First HIV Prevention Drug Approved and Enters Global Market

The medication provides nearly 100% protection against HIV infection. It belongs to a class of drugs known as capsid inhibitors. The critical question remains: how accessible will this groundbreaking drug be to the general population?

The U.S. Food and Drug Administration (FDA) has approved lenacapavir, a new drug designed to prevent HIV infection. Developed by the American biopharmaceutical company Gilead Sciences, it is heralded as the first and currently only medication of its kind available in the U.S.

This drug offers nearly 100% protection against HIV infection. Approximately 1.3 million people contract the disease annually worldwide, including over 30,000 in the U.S. and about 50,000 in Russia. The American online science and technology journal New Atlas suggests that this medication could potentially halt the global HIV epidemic.

To ensure broad access, manufacturers in the U.S. and other countries are signing royalty-free licensing agreements with six generic drug producers for the manufacturing and supply of lenacapavir. This strategy aims to significantly expand the drug`s availability.

Lenacapavir belongs to the class of drugs known as capsid inhibitors, which offer nearly complete protection against HIV infection. The capsid is a protein shell that encapsulates and shields the virus`s genetic material, playing a crucial role in its transportation into the host cell. Once inside, the capsid disassembles, allowing the virus to replicate itself; lenacapavir, however, thwarts this vital process, preventing viral multiplication.

Last year, Science magazine lauded lenacapavir as the `breakthrough of the year`, recognizing its profound scientific significance and potential impact.

Earlier this month, Gilead Sciences announced a strategic partnership with the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Together, these organizations plan to deliver batches of the drug, without any profit for the pharmaceutical company, to 120 high-burden, low-income countries. This collaboration underscores a commitment to global health equity.

Preliminary estimates suggest that this initiative could lead to up to two million people being treated within three years. The pivotal question remains: will this ultimately lead to a comprehensive victory over the HIV epidemic?

Konstantin Severinov, Head of the `National Genetic Initiative`, Doctor of Biological Sciences, and Professor, provides his insights:

This is a well-known drug. Trials have been conducted on its safety and efficacy, and its use has been approved since 2022. Initially, it served as a second-line treatment for individuals for whom existing medications were ineffective. It performed exceptionally well. What is now considered a breakthrough is its potential for prophylactic use; studies on large cohorts have shown that infection rates drop virtually to zero.

— Can this truly stop the HIV epidemic?

Tens of millions of people are already infected. Therefore, the question is more about how widely such prophylactic measures are needed, what the cost implications are, and how effectively it can be delivered to all people in at-risk areas. Currently, a course of the drug costs tens of thousands of dollars, but it is asserted that with generic production and widespread adoption, the cost could fall below one hundred dollars. However, this will only work if there are mass sales and if the drug is in demand and people use it.

In Russia, according to a government decree, patents are no longer generally enforced, which is why `Ozempic` and several other drugs that are actually patent-protected are produced in Russia. Consequently, if such a need arises, this substance could probably be produced, but it would then have to undergo certain trials, as it would be used for prevention rather than for already infected individuals.

Gilead has initiated the drug`s registration process in Australia, Canada, South Africa, Brazil, Switzerland, and other countries, aiming for widespread international availability. In the U.S., the drug will be available for free to those in need through a special program, further emphasizing its public health mission.