HIV Post Exposure Prophylaxis Adjunct A/Prof Levinia Crooks AM Chief Executive Officer Australasian Society for HIV, Viral Hepatitis & Sexual Health Medicine Public Health and Human Biosciences, La Trobe University Centre for social research in health, university of new south wales Supporting the HIV, viral hepatitis and sexual health workforce

ASHM and our role in PrEP Professional society supporting and representing the HIV, viral hepatitis and sexual health workforce Work closely with sector partners, professional and community organisations Australia and New Zealand and work collaboratively with professional and workforce development oranisations in the Asia and Pacific regions Coordinated Australian National PEP Guidelines in 2001 National PrEP Guidelines in 2015 (being updated now) Communiques, training and resources for clinicians Partner with community agencies providing advice to consumers

PrEP Status in Australasia Truvada ® approved by the Australian Therapeutic Goods Administration (TGA) in May 2016. It is now listed on the Australian Register of Therapeutic Goods (ARTG). Not listed in New Zealand Application before the Pharmaceutical Benefits Advisory Committee (PBAC), if supported will be subsidised under the Pharmaceutical Benefits Scheme. Next meeting July 2016, if supported likely to be available late 2016 – early 2017. PrEP is not licensed in New Zealand

Ways drugs can be accessed The Australian government allows people to import drugs for personal use through the Personal Importations Scheme https://www.tga.gov.au/personal-importation- scheme This means that proprietary drug as well as generic drug can be imported Online internet pharmacies sell Truvada and generic bioequivalents Now that the drug is on the ARTG it will also be able to be purchased for full price from the manufacturer

Demonstration Projects A number of research projects make PrEP available VicPrep 115 – Victoria - 2600 PreLude 300 – New South Wales - 3700 QPREP 50 – Queensland - 2000 Each of these has now been extended and a less extensive protocol used to scale-up with the view to realising a public health outcome of reducing new infections.

Quality when buying on line FDA has approved a number of generic providers for supply to PEPFAR programs Gilead has drugs produced under licence by Mylan and marketed through Alphapharm (in some countries) Drug being used in Australia extension projects a mix of Gilead and Mylan/Alphapharm Community organisations can provide information about approved suppliers Avoid on-line services which make false claims Can test drug to determine bioequivalence

Guidelines and Guidance ASHM Australian Guidelines Jurisdictional Guidelines Study Protocols (more stringent in first phase) Study protocols (less stringent in second phase) Guidance to clinicians assisting people to self import

Who should access PrEP It is thought that many people acquire and then transmit HIV before they know they are infected SO WHO SHOULD HAVE PREP: People at greatest risk of acquiring and transmitting HIV, if they were to acquire it People at risk of acquiring HIV People who find consistent condom use difficult

Some observations People (mainly MSM) are going on PrEP and staying on for duration of studies so far MSM interested in PrEP already have high STI burden, and this continues Study participants are taking pills at a regular rate with the majority always maintaining therapeutic dose Self report acceptability and feeling of taking control Bone mineral density and renal complications low Very low or no transmissions, means there is no transmitted resistance

Next iteration of Guidelines Will include: Focus on transgender persons Discussion of consideration of intermittent PrEP Hepatitis C testing while on PrEP Consideration of access for people outside of highest priority research participants

PrEP: part of comprehensive prevention strategy Increase testing Newly infected Identification of people with established infection Increase number of people on treatment Reduce time between diagnosis and treatment Remove barriers to starting treatment Maintain people on treatment Increase promotion of other prevention strategy Condom use STI screening

Regional Network Establish PrEP page on Regional Network Website Upload and link regional and country information Can also link information for patients Website launched today 17 May 2016 http://www.regionalnetwork.ashm.org.au/