Friday, 13 May 2016

PrEP can help us end HIV

It’s not often that a drug’s product information sheet would be cause for excitement, let alone celebration, writes AFAO Executive Director Darryl O'Donell. 

Yet just as experts met in Sydney on 6 May to discuss HIV pre-exposure prophylaxis, Australia’s drug regulator quietly changed the product sheet for the drug Truvada to approve its use to prevent HIV.

This change by Australia’s Therapeutic Goods Administration means that doctors can now write a script for Truvada and it can be dispensed at a chemist. This is groundbreaking because it means Australia’s drug technocrats have said that Truvada is safe, and that it works in preventing sexual transmission of HIV.  

AFAO Executive Director
Darryl O'Donnell
The Australian Federation of AIDS Organisations led the celebration of the news, heralding the decision as a major milestone towards ending HIV transmission. But it is just the first step because although Truvada is now approved for use, it is not yet funded.

In July, Australia’s Pharmaceutical Benefits Advisory Committee will consider whether the Government should subsidise Truvada for PrEP. If subsidised, Truvada will be available at chemists for the cost of an ordinary script. Without subsidy, it’s cost is prohibitive.

AFAO has called on PBAC to consider PrEP swiftly and efficiently – to do its job in providing trusted, expert advice to Government on the cost-effectiveness benefit this drug offers. We will then be calling on the Government to urgently fund this drug. We will make a submission to help PBAC with their consideration, and hope they will look closely at that, recognising the expertise that our communities bring through the experience of our own lives – our ‘community knowing’.

While we wait for PBAC’s decision, we have interim arrangements in place for access to PrEP – demonstration trials and the like in the larger States and Territories – Victoria, New South Wales, Queensland and Western Australia. The rest of Australia has poor access, and there is little sign that governments in those places are taking the need for interim access seriously. 

To those places we say: If the burden of a research trial is too high, look to the Western Australian AIDS Council’s model; it’s an innovative, cheap and effective approach where gay men help each other to access PrEP through online importing, with clinician support. There’s no excuse for jurisdictions to leave gay men without decent access to PrEP for want of a little effort.

There are five important things that PBAC must know as it makes its decision on PrEP.

1. PrEP is essential if we are to achieve our National HIV Strategy goals.

The National HIV Strategy, launched under our current Coalition Government, has set a world-leading goal of virtually eliminating HIV transmission by 2020.

Under our previous Labor Government, Australia co-chaired the 2011 United Nations High Level Meeting on HIV at which member states committed to bold action and targets to prevent HIV. Australia lobbied other nations much poorer than ourselves to commit to ending HIV. It can’t be a message for them but not us.

We understand enough about HIV transmission now to achieve the goal.

More importantly, in Australia we have the means:
  • We have the technology available to prevent HIV – through the potential of PrEP, through HIV treatment to prevent transmission, and through condoms
  • We have the tests to detect HIV early and effectively
  • We have the treatment to keep people well if we detect HIV early and start immediate treatment
  • We have the researchers to monitor patterns in the epidemic and to guide our efforts
  • We have the bi-partisan support of governments
  • We have an excellent primary care system and dedicated clinicians
  • And most of all – and let’s never forget that this is the most important – we have a mobilised gay community that is calling urgently for PrEP to be funded. Our community is saying ‘we can end HIV, if you will give us the means’.

Australia is one of the few countries in the world that is able to realise this goal.

It would be a travesty, a disgrace, for us to fumble this opportunity.

2. The gay community is ready for PrEP

The gay community mobilised early in response to HIV. We coined the phrase safe sex. We talked, we educated and cared for each other and we lost a great many people.

And the truth of gay men’s responses to HIV is that we’ve never stopped doing that.

The extraordinary energy, the passion, the organising, the debate, the requests to doctors, the posters in streets, the Facebook groups, the online purchasing, the education forums, the access arrangements, the advocacy that we see in relation to PrEP – all of this puts paid to the homophobic lie that says gay men are complacent in the face of the epidemic.

What ignorant rubbish.

We are not perfect. We don’t always get it right. We don’t always test as often as we should. So it might be once a year rather than twice. We might use condoms most of the time, but get it wrong sometimes. We might struggle. We might make choices. Sometimes choices we regret. As we all do. The kinds of choices when we realise the light we ran had a camera. The choice to stand on a chair rather than a ladder. Human choices made in real life settings.

But we – gay men – continue to be responding to this epidemic 35 years into it – to be doing a damn fine job of containing HIV, of limiting it. We are leading a world-beating response and achieving low incidence at levels other countries can only dream of. We are testing at extraordinary rates. In fact, we are testing more now than in recent years. We continue to be leading the conversation and to be calling for help so that we can end HIV.

The homophobia of the lie of gay men’s complacency rests in its premise that we are entitled to ask more of gay men than we’d ask of others. And that when we fail to achieve unattainable standards, that we can be sanctioned for that.

As gay men, as communities, the importance of PrEP is that it gives us another means, another tool, to help us to do what we have been trying to do since the beginning.

HIV research shows us very clearly that gay men know a great deal about HIV. About its transmission and its prevention. None more so than gay men with HIV.

By early 2015, an eon ago, three-quarters of gay men had heard of PrEP.

Most of those had a generally positive reaction to it.

PrEP represents new information about HIV, and we see repeatedly, that gay men will respond to new information, that they want to know about HIV.

Our AIDS Councils have responded to that and they continue to do so, and we’ve seen a groundswell of grass roots organising as we educate each other about this technology.

3. The gay community will adapt around PrEP

Gay men are adapting to PrEP just as they’ve adapted to other changes in the epidemic: new tests, better treatment, and new ways of staying safe.

As with all of those adaptations, we will see variability in gay men’s responses to PrEP.

Not all gay men will want to use PrEP. Interest does not necessarily translate to uptake, and nor should it.

Importantly, we see that the gay men who are most engaged with PrEP, those who have worked hardest to access PrEP, who have signed up to trials, who are personally importing PrEP, are those who are at most risk. These, to a very great degree, are gay men making very sensible and considered decisions that since they are more sexually active, since they are having sex with casual partners, since condoms might be more problematic, that PrEP is a good option for them. 

We also see many gay men who, likewise, are electing not to pursue PrEP – who are comfortable with the existing range of strategies available.

There will be many gay men who will never use PrEP, in fact, it’s entirely possible most gay men will never use PrEP.

But we should be cautious of artificially dichotomising the community into PrEP and non-PrEP users or into condom and non-condom users.

It’s more likely that we will see gay men utilising the technology that works best for them at particular moments in their lives. For most of those gay men who will try PrEP at some point, it will be something used for a period of time. Perhaps several periods of time.

During some periods, condoms will be preferred. At others, they will be in relationships with agreements about testing. At others still, they may wish to use PrEP.

The use of PrEP will be variable, and from everything we’ve seen and know, we expect gay men will use it consideredly to protect themselves during periods of higher risk. 

4. Current access arrangements can only be interim

AFAO has applauded the recognition by some States and Territories that urgent PrEP access is needed, and has welcomed the investment they’ve made in trials and interim access arrangements.

Those arrangements will save a great number of people from needlessly acquiring HIV.

We are also grateful that Australia has arrangements that allow for the personal importation of medicines. A good number of gay men are importing generic versions of Truvada from overseas.

But let’s tell the truth about this: these arrangements are a wholly inadequate substitute for the access our superb health care system is designed to provide.

There are real problems with our current arrangements. We hear of gay men receiving PrEP scripts with five repeats, meaning they are accessing PrEP online without regular monitoring and STI screening. We hear of online providers asking for a script only once and dispensing repeats against it. We have problems and uncertainty with Customs stopping shipments. We have the costs and delays of personal importation. We have the consent requirements, the burdens and the needless costs of trials. We have inequity of access across our federated system.

But most of all, we have no regularised means of access until we have PBS-funded access. Until then, we have workarounds – however welcome – and piecemeal arrangements. Until then, we have people who need PrEP who are missing out and we have already heard far too many stories of gay men getting HIV while waiting for PrEP access. These are preventable infections.

5. If made available, PrEP can help us end HIV

Our communities will be calling for PBAC to recommend that PrEP be subsidised and for the government to then urgently fund PrEP.

But what might this look like?

AFAO is working with its members and others from our communities to explore some of the questions that need to be answered as we prepare our advice to PBAC.

We’re asking who should PrEP be available to. All people? Presumably not. All people at high risk of HIV? Well yes, but let’s define high risk. Too narrow a definition and we fail to avert avoidable and costly infections. Too wide a definition and there will no doubt be concern about cost.

Presumably we must include the option of all people who are likely to have condomless anal sex with gay men. And presumably we must include the capacity, the flexibility, for patients with their clinicians to recognise the circumstances of HIV risk that would make PrEP a suitable option for them. There will be others beyond gay men who will also benefit from PrEP. We are fortunate in Australia to have excellent guidance on PrEP prescribing, and the guidance will continue to evolve with the best evidence.

We must also ask questions about adherence. Will PrEP users be adherent to the dosing requirements of PrEP? We are fortunate with PrEP that despite recommendations for daily dosing, we know that there is some capacity for missed doses without compromising effectiveness. We also know that within the gay community we have the most knowledgeable experts on HIV – those with HIV themselves – who are among the most active in leading conversations about PrEP, taking pills, and treatment. As we always have, we will continue to educate and support ourselves and each other around PrEP.

We might ask: will PrEP users be able to make the necessary judgements about the risks and benefits of PrEP? Absolutely. This is not an ignorant community into which a foreign technology is being transposed. Being a gay man, or a person at risk of HIV, means navigating your sexual life with risk. Whatever choices we make, no gay man has the option of not thinking about HIV or not thinking about the pros and cons of the decisions we make about risk and safety. It is always present and we are very experienced in weighing up costs and benefits. We will weigh up PrEP and make the best decisions we can just as we’ve always done.

There are some questions that are less certain: who should prescribe PrEP? We are fortunate to have a great deal of HIV expertise among our doctors who are authorised to prescribe HIV medicines. But there are too few of them, and there are many places where it’s hard to find a prescriber. PrEP isn’t clinically complex and decisions about prescribing, informed by expert guidance on eligibility, are well within routine standards of clinical practice for general practitioners.

We ought to be very wary about locking up arrangements for PrEP in ways that restrict its benefits to only those who can see a small number of prescribers. We must also be aware that most HIV diagnoses are not made by these authorised prescribers, meaning most people at risk of HIV are accessing routine sexual health care at their local GP. If prescribing is restricted, we will be forcing people at risk of HIV to change their care arrangements.

But are there midway-points that should be considered – perhaps prescribing with some consultation with an expert, at least at the point of initial prescription? This would seem to offer the benefit of a clinician prescribing PrEP knowing who they can consult and being pointed to the best clinical guidance for prescribing, monitoring and STI screening. Access to PrEP isn’t just about writing a script. It’s an opportunity for regular STI check-ups and for discussing other issues, perhaps around methamphetamine use, or mental health. PrEP is an opportunity because it brings gay men into clinics when they otherwise might not attend.

PrEP dispensing, it goes without saying, must be via community pharmacies. 

So on 6 May, through a quiet change on page 20 of the Truvada product information sheet, Australia joined a growing number of countries that have recognised that PrEP is safe and that it works. Australia has made some progress, but we need to complete the job.

PrEP is a powerful tool. It can break the back of HIV transmission among gay men in Australia. With effective access, we can dramatically drive down rates of HIV infection. Australia has the systems and infrastructure in place – not least through our community AIDS Councils and community networks – that mean PrEP can be easily integrated into existing education and care arrangements. But we now need this groundbreaking tool to be funded so we are making the most of this remarkable development. Just as the oral contraceptive has transformed the lives of millions of women, PrEP put the power of prevention in the hands of those who need it. 

PrEP can help us end HIV. 

Adapted from a speech given by Darryl O’Donnell, Executive Director, Australian Federation of AIDS Organisations, at the National Forum on HIV Pre-Exposure Prophylaxis, held 6 May 2016.

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