Alternative approved as tenofovir shortage hits

The new brand of antiretroviral tablets, registered in the US, will be available on the PBS from next month.

Amid a shortage of the antiretroviral drug tenofovir the TGA has approved an alternative, to be listed on the PBS under the same conditions as existing PBS-listed antiretrovirals.

Emtricitabine and tenofovir disoproxil fumarate 200mg/300mg tablets from US maker Laurus Labs will be available from 1 October until the TGA’s approval, granted under section 19A of the Therapeutic Goods Act 1989, lapses on 31 January.

That section of the Act allows medicines that are approved by and registered with an overseas body, but are not listed on the Australian Register for Therapeutic Goods, to be imported and supplied where a registered treatment is unavailable or in short supply.

The TGA’s medicine shortage reports database currently lists five tenofovir-containing medications as being unavailable, with supply not expected to be available until the end of October for some products, with others not expected to arrive on our shores until March next year.

The medication shortage is placing additional pressure on the state of sexual health in Australia, with research presented at this month’s ASHM HIV & AIDS conference reporting not enough young people are using pre-exposure prophylaxis (PrEP) – or any other form of effective prevention.

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New HIV cases increased in 2023

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The Kirby Institute reported this month that while the number of new HIV diagnoses had fallen by roughly a third over the last decade, case numbers increased in 2023 relative to the figures from 2022 (722 versus 553).

Dr Skye McGregor, surveillance innovation group lead at the Kirby, was particularly concerned by the finding that 37% of new HIV cases last year were considered a “late” diagnosis, a figure that exceeded 50% when heterosexual cases were considered.

A late diagnosis means someone could have been living with and potentially spreading HIV for years.

“We need to increase access to testing, treatment and prevention in a targeted and equitable way, to ensure those most in need can easily access services,” Dr McGregor said in early September.

“Regular sexual-health testing is important for anyone who has changed sexual partners or who hasn’t used a condom. A blood test for syphilis and HIV should be part of your routine sexual health screen with your GP.”