FDA approves first-in-class HIV prevention shot

The United States Food and Drug Administration has approved a drug that almost completely protects against infection by the type 1 human immunodeficiency virus (HIV-1) and should only be given twice a year. The Injectable Antiretroviral Medication of Gilead Science Yeztugo (Lenacapavir) is 100% protective for people who need to reduce the risk of HIV sexually acquired. It is a primary medicine in class that works by a new mechanism that disrupts the HIV-1 capsid protein which constitutes the shell of the virus. Other HIV drugs have a different target.

Gilead President Daniel O’Day has described the approval of “historic” and, in a statement, said that the drug could “end the HIV epidemic”. The approval was based on two published clinical trials: objective 1, conducted in 5,000 women in South Africa and Uganda, where there was no infection, and the objective 2, in 3,200 men cisgenres, transgender women and men, and non-binary people from several countries, notably Argentina, Mexico, South Africa, Peru, Thailand and the United States, where 2 participants were infected.