Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine HIV pre-exposure prophylaxis: clinical guidelines. Update April 2018.

Daily use of coformulated tenofovir and emtricitabine for HIV pre-exposure prophylaxis (PrEP) by populations at high risk of HIV infection is now recommended in guidelines from the United States, Europe and Australia and globally through the 2015 WHO guidelines. These 2017 Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine's (ASHM) PrEP Guidelines are an updated adaptation of the 2014 US Centers for Disease Control's PrEP guidelines and are designed to: •Support the prescription of PrEP using forms of coformulated tenofovir and emtricitabine that have been registered in Australia by the Therapeutic Goods Administration and other bioequivalent generic drugs that are available in Australia through self-importation, private prescription or Australian PrEP clinical trials•Assist clinicians in the evaluation of patients who are seeking PrEP•Assist clinicians in commencing and monitoring patients on PrEP including PrEP dosing schedules, management of side-effects and toxicity, use of PrEP in pregnancy and in chronic hepatitis B infection and how to cease PrEP Daily PrEP with co-formulated tenofovir and emtricitabine, used continuously or for shorter periods of time, is recommended in these guidelines as a key HIV-prevention option for men who have sex with men (MSM), transgender men and women, heterosexual men and women, and people who inject drugs (PWID) at substantial risk of HIV acquisition. These guidelines were updated in April 2018 and include changes to the recommendations regarding the choice of daily or on-demand PrEP.

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine HIV pre-exposure prophylaxis: clinical guidelines. Update April 2018.

Daily use of coformulated tenofovir and emtricitabine for HIV pre-exposure prophylaxis (PrEP) by populations at high risk of HIV infection is now recommended in guidelines from the United States, Europe and Australia and globally through the 2015 WHO guidelines. These 2017 Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine's (ASHM) PrEP Guidelines are an updated adaptation of the 2014 US Centers for Disease Control's PrEP guidelines and are designed to: •Support the prescription of PrEP using forms of coformulated tenofovir and emtricitabine that have been registered in Australia by the Therapeutic Goods Administration and other bioequivalent generic drugs that are available in Australia through self-importation, private prescription or Australian PrEP clinical trials•Assist clinicians in the evaluation of patients who are seeking PrEP•Assist clinicians in commencing and monitoring patients on PrEP including PrEP dosing schedules, management of side-effects and toxicity, use of PrEP in pregnancy and in chronic hepatitis B infection and how to cease PrEP Daily PrEP with co-formulated tenofovir and emtricitabine, used continuously or for shorter periods of time, is recommended in these guidelines as a key HIV-prevention option for men who have sex with men (MSM), transgender men and women, heterosexual men and women, and people who inject drugs (PWID) at substantial risk of HIV acquisition. These guidelines were updated in April 2018 and include changes to the recommendations regarding the choice of daily or on-demand PrEP.

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine HIV pre-exposure prophylaxis: clinical guidelines.

Daily use of coformulated tenofovir and emtricitabine for HIV pre-exposure prophylaxis (PrEP) by populations at high risk of HIV infection is now recommended in guidelines from the United States, Europe and Australia and globally through the 2015 WHO guidelines. These 2017 Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine's (ASHM) PrEP Guidelines are an updated adaptation of the 2014 US Centers for Disease Control's PrEP guidelines and are designed to: •Support the prescription of PrEP using forms of coformulated tenofovir and emtricitabine that have been registered in Australia by the Therapeutic Goods Administration and other bioequivalent generic drugs that are available in Australia through self-importation, private prescription or Australian PrEP clinical trials•Assist clinicians in the evaluation of patients who are seeking PrEP•Assist clinicians in commencing and monitoring patients on PrEP including PrEP dosing schedules, management of side-effects and toxicity, use of PrEP in pregnancy and in chronic hepatitis B infection and how to cease PrEP Daily PrEP with co-formulated tenofovir and emtricitabine, used continuously or for shorter periods of time, is recommended in these guidelines as a key HIV-prevention option for men who have sex with men (MSM), transgender men and women, heterosexual men and women, and people who inject drugs (PWID) at substantial risk of HIV acquisition.

Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs.

Globally, it is estimated that 71.1 million people have chronic hepatitis C virus (HCV) infection, including an estimated 7.5 million people who have recently injected drugs (PWID). There is an additional large, but unquantified, burden among those PWID who have ceased injecting. The incidence of HCV infection among current PWID also remains high in many settings. Morbidity and mortality due to liver disease among PWID with HCV infection continues to increase, despite the advent of well-tolerated, simple interferon-free direct-acting antiviral (DAA) HCV regimens with cure rates >95%. As a result of this important clinical breakthrough, there is potential to reverse the rising burden of advanced liver disease with increased treatment and strive for HCV elimination among PWID. Unfortunately, there are many gaps in knowledge that represent barriers to effective prevention and management of HCV among PWID. The Kirby Institute, UNSW Sydney and the International Network on Hepatitis in Substance Users (INHSU) established an expert round table panel to assess current research gaps and establish future research priorities for the prevention and management of HCV among PWID. This round table consisted of a one-day workshop held on 6 September, 2016, in Oslo, Norway, prior to the International Symposium on Hepatitis in Substance Users (INHSU 2016). International experts in drug and alcohol, infectious diseases, and hepatology were brought together to discuss the available scientific evidence, gaps in research, and develop research priorities. Topics for discussion included the epidemiology of injecting drug use, HCV, and HIV among PWID, HCV prevention, HCV testing, linkage to HCV care and treatment, DAA treatment for HCV infection, and reinfection following successful treatment. This paper highlights the outcomes of the roundtable discussion focused on future research priorities for enhancing HCV prevention, testing, linkage to care and DAA treatment for PWID as we strive for global elimination of HCV infection.

Sexual transmission of HIV and the law: an Australian medical consensus statement.

INTRODUCTION: Criminal cases involving human immunodeficiency virus transmission or exposure require that courts correctly comprehend the rapidly evolving science of HIV transmission and the impact of an HIV diagnosis. This consensus statement, written by leading HIV clinicians and scientists, provides current scientific evidence to facilitate just outcomes in Australian criminal cases involving HIV.Main recommendations: Caution should be exercised when considering charges or prosecutions regarding HIV transmission or exposure because:Scientific evidence shows that the risk of HIV transmission during sex between partners of different HIV serostatus can be low, negligible or too low to quantify, even when the HIV-positive partner is not taking effective antiretroviral therapy, depending on the nature of the sexual act, the viral load of the partner with HIV, and whether a condom or pre-exposure prophylaxis is employed to reduce risk.The use of phylogenetic analysis in cases of suspected HIV transmission requires careful consideration of its limited probative value as evidence of causation of HIV infection, although such an approach may provide valuable information, particularly in relation to excluding HIV transmission between individuals.Most people recently infected with HIV are able to commence simple treatment providing them a normal and healthy life expectancy, largely comparable with their HIV-negative peers. Among people who have been diagnosed and are receiving treatment, HIV is rarely life threatening. People with HIV can conceive children with negligible risk to their partner and low risk to their child.Changes in management as result of the consensus statement: Given the limited risk of HIV transmission per sexual act and the limited long term harms experienced by most people recently diagnosed with HIV, appropriate care should be taken before HIV prosecutions are pursued. Careful attention should be paid to the best scientific evidence on HIV risk and harms, with consideration given to alternatives to prosecution, including public health management.

HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV.

BACKGROUND: The leading causes of morbidity and mortality for people in high-income countries living with HIV are now non-AIDS malignancies, cardiovascular disease and other non-communicable diseases associated with ageing. This protocol describes the trial of HealthMap, a model of care for people with HIV (PWHIV) that includes use of an interactive shared health record and self-management support. The aims of the HealthMap trial are to evaluate engagement of PWHIV and healthcare providers with the model, and its effectiveness for reducing coronary heart disease risk, enhancing self-management, and improving mental health and quality of life of PWHIV. METHODS/DESIGN: The study is a two-arm cluster randomised trial involving HIV clinical sites in several states in Australia. Doctors will be randomised to the HealthMap model (immediate arm) or to proceed with usual care (deferred arm). People with HIV whose doctors are randomised to the immediate arm receive 1) new opportunities to discuss their health status and goals with their HIV doctor using a HealthMap shared health record; 2) access to their own health record from home; 3) access to health coaching delivered by telephone and online; and 4) access to a peer moderated online group chat programme. Data will be collected from participating PWHIV (n = 710) at baseline, 6 months, and 12 months and from participating doctors (n = 60) at baseline and 12 months. The control arm will be offered the HealthMap intervention at the end of the trial. The primary study outcomes, measured at 12 months, are 1) 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by a Framingham Heart Study risk equation; and 2) Positive and Active Engagement in Life Scale from the Health Education Impact Questionnaire (heiQ). DISCUSSION: The study will determine the viability and utility of a novel technology-supported model of care for maintaining the health and wellbeing of people with HIV. If shown to be effective, the HealthMap model may provide a generalisable, scalable and sustainable system for supporting the care needs of people with HIV, addressing issues of equity of access. TRIAL REGISTRATION: Universal Trial Number (UTN) U111111506489; ClinicalTrial.gov Id NCT02178930 submitted 29 June 2014.

Evolving views and practices of antiretroviral treatment prescribers in Australia.

OBJECTIVE: To examine whether there have been recent changes in Australian antiretroviral treatment (ART) prescribers' perceptions and practices relating to early ART initiation, which was defined as commencing ART when a patient's CD4+ T-cell count approaches 500 cells/mm3 or immediately after a patient is diagnosed with HIV. DESIGN, PARTICIPANTS AND SETTING: Self-completed, anonymous, cross-sectional surveys, targeting all ART prescribers in Australia, were conducted online in 2012 and 2013. The surveys included questions on prescriber factors, CD4+ T-cell count at which prescribers would most strongly recommend ART initiation, and perceived patient characteristics that could change prescribers' practices of early initiation of ART. MAIN OUTCOME MEASURES: Proportions of ART prescribers recommending early ART initiation. RESULTS: We analysed responses from 108 participants in 2012 and 82 participants in 2013. In both years, more male than female prescribers participated. The median age of participants was 49 years in 2012 and 50 years in 2013. In both rounds, over 60% had more than 10 years' experience in treating HIV-positive patients. More prescribers in 2013 stated that they would most strongly recommend early ART initiation compared with those in 2012 (50.0% [95% CI, 38.7%-61.3%] v 26.9% [95% CI, 18.8%-36.2%]; P=0.001). The prescribers' primary concern was more about individual patient than public health benefit. Out of 824 patients for whom ART was initiated, as reported by prescribers in 2013, only 108 (13.1% [95% CI, 10.9%-15.6%]) were given ART primarily to prevent onward HIV transmission. The number of patients for whom ART was initiated was significantly associated with prescribers' HIV caseload even after adjusting for prescriber type (adjusted odds ratio, 1.73 [95% CI, 1.47-2.03]; P<0.001); of the 37 who had initiated ART for 10 or more patients, 29 had a high HIV caseload. In 2013, 60 prescribers (73.2% [95% CI, 62.2%-82.4%]) reported that they routinely recommended ART to treatment-naive, asymptomatic patients with a CD4+ T-cell count of 350-500 cells/mm3. CONCLUSION: Our findings show increasing acceptance of and support for early ART initiation primarily as treatment and not as prevention.

Challenges of providing HIV care in general practice.

As the management of HIV changes and demand for HIV health services in primary care settings increases, new approaches to engaging the general practice workforce with HIV medicine are required. This paper reports on qualitative research conducted with 47 clinicians who provide HIV care in general practice settings around Australia, including accredited HIV s100 prescribers as well as other GPs and general practice nurses. Balanced numbers of men and women took part; less than one-quarter were based outside of urban metropolitan settings. The most significant workforce challenges that participants said they faced in providing HIV care in general practice were keeping up with knowledge, navigating low caseload and regional issues, balancing quality care with cost factors, and addressing the persistent social stigma associated with HIV. Strategic responses developed by participants to address these challenges included thinking more creatively about business and caseload planning, pursuing opportunities to share care with specialist clinicians, and challenging prejudiced attitudes amongst patients and colleagues. Understanding and supporting the needs of the general practice workforce in both high and low HIV caseload settings will be essential in ensuring Australia has the capacity to respond to emerging priorities in HIV prevention and care.

Mobilisation, politics, investment and constant adaptation: lessons from the Australian health-promotion response to HIV.

ISSUE ADDRESSED: The Australian response to HIV oversaw one of the most rapid and sustained changes in community behaviour in Australia's health-promotion history. The combined action of communities of gay men, sex workers, people who inject drugs, people living with HIV and clinicians working in partnership with government, public health and research has been recognised for many years as highly successful in minimising the HIV epidemic. METHODS: This article will show how the Australian HIV partnership response moved from a crisis response to a constant and continuously adapting response, with challenges in sustaining the partnership. Drawing on key themes, lessons for broader health promotion are identified. RESULTS: The Australian HIV response has shown that a partnership that is engaged, politically active, adaptive and resourced to work across multiple social, structural, behavioural and health-service levels can reduce the transmission and impact of HIV. CONCLUSIONS: The experience of the response to HIV, including its successes and failures, has lessons applicable across health promotion. This includes the need to harness community mobilisation and action; sustain participation, investment and leadership across the partnership; commit to social, political and structural approaches; and build and use evidence from multiple sources to continuously adapt and evolve. So what? The Australian HIV response was one of the first health issues to have the Ottawa Charter embedded from the beginning, and has many lessons to offer broader health promotion and common challenges. As a profession and a movement, health promotion needs to engage with the interactions and synergies across the promotion of health, learn from our evidence, and resist the siloing of our responses.

HIV service capacity: identifying current and future areas of clinical shortage.

UNLABELLED: Background The capacity of HIV services to meet the clinical needs of people living with HIV (PLHIV) has not been evaluated. Similarly, whether HIV services are positioned to respond to increases in patient demand outside metropolitan centres over the next decade is unknown. METHODS: A novel statistical methodology was used to estimate HIV clinical service capacity in Australia. A survey of HIV services was conducted. Geostatistical analysis was used to identify significant regions of clinical service undersupply relative to the estimated number of PLHIV in 2010 and 2020. RESULTS: In 2010, an estimated 2074 PLHIV (9.7% of all PLHIV) resided in regions more than 15km from a clinical service provider; 485 PLHIV (2.3% of all PLHIV) live >50km away. By 2020, this is estimated to rise to 3419 and 807 (11.5% and 2.7% of estimated PLHIV) for 15km and 50km, respectively. To meet this demand, the establishment of new HIV services are required in the areas of greatest HIV clinical undersupply. In 2010, these are northern Sydney and western New South Wales, the Queensland mid-north coast and the outer suburbs of Melbourne. At the current estimated rate of increase in PLHIV, areas that will become critically undersupplied by 2020 include south-west Sydney, the outer suburbs of Brisbane and Western Australia. CONCLUSIONS: This study provides a quantitative assessment using modern statistical techniques to identify HIV clinical service gaps that is applicable in developed and nondeveloped settings. Training of new HIV clinicians should be directed towards undersupplied areas.

Australian prescribers' perspectives on ART initiation in the era of "treatment as prevention".

This study explores Australian prescribers' attitudes towards Treatment as Prevention (TasP) and their practices around initiating combination antiretroviral treatment (cART) for HIV. A brief online survey was conducted nationally amongst antiretroviral treatment (ART) prescribers in Australia. The sample broadly represented ART prescribers in Australia (N = 108), with 40.7% general practitioners (GPs), 25.9% sexual health clinic-based physicians and 21.3% hospital-based infectious diseases physicians. About 60% of respondents had been treating HIV-positive patients for more than 10 years. Respondents estimated that about 70-80% of all their HIV-positive patients were receiving ART. Over half of the prescribers agreed very strongly that their primary concern in recommending cART initiation was clinical benefit to individual patients rather than any population benefit. A majority of the prescribers (68.5%) strongly endorsed cART initiation before CD4+ T-cell count drops below 350 cells/mm(3), and a further 22.2% strongly endorsed cART initiation before CD4+ T-cell count drops below 500 cells/mm(3). Regarding the optimal timing of cART initiation, this study shows that prescribers in Australia in 2012 focus primarily on the benefits for their individual patients. Prescribers may need more convincing evidence of individual health benefits or increased knowledge about the population health benefits for a TasP approach to be effective in Australia.

Demand for HIV clinical services is increasing in Australia but supply is decreasing.

BACKGROUND: HIV clinical service planning requires accurate estimates of the number of people living with HIV (PLHIV) and the capacity of existing clinical services, each by geographical location. The aim of this study was to quantify current HIV clinical service capacity in Australia. METHODS: This study was a retrospective analysis of records of HIV clinical service capacity in Australia. Participants were general practitioners who completed an annual survey in 2007-2009. Information on the number of hospital departments, sexual health services, antiretroviral-prescribing general practitioners (ARV-GPs) and shared-care services providing expertise in HIV management from 2007 to 2010 were also available. RESULTS: From 2007 to 2009, the proportion of ARV-GP survey respondents treating 2-9 patients with HIV per week increased from 36.5% to 49.1%, with a corresponding decrease in the average proportion who saw less than one patient with HIV per week. The estimated number of PLHIV has increased by 12.5% in metropolitan areas, and 16.5% in rural and remote areas over the period 2007-2010; however, the total number of services with at least one HIV ARV-GP has decreased over the same period. CONCLUSIONS: Current methods to estimate clinical service capacity reveal decreasing supply in the workforce in Australia despite increasing numbers of PLHIV. Further training of HIV clinicians and their placement in regions of greatest supply-demand deficits are required. Further studies are required to precisely quantify and locate the capacity of the HIV clinical workforce with expertise in HIV case-management to enable efficient service planning.