US drugs regulator approves first injectable treatment to prevent HIV

The US Food and Drug Administration has approved the first injectable treatment to prevent HIV, marking a pivotal moment in the fight against the epidemic.

GlaxoSmithKline said late on Monday that US drug regulators had approved use of cabotegravir, a long-acting injectable drug made by ViiV Healthcare, which is majority owned by GSK and also backed by Pfizer and Shionogi, to prevent HIV in at-risk adults and adolescents.

The drug, whose branded name is Apretude, can be given as few as six times a year, in contrast with the current regimen for pre-exposure prophylaxis (PrEP), which requires adherence to a daily pill.

“We need new tools in our toolbox and I think this is unquestionably the most powerful tool,” Kim Smith, head of research and development at ViiV, told the Financial Times. “There’s a significant number of individuals who start oral PrEP and stop it because either they forget or don’t like taking it”, for example because of the stigma attached to HIV drugs.

According to the US Centers for Disease Control and Prevention, in 2020, about a quarter of the 1.2m people for whom PrEP is recommended in the US were prescribed it.

Debra Birnkrant, the director of the antivirals division at the FDA’s centre for drug evaluation and research, said the drug would be “critical in 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.”

The drug will retail at $3,700 per dose in the US, GSK said, and Smith noted the company had programmes for people unable to obtain it, including those without insurance.

The drug is better at preventing infection than a daily dose of Truvada, an oral drug made by Gilead Sciences, according to the results of a study made public last year.

Smith said ViiV had prioritised seeking approval in the countries that participated in the original studies demonstrating the drug’s efficacy, such as South Africa, Thailand, and Vietnam. She said the company expects to file for approval in the UK and the EU next year.

HIV, the human immunodeficiency virus that can lead to Aids, was identified more than 40 years ago, infecting almost 80m. More than 36m have died from Aids-related illnesses since the pandemic began, according to Unaids.