Tagged with HIV prevention

On the PBAC rejection of Truvada as PrEP

A couple of (lengthy) comments on the ‪#‎PrEP‬ decision today:

1. Don’t blame PBAC

We’re all angry and disappointed by this decision, but it’s important we’re clear where our anger is directed. A fair few of the comments I’ve seen in the last couple of hours have expressed anger at PBAC for making the decision the way they did. But it’s Gilead, not PBAC, we should be angry with.
PBAC operates to a very narrowly-defined mandate: its one and only task is to determine whether drug listing are cost-effective. For a novel intervention like PrEP, that means comparing the cost of what the drug company is offering with the cost of doing nothing. Simply put, if the benefit is greater than the cost, the drug gets recommended; in this case, the cost outweighed the benefit.

PBAC also only considers the application made by the drug company. To protect its profits, Gilead chose to make their application based on only approving PrEP for people at very high risk of HIV (specifically, those with a greater than 3% risk of infection in 12 months), and at a high cost (we don’t know the exact cost they quoted, but we can assume it’s not much different from the current PBS price of $750/month). PBAC quite rightly questioned how practical or feasible it would be for doctors to determine which of their patients had a greater than 3% annual risk of HIV infection, and made it crystal clear they would prefer to see an application that would make PrEP available to everyone who could benefit, at an appropriately reduced price.

Let’s be clear: those pills cost a few sets each to make, and Gilead had a choice about how to structure its PBAC application. It chose to take a path that would give it the best return while denying PrEP to the majority of people who could benefit from it. That proposal would have seen hundreds of needless HIV infections every year, because its not just people at highest risk who get HIV.

2. The language of the decision

A couple of phrases in the PBAC decision seem to have inflamed people’s passions. I think some clarity is needed.

“attempts to restrict the eligible population by quantifying an individual’s future risk of HIV infection based on self-reported future behaviour, and limiting access to those with a predicted annual risk of infection of 3% or higher, may not be feasible or acceptable to clinicians and consumers.”

This, I think, is unproblematic. PBAC is saying that Gilead’s proposal to limit the use of PrEP to people at high risk “may not be feasible or acceptable.” It would require clinicians to make an assessment of the annual risk of HIV infection based on the patient’s self-reported behaviour. This is likely to be both inexact and practically impossible – if you were a doctor, could you make this judgement in a meaningful way? As PBAC goes on to say, far better to make the drug more widely available and let doctors and patients decided together if they feel the benefit outweighs the risk for that person.

“The PBAC noted that the efficacy of Truvada was highly dependent on adherence, and that it is not clear if subjects at high risk of contracting HIV due to self-reported low adherence to safer sex practices would also have lower adherence to medication.”

This sentence has a lot of people riled up, who have characterised it as saying ‘if gay men can’t be bothered using condoms, why would they bother taking PrEP?’ I think the statement refers back to the earlier questions about the viability of limiting PrEP to people at high risk. Many people at highest risk of HIV have difficulty with safe sex for quite legitimate structural reasons – homelessness, poor mental health, substance abuse issues, low literacy, etc. Limiting PrEP to that group could artificially increase the proportion of PrEP users who have adherence problems (due to the same structural factors) and consequently, this may not be the most efficient way to use the drug. Again, if the price were lower, it could be prescribed based on patient choice rather than arbitrary criteria, and we know most medicines work best when used that way.

Today’s decision has been a huge disappointment, but it’s not the end of the road. It often takes several application to PBAC before a new drug or indication is approved, and Gilead should be encouraged to resubmit. But we as a community have to hold the company to account – its next application must be structured around delivering the best public health outcomes, not the highest profits. Gilead stands to make a lot of money out of PrEP, even if they reduce the price radically, which is what they have to do before we get the outcome we want and need. The gay community has been doing its part to combat this disease for 30+ years, while Gilead and other drug companies have profited massively from it. It’s time for them to come to the table and do their part to prevent, not just profit from, HIV infections.

In the meantime, unfortunately there will be dozens or hundreds of needless HIV infections. We need to do what we can to minimise those, and to care for the unlucky ones who slip through the cracks.

Pills cost pennies, Gilead’s greed is ruining lives.

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Australia’s HIV transmission rate falls

New data out of the Kirby Institute shows that the rate of HIV transmission in Australia has fallen, returning to a downward trend that has been the norm for more than a decade. So why are the papers saying that HIV infections are ‘at an 20-year high‘?

As I have been arguing for several years (see this post from 2013 and this one from 2010) the use of raw diagnoses as the only measure of progress against HIV in Australia fails to take account of the reality that there are more people living with HIV every year. With a greater HIV-positive population, in any HIV prevention scenario a greater number of new diagnoses can be expected. Because this is the case, simply looking at the number of new diagnoses tends to mask the considerable success we have had in combating HIV.

Here’s a graph that shows (in pink) the ‘HIV transmission rate’ (the number of new infections recorded per 100 people living with HIV) in Australia over the last 13 years:

HIV tx rate 2013


The blue line shows the official HIV stats, and there’s no doubt they have trended upwards over the period. That’s nobody’s idea of good news, least of all mine. We want to turn that line around (and I think we will soon).

The pink line is my estimate of the HIV transmission rate. As you can see, it has actually fallen in nine out of the last 11 years and, despite a rise last year, it looks to be trending downwards. That is a good sign that, despite the rising population of PLHIV, the percentage of people who pass HIV on has been falling. That is a marker of success that is ignored by the official reports.

The use of the transmission rate as an alternative to the raw numbers isn’t just my idea: the US National HIV/AIDS Strategy uses it. The CDC uses it. Peer-reviewed epidemiological studies use it.

I am not suggesting we should ditch the reporting of the raw numbers – they are a useful and important measure. Governments and health economists care, as they should, about the numbers of people who will need medical care and support into the future. But they are less helpful when measuring the success of HIV prevention campaigns. A rise in infections doesn’t mean that prevention is failing unless the rise is greater than that which can be attributed to the increased PLHIV population. In fact, as the graph above shows, in most recent years the rise in infections is below that natural increase and that means we have had some measure of success – not that you’d know it from reading media reports or Kirby Institute press releases.

Stories headlined ‘HIV infections at a 20-year high’ suggest that, 20 years ago, things were better than they are now. They weren’t: people were dying in droves. The rate of HIV infections in 1994 was unnaturally low because a large proportion of PLHIV were seriously ill and dying. Suggesting that we have an alarming rise in new infections 20 years later, when we have twice as many people living with HIV and most of them are leading healthy, productive (and sexually active) lives is blinkered pessimism.

Disclaimer: as with my previous posts on this topic, I have to point out that I am neither an epidemiologist nor a statistician, and while my estimate is based on published data from the Kirby Institute, I don’t have access to the detailed data on which it is based. 

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How much evidence do you need?

Newly-elected AFAO vice-president Bridget Haire has a timely piece on the ABC Science website about HIV prevention technologies, calling for regulatory action to make these available in Australia.

If a person with HIV consistently takes effective anti-HIV medication, the chances of them infecting a sexual partner are close to zero. The condom, while remaining cheap, effective and sometimes convenient, is now just one part of the HIV prevention toolbox rather than the whole kit and kaboodle — in theory at least.

But in practice, access to these new forms of HIV prevention is constrained by regulatory systems, concerns about cost, and a fear of new technologies eroding the ‘condom culture’ that saw the whole scale adoption of condoms by gay men worldwide in the mid-80s, who perceived the threat of HIV, and improvised a form of protection.

Read the full article here.

Also recommended:

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Time to go home


The International AIDS Conference is drawing to a close and with it, so is my long overseas journey. Tomorrow I’m off to London, then Singapore, then Melbourne and home. I’m ready.

The conference has been amazing – there is much good work being done out there and I’ve found plenty to be inspired by, challenged by, and occasionally angered by. I’ve met some fantastic people, including this guy, this guy, this guy and lots of others who aren’t so easily linked to. Plus I’ve renewed a lot of friendships built up over previous conferences and events.

The two “big deals” out of this meeting for me are the microbicides breakthrough (of course) and the focus on criminalisation of HIV transmission/exposure, and the complex legal, ethical and public health challenges associated with that. I’ll be writing about those two for an upcoming issue of Positive Living.

As the meeting winds up, it would be easy to be dismissive of the prospects for anything to really change in the course of the HIV epidemic – to judge the event as long on talk and short on action – but I’ll suppress my usual cynicism and say that I do think these events make a difference, if only to remind those of us working in the field of how much remains to be done and how comprehensively the leaders of the world have failed to take decisive and meaningful action to save people’s lives.

We are making progress. We have new prevention technologies coming on line – the successful CAPRISA microbicide trial will be a milestone in the history of the HIV epidemic, and there is every reason to expect that research into pre-exposure prophylaxis (PrEP) and treatment-as-prevention will give us new prevention tools and the hope of a prevention paradigm that goes beyond the “just use condoms” message that I have argued is unsustainable in the long term.

Unfortunately, not a lot of this is getting through to the people who have the power to make decisions, and so often we see public policy driven by prejudice, fear and moralisation rather than evidence of what works. As Gill Greer, Director-General of IPPF, said in a session the other day, “when morality gets in the way of policy, the result is too often morbidity and mortality.”

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March for Human Rights at AIDS 2010


One of the perennial set-piece events for the International AIDS Conference is the big, colourful march through the centre of the host city demanding universal access/equal rights/new drugs/whatever the focus is on this time round. Last night’s event, marching through Vienna to Heroes’ Square, was no disappointment.

Many thousands of activists, advocates and people living with HIV made a loud, brash and joyous sight as they moved through the city. For me it’s the one moment of jubilation in a long week of scientific data and depressing news about the march of HIV in the developing world. This year we had extra cause to celebrate – the fantastic news this week about the success of a vaginal microbicide trial – and we made the most of that while working to highlight human rights issues. Will (above) decided he’d stand up for the human rights of African men’s foreskins.

Lots more photos on Flickr.

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