What you need to know:
- The new treatment would enable more people showing resistance to current regimens to get on treatment.
- The European Commission approval applies to all 27 member states, Norway, Iceland and Liechtenstein.
European Commission has approved twice-yearly injections and tablets for treating HIV infection in adults with multi-drug resistant HIV.
The twice-yearly antiretroviral is for treating people with multidrug-resistant HIV who cannot otherwise construct a fully suppressive regimen.
Lenacapavir has also shown promise for first-line treatment and pre-exposure prophylaxis (PrEP), but this week's approval only covers previously treated people.
It has no known cross-resistance to other existing drug classes, offering a new, every six-month treatment option for people with HIV whose virus no longer effectively responds to their current therapy.
"Lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who are at greater risk of progressing to Aids," said Jean-Michel Molina who is a Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals.
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According to Molina, in the CAPELLA study, lenacapavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery in people with multi-drug resistant HIV.
CD4 cells are a type of white blood cell.
They're also called CD4 T lymphocytes or "helper T cells." They help fight infection by triggering your immune system to destroy viruses, bacteria, and other germs that may make you sick.
HIV attacks and destroys CD4 cells. Without treatment, HIV may destroy so many CD4 cells that your immune system will have trouble fighting off infections.
If one has AIDS, their CD4 count is so low that they may develop severe infections from viruses, bacteria, or fungi that usually don't cause problems in healthy people.
These are called "opportunistic infections," and they can become life-threatening. AIDS increases your risk of developing certain cancers, too.
Further, Molina added that Lenacapavir provides an innovative long-acting HIV therapy option with the potential to transform the clinical landscape.
UNAIDS Executive Director Winnie Byanyima said the new treatment would enable more people showing resistance to current regimens to get on treatment.
"It is great news that a range of long-acting HIV treatment options are set to come on stream. A range of options for long-acting treatments, received every few months, could enable more people to get on treatment or offer better clinical options for patients showing resistance to current regimens, therefore staying longer on treatment, and prevent many AIDS-related deaths – if they become available for all who need them,"
UNAIDS further urged an expansion of the number of countries included. Currently, many upper-middle-income countries do not have access to these technologies.
"Achieving global targets to end AIDS would require countries worldwide to access newer technologies. As a range of companies advances their development of long-acting HIV treatments, they should build on ViiV's precedent, expanding the number of countries, and learn from it by not waiting until after launch to transfer the technology.
The European Commission approval applies to all 27 member states, Norway, Iceland and Liechtenstein.
In the U.S., Lenacapavir is under FDA review, with a decision due on December 27, 2022.
This is Lenacapavir's second go-around with the FDA. The U.S. regulatory agency had refused to approve Lenacapavir in March of this year, citing issues related to the compatibility of vials and Lenacapavir solution.
Lenacapavir (formerly known as GS-6207) disrupts the HIV capsid, the cone-shaped shell surrounding the viral genetic material and essential enzymes. Laboratory studies have shown that it interferes with multiple stages of the HIV lifecycle. Because it works differently from existing drugs, Lenacapavir remains active against HIV, which has developed resistance to other antiretrovirals.
Lenacapavir has a long half-life in the body, allowing it to be administered by subcutaneous injection once every six months. It needs to be taken in combination with other antiretrovirals, which are currently oral medications taken daily.
When starting Lenacapavir, a tablet formulation is used first for a two-week 'loading period' to establish an adequate drug level before starting the long-acting injections.