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Approval of only twice-yearly HIV treatment option

Published on 22/08/22 at 10:49am

The European Commission (EC) has granted a Marketing Authorisation for Sunlenca (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV.

The authorisation has been granted for patients for whom it is otherwise not possible to construct a suppressive antiviral regimen. In spite of significant advances in ARV therapy, there remain numerous critical and pressing unmet needs for those living with HIV, particularly those with HIV who are heavily-treatment experienced, with limited therapy options, and unable to maintain virologic suppression due to resistance or challenges adhering to a complex regimen.

This complexity increases the chance of suboptimal adherence and treatment failure, leading to possible poor outcomes for people living with HIV. This underscores the need for a new treatment option that is active against resistant variants of the virus, with a novel mechanism of action.

“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, MD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. “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. Lenacapavir provides an innovative long-acting HIV therapy option with the potential to transform the clinical landscape.”

“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. “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.”

Ana Ovey

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