The United States Food and Drug Administration has approved a highly effective new HIV-prevention medication. According to news reports, the drug has been able to nearly eliminate HIV’s spread among those given an injection every six months at the clinical trial. Known as Yeztugo, the drug has brought hope that the medication could accelerate the stubbornly low decline of HIV transmission.

"This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," said Denial O’Day, Chairman and Chief Executive Officer of Gilead Sciences.

"This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life's work to end HIV, and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality,” he added. According to experts, the drug with the generic name lenacapavir is significantly more effective than the existing oral HIV-prevention drugs, as it addresses the challenges of sticking to a daily pill regimen for those who are at high risk of HIV.

Even though HIV prevention drugs – also known as pre-exposure prophylaxis – have existed for many years, their global impact has been limited due to the need for daily pill intake, a routine many patients struggle to follow consistently.

Two large clinical trials were conducted for the drug – with the first involving more than 2,000 women in sub-Saharan Africa, resulting in a 100 per cent reduction in infections and demonstrating superiority over the daily oral pill Truvada. In the second trial – which involved over 2,000 men and gender-diverse individuals – only two infections were recorded – a 99.9 per cent prevention rate, again surpassing Truvada.

Calling it the “breakthrough of the year”, the results of the trials were published in The New England Journal of Medicine.

According to the scientists, all forms of PrEP work in the same way – if there is enough of the drug present in the body when a person is exposed to HIV, it is super effective at preventing the virus from taking hold and establishing a lifelong infection. Lenacapavir is so long-acting that it needs to be injected only twice a year.

However, Yeztugo’s use as PrEP against HIV emerges into a political climate that experts warn could derail progress against the spread of the virus. HIV experts are concerned that Yeztugo’s full potential might remain unrealised.

Also, there are several concerns regarding the cost of the drug. While Gilead has not disclosed a price for Yeztugo, experts estimate the US launch cost could reach $25,000 per year. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, though that is expected to drop when used as a preventive.