Published: 3 June 2017

Off-label: the changing boundaries of prevention

HIV Australia | Vol. 13 No. 2 | July 2015

Dean Murphy

DEAN MURPHY looks at the growing trend of personal PrEP importation in Australia and considers the multiple representations of biomedical prevention.

A recent story on ABC TV’s 7.30 called ‘PrEP: The blue pill being used to prevent HIV’, was an interesting foray by mainstream media exploring the issue of HIV pre-exposure prophylaxis (PrEP).

The story follows earlier coverage by SBS Television and ABC Radio over the last year. In recent weeks, I’ve also been contacted by several community and student media journalists with inquiries about PrEP.

This flurry of media activity on the topic suggests that interest in PrEP in Australia is currently very high.

The story on 7.30 featured a range of PrEP users, including one man who is currently taking part in a PrEP demonstration project in Australia, an African-American man accessing PrEP in a relatively straightforward way in the US, one man who sees himself as a potential user of PrEP in the future, and one man who is importing a generic version of Truvada into Australia for use as PrEP.

The story also described how ‘many gay men are forced to come up with creative ways of obtaining the drug’, referring to importation from overseas.

Chris, one man in the story, outlined the steps he follows as part of this process. Importing drugs for personal use (limited to a supply of three months at a time) is perfectly legitimate, and general information about how to do it is provided on the website of the TGA (Therapeutic Goods Administration).1

Importantly, importation of drugs needs to be accompanied by a prescription from an Australian doctor. Recently, HIV prevention community organisations such as ACON and Victorian AIDS Council (VAC) began providing advice on personal importation of generic versions of Truvada.

The Australasian Society for HIV Medicine (ASHM) also now provides advice to clinicians on managing patients importing antiretrovirals (ARVs) for PrEP, including guidance on importation.

The title of the story was presumably an attempt to make a connection between PrEP, or specifically Truvada, and Viagra (sildenafil) commonly known as ‘the little blue pill’.

Some media and other commentators in the US have taken this analogy further by dubbing Truvada as a ‘party drug’, noting also that there is a street market in cocktails of crystal methamphetamine, Truvada and Viagra together – labelled ‘MTV’.2

This underlines how the media as well as research literature often frames gay men’s interest in antiretrovirals for prevention in a similar way to illicit drug use, in that ARVs are enacted as unprotected sex.

However, despite these similarities in framing, there has not been any serious attempt to think about these different types of drugs together.

What is PrEP?

An important question is what PrEP is, or rather what are the many PrEPs that emerge in different locations? This question is likely to be further complicated by different ways of accessing ARVs for prevention.

The current situation in Australia

Clinical trials and observational studies have determined the efficacy and effectiveness of daily dosing of the antiretroviral combination drug (brand name Truvada) in dramatically reducing the risk of acquiring HIV.

Truvada is a pre-existing drug that is used to treat HIV infection, however it is not licensed or subsidised for prevention in Australia.

Truvada is only available for pre-exposure prophylaxis through ‘demonstration projects’ in Victoria and New South Wales (and soon in Queensland).

Additional options for accessing Truvada for prophylactic use are through private off-label prescribing within Australia, and/or through importing generic versions of Truvada thorough online purchasing.

The Australasian Society for HIV Medicine (ASHM) recently published guidelines on prescribing Truvada as pre-exposure prophylaxis for people at high risk of HIV.3

Earlier this year the manufacturer of Truvada made a TGA application, but the evaluation process could take 12 months or more, meaning that Truvada is not likely be listed for PrEP in the immediate future.

A separate application would need to be made to the Pharmaceutical Benefits Advisory Committee (PBAC) to get subsidy through the PBS. Again, this is a lengthy process, although it could be commenced prior to an outcome from the TGA application.

Although the terms PrEP and Truvada are used almost interchangeably, I would argue that the former is a much more complex object.

Even a cursory glance at media reports, personal accounts and health promotion materials reveal that PrEP is a number of things: a (daily) regimen of pills (that might be accompanied by side effects); a way of controlling one’s own risk of HIV acquisition (rather than trusting others); a signifier of present and/or future risk; a supplement to, or replacement for, condoms; a marker of sexual excess; a pharmaceutical enhancement; an enabler of greater intimacy and of serodiscordant relationships; a way of bypassing difficult HIV disclosure discussions; and a powerful way of removing anxiety around HIV and sex.

PrEP can have unexpected meanings, and meanings that may only emerge in relations with others.

What, for example, does PrEP make different about a sexual encounter between two HIV-negative men when one is on PrEP and the other is not? There are a numerous possibilities.

PrEP can challenge the HIV-negative status of the non-PrEP-taking partner, rendering it less certain.

Alternatively, PrEP can cause problems for the person doing the disclosing, in the sense that the other person understands PrEP use as being more ‘risky’. Both these scenarios have been reported in interviews by gay men taking PrEP.

Off-label PrEP

Although attention since 2011 has been concentrated on access to PrEP through demonstration projects – and more recently on the experiences of men accessing PrEP through these studies – I have become increasingly interested in PrEP outside these more formal arrangements.

Previous surveys have indicated small numbers of gay men accessing ARVs for PrEP through importation, private prescribing within Australia, or through diversion of ARVs from people living with HIV.

It is not known how many people are actually accessing ARVs in this way, but indications from social media, HIV organisations, and recent qualitative research, suggests that there has been a rapid increase alongside a general increase in awareness of PrEP.

Given that the number of people involved in the PrEP demonstration projects is currently at 465 in total, the number of people accessing Truvada in other ways is likely to quickly exceed this, if it hasn’t already.

There is very little formal research so far on the experiences and practices of people importing ARVs for PrEP (or diverting prescribed ARVs) and how the experiences and practices of men importing generic Truvada compare to those men accessing Truvada through demonstration projects in Australia.

In addition to the meanings of PrEP already mentioned, some thoughts on relevant areas to explore are:

  1. People’s experiences of accessing ARVs for PrEP. What services do they use? Are there issues of affordability that prevent some people from using this option? How reliable are delivery times and supply continuity?
  2. Clinical guidance. To what extent does the use of PrEP among gay men correspond to the recently drafted national guidelines? Is purchasing of ARVs undertaken in conjunction with a health-care provider? Is screening being undertaken prior to commencing ARVs? Are people attending for the recommended quarterly visits, including HIV and STI testing?
  3. Patterns of use. Are people using PrEP on a daily dosing basis, or are they using it in different ways, i.e., intermittently, on an event-driven basis, or ‘seasonally’? And if people are not taking it daily, is this primarily influenced by concerns about toxicity and side effects, self-assessment of only occasional risk of HIV acquisition, or for financial reasons (or indeed for all of these reasons).
  4. Efficacy/effectiveness. Do people have confidence in ARVs for prevention (both in a general sense, and also specifically related to generic versions of the drug as opposed to brand-name Truvada)?
  5. Changes in behaviour and/or existing prevention strategies. Does the use of condoms and other risk reduction strategies decrease after starting PrEP, or remain the same, or paradoxically increase, as it did in clinical trials?

Pill talk

The recent 7.30 story was consistent with other recent media coverage on PrEP in the sense that it positioned the ARVs themselves centre stage.

PrEP health promotion campaign collateral from US-based Gay Men’s Health Crisis (GMHC). The campaign features the now ubiquitous image of a person holding up a Truvada pill.

Most media stories on PrEP, including in social media, contain almost the exact same image, i.e. a person holding the pill between their thumb and finger, showing the GILEAD imprint (usually) or the 701 imprint on the other side.

Other variations in health promotion materials include images of the pills alone, or spilling out of a bottle, or interestingly out of a condom, without any link to the people who might be taking them.

These images are a jolting reminder of how rarely we see images of ARVs anymore, and how paradoxical it is that images of ARVs now represent prevention rather than treatment.

It is already clear from repeat surveys conducted biennially since 2011 that those gay men who are the most willing to take PrEP are those who are also those who perceive themselves to be at highest risk;4 5 and based on information available so far, it seems that a similar group of men have accessed PrEP through the demonstration projects.

Clinicians’ (and other health care providers’) attitudes to PrEP may be a significant barrier.

Based on a study of people working in the HIV sector conducted in 2014, there was moderate agreement among participants that PrEP was effective (lower than for condoms and ‘treatment as prevention’) and participants reported that they were only moderately likely to recommend PrEP to gay men.6

Specifically among clinicians among in this sample, there were negative attitudes to providing PrEP because of the perceived costs (especially when compared to existing HIV prevention measures).7

Some respondents explicitly framed provision of PrEP as subsidising gay men to have sex without condoms, and were for this reason uncomfortable with it as a strategy.8

Clearly a great deal of work will need to be undertaken with this group to overcome these attitudes and for potential users of PrEP to be able to talk openly with their health care providers about it.

There is a sense of urgency about this task too, because PrEP demonstrates how the boundaries of prevention are changing. Arguably, the most medicalised form of prevention to date can now also exist somewhat outside the control of medicine.


Demonstration projects and personal importation both offer only interim solutions (so not actual solutions) to providing ongoing access for those people already on PrEP and to making PrEP more available to others who would benefit from it – which would in turn have an important impact on the epidemic.

The continued availability of Truvada for demonstration projects is uncertain, although an 18-month extension of supply for those people on the demonstration projects has created some breathing space for participants, especially those in Victoria who were in the last few weeks of their 12-month supply.

Also, the current negotiations in the Trans-Pacific Partnership agreement contain both positive and negative signals.

On the one hand, future decisions by the Pharmaceutical Benefits Advisory Committee not to list a drug, or to list it subject to certain conditions, could be overturned.9

On the other hand it is not hard to imagine pharmaceutical companies seeking to prevent importation of generic versions of ARVs if this prevents sales of brand-name drugs.

Dean Murphy is currently conducting a study called Off Label on the experiences of gay men importing antiretrovirals for use as PrEP. For more information, or to take part, please email


1 See:

2 Kurtz, S., Buttram, M., Surratt, H. (2013). Vulnerable infected populations and street markets for ARVs: Potential implications for PrEP rollout in the USA. AIDS Care, 26(4), 411–415. doi:

3 Australian National PrEP Guidelines are available at:

4 Holt, M., Lea, T., Murphy, D., Ellard, J., Rosengarten, M., Kippax, S., De Wit, J. (2014). Willingness to use HIV preexposure prophylaxis has declined among australian gay and bisexual men: results from repeated national surveys, 2011–2013. J Acquir Immune Defic Syndr, 67(2), 222–226. doi:

5 Holt, M., Murphy, D., Callander, D., Ellard, J., Rosengarten, M., Kippax, S., de Wit, J. (2012). Willingness to use HIV preexposure prophylaxis and the likelihood of decreased condom use are both associated with unprotected anal intercourse and the perceived likelihood of becoming HIV positive among Australian gay and bisexual men. Sex Transm Infect, 88(4), 258–263. doi:

6 Murphy, D. (2015). Clinicians’ attitudes to HIV pre-exposure prophylaxis (presentation). Paper presented at the Queensland HIV Foundation.

7 ibid.

8 ibid.

9 Gleeson, D. (2015, 11 June). Big pharma is the real winner in TPP plan. ABC (The Drum) Retrieved from:

Dean Murphy is a Research Fellow at the Centre for Social Research in Health (CSRH), UNSW Australia, and the National Drug Research Institute (Curtin University). He is an investigator on the VicPrEP and PrELUDE demonstration projects and the PrEPARE Project.