FDA approves world’s first injectable treatment to prevent HIV: What this means in fight against AIDS

The FDA is hopeful that a long-acting injectable drug for HIV prevention will boost uptake of such medication in high-risk groups.

Earlier this week, the US Food and Drug Administration (FDA) approved the world’s first-ever injectable medication capable of reducing the risk of acquiring HIV.

The injectable, known as Apretude or by its generic name, ‘cabotegravir extended-release injectable suspension,’ has been hailed as a gamechanger in the fight against HIV and comes as an alternative to daily pills currently used in HIV prevention like Truvada and Descovy. Although these pills are up to 99 per cent effective in preventing HIV through sexual transmission, they must be taken daily to be effective, says the Centers for Disease Control and Prevention (CDC).

But with Apretude, treatment begins with two initial shots administered at a one-month interval, after which patients will only be required to take an injection every two months, said the FDA’s statement.

“This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” said Dr Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research via a statement.

While orally administered medication has proven effective in preventing HIV, several complications remain over awareness and adherence to a clinical programme. In many cases, individuals may not be forthright with medical experts in detailing their sexual habits and behaviours, effectively disabling doctors from prescribing appropriate preventative medication. Difficulties in sticking to a daily regimen and the persistent stigma around HIV also often leads to cases of HIV which could have been prevented.

The FDA is hopeful that a long-acting injectable drug for HIV prevention will boost uptake of such medication in high-risk groups. Pre-exposure prophylaxis (PrEP) drugs – medications taken to prevent HIV – are recommended for roughly 1.2 million people in the US alone, and in 2020, 25 per cent of this cohort received a prescription for such pills. Although this is up from just 3 per cent in 2015, “there remains significant room for improvement,” the FDA’s statement reads.

How effective is Apretude?

Two clinical trials were conducted to assess the effectiveness of Apretude in reducing the risk of HIV infection.

The first trial included almost 4,600 cisgender men and transgender women who participate in sexual activity with other men. Those who were administered Apretude had a 69 per cent lower risk of being infected with HIV than other participants who were given Truvada.

In the second trial involving 3,200 at-risk cisgender women, it was found that those who took Apretude had a 90 per cent lower risk of contracting HIV compared to participants who took Truvada. Both trials were randomised and double-blind.

The FDA has now approved Apretude for use in at-risk adults and adolescents weighing, at least, 35 kg. Patients are given the option of taking an oral formulation of cabotegravir daily for four weeks before starting the injectable treatment to gauge how they respond to the drug. However, patients must be tested for HIV and found to be negative prior to starting the treatment.

Updated: December 23, 2021 — 6:18 am