The American company Gilead Sciences, Inc. has conducted the first clinical trials of the last, third phase of its new drug for the human immunodeficiency virus (HIV) lenacapavir. And the medicine has shown absolute effectiveness: according to the manufacturer, this is the first medication in history that protects against HIV by 100%.
Lenacapavir is a new injectable drug that, when taken twice a year, provides 100 percent protection against HIV infection. If approved, after further research, the drug will become another effective way to fight the infection, which will eventually bring people closer to eradicating it. What is important is that lenacapavir only needs to be taken twice a year to achieve stable results.
Lenacapavir is a substance that prevents the HIV virus from penetrating healthy cells and infecting them. It works like this: all viruses have a special internal shell made of protein, the capsid. It contains the genetic material of the dangerous pathogen, which is crucial for transporting the virus into the host cells: as soon as the virus penetrates inside, the capsid is destroyed and the material it contains gets inside, starting to copy itself. Lenacapavir stops this process, as a result of which the virus does not spread throughout the body. This makes lenacapavir an excellent way to prevent HIV.
In people already infected with HIV, lenacapavir prevents the virus from producing progeny, making them defective. This makes the virus unable to infect other cells, stopping the spread of the disease.
The Phase III trial of lenacapavir took place in South Africa and Uganda. The study involved more than 5,300 women aged 16 to 25. Different groups of participants received lenacapavir or other classes of oral drugs that also have a therapeutic effect: Gilead, Descovy or Truvada.
At the end of the one-year trial, the researchers found no cases of infection among more than 2,000 women taking lenacapavir. On the other hand, the results were less clear among subjects taking Descovy and Truvada: 16 cases of infection in people taking the former and 39 in those taking the latter.
Thus, lenacapavir demonstrated superiority among its analogues: injections not only remained effective for six months, but also showed 100% effectiveness.
Despite the success of the new study, clinical trials of the injection are not over yet. At present, the US Food and Drug Administration (FDA) has approved its use as part of combination therapy with other antiviral drugs to treat HIV infection in patients who have stopped responding to other drugs or cannot take them due to intolerance.
The study of lenacapavir is currently ongoing. The next step is to test the drug in control groups of women and people of both sexes who inject drugs.
Even so, at this stage the drug is not affordable for everyone: injections in the first year of therapy will cost patients $42,000. And although the price will drop to $39,000 in the future, it is still an extremely expensive procedure. However, the developer promises that the price will drop when the results of future studies of lenacapavir become known.
Clinical trials in Africa have confirmed the high efficiency of the recently developed drug lenacapavir, whose injections protect the patient’s body from HIV infection for six months with an estimated 100% efficiency. This was reported on the website of the drug’s developer, the American pharmaceutical corporation Gilead Sciences.
“Existing HIV prevention methods are also highly effective when taken with adherence. Lenacapavir only needs to be taken twice a year, which could potentially make this HIV prevention option more attractive and more convenient for patients in terms of adherence,” said University of Cape Town professor Linda-Gail Becker, whose words are quoted by the press service of Gilead Sciences.
In recent years, scientists have begun to focus their efforts on developing drugs and HIV prevention agents that can suppress the replication of the immunodeficiency virus in the cells of sick people for a very long time or protect healthy patients from infection (PrEP). This approach, scientists believe, will help slow the spread of HIV in developing countries in Africa and Asia.
Scientists have conducted large-scale clinical trials of one such drug, lenacapavir, developed by researchers from Gilead Sciences and approved for clinical use in the United States, Canada, and the EU at the end of 2022. Its molecules are capable of binding to the protein units that make up the shell of immunodeficiency viruses, which leads to the formation of defective HIV particles.
The scientists say these trial results show that lenacapavir provides long-lasting protection against HIV, which is important for people who cannot take other PrEP medications daily or weekly. The researchers hope that lenacapavir could help slow the spread of HIV in Africa and other areas of the world where the number of people with the virus is growing rapidly.
