The Australian government is being pressured to make it easier for people to access medication that significantly reduces the risk of HIV transmission.

There have been great leaps and bounds in the treatment and prevention of HIV infection in Australia. HIV infection rates have remained relatively stable over the past three years at about 1000 a year, with 1081 newly diagnosed infections in Australia in 2014, according to the Kirby Institute’s annual surveillance report. The main method for HIV transmission remains men having sex with men, accounting for 70% of cases in 2014.

But in Australia there are limited avenues to access medication now increasingly used in the United States to reduce the spread of HIV.

Pre-exposure prophylaxis, or PrEP, is a tablet people can take once a day that contains two antiretroviral drugs — the same drugs used to treat HIV-positive people — that prevent HIV replication in cells exposed to HIV, and thus prevent it taking hold permanently in the body. Truvada, the brand-name drug containing the antiviral drugs tenofovir and emtricitabine, was approved for use as PrEP in the US by the Food and Drug Administration in 2012, but it has not been approved for PrEP in Australia.

Studies and use in places like the United States have shown that those who take the drug daily and are exposed to HIV during sex have a dramatically reduced chance of contracting HIV. In the UK, Canada, and France, trials showed an up to 94% reduction in risk of HIV infection among study participants, while those participating in the study did not increase their sexual risk taking in response to the reduced risk of HIV exposure. Reportedly, the trials in Australia have shown no HIV infections so far for those taking the drug.

There have been trials in Queensland, Victoria and New South Wales, but until today there were only around 500 places in the program Australia-wide (one of the trials in NSW has been vastly expanded today). For those who are in the trial, the drug is free, but to obtain the drug in Australia outside this trial the costs are immense. The Australasian Society for HIV Medicine recommends that the drug be taken by people at ongoing high risk for HIV infection, such as people who have sex without condoms, men who have sex with multiple male partners, and those in a relationship with someone who has HIV.

Currently, only people living with HIV or those treating immediate exposure to HIV can access Truvada in Australia. It is not yet licensed for use as PrEP by the Therapeutic Goods Administration (TGA), and therefore is not currently subsidised on the Pharmaceutical Benefits Scheme. To obtain the drug in Australia for PrEP, it is possible to get what is called an “off-label” prescription from a doctor, where the doctor asks Truvada manufacturer Gilead to supply the drug, which costs around $13,500 for a 12-month supply, according to the Australasian Society for HIV Medicine.

The other option is to attempt to import a generic version of Truvada from overseas under Australia’s personal importation scheme for medicines, where the cost is estimated to be $1300 for 12 months. That still requires getting a prescription from a doctor, and patients can only get a three-month supply at a time.

Gilead has begun the process to get Truvada approved for PrEP in Australia, but it could take until mid-2016 before the TGA approves the drug. A spokesperson for Gilead Sciences ANZ told Crikey the application was lodged in April, and approval may be possible in 2016.

A spokeswoman for the federal Department of Health told Crikey that while Gilead had publicly announced its application to the TGA, confidentiality requirements restricted the TGA from releasing information about applications it “may or may not have received”.

Until it was approved for PrEP, prescribing Truvada “off-label” was allowed, the spokeswoman said: “This practice is not regulated or controlled by the TGA, as it is at the discretion of the prescribing physician.”

New Greens Senator Robert Simms, who has been given portfolio responsibility for sexuality issues for the Greens, passed a motion in the Senate on Monday calling on the government to “urgently remove regulatory barriers to access to PrEP, rapid HIV tests and home self-tests”.

Simms told Crikey that the government could come up with an “interim arrangement” until the TGA process was complete.

“Sometimes when these approval processes are underway, governments are able to come up with interim solutions to try and expand the trial. I’m wanting them to put some pressure on the TGA to try and speed up the approval process, but also wanting them to find a stop-gap solution in the interim,” he said.

Simms said the government could potentially buy Truvada stock, make it available and expand the trials.

Health Minister Sussan Ley said in a statement that it was important for the safety of patients for the TGA to independently review the evidence before making a decision on whether to approve Truvada for use as PrEP. Ley pointed out Gilead could have applied to the TGA at the same time as it sought approval in the United States:

“PrEP is a perfect example of an issue I highlighted earlier this year which is that drug companies wait until after the drug has been approved in the larger US market before submitting an application in Australia. If the drug company in this case had submitted an application for this drug to be used in HIV prophylaxis in Australia three years ago like it did in the US, perhaps we would be in a different situation now.”

The Gilead Sciences ANZ spokesperson said Australia was the first country outside the US where Gilead had sought formal regulatory approval for Truvada for PrEP, and the company had provided $4 million for the projects in New South Wales, Queensland, and Victoria.

Marking World AIDS Day, New South Wales Health Minister Jillian Skinner today announced that the government aimed to “virtually eliminate” HIV transmission by 2020, and announced an expansion of the trial in New South Wales from 300 men to 3700 high-risk men as part of a wide-scale project. The NSW government will also trial HIV home-testing kits.

Kirby Institute’s Professor Andrew Grulich, who is heading up the expanded trial, told Crikey no one in the initial trial had become HIV positive. The expanded trial aims to reduce HIV diagnoses in New South Wales by 50% in two years.

“We just need to use the drug,” Grulich said. “It’s a shame it has taken so long to approve, but it’s with the TGA now, and moves like the one today announced by Jillian Skinner are terrific because they bypass the TGA process by providing access in the form of a very large trial.”

Once TGA approval is given, Gilead will need to apply to have Truvada listed on the PBS to make it cheaper to access in Australia. Grulich said this could take months or years depending on the negotiations over the cost with the government.

Victorian Health Minister Jill Hennessy today announced new clinical guidelines for GPs to prescribe off-label PrEP to patients until the drug is approved by the TGA, and she is also aiming for the virtual elimination of HIV transmission by 2020. The City of Melbourne has signed up to the Fast-Track Cities pledge, aiming for 90% of people who are HIV positive to know their status and 90% of people in treatment for HIV to have an undetectable viral load by 2020.

While long-term effects of the drug are yet to be known, researchers have said the drug appears to be generally safe and well-tolerated, but have said it has been associated with “small yet statistically significant decreases in liver and kidney function, and bone mineral density”. These side effects are resolved after people stop using PrEP, researchers have stated.

Update: Added comment from Gilead.

Peter Fray

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