EDITORIAL
Dr Daniel Vujcich (he/him) is the CEO of WAAC.
A new HIV prevention option, Apretude (generic name: cabotegravir), is now available in Australia through a compassionate access program. This long-acting injectable form of pre-exposure prophylaxis (PrEP) offers an alternative to daily oral pills and provides an important option for individuals for whom oral adherence is challenging.
The program, launched by ViiV Healthcare, allows a small number of eligible Australians to access the medication at no cost, though broader access remains limited until the drug receives subsidisation under the Pharmaceutical Benefits Scheme (PBS).
What is Apretude?
Apretude is an injectable medication developed and marketed by ViiV Healthcare anddesigned to provide ongoing sexual protection against HIV without the need for daily oral pills. The regimen begins with two initiation injections given one month apart, followed by an intramuscular injection every two months administered by a healthcare provider.
Each injection provides about 2 months of continuous protection, offering an alternative for people who struggle with daily PrEP pills, have medical contradictions to oral PrEP (e.g. renal impairment and conditions affecting bone density), or who prefer the privacy of periodic clinic-based injections.
The status of Apretude in Australia
Apretude was approved by the Therapeutic Goods Administration (TGA) in 2022 as a form of HIV prevention for people at risk of HIV infection. However, it is not yet subsidised by the PBS because the Australian Government and ViiV Healthcare have not reached an agreement on the pricing of the drug.
In the meantime, ViiV Healthcare has launched a compassionate access program, which will offer the drug free of charge to a limited number of people across Australia. This program is designed for individuals who have experienced significant clinical or social need for long-acting PrEP. Applications must be submitted by a clinician and will be assessed by two independent expert consultants.
How to access Apretude
The compassionate access program opens for applications on 1 August 2025. People who are interested must first consult with their healthcare provider, who can submit an application on their behalf. Clinicians will evaluate whether injectable PrEP is a suitable option for the individual, based on factors such as their inability to take oral PrEP or other health and social considerations.
The program is capped at 100 participants nationwide, and geographic diversity will be considered when reviewing applications. However, eligibility will primarily focus on clinical need rather than location.
Call for more accessible PrEP
While the compassionate access program is an important step in providing access to Apretude, WAAC is calling for the Australian government and ViiV Healthcare to reach a pricing agreement and make Apretude more widely available. Ensuring the drug is listed on the PBS would make it accessible to anyone who could benefit, much like daily oral PrEP, which is already subsidised.
Access to a greater suite of PrEP options is essential for Australia to meet its goal of achieving virtual HIV elimination by 2030. Currently, the lack of PBS listing creates an unfair barrier, and WAAC urges the government and ViiV Healthcare to work together to resolve this issue promptly.
How to find out more
If you’re interested in exploring Apretude as an option, speak to your GP or visit WAAC’s M Clinic in West Perth or online for more information. Healthcare providers can help determine whether long-acting injectable PrEP is the right choice for you and assist in navigating the compassionate access program. Remember that the program begins in August 2025 and is limited to just 100 recipients nationwide, so acting early and consulting your doctor soon is advisable.
For those seeking more information about oral PrEP, WAAC provides a range of resources. Daily and on-demand oral PrEP is a highly effective option for most people, reducing the risk of acquiring HIV through sexual contact by nearly 100% when taken as prescribed. WAAC’s website offers comprehensive information on how to get started with oral PrEP, including the Little Book of PrEP, a handy guide that explains how PrEP works and how to take it.
Watch this space!
Apretude is just one of the new prevention tools becoming available, and other long-acting PrEP options are in the pipeline from different pharmaceutical companies. For example, Gilead Sciences has developed an injectable PrEP medication (brand name Yeztugo) that only needs to be dosed twice a year. Gilead has submitted an application for TGA approval.
In the coming years, we can expect an expanding toolkit of PrEP methods, which will allow individuals to choose the HIV prevention strategy that best fits their lifestyle and needs. Staying informed through organisations like WAAC and talking with healthcare providers will help you take advantage of these options as they become available. In the meantime, WAAC will continue to advocate for equitable access to new HIV prevention tools, ensuring that medical advancements are affordable and available to everyone who could benefit.
Dr Daniel Vujcich
