💯 New drug shows one hundred percent protection against HIV infection

• A clinical trial showed that the drug lenacapavir protected 100 percent of women and girls against HIV infection.
• The drug only needs to be injected twice a year to provide full protection.
• New results from a phase I study suggest that an annual injection may be sufficient for long-lasting protection.

Exceptional results in HIV prevention

A new drug, lenacapavir, has shown exceptional results in clinical trials for preventing HIV. In a large study with over 5000 women and teenage girls in Uganda and South Africa, there were no HIV cases among participants who received lenacapavir injections twice a year.

In a second study with 3265 men and gender-diverse individuals, the biannual injections reduced the incidence of HIV by 96 percent.

Annual dose shows promising results

Recently, researchers from Gilead Sciences presented results from a smaller phase I study where 40 healthy volunteers in the US tested a new formulation of the drug. Participants received an injection in their glute muscles instead of under the skin as in previous studies.

One year after the injection, participants still had high levels of the drug in their blood plasma - levels that were higher than in people who were protected against HIV in last year's studies. This suggests that an annual injection can be as effective as the biannual injections.

"It will be a total change if it works, which looks promising from the phase I data," says Carina Marquez, associate professor of medicine at the University of California, San Francisco.

Simpler treatment with longer protection

Longer intervals between doses can make a big difference. It can be difficult for people to remember to take daily pills when they are healthy, and there is a stigma attached to HIV preventive medications.

"People are concerned about people hearing the pills shake in their purse on the bus... or seeing them on a medicine cabinet or bedside table," explains Moupali Das, vice president of HIV prevention at Gilead Sciences.

Lenacapavir works by interfering with the virus's ability to replicate. The drug has unusual properties that allow it to remain in the blood for a long time. Researchers have given the drug nicknames like "magical" and "the unicorn" due to its unique properties.

Access and future plans

Gilead has submitted applications for approval of the biannual form of lenacapavir to the FDA and European Medicines Agency and hopes to receive FDA approval in June.

The company has signed licensing agreements with six generic drug manufacturers who will sell cheaper versions of the drug in 120 low and middle-income countries. In December, Global Fund and other organizations announced plans to secure access to the biannual drug for 2 million people in such countries.

According to estimates, 630,000 people died from HIV-related causes during 2023, and an additional 1.3 million people acquired HIV that same year.

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