Injectable monthly HIV treatment passes ‘pivotal’ medical trial

A long-lasting injectable monthly treatment for people living with HIV has passed a major phase of clinical trials in what researchers say could be a “paradigm shift”.

Results from the Antiretroviral Therapy as Long-Acting Suppression (ATLAS) and First-Long-Acting Injectable Regimen (FLAIR) trials of the treatment were presented at the Conference on Retroviruses and Opportunistic Infections 2019.

The injectable regimen was found to have similar efficacy to in maintaining an undetectable viral load (UVL) compared to the standard daily, three-drug oral regimen.

The doctors behind the trials believe the injectable treatment, a combination of cabotegravir and rilpivirine, has the potential to revolutionise the HIV treatment landscape.

“The positive safety and efficacy results from the ATLAS study reinforce the potential of cabotegravir and rilpivirine as the first long-acting, injectable option for people living with HIV,” said ATLAS lead investigator Dr Susan Swindells.

“This novel approach may help alleviate the burden often associated with daily, oral treatment regimens and contribute to making HIV a smaller part of peoples’ lives.”

“We now have positive results from two pivotal phase III studies demonstrating that this long-acting, once-monthly injectable regimen has similar efficacy, safety and tolerability to a daily, oral three-drug regimen for the treatment of HIV,” said Dr John Pottage.

The FLAIR trial’s lead investigator Dr Chloe Orkin said the treatment could be a “big paradigm shift” in how treatment is offered for people living with HIV.

Pottage said that “nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy”.

Swindells said that the convenience of a monthly injection was appealing because it could help people living with HIV avoid stigma.

“They like not having to worry about taking their pills every day…they get their injection and they’re good to go,” she said.

“They don’t have to think about having HIV every day, they don’t have to worry about co-workers or housemates seeing their pill bottles – there’s maybe some relief of the stigma of HIV if they don’t have to think about it every day.”

The ATLAS study included participants around the world, including Australia.

While the trial results are significant, it could be some time before it becomes available, with Pottage saying that applications to regulatory authorities will be submitted later this year.

Last week a UK man became the second person to be “functionally cured” of HIV, however the complex stem cell treatment is only able to be given in extremely rare circumstances.

Nevertheless, the International AIDS Society’s Sharon Lewin said the news “gives us hope that it’s going to be feasible one day to eliminate the virus” as researchers continue to explore ways to streamline HIV treatment.

Last year, the Therapeutic Goods Administration approved the first two-drug, single-pill HIV treatment to be made available in Australia.