Jul 11, 2024 11:14:00

What is Lenacapavir, the new HIV prevention drug that showed 100% efficacy in clinical trials?

by

NIAID

Large-scale clinical trials in South Africa and Uganda have shown that a new PrEP (pre-exposure prophylaxis) drug called lenacapavir, given as an injection once every six months, can 100% prevent HIV infection. Professor Linda Gayle Becker, deputy director of the Desmond Tutu HIV Centre at the University of Cape Town's Institute of Infectious Diseases and Molecular Medicine, explains lenacapavir and its clinical trials.

HIV breakthrough: drug trial shows injection twice a year is 100% effective against infection
https://theconversation.com/hiv-breakthrough-drug-trial-shows-injection-twice-a-year-is-100-effective-against-infection-233295

HIV is a retrovirus that causes acquired immune deficiency syndrome (AIDS). HIV infects and destroys T cells and macrophages, which are responsible for the immune system, resulting in the loss of cell-mediated immunity.

It is estimated that 1.3 million people worldwide will be newly infected with HIV in 2023 alone, and if things continue as they are, the goal of eradicating AIDS by 2030 will not be achieved. On the other hand, PrEP drugs are not a surefire preventative treatment, and they have a high hurdle in that they must be taken every day to be effective.

In order for the virus to grow, it must inject its genetic information into the chromosomes of the cell after infecting it. At this time, the genetic information is wrapped in a protein shell called a capsid. Lenacapavir, developed by the pharmaceutical company Gilead Sciences, has a different mechanism of action from conventional PrEP, and by inhibiting the production of this capsid, it has the effect of suppressing the growth of HIV.

Lenacapavir is taken orally or by subcutaneous injection. Subcutaneous injection is said to be effective even if taken once every six months, which is an advantage over conventional PrEP drugs.

The clinical trial, conducted by the Desmond Tutu HIV Centre at the University of Cape Town's Institute of Infectious Diseases and Molecular Medicine, involved 5,000 female subjects aged 16 to 25 at three sites in Uganda and 25 sites in South Africa. According to the research team, young women in eastern and southern Africa are particularly at the forefront of HIV infection and are often unable to take PrEP medication daily for social reasons.

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The results of the clinical trial showed that none of the 2,134 people taking lenacapavir became infected with HIV, confirming 100% efficacy, compared with 16 of 1,068 people taking Truvada and 39 of 2,136 people taking Descovy who became infected with HIV.

Twice-yearly HIV prevention drug 'Lenacapavir' shows 100% efficacy in HIV prevention in Phase III clinical trial - GIGAZINE

'We hope that this new drug will be adopted into WHO and national guidelines, and that it will begin to be tested in more studies to better understand how to implement it in real-world situations,' said Professor Becker.

In addition, the subjects in this clinical trial were only women, but the research team said that further trials are required to investigate whether the effect differs depending on the style of sexual intercourse that is the route of infection.