ViiV's Cabenuva enhances control of unsuppressed HIV

ViiV Healthcare's long-acting injectable HIV treatment, Cabenuva, has proved to be more effective than daily oral therapy for people in whom the virus is unsuppressed despite antiretroviral therapy (ART).

In the phase 3b CROWN trial, Cabenuva (cabotegravir and rilpivirine) administered by injection every two months achieved superior rates of viral suppression at six months compared with standard oral ART in adult and adolescent HIV patients who had detectable levels of the virus at enrolment.

ViiV, majority-owned by GSK with Shionogi as a shareholder, said the result builds on the LATITUDE study of Cabenuva in people struggling to adhere to oral ART, which found that a monthly dose of the long-acting injectable was better at suppressing viral load.

Cabenuva is already approved as an alternative to oral ART in people living with HIV whose virus levels are under control, and GSK said that it intends to file for approval for the drug in the unsuppressed population on the strength of the clinical data.

The only exception would be patients who have proven resistance to integrase inhibitors or non-nucleoside reverse transcriptase inhibitors, the two classes represented in Cabenuva.

It has been estimated that around one-third of people living with HIV in the US struggle with maintaining viral suppression, for any reason.

It is worth noting that Cabenuva is already being used off-label in some unsuppressed patients after being added to HHS treatment guidelines for select groups, such as those who struggle to adhere to daily oral ART despite extensive efforts.

Extending Cabenuva's label to include that group could help ViiV's drug encroach on territory held by Gilead Sciences' twice-yearly injectable Sunlenca (lenacapavir), which is approved for adults with multidrug-resistant (MDR) HIV where treatment failure is due to resistance, intolerance, or safety considerations, on the strength of the phase 2/3 CAPELLA trial.

"People living with HIV who experience challenges achieving or maintaining viral suppression with daily oral therapy continue to face significant barriers to optimising care. The CROWN study was designed to address this important evidence gap," said ViiV's chief medical officer, Jean van Wyk.

"These findings add to the growing body of data around long-acting treatment with cabotegravir plus rilpivirine, and provide important insights into the potential role of this approach for treatment-experienced people living with HIV," he added.

Cabenuva is an important product for ViiV, growing 42% to $1.85 billion last year, while Sunlenca currently remains a niche product for highly treatment-experienced patients with MDR HIV and made $54 million in 2025.

Last year, Gilead launched another twice-yearly lenacapavir product, Yeztugo/Yeytuo, which is approved for HIV pre-exposure prophylaxis (PrEP) and is predicted to top $1 billion in sales this year.