Twice-yearly injection reduced HIV infections by 96 percent, company says

Lenacapavir, a new HIV prevention drug, has proven to dramatically reduce the risk of infection according to data reported from the drugmaker Gilead Sciences, who found two annual injections of the drug reduced HIV infections by 96 percent.

Data from the trial, known as PURPOSE 2, monitored cisgender men, transgender men, transgender women, and gender nonbinary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth. Reports show out of 2,180 participants only two people contracted HIV. 

“With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” Daniel O’Day, chair and CEO of Gilead, said in a statement.

O’Day said the company would now seek to win regulatory approval for the drug.

“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP.”

While the results are good news, the drug is expensive.

The National Institutes of Health have estimated that the two injections of the drug could cost more than $40,000 a year.

Nonetheless, researchers are hoping to see the global impact of the drug in places where treatment is lacking. 

“In the United States, the stubbornly high rate of HIV diagnoses — especially in the U.S. South, and particularly among gay and bisexual men of color and transgender people — demands novel approaches to help people prevent HIV acquisition,” said Colleen Kelley, a professor of medicine at Emory University and a PURPOSE 2 principal investigator.

The drug has not been approved for use anywhere globally by itself, though lenacapavir has been authorized by the U.S. Food and Drug Administration for the treatment of HIV infection in adults, in combination with other medicines.

Gilead is planning to use results from PURPOSE 2 to start the drug approval process throughout different countries.