Update on HIV PrEP for HIV Clinicians
This communique is for clinicians involved in HIV, who may be consulted about HIV Pre-Exposure Prophylaxis (PrEP). It assumes an understanding of HIV prophylaxis.
Consumers in Australia can currently access PrEP through two mechanisms: Drugs can be prescribed 'off-label' with the purchase without subsidy; and then imported into Australia for private use under the Personal Importation Scheme. Alternatively, consumers can seek enrolment in one of the current PrEP demonstration studies projects in Australia. On 9 February 2018 PrEP was recommended for listing on the Pharmaceutical Benefits Scheme (PBS) meaning that they would be subsidised; able to be prescribed by all community GPs and also available for dispensing via community pharmacies.
ASHM, through its PrEP guidelines affirms the PBAC position, that individuals should return a negative HIV test result prior to commencing PrEP. Any individual who is on PrEP will need regular monitoring, prevention and adherence support, and will require maintenance prescriptions.
- As of 6 May 2016, Gilead Sciences’ Truvada® was determined safe and effective by the Therapeutic Drugs Administration (TGA) – the Australian Department of Health regulatory body of therapeutic goods licensed by the Therapeutic Goods Administration (TGA) for use as PrEP, however not subsidised by the Pharmaceutical Benefits Scheme (PBS) for preventative use.
- The application for a PBS listing of Gilead Sciences’ Truvada® was first rejected in August 2016 by the Australian Pharmaceutical Benefits Advisory Committee (PBAC), the key committee of experts which advises new medicines for listing on the PBS, who indicated concerns with unacceptable and uncertain cost-effectiveness based on the target populations and the price proposed in the 2016 submission.
- By December 2016, Mylan and Lupin had their generic versions of co-formulated tenofovir and emtricitabine registered for use as PrEP by the TGA.
- PrEP has been available to individuals in Australia via PrEP demonstration trials in all Australian States and Territories (except the Northern Territory) starting with the EPIC-NSW study in New South Wales in March 2016.
- PBAC announced in August 2017 that it deferred the application from Gilead Sciences and Mylan Australia to have their products approved for PrEP.
- The latest PBAC decision about PrEP was announced on 9 February 2018 recommending PrEP drugs to the PBS
- AFAO and ASHM have produced a PrEP Fact Sheet to assist PrEP users and people with an interest in using PrEP to understand what subsidised access to PrEP through the PBS means. Download the factsheet
ASHM are working in collaboration with community and clinical stakeholders to ensure that resources and training are ready and available to support PBAC changes. The ASHM PrEP online learning module is available now and have been updated to reflect the changes to the PBAC. The definitions of risk for HIV, guidelines and procedures for the appropriate administration and monitoring of PrEP can be found in the ASHM PrEP Clinical Guidelines, a document which provided the behavioural criteria for the PBAC application providing the evidence-based advocacy for PrEP.
Access of PrEP in New Zealand
New Zealand’s PHARMAC (the New Zealand government agency that decides which pharmaceuticals to publicly fund in New Zealand) announced on 6 February, 2018 that Gilead Sciences’ Truvada® will be available to eligible patients as PrEP in pharmacies throughout New Zealand from 1 March, 2018 at the cost of a normal prescription.
For more information, see the New Zealand AIDS Foundation website here.
The ASHM PrEP online learning module for NZ GPs is available now and will be updated to reflect the changes to PHARMAC.
ASHM are supporting the educational needs of GP prescribers and other clinicians in New Zealand who are involved in HIV care in the upcoming 2018 NZ HIV Clinical Update meeting held in Auckland City Hospital on 6 April 2018. A satellite event with presenter Dr Vincent Cornelisse (specialist in sexual health medicine) will be held on 5 April open to all GPs and other clinicians who will be involved with prescribing PrEP. For more information or to register: Visit the website
Information on clinical resources and training supporting the HIV workforce
ASHM continues to support the workforce to ensure access to PrEP and best practice in guidelines, training and resources:
- In July 2017, ASHM Australian HIV Pre-exposure Prophylaxis (PrEP) Clinical Guidelines were published in the Journal of Virus Eradication (Journal of Virus Eradication 2017; 3: pp168–184) for clinicians who will be initiating and monitoring people taking PrEP and are designed to reflect Australia’s epidemiology.
- All clinicians interested in accessing training on HIV PrEP can register to join ASHM’s Online Learning Module – ‘PrEP in practice: Guidance for GPs (Australia)’ or ‘PrEP in practice: Guidance for GPs (New Zealand)’ (Duration: 40 to 60 minutes) via the ASHM Learning Management System: https://lms.ashm.org.au/
- ASHM currently delivers PrEP training to GPs and practice nurses in New South Wales and Queensland supported by the NSW Ministry of Health and the Queensland Health Department. If you are interested in training please complete an expression of interest via firstname.lastname@example.org
Currently in development to be made available in 2018 are new at-a-glance ASHM HIV PrEP resources for clinicians and patients:
- PrEP decision making tool for GPs and Practice Nurses
- Online PrEP training for GPs and Practice nurses in NSW
- PrEP prescribing pathway tool for GPs in NSW
Access Australian PrEP Guidelines published by ASHM in Journal of Virus Eradication
ASHM Australian HIV Pre-exposure Prophylaxis (PrEP) Clinical Guidelines have been published in the Journal of Virus Eradication (Journal of Virus Eradication 2017; 3: pp168–184) representing an adaptation and a revision of the 2014 United States Centers for Disease Control's PrEP guidelines. The 2017 Australian PrEP Guidelines have the benefits of having been being written and edited by clinicians, epidemiologists and representatives of peak Australian HIV community organisations who have significant experience of PrEP in the clinical, research and real-world settings. These guidelines are written for clinicians who will be initiating PrEP and monitoring people taking PrEP and are designed to reflect Australia’s unique epidemiology.
The recommendations included in the Guidelines are designed to:
- support the prescription of PrEP using the ARTG-listed drugs and other bioequivalent generic drugs that are available in Australia, or are being used in Australian PrEP trials
- assist clinicians in their evaluation of patients who are seeking PrEP
- to assist clinicians in commencing and monitoring their patients on PrEP by providing information on 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.
Contributing to PrEP studies in Australia
The Australian Implementation of PrEP trials have recruited participants in all states and territories apart from Northern Territory (numbers at December 2017):
Further Information and the Personal Importation Scheme
ASHM are committed to informing people at risk of HIV on how they can access PrEP while the application process continues. Find links to further information: