CabotegravirApretude
Pre-exposure prophylaxis (PrEP) for HIV-1 infection in persons in whom tenofovir disoproxil and emtricitabine (TD/FTC) is contraindicated, or persons who are intolerant or have reported suboptimal adherence to TD/FTC.
Decisions on record
- Meeting Sep 2023 Recommended Pre-exposure prophylaxis (PrEP) for HIV infection no PSD
- Meeting Jul 2023 Deferred Pre-exposure prophylaxis for human immunodeficiency virus (HIV) infection
Access path
- TGA registered · Apretude
TGA label narrower than the PBS population
- Sep 2023Recommended · restricted
vs Placebo (as proxy for no medical PrEP) in combination with…
- PBS listing · Authority Required
From the public summary
The PBAC deferred making a recommendation for the General Schedule listing of CAB- LA for HIV PrEP to allow further deliberation on the population who should be eligible for CAB-LA as PrEP and the associated PBS restrictions. In deferring making a recommendation, the PBAC considered CAB-LA was at least as effective as oral TD/FTC for PrEP, and was an important option for people who cannot use TD/FTC or cannot use TD/FTC in an effective manner.PSD · Jul 2023
The PBAC noted that in Australia HIV infection rates had trended down significantly over the past 10 years, with strong uptake of oral PrEP since PBS listing following several state-based demonstration studies. The PBAC noted recent estimates from the 45PSD · Jul 2023
Women at risk of HIV (Botswana, Kenya, Malawi, R, DB HPTN-084 3,224 Low South Africa, eSwatini HIV incidence Not used 48 weeks [formerly Swaziland], Uganda and Zimbabwe) TD/FTC versus SoC MSM at high risk (Peru, Three scenarios involving R,DB, iPrEx 2,499 Low Ecuador, Brazil, USA, HIV incidence iPrEx results, and meta-PSD · Jul 2023
2.8 years Thailand, South Africa) analysed results were R, OL, applied to an indirect PROUD 544 High MSM at high risk (England) HIV incidence 24 months comparison against CAB- R, DB LA and used in the IPERGAY 414 Low MSM (France, Canada) HIV incidence 24 months economic evaluation.PSD · Jul 2023
of HIV infection and has an acceptable and manageable safety profile compared to no intervention. Source: Table 1, p 2 of the submission.PSD · Jul 2023
The submission stated that in individuals at risk of HIV infection, CAB-LA as HIV PrEP reduces the risk of HIV infection and has an acceptable and manageable safety profile compared to SoC. Specifically, in individuals at risk of HIV infection and unable to be treated with TD/FTC i.e. as second line treatment.PSD · Jul 2023
The PBAC noted and welcomed the input from individuals (6), health care professionals (6) and organisations (4) via the Consumer Comments facility on the PBS website. The comments from individuals noted some concern regarding the long term safety of both CAB-LA and TD/FTC but suggested the benefits outweigh the risks, and highlighted the need for alternative options to a daily medication, particularly for those who could not adhere to or use TD/FTC.PSD · Jul 2023
• THH made similar comments to the WAAC and also stated that more options will lead to better PrEP coverage for individuals, resulting in fewer HIV transmissions as different people will use the options that best suit their needs.PSD · Jul 2023
Cost-effectiveness
ICER value not stated in the public text; document appears to be truncated before economic analysis details
Decision context
PopulationPersons at risk of HIV infection unable to be treated with TD/FTC due to contraindication, intolerance, or repeated suboptimal adherence; at least 12 years of age and weighing at least 35 kg
Risk sharingRisk Sharing Arrangement proposed by PSCR to address the risk of use in a broader population than the restricted indication
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2023 | Recommended · restricted | Placebo (as proxy for no medical PrEP) in combination with standard of care safer sex practices | — | RCT · HIV infection; safety |
Consumer voice
Consumer input from 6 individuals, 6 health professionals, and 4 organisations supported access to cabotegravir long-acting (CAB-LA) as an alternative to daily oral TD/FTC, particularly for those with adherence difficulties or privacy concerns. Input highlighted that CAB-LA could improve treatment options for people with chaotic living situations and help achieve HIV elimination goals, though clin
many people they see live chaotic lives, including homelessness, isolation, drug and alcohol use, intimate partner violence, mental illness etc. which complicate being able to adhere to oral PrEP dosing requirements. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use (TD/FTC contraindicated/intolerant/non-adherent); TGA label covers all at-risk persons without prior-therapy requirement.