Critics take aim at powerful new HIV drug

It dramatically reduces the risk of infection for those who have sex with people who are HIV-positive, but  that's the problem for some who fear it will just encourage unsafe behaviour. As a trial on this new type of drug starts in Victoria, the battle for Truvada is on.

By LUKE MORTIMER

The Victorian AIDS Council (VAC) is pushing for the approval of a HIV-prevention drug found to reduce the risk of infection by up to 99 per cent when taken daily, despite concerns over the stigmatisation of some users in the US.

Tenofovir/emtricitabine (known commercially as Truvada) was approved as a preventative health measure by the US Food and Drug Administration in 2012, “as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counselling, and regular HIV testing”.

Known as pre-exposure prophylaxis (PrEP), the treatment involves the use of antiretroviral drugs to protect HIV-negative people from contracting the disease through sex with HIV-positive partners.

But VAC senior policy analyst Heath Paynter said there had been opposition to the treatment from members of the gay community in the US who saw it as encouraging promiscuity and unsafe sex.

“We’re very conscious of avoiding the situation in America, where people who go on to PrEP are actually being stigmatised,” he said.

“What they’re actually doing is stigmatising promiscuity or stigmatizing gay sex full stop, instead of actually seeing PrEP as a strategy to help people to make a positive health decision to prevent getting HIV.

“It means that people will not want to disclose their sexual behaviour to a doctor because they will fear being judged as a slut and promiscuous,” he said.

VAC’s warning comes after  AIDS Healthcare Foundation president Michael Weinstein described PrEP as a “a party drug”, dismissing it as less effective than condoms.

“If something comes along that's better than condoms, I'm all for it, but Truvada is not that,” he told The Huffington Post in April.

This view has some support in the medical community locally.

Dr BK Tee, clinical director of The Centre Clinic in St Kilda, which specialises in sexual health, says he wouldn’t prescribe PrEP off-label, because it had to be taken daily to be effective.

“I probably wouldn’t be happy to prescribe [Truvada] yet, unless I know the patient’s going to be completely compliant,” he said.

“I need to be sure that PrEP doesn’t change people’s sexual behavior.”

PrEP user and activist Damon Jacobs, who runs a Facebook group advocating the HIV prevention strategy, says most of his critics are gay men.

“I have been called names, I have been abused by email, on my personal email and on Facebook,” he said.

“These are generally gay men who are vocal on Facebook or on articles’ comment sections.”

In Australia, Truvada is used as a post-contact treatment for people recently exposed to HIV, but the VAC has called on the drug’s producer Gilead to fast-track an application to the Therapeutic Goods Administration (TGA) to have Truvada approved as PrEP.

“Gilead have this formidable HIV-prevention drug, but they’re not even wanting to have it approved, so we really need to,” Mr Paynter said.

Gilead general manager Rob Hetherington said a Victorian PrEP demonstration trial (VicPrEP), which started screening potential participants in June, would help identify how a PrEP program should be implemented, but there had been “no decision on when an application will be made to the TGA for registration”.

“[The] VicPrEP project will certainly inform the final decision,” he said.

The project’s leader, Associate Professor Edwina Wright, said the study would monitor how HIV high-risk populations use PrEP.

“Overall we’re looking at uptake, adherence, behavior, as in behavioral change – less condoms, more condoms – and acceptability,” she said.

“That will help to inform how we introduce it in a more formal sense to the state.”

A previous study – the results of which were released at the recent World AIDS Conference in Melbourne – found that Truvada was 84 per cent effective for people taking two to three doses a week, while no infections were detected in participants who took at least four doses of the drug per week. However, only a third of participants were able to maintain the required level of adherence.