Widespread availability and uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) has the potential to significantly reduce HIV transmission in Australia and globally.

Co-formulated tenofovir and emtricitabine for use as HIV pre-exposure prophylaxis (PrEP) by people at risk of HIV infection is now recommended as standard care in clinical guidelines in the United States of America, Europe and Australia (1, 2, 3), as well as globally through World Health Organization (WHO) guidelines (4). When used with optimal medication adherence, daily PrEP is a highly effective HIV prevention strategy for men who have sex with men (MSM), heterosexual men and women, transgender people, and people who inject drugs who are at-risk of HIV acquisition (5-11). In addition, on-demand<sup>†</sup>PrEP is highly effective in MSM (12-14) and has recently been recommended by the World Health Organisation as an option for MSM (15).

These clinical PrEP guidelines update the 2018 ASHM PrEP guidelines (3) which were initially an adaptation and update of the 2014 United States Centers for Disease Control‘s PrEP guidelines (16).

On May 2016, the Australian Therapeutic Goods Administration (TGA) approved the entry of Truvada coformulated tenofovir disoproxil fumarate and emtricitabine TDF/FTC; Gilead Sciences) onto the Australian Register of Therapeutic Goods (ARTG) for HIV PrEP for people at risk of HIV infection. Since then, a number of generic co-formulations of tenofovir disoproxil* and FTC have been registered by the TGA for HIV PrEP (for simplicity, TD* is used in these guidelines to denote the tenofovir disoproxil component present in the medicines registered for PrEP use in Australia).

From 1 April 2018, the brand and generic versions of TD*/FTC became available through the Australian Pharmaceutical Benefits Scheme (PBS) at subsidised cost for HIV PrEP (17). Whereas previously PrEP was available only through clinical trials, private scripts or through personal importation, it can now be prescribed by all general practitioners (GP) and authorised nurse practitioners using PBS scripts. People with Medicare numbers can fill their scripts through the PBS, however people who are Medicare ineligible can either legally import generic PrEP using the TGA Personal Importation Scheme (PIS) (18), or pay the full price with a private script.

The recommendations in these guidelines are designed to: 

  • support the prescribing of PrEP using either ARTG-listed and PBS subsidised drugs, or the same or other generic drugs that are available through personal importation, or by paying the full price with a private script
  • assist clinicians in their evaluation and HIV risk assessment of patients who are seeking PrEP
  • assist clinicians in initiating their patients on PrEP by providing information on PrEP dosing schedules
  • assist clinicians in the monitoring of patients on PrEP, including testing requirements and management of side-effects and toxicity
  • assist clinicians to be aware of more complex situations such as the use of PrEP in pregnancy and in chronic hepatitis B infection
  • assist clinicians in understanding how to safely cease PrEP.

These guidelines are intended for use by:

  • general practitioners who provide care to people at risk of acquiring HIV infection
  • sexual health physicians and ID physicians who provide care to people at risk of acquiring HIV infection and/or who serve as consultants to primary-care physicians about the use of ARV antiretroviral treatment
  • infectious disease and HIV treatment specialists who may provide PrEP for, or serve as consultants to primary-care physicians about the use of antiretroviral medications
  • trainees and registrars in each of the above categories
  • authorised nurse practitioners who provide care to people at risk of acquiring HIV infection
  • nurses working in nurse-led clinics in consultation with doctors
  • peer workers
  • counsellors and people performing HIV testing, including point-of-care testing
  • health program policymakers
  • health consumers and others with an interest in HIV PrEP.

The Therapeutic Goods Administration (TGA) has not approved this regimen in Australia.