First Approved Capsid Inhibitor-Based HIV Treatment Option

While the U.S. Food and Drug Administration (FDA) has yet to approve an HIV vaccine candidate, approvals have been granted for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection.

Gilead Sciences, Inc. announced today that Sunlenca® (lenacapavir), in combination with other antiretrovirals, has been granted approval by the U.S. FDA for treating HIV-1 infection in HTE adults with MDR HIV-1 infection.

Sunlenca is now the first and only FDA Approved Capsid Inhibitor-Based HIV treatment option.

Sunlenca has a multi-stage mechanism of action distinguishable from other currently approved classes of antiviral agents and no known cross-resistance exhibited in vitro to other existing drug classes.

Sunlenca offers a new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen, says Gilead.

"An effective antiretroviral regimen can be devised for most people living with the virus; however, some people living with HIV no longer have durable viral suppression due to resistance to multiple classes of antiretroviral therapies," said Sorana Segal-Maurer, MD, Director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens, and the Site Principal Investigator for the phase 2/3 CAPELLA clinical trial, in a press release on December 22, 2022.

"The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced people with multi-drug resistant HIV."

"Following today's decision from the FDA, 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 otherwise have limited therapy choices."

Lenacapavir, alone or in combination, is not approved by any regulatory authority outside the U.S., United Kingdom, Canada, or the European Union for any use.

Furthermore, Lenacapavir is a breakthrough innovation with the potential to be a preferred and versatile foundational long-acting agent due to its therapeutic potency and a range of dosing frequencies and routes of administration. 

About one year ago, the FDA issued Approval for Apretude (cabotegravir extended-release injectable suspension) on December 21, 2021, for use in at-risk adults and adolescents weighing at least 77 pounds for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV.

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

This is particularly true for individuals who are heavily treatment-experienced – which accounts for an estimated 2% of adults living with HIV who are on treatment globally –- and are unable to maintain virologic suppression due to resistance, intolerance, or safety considerations.

This type of complexity further increases the chance of treatment failure, underscoring the need for new treatment options that are active against resistant variants of the virus with a novel mechanism of action, says Gilead.

"This news is an important milestone in the work to help end the HIV epidemic as Sunlenca is now the only FDA-approved twice-yearly treatment for people with multi-drug resistant HIV," commented Daniel O'Day, Chairman, and Chief Executive Officer, Gilead Sciences.

"Gilead scientists have developed a unique and potent antiretroviral medicine in Sunlenca with the potential for flexible dosing options."

"Our goal is to deliver multiple long-acting options for treatment and prevention tailored to the needs of people living with HIV and people who could benefit from PrEP medicines."

Lenacapavir is being developed as a foundation for Gilead's future HIV therapies to offer several long-acting options that help address individual needs and preferences that may help optimize outcomes and reduce the burden of care.

Data from the CAPELLA trial support the FDA's Approval for Sunlenca.

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