By Mary Hearty

The European Commission has granted Marketing Authorization for Sunlenca® (lenacapavir), a new treatment option in the form of injection and tablets for people with HIV infection, whose virus no longer effectively responds to their current therapy. The new treatment is used in combination with other antiretroviral drugs.

Lenacapavir is a first-in-class capsid inhibitor with a multi-stage mechanism of action and has no known cross resistance to other existing drug classes, offering a new, every six-month treatment option.

“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,” Jean-Michel Molina, Managing Director of Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals said.

Molina said 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.

Lenacapavir provides an innovative long-acting HIV therapy option with the potential to transform the clinical landscape.

The Marketing Authorization Application (MAA) for lenacapavir is supported by data from the Phase 2 and 3 of CAPELLA study, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced.

In this patient population with significant unmet medical need, 83%, that is, 30 out of 36 of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at Week 52. Additionally, CAPELLA participants achieved a mean increase in CD4 count of 83 cells/µL.

“After more than three decades of driving advancements in HIV treatment and prevention, Gilead scientists have now delivered an innovative new option for long-acting care,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.

O’Day added that Lenacapavir is a unique and potent medicine with the potential for flexible dosing options.

“Following today’s approval, it will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV. Our goal is to deliver multiple long-acting options in the future, in the belief that this will make a fundamental difference in the journey to end the HIV epidemic,” O’Day stated.

Despite the significant advances in ARV therapy, there remain numerous critical and pressing unmet needs for people with HIV.

This is particularly true for people with HIV who are heavily treatment-experienced with limited therapy options and are unable to maintain virologic suppression due to resistance or challenges adhering to a complex regimen.

This type of complexity further increases the chance of suboptimal adherence and treatment failure, underscoring the need for a new treatment option that is active against resistant variants of the virus with a novel mechanism of action.

Following the European Commission’s approval of this new HIV treatment option designed for twice-yearly dosing, Winnie Byanyima, UNAIDS Executive Director said:

‘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. The evidence is clear: monopoly production cannot ensure global availability and affordability. Worldwide availability of affordable long-acting treatments will require the transfer of technology to enable generic production.”

This new milestone comes after the recent decision by ViiV to share its long-acting HIV prevention technology to enable generic production has demonstrated that sharing is possible for companies to do.

Currently, many upper middle-income countries do not have access to these technologies. Achieving global targets to end AIDS would require countries around the world have access to newer technologies.

As a range of companies advance 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.

Byanyima said: “Delays in the transfer of technology of innovative health products cost lives. The process of sharing of long-acting treatment technology, of the intellectual property rights and “recipes”, should not wait for after long-acting HIV treatment medicines are made available to people in rich countries. That process should begin at the early stages of the Research and Development (R&D) cycle. Sharing technology now, to help producers prepare, will save lives and help end the AIDS pandemic. The transfer of pandemic-ending technologies to low- and middle- income countries is not only the right thing to do, it is in the self-interest of rich countries too. We can only end AIDS by ending AIDS everywhere. To end AIDS, share technology. Now.”