Filed under virus

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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It’s not true, is it?

HIV-positive shirt

The International AIDS Conference is starting in Melbourne in a few days. I’m in a convenience store , wearing this T-shirt that says ‘HIV Positive’. There’s music playing, in a language I don’t understand.

“I like the music,” I tell the clerk.

“You probably can’t understand what she’s saying. It’s in Persian – Farsi.”

I hand over my purchases.

“It’s not true, is it?” he says, pointing to my T-shirt as I pay.

“Yes, it is true.” He makes a screwed-up smile, unsure whether I’m pulling his leg. A moment of silence. “Really?”

I tell him about the AIDS conference, and something about the importance of positive people being visible. Another moment of silence.

“You know, when I tell people I’m from Iran, they make assumptions about me, too. It’s good to meet you, my friend.” He shakes my hand and I leave.

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A blunt instrument

The following article about HIV criminalisation, by David Mejia Canales and me, was originally published on the Law Institute of Victoria Young Lawyers’ Blog last week. (Yes I have been published on a ‘young lawyers’ blog – I am aware that is amusing on several levels). 


The International AIDS Conference will be held in Melbourne in July. The conference, one of the largest in the world, attracts tens of thousands of activists, politicians, scientists, doctors and a diverse group of community members affected by HIV.

With the world’s eyes on Melbourne during the conference, it’s timely that we revisit our criminal laws with regards to HIV transmission.

Did you know that s 19A of the Victorian Crimes Act is the only law in any Australian jurisdiction that specifically criminalises the transmission of HIV?  The maximum penalty under the section is 25 years’ imprisonment – equivalent to armed robbery or aggravated crimes of violence.

Section 19A was introduced in 1993 to placate community fears of robberies with HIV-infected blood-filled syringes, but no HIV-positive person has ever been convicted of such a crime. Instead, the law has only ever been used for allegations of sexual transmission.

So is s 19A a good law? It’s only produced one conviction in 20 years (and this was for attempt); it was intended to be used to punish robbers armed with HIV laden syringes but has only been used to lay charges against people who have allegedly transmitted HIV through sex.

This is not to say that intentional transmission of a serious disease like HIV should not be a crime – there’s no doubt it should. But other sections of the Crimes Act are capable of being used should such a scenario occur. Not only that, we have public health processes that can be triggered when HIV transmission occurs, and which are focused on achieving positive behaviour change rather than punishing past wrongs.

In theory, s 19A was intended to protect the public, but what happens in practice is it acts as a disincentive to knowing your HIV status while reinforcing perceptions that people living with HIV are dangerous or malicious. This does no one any good.

Laws don’t exist in a vacuum.  You probably didn’t learn about s 19A at law school, and you definitely didn’t learn about the incredible social baggage a discussion about HIV and transmission brings.

Here are four things you can do today to know more about the fascinating junction of law, human rights and HIV:

  • Register for Beyond Blame: Challenging HIV Criminalisation, an International AIDS Conference affiliated event about the criminalisation of HIV, not just in Victoria but around the world. The event is free to attend but you must register. Keynote speaker: Hon Michael Kirby. Registrations here:
  • Contact organisations like Living Positive Victoria or the Victorian AIDS Council, they can organise speakers or information sessions for you or your organisation to understand HIV and the human rights issues surrounding it. and
  • Take part in the hundreds of events during the International AIDS Conference, for more details:
  • Consider volunteering or donating to the HIV/AIDS Legal Centre, a community legal centre assisting HIV positive Victorians. For details:

What do you think? Is it possible to have a constructive discussion about HIV and decriminalisation of HIV without the fear and hysteria that usually comes with discussions about HIV?

About the authors: David Mejia-Canales is a lawyer and Vice President of the Victorian AIDS Council. Paul Kidd is an HIV activist, current law student at La Trobe University and the Chair of the HIV Legal Working Group at Living Positive Victoria.

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How HIV criminalisation harms prevention, wrecks lives and doesn’t stop a single infection


My op-ed in this week’s Star Observer:

Criminal law processes have been criticised internationally because they provide a disincentive to knowing your HIV status – instead of protecting people from HIV, they actually have a negative impact on prevention. In September, UNAIDS recommended that criminal prosecutions should only occur where HIV transmission actually occurs and where it can be shown that the accused intended to transmit HIV. The report also condemned the use of laws that criminalise non-disclosure of HIV status, such as those in NSW and Tasmania, and HIV-specific criminal laws, such as Victoria’s section 19A.

Read the full article on the Star Observer website.

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HIV infections are going up – or are they?

Lots of discussion over the last couple of days about the recently released annual surveillance report for HIV, which shows a big jump in the number of HIV notifications for the last year, especially in NSW. Obviously any rise in HIV is concerning and I’ll leave it to the experts to debate the likely causes of that rise, but as I have previously argued, a seemingly important measure of the infection rate remains unreported.

Three years ago, I argued that HIV infections aren’t going up, they’re going down – if you consider that the number of new infections must be a function of the number of people living with HIV, the picture over the last few years is starkly different. I’ve updated the data from that post in the chart below (click it for a larger version):

HIV infections 2000-2012

The pink line on the chart shows the number of new diagnoses per 100 people living with HIV, based on the Kirby Institute data. There has been a noticeable increase in that measure over the last year but this follows a long period of decline from a high in 2002 of 6.29 to a low in 2011 of 4.60 (incidence per 100 PLHIV).

My argument here is that, whenever an HIV infection occurs, one HIV-positive person is the source of that infection, and as the number of people living in the community with HIV rises, some rise in the total number of new infections is inevitable. The picture over the last few years shows that rise has been lower than would be predicted by the increase in the HIV-positive population alone, which I think is a strong sign that HIV prevention efforts have been working.

The increase in the last 12 months – from 4.60 to 4.87 (incidence per 100 PLHIV) – represents a 6 percent rise in infections, and while that’s lower than the 10 percent rise in the raw numbers, it’s definitely worrying. But it’s a single data point and we won’t know for a year or two if that is the beginning of a sustained rise or just a blip in the trend.

It’s understandable that researchers, government and the media are troubled by the annual jump in new infections (and it has been an annual event for many years now) but, as long as positive people are remaining healthy and sexually active, at least part of that rise is directly explained by the increase in the population of people who are available to be the source of new infections.

The usual caveats apply: I am neither an epidemiologist nor a statistician, and the only data I have to work with is that published in the surveillance reports. Happy to be corrected on any of the data or to be (politely) disagreed with as to my interpretation of it.

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The AIDS crisis in real time


Starting today, has a new baby sister – a side project I’m starting focusing on the history of the HIV epidemic in Australia.

Real Time AIDS is a Twitter feed, Facebook page and website that will re-highlight the daily events of Australia’s response to the early years of the epidemic, as they happened, but 30 years to the day after.

To put it another way, I’m live blogging the AIDS crisis, on a 30-year delay.

The month coming up marks the 30th anniversary of our first AIDS death, and the months and years following that were a time of hysteria, fear and ignorance that we had to fight to endure. While many of us remember at least some of those events, many of the details, the skirmishes, the daily grind of bad news in the papers, is lost. While few people would be interested in reading a lengthy compilation of those events, following Real Time AIDS on Twitter or Facebook will provide a reminder, every day or every few days, of where we were 30 years ago.

Most of the content will be drawn from media reports and other contemporaneous sources. A lot of it – especially in the early days – won’t be pretty, but I hope being reminded of those years of terror and struggle and death will help reinvigorate our efforts for the work that’s yet to be done.

As the website grows, it will also become a fully searchable, but incomplete, index of media, community and government responses to HIV in Australia – something I think would be of more than passing interest. Whether I can keep it up over the long term depends on your interest and my time. We’ll see.

Above: page one screamer from the [Sydney] Sun, 19 Nov 1984.


The week: 1 June

I don’t remember taking the first pill but I do remember picking them up from the pharmacy. This was in August 1991 – a week or so after I got my HIV diagnosis. The doctor said the treatment options were limited, but there was a drug, called AZT, that would buy me some time. Of course, I’d heard of it.

So with my paperwork in hand I hesitatingly took myself to the pharmacy department at St Vincent’s hospital to pick up my drugs. The pharmacist looked dispassionately at my script, told me to wait, and a short while later handed my the biggest bucket of pills I’d ever seen in my life. It was a month’s supply, but it felt like enough for a year. I stashed the bucket out of sight and, when I got home to my flat in North Bondi, took my first dose. Two decades and sixty-something-thousand tablets later, I’m still here.

This week, I took another step on that path by starting HCV treatment. An extra seven pills a day, a period of abstinence from booze, and a hefty dose of luck, and by Christmas Iris and I hope to be rid of that uninvited hitchhiker for good. As I write this, four days in, I feel rather crap, but glad to have taken this step.

Meanwhile, in the real world, last week’s ugly racist incident at the MCG continues to have repercussions. Eddie McGuire, on Friday night one of the heroes of the story, reverted to form and made a spectacularly ignorant remark on Wednesday morning.

If we were all pulling together to avoid victimising a 13-year-old girl, when the 48-year-old president of Collingwood put his foot in his omnipresent mouth, it presents a unique opportunity for every pundit on the planet to weigh in. McGuire himself didn’t help things with a ham-fisted fauxpology, but the resulting Sturm un Drang did little to inform an understanding of the issue that went any further than ‘you shouldn’t say certain things or people might get upset’. A couple of notable exceptions: Debra Jopson in the (new!) Guardian Australia points out Australia’s ‘covert racism‘ and the six-year-old assault on Indigenous rights that is the Northern Territory Intervention. Helen Razer pointed out that Australia is a racist society and therefore she, he, and we are all racists, and ‘the only way out of this shunless truth is to acknowledge it’.

The Guardian finally launched its much-anticipated Australian edition and, lo, the luvvies were pleased (actually, it’s a welcome addition). It was National Sorry Day again. The British government said it wanted to supply more arms to Syrian rebels, and the Russian government said it would arm the Syrian government, opening the way for a horrible, drawn-out proxy war. An international drugs think-tank warned that the ‘War on Drugs‘ was driving a global hepatitis C epidemic. Cardinal George Pell fronted a Victorian parliamentary inquiry, admitting that the Church covered up paedophile priests, but not taking any responsibility himself. Julia Gillard tweeted in Dothraki. The remains of two Aboriginal men who were unearthed in Tathra in 1961 were reburied in a traditional ceremony. The NSW Court of Appeal ruled that not everyone is male or female.

And finally…

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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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