Are You PrEP’ed for Lenacapavir?
Friday, 23 January, 2026
Gilead Sciences Inc.
Recently, Australia’s Therapeutic Goods Administration (TGA) approved lenacapavir for use as pre-exposure prophylaxis (PrEP). This brings both exciting possibilities and important questions about access for people who want a pharmaceutical option to reduce their risk of contracting HIV.
Lenacapavir is a new type of drug, the first in its class. It has a unique action that prevents the human immunodeficiency virus from replicating. Previously Lenacapavir was only available as a treatment option for those who have been living long-term with HIV and treatment resistance.
PrEP has been available as a daily oral medication for over a decade and there are several ways to take PrEP pills, including “daily”, “periodically” and “on demand”.
What makes Lenacapavir so exciting is that it is a medication formulated to be taken just twice a year through subcutaneous injection. Previously, the only other injectable PrEP formulation was Cabenuva, which is given every 2 months. The development of long-acting injectable medications represents a fundamental shift in how we approach both HIV prevention and treatment.
What is Lenacapavir?
Lenacapavir provides an additional choice of injectable HIV PrEP, following from the successful listing of Cabenuva (CAB-LA) on the TGA and PBS between 2021 and 2022. Cabenuva is a 2monthly injectable PrEP medication, administered by a clinican.
Unlike existing medications, lenacapavir targets the virus capsid, or the protective shell surrounding HIV’s genetic material. It is the first in a new class of drugs called capsid inhibitors.
What makes lenacapavir particularly groundbreaking is the different ways it is administered. Lenacapavir (Yeytuo) can be given as a subcutaneous injection twice a year, or once every six months. This is a huge change from the routine of daily medication for HIV prevention that has been standard for quite some time, which has included either daily oral medication, or injections that last for two months.
In Australia a version of lenacapavir is already available under the brand name ‘Sunlenca’, used for HIV treatment. In combination with other medications, it is used to treat HIV, particularly people who have been living long-term with HIV.
The recent approval of lenacapavir for PrEP means that there is now an approved long-acting medication option to compliment other forms of HIV prevention and to provide people worried about HIV transmission more choice in their options to prevent HIV aquisition. Hopefully with future Pharmaceutical Benefits Scheme listing, lenacapavir will also be affordable and easy to source from a local GP and pharmacy.
Possible Benefits of Lenacapavir
Daily medication can create ongoing issues such as remembering pills when traveling, maintaining privacy, and dealing with daily side effects. These can be frustrating challenges to live with. With twice-yearly injections, medication becomes something that happens at a clinic visit rather than a daily presence.
James Gray from Health Equity Matters notes that “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.”
“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.”
“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”
“We would encourage the manufacturers and the Australian Government to keep affordability in mind during their negotiations to ensure widespread access across the country.”
Where to From Here?
For lenacapavir to become available, several steps must happen:
1. PBAC Engagement: The manufacturer must engage with the Pharmaceutical Benefits Advisory Committee, which evaluates medications for PBS listing based on clinical effectiveness and cost-effectiveness. This is a crucial step for access. Despite the TGA registration, we won’t have access without the PBAC listing.
2. Price Negotiation: If the PBAC recommends listing, negotiations begin between the manufacturer and government on pricing.
3. Distribution and Training: Once listed, the medication must be distributed through healthcare providers, with training on administration and monitoring.
Australia stands at an important moment in the HIV response. The country has made remarkable progress toward virtual elimination of transmission. The PBS listing of Cabenuva in 2022 demonstrated Australia's willingness to invest in innovative HIV treatments.
Lenacapavir could be the next step, offering even greater convenience with twice-yearly injections.
The potential impact extends beyond individual convenience. Tools that make it easier to prevent HIV infection contribute to reducing overall transmission. Lenacapavir could accelerate Australia's already stellar progress toward virtual elimination.
Turning this potential into reality requires fair pricing, PBS subsidy, and commitment to ensuring scientific breakthroughs translate into improved health outcomes for all, not just those who can afford to pay out of pocket. The hope is that lenacapavir will soon follow Cabenuva's path to PBS listing and become accessible to everyone who could benefit.