Gilead Australia Fellowship Research Grants Program

An update on projects from 2018

We are pleased to share with you some exciting updates from the 2018 Gilead Australia Fellowship Research Grants Program. Throughout 2018, grant recipients conducted their research with the aim of informing and shaping best practice in patient care across HIV and chronic viral hepatitis.

The research outcomes are presented in a series of short video clips, which have been developed by each of the recipients. To find out more about their key findings, implications for best practice and plans for future research, click on the video links below.

THE GILEAD AUSTRALIA FELLOWSHIP: RESEARCH GRANTS PROGRAM

Over the past two decades, continued improvements in the understanding of HIV, chronic viral hepatitis and haematological oncology have led to the development of significant new treatments, with multiple therapeutic options now available in these disease areas. As a result, many patients are living longer and have an improved quality of life.

Gilead Sciences Pty Ltd is proud to work in partnership with the Australian research and clinical community to provide opportunities for ongoing scientific investigation and research. However, while much research at a basic science and clinical trial level is focused on drug discovery and evaluation, Gilead recognises that a key part of improving patient care in real terms is the development of approaches to diagnosis, treatment and education at a local practice level. Learnings from successful initiatives can be applied to other communities and/or replicated in other parts of the country, to provide practical solutions to current challenges across HIV, chronic viral hepatitis and haematological oncology.

The aim of the Gilead Australia Fellowship: Research Grants Program is to support the development, exploration and implementation of best practice in enhancing patient care in the specific disease areas of HIV, chronic viral hepatitis and haematological oncology.

2018


MATT YOUNG & JOSS O’LOAN, MEDECO MEDICAL CENTRE INALA & INALA INSTITUTE OF MEDICAL RESEARCH, QLD

The Hep C Kombi Clinic

Grant awarded: $30,000

Background

There are significant barriers in the traditional health model that prevent patients from accessing Hepatitis C care. We need to break down these barriers, simplify the process for patients with Hep C, and get on the road to a cure.

The Kombi Clinic is a comprehensive, mobile Hep C clinic that brings doctors, fibroscans, nurses and a phlebotomist to ensure that all investigations and consults happen at the same time and in the same location. The Kombi Clinic visits locations such as homeless shelters, drop in centres and addiction rehab clinics. We also attend public events and music festivals.

Results

  • Screened over 840 patients
  • 296 were Hep C Antibody positive
  • 200 patients were Hep C RNA positive, and in need of treatment
  • 79% of patients needing treatment were linked to care
  • 96.3% sustained virologic response rate for patients with end of treatment results

Implications for best practice

There is a need to take the clinic to the patient – there is no such thing as a hard to reach patient. Treating Hep C patients in this fashion has success rates on par with other real world outcomes. Setting up clinics in patient-frequented locations breaks down barriers by ensuring easy access to services and limiting loss of patients to follow up.

Ongoing research

Currently, the process is a 2-step approach as formal phlebotomy takes 2–3 weeks. Point of care testing would make us a one-stop-shop, and provide results to patients so they can start treatment at their first clinic. Point of care or a similar simple method may break down testing barriers and be more inviting for patients, and potentially increase the SVR blood tests performed.

The Kombi Clinic is also interested in adding a social or peer worker, and assessing their impact on compliance to treatment and reducing lost to follow up results.

2017


ELIZABETH MOORE, MONASH UNIVERSITY, VIC

Patient reported outcomes in multiple myeloma: real-time reporting to improve care (My-PROMPT)

Grant awarded: $30,000

Multiple myeloma (MM) remains an incurable disease. In Australia, people diagnosed with MM have a five-year survival rate of just 49%. Although improved overall survival remains a major goal of cancer treatment, health-related quality of life (HRQOL) is increasingly important in patients with MM. However, there is little data on the optimal measures to improve QOL. It is believed that directly involving patients in their care to enhance HRQOL warrants investigation.

As a sub-study of the Australia and New Zealand Myeloma and Related Disease Registry (MRDR), the primary aim was to assess the feasibility of real-time reporting of patient-reported outcome (PRO) questionnaires for newly diagnosed MM patients undergoing therapy. More specifically, whether obtaining these results:

  • Can be implemented in the clinical care setting
  • Is seen in a neutral or positive light by patients
  • Results in measurable changes in clinical care

At the time of publication, this feasibility study was not complete. If the study intervention is shown to be feasible, a larger study will be considered in order to assess the impact on HRQOL.

LOREN BRENER, UNIVERSITY OF NSW, NSW

Increasing hepatitis C testing and treatment among sexually adventurous gay men

Grant awarded: $40,000

The predominant mode of hepatitis C transmission is through the sharing of injection equipment. However, over the past decade there has been growing evidence that the incidence of hepatitis C is increasing among HIV-positive men in the absence of injecting.

The aims of this study were to identify ways in which to increase hepatitis C testing and promote treatment among HIV-positive men.

The key findings demonstrated that knowledge of hepatitis C varies considerably including:

  • Uncertainty on extent of sexual transmission of hepatitis C
  • Condoms are known to reduce risk but also considered unrealistic
  • Few had heard about new treatment options and mostly through knowing a patient rather than a doctor or health promotion
  • Most assume hepatitis C is tested as part of their HIV monitoring
  • Hepatitis C is rarely discussed between male sexual partners as opposed to HIV, which is talked about frequently

The implications of these results are:

  • New treatments may provide an incentive for testing
  • A test-and-treat approach may be easily adopted as this cohort is familiar with similar strategies for HIV prevention
  • Existing sexual and informational networks provide an important platform for the promotion of testing and treatment

Based on the findings of the exploratory, qualitative phase of the study, a national online survey has been developed to capture a broader understanding of the knowledge and practices related to hepatitis C transmission, testing and treatment. Future research will focus on exploring new health promotion interventions and further investigation.

TANYA APPLEGATE, THE KIRBY INSTITUTE, UNSW, NSW

The development and implementation of the SHARE Surveillance of HepAtitis C ResistancE) database to monitor the prevalence and impact of Hepatitis C virus resistance to Directly Acting Antiviral therapy in Australia

Grant awarded: $50,000

Hepatitis C virus (HCV) can now be cured with Directly Acting Antiviral (DAA) therapies, however, HCV mutates rapidly and resistance is observed in some patients who fail therapy.

The aim of this project was to develop a simple and practical HCV resistance database called SHARE (Surveillance of HepAtitis C ResistancE) to collect data and facilitate ongoing surveillance of HCV resistance associated substitutions among the Australian population.

The key findings demonstrated that knowledge of hepatitis C varies considerably including:

  • The clinical and genotypic impact of baseline, emergent and cross-class resistance on DAA relapse rates and salvage options in Australia
  • The geographic and temporal trends in resistance during the first two years of DAA treatment scale up in Australia

The outcomes of these analyses are anticipated to:

  • Identify clinical and genotypic predictors of DAA treatment failure due to resistance
  • Inform clinical management and national treatment guidelines
  • Inform public health strategies for HCV resistance and potential transmission
  • Contribute to analysis of the clinical impact of HCV resistance on a global scale and help inform international treatment guidelines

Research will continue through ongoing management and data submission into SHARE to provide further surveillance of HCV resistance and to contribute to global analysis.

CORIE GREY AND VICTORIA SANDE, CURTIN UNIVERSITY, PERTH, WA

Barriers to HIV testing among people born in sub-Saharan Africa and South East Asia

Grant awarded: $40,000

The highest rates of HIV diagnosis in Australia occur among people born in Sub-Saharan Africa (SSA) or South-East Asia (SEA). A third of these are classified as late or advanced diagnosis (4 years after acquisition). Early diagnosis is key to improving health outcomes and requires a better understanding of the barriers and enablers for HIV testing, especially among SSA and SEA populations.

Key findings:

  • The main themes shaping participants understanding and readiness to test for HIV were: experiences of HIV in their home country, (in)visibility of HIV in Australia, perception of ‘safety’ in Australia and risk perception of HIV
  • Enablers for GPs included: having a special interest in sexual health, having a patient request a sexual health screen and routine testing during antenatal visits
  • Potential barriers included: concern around causing offence and fear among patients by suggesting testing, and limited time
  • Having a wide range of testing options for different people may increases rates of testing

These finding support:

  • A broadening of the HIV message to target more than gay men
  • Promotion of more positive voices and stories
  • Incorporation of HIV testing into general health checks rather than focusing on sexual behaviour
  • Exploration of new methods to increase HIV testing

Future research will continue to evaluate different strategies to increase HIV testing.

2016


David Boettiger, The Kirby Institute, UNSW, NSW

Strategies for using direct acting antivirals to eliminate HCV in the HIV/HCV co-infected population

Grant awarded: $20,000

Interferon-based therapies have exhibited poor efficacy and significant toxicity in the HIV/HCV population. Fortunately, early reports indicate direct acting antiviral (DAA) drugs exhibit excellent safety and efficacy in HIV-positive and -negative individuals. Evaluating different strategies for introducing DAAs into the HIV/HCV population is essential for reducing population level viraemia and interrupting future HCV transmission.

This project was designed to investigate DAA treatment strategies that could lead to long-term near elimination of HCV infection in Australia’s HIV+ MSM (men who have sex with men) population. In the early part of the last decade, HCV incidence among Australia’s HIV+ population increased, but has since plateaued. The introduction of DAAs is likely to reduce future HCV incidence, however, it is important that treatment reaches those who inject drugs and engage in high-risk sexual practices.

It is hoped these findings will inform public health initiatives to expand DAA use in Australia and, ultimately help to maximise the benefit of DAAs. Upcoming research will monitor future HCV incidence in Australia’s HIV+ population, evaluate useful initiatives in the Australian HIV+, non-MSM population, and identify potential differences in the public health benefits of different DAA regimens.

Alison Castley, Royal Perth Hospital, WA

Enabling the Australian Molecular Epidemiology Network (AMEN): a national collaborative network of HIV sequencing laboratories

Grant awarded: $20,000

This fellowship focused on monitoring HIV diversity Australia-wide, employing a phylogenetic approach to map HIV subtypes. The Australian Molecular Epidemiology Network (AMEN) was used, involving all Australian states and HIV-1 sequences from ~5000 patients. Further, the prevalence of tenofovir resistance in Western Australia was also assessed.

Key findings from AMEN

  • Increasing HIV-1 diversity in Australia, with more non-B subtypes being identified
  • Similar HIV-1 subtypes are represented statewide, however the proportions of the subtypes differed; Western Australia had the largest proportion of non-B subtypes
  • A wide age distribution exists across all states, including juveniles and over 55s
  • Phylogenetic analysis revealed differences in network size among B and non-B subtypes
  • The data are valuable now and can be assessed in real time in the future to assist with clinical care, educating and intervention strategies

Key findings from surveying tenofovir resistant in Western Australia

  • Low numbers of K65 mutations
  • Transmitted tenofovir resistance identified
  • Significant increases in HIV-1 RNA levels associated with K65 mutation, suggesting increased viral replication fitness
  • A baseline of NRTI DRMs can be utilised to monitor first-line treatment failures particularly when considering the efficacy of PreP and PEP strategies

This study has demonstrated an increasing HIV-1 diversity in Australia and an alarming increased rate of new HIV infections in Australia. Having more ‘visibility’ on HIV epidemiology at the population level can improve patient outcomes and inform rational prevention strategies that can alter recent increasing trends in the Australian HIV epidemic.

Karen Chronister, Kirketon Road Centre, NSW

Expanded Access to Treatment for Hepatitis C Virus among People Who Inject Drugs

Grant awarded: $50,000

Treatment is not only necessary to reduce the continuing burden of chronic hepatitis C virus (HCV) and related liver disease, but also to potentially reduce morbidity by preventing additional infections in high prevalence populations, such as people who inject drugs. With the availability of new simple-dosing regimen HCV treatments, further efforts can be made to increase access to treatment.

This project aims to evaluate the feasibility and acceptability of delivering treatment for HCV to people who inject drugs through an opioid substitution treatment (OST) program within a primary healthcare service, regardless of their participation in OST or opioid dependence.

Thus far, one third of clients commencing treatment have opted for individualised dosing plans. Client and staff feedback reflects that this approach is both acceptable and feasible to expand access to HCV treatment.

Expanding access to HCV treatment through OST or similar programs regardless of participation, as well as individualised adherence and dosing plans, should be considered for clients who may need additional support.

Further examination of treatment outcomes will continue into 2017 and future research related to this approach to expand access for HCV treatment will include analysis to identify predictors of treatment completion when clients receive individualised treatment plans through the OST program.

Joseph Doyle, St Vincent’s Hospital Melbourne, Vic

Monitoring hepatitis C incidence during a state-wide treatment scale-up program in Victorian prisons

Grant awarded: $20,000

Hepatitis C virus (HCV) infects 34 million people per year and transmission is primarily among people who inject drugs (PWID) in high-income countries. Incarceration is an independent risk factor for transmission and HCV incidence in custodial settings internationally is estimated at 16 cases per 100 person-years.

St Vincent’s Hospital and Department of Justice established the state-wide prison hepatitis management program in 2015 to rapidly increase HCV treatment uptake. The purpose of this research was to:

  • determine HCV incidence, prevalence and reinfection incidence among individuals in the Victorian Custodial System
  • establish a sustainable system for ongoing monitoring for HCV incidence and prevalence in Victorian prisons
  • measure the effect of the first year of treatment scale-up on HCV incidence and prevalence in Victorian prisons.

Thus far, over 850 people have been assessed for HCV and more than 350 people have started treatment. The outcomes of treatment in prison settings have been similar to those in the community; and there has been only one documented case of reinfection.

These findings demonstrate that delivering HCV treatment in prisons is highly feasible. Monitoring new HCV cases and the burden of disease moving forward will be critical in measuring the wider impact of treatment.

Joshua Duyker, Queensland Positive People, Qld

Innovative methods to increase HIV testing among MSM in regional Queensland

Grant awarded: $20,000

People living in rural, regional and remote areas of Queensland have limited access to a myriad of health services, including sexual health and HIV testing. This potentially attributes to infrequent rates of testing and leads to undiagnosed cases of HIV and STIs among those most at risk, such as men who have sex with men (MSM). Community-based testing provides an alternative testing service and can be beneficial to individuals who face barriers in accessing healthcare services. There is evidence to suggest that HIV testing from a mobile clinic van in community sites is acceptable among MSM who live in metropolitan areas.

This project implemented a time-limited, peer-led mobile clinic van intervention in Toowoomba to determine if it is a feasible and acceptable method for regional MSM to engage with HIV testing in regional, resource-limited settings. Additional objectives of the research were to ascertain whether the use of ‘online’ networks and respondent-driven sampling were acceptable recruitment methods, and to determine regional MSM’s attitudes towards and future use of accessing a postal home HIV test kit.

Findings indicate that acceptability of testing from a mobile van clinic is high and that such a service would increase testing frequency. Although 10 participants would agree to refer friends for HIV/STI testing via an incentive coupon, none of the participants took part in respondent driven sampling.

Future research may seek to compare data between HIV point of care testing in regional and urban settings and develop referral pathways, promotion and evaluation regarding self-testing options.

Mary Fenech, Royal Brisbane and Women’s Hospital, Qld

Assessing and addressing healthcare providers’ attitudes to treatment of HCV in Injecting Drug Users

Grant awarded: $40,000

Miriam Levy, Liverpool Hospital, NSW

Perinatal transmission of HBV – Is it time to change the Australian guidelines for infant follow up?

Grant awarded: $20,000

Mother to baby transmission of hepatitis B virus (HBV) results in chronic infection in 90% of newborns and treatment is rarely curative; prevention is therefore critical. This project assessed mother-to-baby transmission of HBV and aimed to:

  • characterise a cohort of pregnant HBV mothers presenting to a healthcare service in the last 4 years (n=400) including clinical virological and obstetric features
  • establish the rate of perinatal transmission and successful vaccination
  • statistically identify the correlates for perinatal transmission and power of the findings
  • determine a threshold below which testing the infant may be confidently avoided.

The research findings were recently presented at European Association for the Study of Liver (EASL) congress and it is hoped these will also be in publication in early 2017.

Rhondda Lewis, Cairns Sexual Health Service, Queensland Health, Qld

Chronic Hepatitis B management and health promotion mapping in Far North Queensland

Grant awarded: $20,000

Aboriginal and Torres Strait Islander people have significantly higher rates of HBV infection and the complications of liver cirrhosis and liver cancer compared with non-Indigenous populations in Australia. Cairns Sexual Health Service developed and focus tested a hepatitis B toolkit of locally produced resources and promotional material for staff and Aboriginal and Torres Strait Islander people living with chronic hepatitis B (CHB) in Far North Queensland, with the aim of raising awareness of CHB and improving pathways between communities, health services (and the local correctional centre) and patients.

Focus testing showed a divide between what the health professional would like the patient to know, and what the community member was interested in hearing and reading. It also showed that the style, vocabulary and jargon of a resource written by health professionals were perceived as overly wordy and unclear by community members. Translating the document to be useful for both health staff and useful in a low literacy situation proved difficult, and an understanding was also reached that these resources were only to assist in conversations with the community rather than being their only explanation of CHB.

Far North Queensland is at the brink of key developments and achievements in community literacy, participation, clinical management and treatment of CHB. Key stakeholders and clinicians in Far North Queensland represent a diverse range of experience, backgrounds, and ideas for moving forward with CHB management, hence there is a need to bring this network together and produce communication that is consistent and agreed upon by them, and is also acceptable to the community.

Kate Mackie, Alfred Health, Vic

Pharmacist Review of Medications for HIV+ people seen in General Practice (PROM-GP)

Grant awarded: $50,000

For many patients with HIV living in Victoria, their HIV care is managed by a GP at one of the three high HIV caseload GP clinics in Melbourne (Prahran Market Clinic, Centre Clinic, and Northside Clinic). These patients often obtain their antiretrovirals from The Alfred or Melbourne Sexual Health Centre pharmacy, and anecdotally we find that a complete review of their medications can be difficult in the hospital pharmacy dispensary setting. We hypothesised that integrating the HIV pharmacist into the high HIV caseload GP clinics to perform medication reviews will demonstrate that medication-related problems (MRPs) can be effectively identified and managed.

To evaluate the effectiveness of a HIV specialist pharmacist consultation based within high HIV caseload GP clinics, we assessed the number and types of MRPs identified by pharmacists.

One hundred patients that were HIV+ were recruited over the 5-month recruitment phase across the three high HIV caseload GP clinics. A total of 550 MRPs were identified, with 262 of these being of significant risk (moderate or high risk) and recommendations for their management made by the pharmacist. Preliminary results indicate about two thirds of the significant MRPs have been resolved.

These findings suggest that this innovative model of integrating a clinical (specialised) pharmacist into GP practices could help facilitate improved care in the ageing HIV ambulatory population.

2015 VIDEOS


Overview

Highlights from the Gilead Australia Fellowship: Research Grants Program Best Practice Sharing Symposium

How previous Fellowship grant recipients are working to improve patient care in the areas of HIV and chronic viral hepatitis


HIV

HIV-positive children transitioning to adolescence and adulthood

Assessing neurocognition, mood and adherence in culturally and linguistically diverse (CALD) HIV-positive persons

Understanding losses to follow-up from HIV care and interventions to re-engage lost patients


Barriers to HIV-therapy adherence

HIV testing patterns and behaviours in the Vietnamese migrant population in Queensland


Chronic viral hepatitis

Animating hepatitis B: youth as agents of change

Understanding hepatitis C direct-acting antivirals in a cohort of people who inject drugs

Animated films as a medium to raise Hepatitis B community awareness


Psychosocial Screening Tool to improve uptake of HCV Treatment

‘B in IT’ Community Based Care for CHB

Fibrocare: improving chronic HCV assessment in general practice using Fibroscans


Salivary Rapid Testing for Hepatitis B in remote Indigenous communities

Facilitating Hepatitis B screening and treatment in the Hmong community of North Queensland


HIV and chronic viral hepatitis

Virological failure in the Second-Line study and relationship to plasma drug levels


Haematological oncology

Coming in 2018 after the first haematological oncology projects from 2017 are completed