less than 1% for more than a decade. The reasons for the very low treatment rates include the relative effectiveness, duration and toxicity of current treatments when compared with the promise of future treatments.

In the ACT there are many people living with chronic hepatitis C who are actively engaged with specialist clinics but for whom treatment is not provided. Many more in the community without specialist management and advice are aware of the advances in antiviral treatment and are making decisions to defer treatment.

The recent availability of simeprevir has been useful for some people living with genotype 1 hepatitis C. Some members of Hepatitis ACT have reported taking this opportunity to commence treatment on the basis that (a) they do not want to risk serious complications by postponing treatment any longer, (b) simeprevir may halve their treatment time from 12 months to six months, (c) simeprevir offers a greater chance of a cure than did the Interferon/ribavirin combination therapy, (d) although the Interferon component of treatment with simeprevir is a daunting prospect, some people feel they can endure for six months what they could not endure for 12 months.

That said, as the Committee may know, simeprevir is suitable only for genotype 1 hepatitis C and the Interferon component makes it unsafe for people with advanced liver disease. For those people, all they can do is wait in hope that new treatments will be approved and available before the arrival of liver cancer or liver failure. In recent days Hepatitis ACT has been advocating for a person living with hepatitis C who has developed cirrhosis and is living with other complicating factors. Their treating specialist is very concerned and has urged them to pursue compassionate early access. As this stage the person is advised they are not eligible for the pharma company patient support program because they are not yet on a liver transplant waiting list. Whilst there remains no access under the PBS to a suitable treatment, people in these extremely unfortunate situations have no access to medicines they need to prevent progression to a liver transplant waiting list until they become liver transplant candidates.

The anticipated imminent availability of Interferon-free treatment regimes has created much excitement and optimism for affected communities and clinicians alike. People understand that these medicines present significant advantages over currently available treatment options. The development of new treatments is the main reason why clinicians and affected individuals have been deferring hepatitis C treatment in recent years.

Q2. What do you see as the benefits of this new medicine for you?

Australia is facing a massive rise in rates of serious liver disease from chronic hepatitis C. Modelling1 reveals that without a significant change in rates of treatment, hepatitis C will be responsible for:

• 230 per cent increase in liver-related deaths (from 530 deaths in 2013 to more than 1,700 cases in 2030)
• 245 per cent increase in liver cancer cases (from 590 in 2013 to more than 2,000 cases in 2030)
• 175 per cent increase in compensated cirrhosis and 190 per cent increase in decompensated cirrhosis (from 15,000 cirrhotics in 2013 to more than 42,000 in 2030).

The ACT community will benefit from these new treatments as they create opportunities for more people to undergo treatment each year. They will achieve an increase on current low treatment rates by accelerating through-put of specialist clinics and by increasing demand for treatment. These new treatments will also improve patient treatment experience and increase cure rates.

Improvements to patient treatment experience will be achieved because these new treatments are safer, more tolerable, less complicated, shorter and more effective. They will also overwhelmingly replace the need for Interferon – with its debilitating side effect profile – which presents sometimes intolerable and usually arduous complications that can effect a person in all areas of their life. Interferon cannot be safely used to treat patients with the most advanced liver disease; a situation that currently leaves those most desperate for treatment without a treatment option.

Increased cure rates with these new medicines have been demonstrated unequivocally. In addition to creating an increase in the number of people offered treatment, better cure rates will drive improvements in long-term health outcomes and a reduction in complications such as hepatitis C related cirrhosis, liver failure, liver cancer, liver transplant, and preventable mortality.

Q3. How will your life and that of your family and carers be improved by this new medicine?

In addition to the effects on a person’s liver, hepatitis C impacts the chronically affected in many areas of their lives. Affected communities experience poorer mental health, stigma and discrimination, and an ever-present awareness of the potential for onward transmission. The symptoms of hepatitis C can also create challenges for people in their employment, their relationships, and their capacity to participate fully in community life.

Access to the best available hepatitis C medicines will improve the health and wellbeing of affected communities and the ACT community more broadly. Affected individuals will experience better treatment access and cure rates and therefore better long-term health (including reductions in rates of cirrhosis, liver failure, liver cancer, liver transplant, and preventable mortality). Families and carers will be spared the negative effects of current treatment of loved ones, and increasingly spared the negative effects and symptoms of untreated hepatitis C.

In order to maximise the benefit to individuals and communities of new hepatitis C treatments, immediate and unrestricted access is critical:

• Treatment restrictions will place further barriers before the affected community. Most are not engaged in specialist care now and restricted access will prevent people from coming forward – including many already living with serious liver disease.
• Clinically it is not possible to determine which patients will die of hepatitis C from the many already living with moderate fibrosis (who in natural history studies have been shown to have a risk of adverse liver outcomes).
• Patients with previously treatment non-responsive hepatitis C have a high risk of adverse liver outcomes, even if non-cirrhotic.
• Restricting access to the best available treatments to provide only for those with the most serious liver disease is perverse. The effect of providing treatments that could prevent serious liver disease only to those who have progressed to serious liver disease is akin to placing ambulances at the bottom of the cliff, rather than a fence at the top.
• Morbidity from hepatitis C is substantial and unrelated to severity of liver disease. A 2012 report produced by the Boston Consulting Group2 found that for every dollar spent to treat hepatitis C, a further $4 were spent by governments to combat the consequences of not treating.

Q4. What other benefits can you see from having this medicine on the PBS?

Much has been said of the potential to virtually eradicate the hepatitis C epidemic in Australia, courtesy of incredible advances in hepatitis C medicine. Of the appallingly low hepatitis C treatment rates in previous years, clinicians and affected communities both cried “if only we had better medicines”. Those better medicines are here, and now clinicians and affected communities are crying “if only we had access to those better medicines”.

As the Committee is aware, the best available hepatitis C medicines are already approved in other countries. Having these medicines on the PBS is essential if we are to realise the targets agreed by all governments in the Fourth National Hepatitis C Strategy to “increase the number of people receiving antiviral treatment by 50 per cent each year” over the life of the strategy. With these medicines available on the PBS, by 2017 approximately 5% of people living with hepatitis C, would be treated annually.

It is important to also consider the following information in order to contextualise the opportunity that lies before PBAC and the Australian Government.

• The current treatments for hepatitis C offered under the PBS in Australia are less effective, require longer dosing periods and have more side-effects than the best available medicines currently being considered by PBAC.
• The number of people who die each year from hepatitis C-related liver disease has been estimated at 630.3 Hepatitis C-related deaths surpassed HIV-related mortality by 2000 and unlike HIV-related deaths have continued to climb.
• Chronic hepatitis C was estimated to be the underlying cause of liver disease in 30.2% of liver transplants in Australia during 2013.4
• Liver cancer is now the faster increasing cause of cancer death, having tripled between 1982 and 2007.5
• Once a person with hepatitis C has developed cirrhosis, they remain at heightened risk of liver cancer regardless of whether they receive treatment and cure hepatitis C. Such people will require ongoing monitoring and care and will continue to add to the demand for future health services. Successfully treated before progressing to cirrhosis, this outcome is mitigated.

1 Razavi H, Et al. The present and future disease burden of hepatitis C virus (HCV) infection with today’s treatment paradigm. Journal of Viral Hepatitis 2014, 21, (Suppl. 1), 34-59
2 http://static1.squarespace.com/static/50ff0804e4b007d5a9abe0a5/t/51ca2984e4b01fa56e27de4d/1372203396232/The+Economic+Impact+of+Hepatitis+C+in+Australia_FINAL.pdf
3 Kirby Institute, HIV, viral hepatitis and sexually transmissible infections in Australia, Annual Surveillance Report 2014
4 Ibid.
5 Australian Institute of Health and Welfare Report http://www.aihw.gov.au/publication-detail/?id=10737421461

Chronic and Primary Health Policy Unit
ACT Health
GPO Box 825
CANBERRA ACT 2601

Dear Ms Hare

Thank you for the opportunity to comment on the Discussion Paper Development of the ACT’s Response to the National HIV, Sexually Transmissible Infection and Blood Borne Virus Strategies 2015 – 2017.

Why is Hepatitis ACT making this submission?

As Canberra’s community hepatitis organisation, Hepatitis ACT represents the interests of more than 7,500 viral hepatitis affected people. Our membership is composed of people living with viral hepatitis, families and carers, and people professionally involved in relevant issues. The number of affected people continues to grow each year – as evidenced by the 25 per cent increase in the number of people diagnosed in the ACT with hepatitis C in 2013. Some 295 people were diagnosed with either hepatitis C or hepatitis B in 2013, a significant increase on the 254 notifications in 2012.

Guiding Principles

Hepatitis ACT commends the proposed adoption of the key guiding principles outlined in the five National Strategies. The adoption of those principles can help create the conditions and relationships necessary to best respond to the hepatitis C and B epidemics and, as the national strategies aspire, “to ensure that affected individuals and communities remain at the heart of our response and involved in activities as they are proposed, developed and implemented”.

The principles ‘partnership’ and ‘meaningful involvement of affected communities’ are already adopted by ACT Health (as articulated in Annual Reports) and Hepatitis ACT (in our Strategic Plan). The ACT Health Annual Reports recognise that building an effective healthcare system requires genuine collaboration and that those most affected should influence the development, delivery and review of healthcare services. Enhancing the commitment to partnership and meaningful involvement in the ACT’s Response might help unblock the flow of important information between ACT Health and the community. How can the community and those most-affected influence the development, delivery and review of healthcare services if timely information about the provision of healthcare services is not forthcoming?

According to the National Strategies the principle ‘commitment to evidence-based policy and programs’ requires “an evidence base built on high quality research and surveillance, monitoring and evaluation. A strong and constantly refining evidence base is essential to meet new challenges, and evaluate current and new interventions and effective social policy.” Not only is this principle relevant to the continuing unavailability of important information, but also to the extent to which viral hepatitis is prioritised in ACT public health reporting. When viral hepatitis is omitted or relegated, and where comparable conditions are highlighted and prioritised, this unfairly diminishes the focus and relative priority placed on the condition and more importantly upon those who live with it.

‘Access and equity’ is another guiding principle that, if applied to viral hepatitis, has the potential to radically improve the lives and health outcomes of people affected. Hepatitis ACT maintains that “disease” should be added to our understanding of the multiple dimensions of inequity included in the National Strategies. For example, it is inequitable and unacceptable that only 1% of the hepatitis C affected population (and 5% for hepatitis B) is treated in Australia each year (and our community has no way of knowing how the provision of treatment in the ACT compares). This inequity is without precedent.

Priority Populations

Hepatitis ACT supports the adoption of the priority populations outlined in the five National Strategies. ‘People living with hepatitis B’ should also be included.

Suggested ACT Priorities for Action

Hepatitis ACT supports the identification of immediate priorities to ensure that time and resources are first directed where they are needed most. This approach resonates particularly with viral hepatitis and can be informed by the application of the guiding principles. Priorities should also be informed by the commitment to targets inherent in the ACT Health Minister’s endorsement of the National Strategies. As such, the priorities should be strengthened as follows.

Fourth National Hepatitis C Strategy 2014-2017

• Advocate for and support timely and broad-based access to newly developed and proven treatments for HCV through the Pharmaceutical Benefits Scheme
• Increase by 50% each year the number of people undergoing treatment for hepatitis C, including through shared care models
• Reduce the incidence of new hepatitis C infections by 50% by increasing access to education and prevention strategies, including expanding access to sterile injecting equipment in community and correctional settings
• Improve collection, analysis, reporting, and publication of viral hepatitis treatment and surveillance data in the ACT
• Increase the number of people living with viral hepatitis accessing high quality and regular liver check-ups

Second National Hepatitis B Strategy 2014-2017

• Increase vaccination amongst eligible and at-risk priority populations, including for those working in high-risk occupations
• Ensure access to appropriate prevention, testing, treatment and support services for people from culturally and linguistically diverse backgrounds living with or at risk of hepatitis B
• Increase to 15% the proportion of people living with chronic hepatitis B undergoing antiviral treatment for hepatitis B
• Support targeted messages to people living with or at risk of hepatitis B on the importance of prevention, testing, monitoring and treatment

What information do we need to monitor progress? Do we currently have access to this information? If not, what needs to change?

The ACT’s Response to the National HIV, Sexually Transmissible Infection and Blood Borne Virus Strategies 2015 – 2017 should contextualise the response with a comprehensive data picture of blood borne viruses and sexually transmissible infections in the ACT. To borrow from the Kirby Annual Surveillance Report, the data presented could provide a reference for organisations and individuals interested in the occurrence of these infectious diseases, drawing together relevant data from many sources into a single comprehensive report. Included should be up-to-date information (presented to enable (i) comparisons with national data and other jurisdictions and (ii) identification of trends) on prevalence, incidence, notifications, testing, treatment, burden of disease and mortality, government funding, and available programs and services. The Response could also present relevant information from reports such as ACT Drug Trends 2013: Findings from the Illicit Drug Reporting System, the Canberra Gay Community Periodic Survey report; the HIV Seroconversion Study report; Australian NSP Survey Data Reports; reports on the implementation of the Strategic Framework for the Management of Blood-Borne Viruses in the Alexander Maconochie Centre 2013 – 2017.

Some of the necessary information is available and published. Some is collected by ACT Health but is not published. Other necessary information is collected within ACT Health but is not reported within ACT Health or publicly. In the second instance, access to the information will require approval to publish some of what is reported confidentially. In the third instance the necessary change requires willingness, an appreciation of the guiding principles addressed previously, and implementation of the ACT Government’s commitment to ‘Open Government’.

In early 2014 the Auditor General conducted a performance audit of the Canberra Hospital’s Gastroenterology and Hepatology Unit – including the Liver Clinic. Hepatitis ACT contributed input from members to that audit. The resulting Audit Report was tabled in the Legislative Assembly and yet there has been no formal response to the many and significant issues raised. Whilst it is heartening that numbers of affected people at short notice might put their hands up to assist government in this way, at the same time the ongoing lack of response is disappointing. Given some of the issues raised and recommendations relate to bigger picture issues and might therefore be relevant to the development of an ACT response to the National Strategies, this consultation process and the development of an ACT implementation plan should prompt a formal government response to the Auditor General’s report. Ideally the latter should inform the former.

I look forward to working with you and other stakeholders at the Consultation Forum scheduled for Tuesday, 24 February 2015 at the ANU. Should you require additional information about this submission, please don’t hesitate to contact me at Hepatitis ACT on executive (at) hepatitisACT.com.au> or (02) 6230 6344.

Yours sincerely

John Didlick

Executive Officer

February 2014