Published: 4 July 2025

Lenacapavir and the future of PrEP in Australia

By Aldo Spina

What if HIV prevention didn’t need a daily pill or careful planning around sex? That’s the promise of long-acting PrEP, and a new option on the horizon could make a real difference in Australia. With just one injection every six months, it could offer reliable, discreet, long-term protection. Research trial results are very promising and the potential benefits for people at risk of HIV in Australia are significant.

PrEP has played a significant role in reducing HIV transmission in Australia, particularly among gay and bisexual men in urban areas. However, access and uptake are not evenly distributed with Aboriginal and Torres Strait Islander people, younger people, people from culturally diverse backgrounds, bisexual men, and those living in rural or remote regions facing additional and unaddressed barriers to accessing PrEP and are thus less likely to be on PrEP. For some, the daily pill presents as a significant hurdle. It can be difficult to maintain, may feel stigmatising, or may not align with an individual’s lifestyle – particularly the case for those living or working remotely. Although on-demand PrEP offers more flexibility, it still requires planning and precise timing, which might not be suitable for everyone.

That’s where a long-acting option like Lenacapavir could be beneficial. It is an injection administered just twice a year. The latest results from the PURPOSE 2 study demonstrate its benefits. Among more than 3,000 participants, HIV infections decreased by 96 per cent.[1] The trial included cis and trans men, trans women, and non-binary people who have sex with men, demonstrating that this option is both safe and effective across diverse communities. Lenacapavir was approved in June 2025 by the United States Food and Drug Administration for PrEP use in the United States, with market access likely not long after. It is not yet available in Australia.

The implications for Australia are significant. A six-monthly injection could be a more convenient, discreet, and attractive choice for many. It might be especially advantageous for:

  • people who travel frequently or have irregular routines
  • those who want to avoid carrying or taking daily medication
  • people with medical contraindications to oral PrEP
  • those who have never used PrEP before due to stigma or lifestyle fit
  • trans and gender diverse community members who otherwise would need to rely solely on daily PrEP.

Recent surveys in Australia show strong interest in long-acting PrEP among gay and bisexual men, with a higher preference for six-monthly injections than for daily or on-demand options.

The National HIV Taskforce has recommended that the Australian Government fast-track access to long-acting injectable PrEP. The Ninth National HIV Strategy has also prioritised expanding access to PrEP as a key action. This requires timely regulatory approval of new PrEP options, subsidising long-acting PrEP through the Pharmaceutical Benefits Scheme and planning for an equitable rollout focused on priority populations.

Long-acting PrEP like Lenacapavir will not replace daily pills or on-demand PrEP. Instead, it provides another important option in our HIV prevention toolkit. This option could simplify prevention and increase its accessibility to more people. For many, a twice-yearly injection could be exactly what they need.

An important consideration to the success of Lenacapavir uptake, particularly among those not currently taking PrEP will be cost. Additional thought and action need to be taken to ensure that communities most at risk of HIV transmission are afforded the ability to access and maintain the use of protection options like Lenacapavir. Additionally, for many within the community not currently aware of or feeling comfortable using PrEP, more work remains to improve community awareness, trust and access to biomedical preventions such as oral PrEP and injectable PrEP.

[1] https://www.gilead.com/news/news-details/2024/gilead-presents-full-purpose-2-data-results-for-twice-yearly-lenacapavir-for-hiv-prevention-at-hiv-glasgow.