A recently published NEJM article claims a very much successful trials of a new drug. Twice-yearly shots were 100% effective at preventing new transmissions of HIV, this new landmark study shows.
The study included more than 5,000 women and girls ages 16 to 25 living in South Africa and Uganda.
An estimated 1.3 million people worldwide are newly infected with HIV annually. More than 600,000 people die from AIDS-related illnesses each year. One of the main challenges of implementing campaigns for effective preventive medicine (known as preexposure prophylaxis, or PrEP) is that many people at high risk of HIV do not take them daily because of a variety of factors, including access.
The shots, marketed under the name Sunlenca, are made by the U.S. pharmaceutical company Gilead. Also known by its generic name of lenacapavir, Sunlenca is currently approved in the U.S. as a treatment for HIV, and Gilead said it may seek approval for the medicine as a preventive measure, pending results of an ongoing study among men.
“These data confirm that twice-yearly lenacapavir for HIV prevention is a breakthrough advance with huge public health potential,” said Sharon Lewin, PhD, a physician-researcher and president of the International AIDS Society, in a statement. “If approved and delivered – rapidly, affordably, and equitably – to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention. We all owe a debt of gratitude to the thousands of young women in South Africa and Uganda who volunteered to be part of this study.”
The current price for lenacapavir is more than $40,000 for the first year, but a separate study also presented at the conference estimated that producing the medicine at a larger scale could pave the way for a cost of $40 per treatment. The group "Doctors Without Borders" called for global action to make the medicine affordable and accessible as soon as possible, adding that the organization is eager to start offering the medicine through its medical programs.
PS: How it works....
In essence, lenacapavir tackles the capsid, a conical structure that harbours the RNA (ribonucleic acid) of HIV and other proteins that HIV uses to enter and replicate in human cells. The medication works in two ways: First, it interrupts viral replication by preventing HIV from reaching the nucleus of an infected cell, which then blocks reproduction.
As an HIV-1 capsid inhibitor, it is designed to inhibit HIV at multiple stages of its lifecycle. It works by interfering with three essential steps of HIV-1 viral replication: nuclear transport, virus assembly and release, and capsid core formation. The capsid core contains and protects viral RNA and enzymes, all of which play essential roles in HIV-1 replication. The HIV-1 viral lifecycle is dependent on the function of the capsid at these stages of replication.
This mechanism of action is distinguishable from other currently approved classes of antiviral agents, most of which act on just one stage of viral replication. Lenacapivir also has no known cross-resistance exhibited in vitro to other existing antiretroviral classes. Essentially, this means that it is fully active against variants with select gene mutations that are known to cause antiretroviral resistance.
For this reason, the drug has already been approved by the FDA for the treatment of multi-drug resistant HIV under the brand name Sunleca, to be used in combination with other antiretrovirals.
The second mechanism is for cases in which integration of the HIV genome has already occurred. In this instance, lenacapavir interferes with production of viral progeny, “making them defective so that they are not able to infect other cells.” Therefore, it works in both early and late stages of the HIV life cycle to disrupt replication.
The study included more than 5,000 women and girls ages 16 to 25 living in South Africa and Uganda.
An estimated 1.3 million people worldwide are newly infected with HIV annually. More than 600,000 people die from AIDS-related illnesses each year. One of the main challenges of implementing campaigns for effective preventive medicine (known as preexposure prophylaxis, or PrEP) is that many people at high risk of HIV do not take them daily because of a variety of factors, including access.
The shots, marketed under the name Sunlenca, are made by the U.S. pharmaceutical company Gilead. Also known by its generic name of lenacapavir, Sunlenca is currently approved in the U.S. as a treatment for HIV, and Gilead said it may seek approval for the medicine as a preventive measure, pending results of an ongoing study among men.
“These data confirm that twice-yearly lenacapavir for HIV prevention is a breakthrough advance with huge public health potential,” said Sharon Lewin, PhD, a physician-researcher and president of the International AIDS Society, in a statement. “If approved and delivered – rapidly, affordably, and equitably – to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention. We all owe a debt of gratitude to the thousands of young women in South Africa and Uganda who volunteered to be part of this study.”
The current price for lenacapavir is more than $40,000 for the first year, but a separate study also presented at the conference estimated that producing the medicine at a larger scale could pave the way for a cost of $40 per treatment. The group "Doctors Without Borders" called for global action to make the medicine affordable and accessible as soon as possible, adding that the organization is eager to start offering the medicine through its medical programs.
PS: How it works....
In essence, lenacapavir tackles the capsid, a conical structure that harbours the RNA (ribonucleic acid) of HIV and other proteins that HIV uses to enter and replicate in human cells. The medication works in two ways: First, it interrupts viral replication by preventing HIV from reaching the nucleus of an infected cell, which then blocks reproduction.
As an HIV-1 capsid inhibitor, it is designed to inhibit HIV at multiple stages of its lifecycle. It works by interfering with three essential steps of HIV-1 viral replication: nuclear transport, virus assembly and release, and capsid core formation. The capsid core contains and protects viral RNA and enzymes, all of which play essential roles in HIV-1 replication. The HIV-1 viral lifecycle is dependent on the function of the capsid at these stages of replication.
This mechanism of action is distinguishable from other currently approved classes of antiviral agents, most of which act on just one stage of viral replication. Lenacapivir also has no known cross-resistance exhibited in vitro to other existing antiretroviral classes. Essentially, this means that it is fully active against variants with select gene mutations that are known to cause antiretroviral resistance.
For this reason, the drug has already been approved by the FDA for the treatment of multi-drug resistant HIV under the brand name Sunleca, to be used in combination with other antiretrovirals.
The second mechanism is for cases in which integration of the HIV genome has already occurred. In this instance, lenacapavir interferes with production of viral progeny, “making them defective so that they are not able to infect other cells.” Therefore, it works in both early and late stages of the HIV life cycle to disrupt replication.
