The US Food and Drug Administration has approved the world’s only twice-yearly injection to prevent HIV – but it remains unclear when the treatment will become available in Australia.
The highly effective medication, Lenacapavir – sold under the brand name Yeztugo – was developed by Gilead Sciences and is administered via a subcutaneous (under-the-skin) injection every six months.
In a media release this week, Gilead said it had filed for regulatory approval with Australian authorities – the first step before it can apply to have the medication listed on the Pharmaceutical Benefits Scheme (PBS), which provides Australians with access to subsidised medications.
In two major clinical trials involving people at high risk of contracting HIV, the injection almost completely prevented new infections. One study found it to be 89 per cent more effective than existing oral PrEP medications.
“These kinds of results are unprecedented,” said Dr Jared Baeten, senior vice president of virology clinical development at Gilead Sciences, in an interview with NBC News in September last year.
“I have moments like this where I truly am speechless. What this can mean for the trajectory of the HIV epidemic is everything that all the world has imagined for years. We can actually turn off new infections.”
The drug is administered as two injections under the skin each year, which leave a small deposit of medication that is slowly absorbed into the body over time.
One potential drawback is that the injection site, typically in the abdomen, can leave a small visible lump in people with low body fat. In practice, some may find the mark off-putting or even stigmatising.
A long-acting injectable was recommended to the federal government in the 2023 National HIV Taskforce Report, which stated: “The Australian Government should consider fast-tracking the availability of long-acting, injectable PrEP on the Australian market to reach PrEP users and to support ongoing use.”
If approved, Yeztugo would be the second injectable HIV medication available in Australia. The other, Cabenuva, is administered every two months.
Cabenuva, supplied by pharmaceutical company ViiV, already has Therapeutic Goods Administration approval. The company confirmed to Gay Sydney News that it is working with the Pharmaceutical Benefits Advisory Committee to have the drug listed on the Pharmaceutical Benefits Scheme.
Dash Heath-Paynter, chief executive officer of Australian non-profit AIDS organisation Health Equity Matters, said the newly approved US treatment would be welcomed by many in Australia.
“The US FDA’s approval of six-monthly injectable PrEP is an important signal of America’s confidence in this new HIV prevention technology,” he said.
“We know there are people who are not taking oral [medication] because this strategy is not right for them.
“Therefore, it is important we assess all available safe and effective HIV prevention options to ensure the most advanced pre-exposure prophylaxis (PrEP) technology is rapidly available in Australia.”
Heath-Paynter said he hoped the drug would be made available to Australians without delay.
“We encourage the manufacturer and the federal government to work collaboratively to find a way to ensure access to six-monthly injectable PrEP in Australia is achieved as quickly as possible.”
However, cost could prove a barrier. Yeztugo is reportedly priced at $US14,109 ($21,777) per injection – equivalent to about $US2351 ($3631) per month over a six-month period.
Access in Australia could be broadened if the drug is approved and added to the Pharmaceutical Benefits Scheme, which already subsidises oral PrEP.
The federal Department of Health confirmed to Gay Sydney News that Yeztugo would be eligible for Pharmaceutical Benefits Scheme consideration if the manufacturer submits an application.
Gay Sydney News reporter