US pharmaceutical giant Gilead Sciences has begun the application process to have Truvada approved for PrEP in Australia, removing one of the most significant hurdles currently preventing access to the HIV-prevention drug and opening the door to affordable access.
While Australians with a prescription for Truvada as PrEP (or pre-exposure prophylaxis) can currently access the drug through overseas websites, approval from the Therapeutic Goods Administration (TGA) — the country’s peak regulatory body for medicines and blood products — would simplify the process.
More importantly, TGA approval would open the door to approval for PrEP under the Pharmaceutical Benefits Scheme (PBS), allowing people to access the drug cheaply. Even with TGA approval, PrEP comes with a prohibitive price tag of around $800 per month.
Gilead’s medical director Howard Wraight told the Star Observer that Gilead is currently in the pre-submission phase of the TGA’s applications process, which takes around three months.
“Once that’s completed we put in the formal application, so that goes in in about three months’ time, then it takes 12 months from that period to complete the evaluation process, so we would expect an outcome from that TGA submission midway through next year,” he said.
Wraight said Gilead’s decision to submit an application to the TGA now was a response to increased community demand for PrEP.
“Changing community attitudes to PrEP, and requests from various stakeholders within the community and from the treating physicians has prompted us to put in an application,” he explained.
Australian Federation of AIDS Organisations (AFAO) executive director Rob Lake told the Star Observer that Gilead’s application was a vital step towards having PrEP listed on the PBS, which would allow people to access the drug affordably.
“It begins that process, because with the PBS, nothing can happen without TGA approval,” Lake told the Star Observer.
“It also really gives an Australian stamp to PrEP and its use, and I think hopefully for people who are interested in it and wanting to know about it, they can be more confident that it’s being considered and thought about in an Australian context.”
The conversation around PrEP in Australia’s gay community was re-energised last week during the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, which saw new evidence supporting the drug’s effectiveness as a HIV prevention measure.
In particular the PROUD study out of the UK showed that even under “real world” conditions, where participants were not always completely adherent to the drug regimen, PrEP reduced the risk of HIV infection by 86 per cent.
In response to the CROI announcements, the Victorian AIDS Council (VAC) launched an online petition to have PrEP approved in Australia, increasing community support for access to the drug.
Asked about the company’s role in the process going forward, Gilead said outside of facilitating regulatory approval it would be up to the community to determine how PrEP would be used in Australia.
“Gilead’s never seen this as a commercial opportunity, and the way that PrEP is actually managed in the United States is it’s managed through the medical side of the organisation, not the commercial side,” Wraight told the Star Observer.
“We would see a similar situation here in Australia, that we’ll facilitate getting regulatory approval, but we really need to hand it over to the community and to the treating physicians and to the stakeholders outside of the company to determine where PrEP would be used and positioned in Australia.”
Other peak HIV organisations in Australia have welcomed the news, with ACON chief executive Nicolas Parkhill telling the Star Observer his organisation had lobbied Gilead to make the TGA application.
“It is absolutely essential that we get access to PrEP as soon as possible if we want a contemporary HIV response that allows us to meet the targets of 2020,” he said.
Parkhill stressed that Gilead’s TGA application was just one of a number of hurdles in the way of widespread, affordable access to PrEP.
VAC chief executive Simon Ruth called this “a great step in the right direction”, but told the Star Observer mid-2016 would be too long to wait for affordable access to PrEP.
“I really hope the government expedites the response, because we really can’t wait until the middle of next year to make PrEP available in Australia,” he said.
“We know it works, we know it’s safe, and we know we need it.”
From here, AFAO, VAC and ACON all said the role for the HIV sector would be to find ways to expedite the regulatory processes, whether through lobbying government, the TGA, or by continuing to build community support — for example through the PrEP demonstrations currently under way in NSW and Victoria.
“Clearly someone has the power to (expedite the process), and it’s just about figuring out who that person is and putting pressure on them to move this along as fast as we can,” Ruth said.