FDA approves twice-a-year injection for HIV prevention

A drug currently used to treat certain HIV infections has also, on Wednesday,received approval from the US Food and Drug Administration to be used to prevent HIV.

Gilead Sciences, maker of the drug, announced that a twice-a-year injection of lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo. In clinical trials, the drug was found to dramatically reduce the risk of infection and provide near-total protection against HIV, significantly more than the primary options available for pre-exposure prophylaxis or PrEP.

Therapies called PrEP have been used to prevent HIV infections for years. In the United States, this may involve taking pills, such as a daily medication called Truvada, or getting shots, such as injections every two months of the medication Apretude. But a twice-yearly shot of lenacapavir has now become another option in the prevention toolbox – making it the first and only such shot for HIV prevention.

"Yeztugo could be the transformative PrEP option we've been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic," Dr. Carlos del Rio, a distinguished professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research, said in a Gilead news release. "A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing."

With any PrEP drug, "by having that medicine in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It arrests infection from taking hold," said Dr. Jared Baeten, senior vice president of clinical development and the virology therapeutic area head at Gilead Sciences.

The human immunodeficiency virus or HIV, spread primarily through unprotected sex or sharing needles, attacks the body's immune system, and without treatment, it can lead to acquired immunodeficiency syndrome or AIDS. Although rates of new HIV infections have fallen in the US, about 1.2 million people are estimated to have HIV, and about 13% of them may not know it.

'People can get it privately'

A study called the PURPOSE 2 trial found that just two shots a year of lenacapavir can reduce the risk of HIV infection by 96%, proving it to offer near-total protection against HIV. Another study, the PURPOSE 1 trial, found that lenacapavir demonstrated 100% efficacy for HIV prevention in women.

"Lenacapavir is a unique option for people for HIV prevention because it's an injection given just twice a year. So people can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later," Baeten said. "For many people, that might be the empowered, private option that might make HIV prevention workable in their lives."

From : CNN