Long-Acting HIV PrEP Drug Lenacapavir Approved – But Access Is Vital, Say Health Bodies

Australia has taken another regulatory step in HIV prevention, with the Therapeutic Goods Administration (TGA) approving the long-acting HIV drug lenacapavir for use as pre-exposure prophylaxis (PrEP).

The twice-yearly injectable medication has been registered by the TGA, making it the second approved in Australia. However, despite the registration, lenacapavir is not yet available to the community.

Health advocacy body Health Equity Matters has welcomed the approval, describing it as an important development for HIV prevention, while stressing that access and affordability remain unresolved.

“It’s critical that long-acting PrEP is subsidised via the Pharmaceutical Benefits Scheme. These long-acting options remove barriers for so many people, but we need to ensure they are affordable. We currently have two options registered but neither is available yet,” Health Equity Matters acting chief executive James Gray said.

Gray urged both government and pharmaceutical manufacturers to prioritise equitable access during negotiations. “We would encourage the manufacturers and the Australian Government to keep affordability in mind during their negotiations to ensure widespread access across the country,” he said.

Lenacapavir is administered as an injection just twice a year, offering long-term HIV protection and an alternative to daily or on-demand oral PrEP. Clinical trial data involving more than 3,000 participants from a range of populations found HIV infections fell by 96 per cent among those using the drug.

According to Health Equity Matters, long-acting PrEP options may be particularly beneficial for people who find daily medication difficult to maintain, including those who experience stigma around pill-taking or face barriers to regular access to healthcare.

“Long-acting PrEP options may be better suited for people who find daily or on-demand PrEP difficult to tolerate, stigmatising or hard to access in their communities, including rural and remote areas,” Gray said.

“Injections can be more discreet, and are also potentially a better option for people who don’t have a regular routine, or travel a lot, which may create a barrier to maintaining the daily medication or having on-demand PrEP.”

Lenacapavir approved in US, and recommended in Europe

Internationally, lenacapavir has been approved for HIV prevention use in the United States, and regulators in Europe have recommended its approval as the first twice-yearly injectable PrEP option.

While the TGA’s approval marks a significant regulatory milestone in getting Australia closer to its goal of virtual elimination of new HIV transmissions by 2030, advocates say the public health impact of lenacapavir in Australia will depend on timely decisions around accessibility: namely pricing, Pharmaceutical Benefits Scheme listing and national rollout.