Imagining an Australia with PrEP

HIV Australia | Vol. 13 No. 1 | April 2015

By Heath Paynter

As awareness about HIV pre-exposure prophylaxis (PrEP) grows in Australia, the US experience with PrEP, where it has been approved since July 2012, offers some useful insights.¹

Using that experience as a starting point, this article will consider the major issues associated with PrEP and raise questions that Australia might need to consider.

The data around PrEP’s effectiveness in preventing HIV will not be reviewed here, other than to say that the science is clear: if an individual takes Truvada daily, they are not at risk of acquiring HIV.^2, ^3, ^4, ^5,

PrEP and moral panic

The debate on PrEP in the United States has often been cast in black and white terms, and what is missing in much of the early commentary is a coherent defence of PrEP.
Since its approval by the US Food and Drug Administration (FDA) in July 2012, uptake of PrEP among men who have sex with men (MSM) in the US has been slow.⁶

The initial public discourse centred around fears that it would displace condom use. This commentary largely focused on promiscuity and condomless sex and overlooked the complex ways in which people have sex and manage risk.

In 2013, when the Centers for Disease Control and Prevention (CDC) announced that condomless sex among men who have sex with men had increased 20 percent between 2005 to 2011,⁷ a report in The New York Times said that this figure was spurring HIV fears and ‘heightening concerns among health officials worldwide’.⁸

In The New Yorker, columnist Michael Specter wrote, ‘If unprotected anal sex is rising among gay men … the rates of HIV infection will surely follow.’⁹

Around the same time, Michael Weinstein, the head of the AIDS Healthcare Foundation¹⁰ said PrEP ‘shows just how disposable we consider the lives of gay men’¹¹ and that PrEP was ‘a plot by Gilead to force young people onto unnecessary medication.’¹² Weinstein has also sought to cast PrEP as ‘a party drug’.¹³

The public comments in the US about PrEP have shaped perceptions of this HIV prevention strategy. In so doing, prospective recipients of PrEP have been judged through the lens of deviancy, recalcitrance and otherness, rather than being appreciated as individuals who are making a decision to improve their sexual health, wellbeing and reduce their risk of acquiring a chronic illness and, by extension, their reliance on the public health system.

US endorsement of PrEP

It took almost two years for the CDC to release clinical guidelines on, and by implication, endorse PrEP.¹⁴ This was followed by a joint letter from 66 HIV/AIDS organisations in the USA supporting the CDC’s endorsement.¹⁵

By mid-2014, as awareness of PrEP in the US increased, New York Governor Andrew Cuomo endorsed PrEP as part of a project called The Campaign to End AIDS (C2EA), targeting individuals at high risk of HIV.¹⁶ This incorporated PrEP into a three-pronged plan to end the AIDS epidemic in New York State.

Similarly, in San Francisco PrEP is part of Getting to Zero, a plan which aims to reduce HIV infections in San Francisco by 90 percent by 2020.¹⁷ These strategies seem to be having some impact, with evidence that PrEP use in the US is increasing, although uptake is still not as widespread as many advocates had hoped.^18, ¹⁹

Accessibility

Given PrEP’s effectiveness as an HIV risk reduction strategy, affordability is critical if PrEP is to reach the individuals who stand to benefit the most from it.

In promoting PrEP, advocates should not just focus on the costs of the medication, which in Australia is $800 per month, but rather consider the preventative health benefits that PrEP offers.

In the US, the Affordable Care Act potentially creates a new framework for coordinating the delivery of prevention services.

In the context of PrEP, individual patients sign up for regular testing, which includes counselling around PrEP use and opportunities for addressing mental health issues, alcohol and other drug issues, sexually transmissible infections (STI) screenings, and other ancillary services to be addressed through primary care. For those with medical insurance, the insurer will cover the cost of Truvada.

The amount of the co-payment covered by the insurer depends on the level and type of cover.

PrEP in the US involves regular medical consultations providing people who belong to low socio-economic communities with a high prevalence of HIV the opportunity for routine medical screening and linkages to healthcare services they might not otherwise have.

PrEP is often considered through the template of the cost of Truvada alone, and not as a tool that provides individuals at high risk of HIV with access to healthcare settings, medical testing and counselling that people who belong to low socio-economic communities would not otherwise have.

Given the preventative benefits PrEP offers, we need to consider whether there is an ethical imperative to extend the benefits of antiretroviral treatment to HIV-negative people in equal measure to the way it is extended to HIV-positive people.

Guidelines on PrEP have been developed by the Australasian Society for HIV Medicine (ASHM) for clinicians who may be consulted regarding PrEP.

Pending TGA approval, this is for off-label use or for imported medications, and has been informed by guidelines developed for PrEP demonstration projects in Victoria, New South Wales and Queensland.²⁰

If PrEP were to be approved in Australia, one of the challenges for physicians and policy analysts will be ensuring that PrEP reaches individuals and populations who can benefit most from it.

In the US ‘racial disparities in clinical judgment and prescription practices related to HIV treatment have been well documented …

The limited specificity of existing guidelines [for PrEP] potentially heightens the risk of discriminatory prescription practices occurring as they have with prescribing antiretroviral treatment [for positive people], thus posing a potential barrier to access [for high risk individuals from low socio-economic backgrounds.]’²¹

Despite evidence of ‘high interest’ identified among men who have sex with men (MSM) involved in a recent US PrEP demonstration project,²² researchers noted that there was low uptake among black MSM and transgender women, saying that ‘additional strategies to increase community awareness of PrEP and engage these populations in PrEP programs are urgently needed.’²³

Ensuring PrEP reaches African Americans and people of colour at high risk of HIV appears to be an ongoing challenge in the US. In January 2014, the NYC Department of Health released guidelines for prescribing PrEP.²⁴

While these guidelines are more specific and highlight population groups who should be offered PrEP, they do not address the potential for racial discrimination amongst prescribers in the US. Nor do they address the fact that the people most at risk of HIV are also unlikely to be linked to health care services and, more critically, have medical insurance.

If non-specific guidelines are adopted in Australia the concern is how do we reach individuals at high risk of HIV beyond those already linked to sexual health services?

For instance, recently arrived migrants from countries with a high prevalence of HIV who are less likely to frequent sexual health clinics and have fewer specialist health services, or others who because of their circumstances are at risk of HIV?
Reshaping the prevention narrative

In the US, PrEP guidelines identify ‘men who have sex with men who engage in unprotected anal intercourse’ as candidates for PrEP.²⁵

Because of its effectiveness at blocking HIV, PrEP potentially permits sexual behaviours that traditional public health norms and HIV prevention strategies have rejected or considered less effective than condoms.

At this level, PrEP has the potential to reshape HIV prevention norms and, in turn, herald a more dynamic approach to HIV prevention, both practically and morally.

Historically, condoms have been the first-line strategy for reducing the risk of HIV transmission. In contrast, condomless sex, or barebacking, has been stigmatised and condemned as an action that endangers. The real challenge with PrEP is challenging attitudes towards condomless sex.

For PrEP to reach individuals who can most benefit from it, safe sex needs to be understood, in the words of one commentator, ‘as a dynamic practice that takes different forms in different historical and cultural contexts.’^26, ²⁷

Condomless sex has always been a part of the gay sex narrative, however, in the past the tools available to attenuate the risks of acquiring HIV through barebacking were limited to ‘serosorting’, ‘strategic positioning’ ‘undetectable viral load’, and ‘PEP’ (post-exposure prophylaxis) in the event of accidental exposure. PrEP augments these existing strategies by allowing individuals to manage risk prospectively, regardless of condom use.

Stigma and shame

If PrEP is to reshape HIV prevention, the gay community needs to welcome PrEP as a strategy that supports the health and wellbeing of certain individuals, and not as a strategy that is reserved for individuals who are seen as shirking their responsibility to use socially acceptable prevention strategies like condoms.

One of the interesting areas of commentary about PrEP in the US has been around the issue of stigma and PrEP, or more specifically the trope, ‘Truvada whores’.²⁸ I am referring here to stigma not from outside the gay community, but from within: gay-on-gay shaming.

Stigma of the kind Dan Savage fuelled when he said of gay men and PrEP, ‘The guys these sensible health care folks are trying to reach are not sensible. They are self-identified idiots who can only be saved by a vaccine’.²⁹

This sentiment casts PrEP as the last resort prevention strategy offered to those who are considered non-compliant with socially accepted prevention strategies, like condom use.

It stops a wider interrogation of a new and highly effective risk reduction method that for certain people could provide considerable health benefits, and a wider discussion about safe sex and gay men’s sexual behaviours.

PrEP and the Australian context: where to from here?

To capitalise on the opportunities presented by this new HIV prevention paradigm, general practitioners (GPs) need to provide an available and safe space for individuals to talk candidly about their sexual risk so that their candidacy for PrEP can be objectively evaluated.

As discussed, physician subjectivity may preclude certain people from being granted PrEP, but this depends on the individual making it to a consultation in the first place.

To encourage individuals to discuss their readiness for PrEP we need to consider how we can focus the PrEP narrative on sexual health and wellbeing rather than on a narrative that codifies a PrEP recipient as a recalcitrant or an individual in need of special care.

If the narrative focuses on the benefits of PrEP, individuals will be more likely to enter into a conversation with their GP about the possibilities of PrEP.

A narrative that casts PrEP as lacking in credibility, and the potential recipients as bad will lead to non-engagement and disinterest amongst those who can benefit from PrEP, a situation that, it would appear, characterises the US context thus far.

PrEP is not going to end the epidemic alone, and the cost effectiveness of this HIV prevention strategy is still to be properly understood, but for those individuals who might be prescribed PrEP its impact in terms of reducing the risk of HIV and the anxiety associated with being at risk of HIV is considerable.

If in Australia we can empower the community to recognise PrEP as an additional measure in the suite of prevention tools available to specific individuals who are unable to consistently use condoms, the hope is that those who can benefit most from PrEP will get access to it.

So what do I imagine happening in Australia?

I imagine AIDS organisations and Positive organisations supporting the availability of PrEP to individuals who want to avoid HIV acquisition. The approval of PrEP needs to be accompanied by a framework that supports GPs and the community to understand PrEP.

This should include guidelines for GPs that support the availability of PrEP to individuals and minority groups with a high prevalence of HIV who might not be connected to primary care.

Community organisations should be resourced to provide health promotion that engages the community and raises awareness about PrEP.

This could be through community fora and/or the provision of PrEP education workers. Studies will also be needed to interpret the data generated by demonstration projects underway in some states,³⁰and additional research to monitor community attitudes, knowledge and expectations of PrEP.

This should also include research to arm prescribers with knowledge about minority and disadvantaged communities with a high prevalence of HIV who could benefit from PrEP.

References

1 U.S. Food and Drug Administration (FDA). (2012, 16 July). FDA approves first drug for reducing the risk of sexually acquired HIV infection. Media release. Retrieved from: www.fda.gov

2 The results of iPrEx OLE indicated 100% effectiveness among those individuals taking four or more doses of Truvada a week. See: Grant, R., et al. (2014, 22 July). Results of the iPrEx open label extension (iPrEx OLE) in men and transgender woman who have sex with men: PrEP uptake, sexual practices, and HIV incidence. Paper presented at the 20th International AIDS Conference, Melbourne. Abstract TUAC0105LB.

3 Global iPrEx study, available at: www.iprexole.com. This study found that Truvada provides 99% protection against HIV in gay men when taken daily.

4 McCormack S., Dunn, D. (2015, 24 February). Pragmatic Open-Label Randomised Trial of Preexposure Prophylaxis: The PROUD Study. Paper presented at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI 2015), Seattle. Abstract 22LB.

5 Molina J., Capitant, C., Charreau, I., Meyer, L., Spire, B., Pialoux, G., et al. (2015, February). On Demand PrEP With Oral TDF-FTC in MSM: Results of the ANRS Ipergay Trial. Paper presented at CROI 2015, Seattle. Abstract 22LB.

6 Kirby, T., Thornber-Dunwell, M. (2014). Uptake of PrEP for HIV slow among MSM. The Lancet, 383(9915). dx.doi.org/10.1016/S0140-6736(14)60137-9

7 Paz-Bailey, G., Hall, I., Wolitski, R., Prejean, J., Van Handel, M., Le, B., et al. (2013, 29 November). HIV Testing and Risk Behaviors Among Gay, Bisexual, and Other Men Who Have Sex with Men. Morbidity and Mortality Weekly Report (MMWR), 62(47), 958–962.

8 McNeill, D. (2013, 27 November). Rise in unprotected sex by gay men spurs HIV fears. The New York Times. Retrieved from: www.nytimes.com

9 Specter, M. (2013, 29 November). What young gay men don’t know about AIDS. The New Yorker. Retrieved from: www.newyorker.com

10 The AIDS Health Foundation, based in Los Angeles, is the largest specialised provider of HIV/AIDS medical care in the US.

11 Weinstein, M. (2010, 30 December). Opinion: Advancing on AIDS, or giving up on gay men? San Jose Mercury News. Retrieved from: www.mercurynews.com

12 Glazek, C. (2013, 30 September). Why is no one on the first treatment to prevent H.I.V.? The New Yorker. Retrieved from: www.newyorker.com

13 Crary, D. (2014, 7 April). Truvada, HIV Prevention Drug, Divides Gay Community. Huffpost Gay Voices. Retrieved from: www.huffingtonpost.com

14 See: Centers for Disease Control and Prevention (CDC). (2014). Preexposure prophylaxis for the prevention on HIV infection in the United States: a clinical practice guideline. US Public Health Service. Retrieved from: www.cdc.gov

15 By 20 May 2014, 116 organisations had signed on to endorse their support for the guidelines. For the full list of organisations see: myprepexperience.blogspot.ca

16 For further information, see the Campaign to End AIDS website at: www.c2ea.org

17 For further information on the Getting to Zero draft strategic plan see: www.sfhiv.org

18 Highleyman, L. (2014, 7 November). Truvada PrEP use rising in United States, especially among men. Retrieved from: www.aidsmap.com

19 At CROI 2015 it was reported, that although uptake of PrEP in San Francisco is increasing, it is only reaching around of a third of those that it could benefit. See: Highlyman, L. (2015, 25 February). PrEP use rising in San Francisco, but scaling up could further cut new infections. Retrieved from: www.aidsmap.com

20 Australian National PrEP Guidelines – Approved by the ASHM HIV Clinical Sub-Committee on 16 February 2015 – are available at: arv.ashm.org.au

21 Calabrese, S., Earnshaw, V., Underhill, K., Hansen, N., Dovidio, J. (2014).The Impact of Patient Race on Clinical Decisions Related to Prescribing HIV PrEP: Assumptions About Sexual Risk Compensation and Implications for access. AIDS Behaviour, 18(2). This was an experiment among medical students to prescribe PrEP based on hypothetical scenarios where the race of the patient was varied to test likelihood of prescribing.

22 Elion, R., Doblecki-Lewis, S., Cohen, S., Castro, J., Buchbinder, S., Estrada, Y., et al. (2014, July). High levels of interest in PrEP and baseline risk behaviors among MSM enrolled in the US PrEP Demonstration (Demo) project. Poster presented at the 20th International AIDS Conference, Melbourne. Abstract THPE187 – Poster Exhibition.

23 Cairns, G. (2014, 17 March). Very different levels of PrEP uptake and adherence in three US cities, demonstration project finds. Retrieved from: www.aidsmap.com

24 See: www.hivguidelines.org

25 See Table 1 at: www.hivguidelines.org

26Race, K. (2003). Revaluation of risk among gay men. AIDS Education and Prevention, 15(4), 369–381.

27 Race, K. (2010). Engaging in a culture of barebacking: gay men and the risk of HIV prevention. In: Davis, M., Squire, C. (eds.), HIV Treatment and Prevention Technologies in International Perspective. Palgrave Macmillan, Hampshire.

28 For a wider discussion of this issue see: Glazek, C. (2014, 20 May). Why I am a Truvada Whore. Retrieved from: www.out.com

29 Morgan, R. (2013). Sex and the HIV Morning After Pill. The New York Times. Retrieved from: www.nytimes.com

30 There are currently demonstration studies underway in Victoria and New South Wales, and a forthcoming study in Queensland.

Heath Paynter is Senior Policy Analyst at the Victorian AIDS Council.