Issue 19 / 23 May 2016

LEADING Australian HIV researchers are calling for the antiretroviral drug, emtricitabine and tenofovir disoproxil fumarate (Truvada), to be listed on the Pharmaceutical Benefits Scheme (PBS) as pre-exposure prophylaxis (PrEP) therapy for people at high risk of contracting HIV, after the drug’s regulatory approval earlier this month.

Professor Andrew Grulich, head of the HIV Epidemiology and Prevention Program at The Kirby Institute, University of New South Wales, said a PBS listing for Truvada as PrEP was “absolutely critical” to maximise the prevention impact of the drug, which is taken daily.

“The retail cost of the drug is close to $1000 a month in Australia, which is obviously not affordable to anybody except very small minorities,” Professor Grulich told MJA InSight.

The Pharmaceutical Benefits Advisory Committee is set to consider the drug’s listing on the PBS in early July.

Professor Grulich urged swift action to ensure that PrEP was available to the high-risk target population as soon as possible, adding that PrEP could be provided at a fraction of the cost of treating a patient with HIV.

“We believe that the best way to roll out PrEP is to the high-risk people, to target them almost to saturation. That disrupts the chains of transmission and, in a way, is almost like the herd protection provided by vaccines,” he said. “If we can get the high-risk people on PrEP quickly, we should be able to get a very marked decline in HIV infections quite quickly.”

Australia’s rate of HIV transmission had been rising for several years, but it was stable for the 3 years to 2014, with 1081 of newly diagnosed HIV cases in 2014, 1028 in 2013, and 1064 in 2012.

The Kirby Institute has estimated that at the end of 2014, around 27 150 people were living with HIV infection in Australia, with about 3350 (12%) of those people being unaware of their HIV positive status.

Associate Professor Mark Stoovè, Head of HIV Research at the Burnet Institute, said listing Truvada on the PBS for PrEP would encourage appropriate clinical care strategies for at-risk people.

“Having Truvada listed on the PBS will make it more likely that people take PrEP appropriately, with clinic contacts providing the opportunity to remind individuals about the importance of adherence,” Professor Stoovè told MJA InSight.

He said without PBS approval, the drug would continue to be sourced more cheaply offshore, with at-risk individuals bypassing the health system.

“The meaningfulness of the regulatory approval is diminished if it doesn’t ultimately get listed on the PBS,” Professor Stoovè said.

Truvada is also approved for PrEP in the US, Canada, and France. In Australia, manufacturer Gilead Sciences is seeking an authority-required PBS listing of the drug “to reduce the risk of sexually acquired HIV infection in adults at substantial risk of HIV infection”.

Professor Grulich said Australia’s national guidelines on PrEP, which had been developed on the back of “good, longitudinal research” in Australia, would be helpful in defining the target population.

“[The guidelines] set out categories of gay men defined by elements of their sexual behaviour, or any person in a relationship with an HIV-positive person – heterosexual or homosexual person – where the HIV-positive person is not on treatment with undetectable viral load,” he said.

A key concern with the increased use of Truvada for PrEP is a reduction in condom use, which could increase transmission of other sexually transmitted infections.

Professor Stoovè agreed that this was a major concern, and represented a “perfect storm” for the transmission of sexually transmitted infections (STIs) among gay men. However, he said, Australia had already been seeing significant increases in the incidence of STIs – particularly gonorrhoea and syphilis – among some men who had sex with men, and a PBS listing for PrEP would encourage these men at risk to engage in the health system.

“The testing rates for STIs among gay men are suboptimal, and many do not adhere to the guidelines. So, while PrEP may facilitate the transmission of other STIs, it will also be an offset if we can get men to adhere to 3-monthly presentations for PrEP, and more regular STI testing.”

Professor Grulich agreed that the impact on the incidence of other STIs was a “real concern”, but likened these concerns to those raised 40 years ago with the introduction of the oral contraceptive pill.

“It certainly didn’t stop us allowing women to control their fertility, and it most certainly shouldn’t stop us from allowing people to control their risk of HIV infection,” Professor Grulich said.

He concurred that gonorrhoea and syphilis had been on the rise in Australia for some years, and the implementation of a PrEP program may help to increase the detection of undetected STIs.

“We can’t immediately interpret an increase in STIs as being due to an increase in risk behaviours,” he said.
With a global deadline to end HIV by 2020 just around the corner, PrEP will play “an incredibly important part alongside the HIV care cascade prevention approach”, Professor Stoovè said.

“The global elimination goals are framed largely around the HIV cascade, with modelling based on 90% of people living with HIV being diagnosed, 90% diagnosed on treatment, and 90% of those on treatment being virally suppressed,” he said.

However, Professor Stoovè was doubtful that this goal would be met.

“We’re highly unlikely, even with PrEP, to meet the 2020 goals; however, it is a laudable aspirational goal within our lifetime.”

Clinical trials of Truvada as PrEP have been underway in New South Wales, Victoria and Queensland since 2014.

4 thoughts on “Truvada gets TGA nod, but PBS listing vital

  1. J.M.Forrest says:


    Another huge burden for the Australian tax payer for another preventative rather than a curative treatment, and another encouragement for increased, unprotected sexual activity in the homosexual community !

  2. Sandra Skinner says:

    Why not focus on educating how risky these behaviours are, and that there is no safe way to engage in them?  This country is already in tremendous debt, we’ve had shortages of drugs like pencillin and slow release metformin and we’re expected to pay for an expensive new drug to mitigate high risk lifestyles? 

  3. stephen sonneveld says:

    surely if a cost benefit analysis finds this preventative treatment is effective avoids the costs of treatment of HIV positive individuals, then we should encourage its use and give it a PBS LISTING. 

    Using scare tactics to suggests increased unprotected sexual activity and increased risk of other sexually transmitted but readily treatable STI’s, is not an argument against its use and introduction. 

    The adage PREVENTION IS BETTER THAN CURE still stands.


  4. Clancy Reid says:

    Apart from it being the ethically right thing to do by those inviduals at higher risk of HIV transmission (those in a relationship with a HIV-positive individual, those who struggle to use condoms for drug-related, mental health or peer pressure reasons, for example, or just those who make mistakes), it makes economic sense to prevent the predicted infections now than pay far more for a lifetime of HIV medication, which is both costlier and more debilitating to the patient. We’ll have few infections and more productive citizens if we target those at-risk of HIV infection. It would be scandalous if the PBS didn’t list Truvada.

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