ViiV Healthcare and GSK’s Cabenuva in a Phase III study showed superior efficacy versus daily oral antiretroviral treatment in HIV patients with a history of difficulties in taking daily pills.
Pictured: GSK’s headquarters in Poznan, Poland/iStock, Wirestock
HIV-focused biotech ViiV Healthcare, which is majority owned by GSK, on Wednesday posted interim findings from the Phase III LATITUDE trial demonstrating that its long-acting injectable HIV drug Cabenuva (cabotegravir plus rilpivirine) is better than oral daily antiretroviral treatment in patients who have trouble sticking to their medication schedule.
The companies did not reveal specific data in their announcement but said that a Data Safety Monitoring Board (DSMB) reviewed LATITUDE’s data last week and found that “the evidence indicated superior efficacy of long-acting [antiretroviral treatment] over daily oral standard of care.”
The DSMB also recommended that eligible participants should be offered Cabenuva, according to the announcement.
“There are many reasons why people may find it challenging to stay on daily oral treatment and the LATITUDE study shows cabotegravir and rilpivirine injectable treatment can help them keep their virus suppressed, which benefits their overall health,” ViiV R&D head Kimberly Smith said in a statement.
Sponsored by the National Institute of Allergy and Infectious Diseases, LATITUDE is a randomized, open-label, parallel-assignment study enrolling 350 people living with HIV who have a history of suboptimal treatment adherence and showed evidence of viremia. Patients were screened to make sure that their infection was not resistant to the study drugs.
Once enrolled, patients were first guided through a three-drug oral antiretroviral treatment (ART) regimen until viral suppression. Patients were then randomly assigned to receive the long-acting injectable Cabenuva or to continue with daily oral ART. LATITUDE’s primary outcome measure is regimen failure, while key secondary endpoints include virologic failure and treatment-related failure.
GSK and ViiV’s Cabenuva is a combination of two anti-HIV agents: the integrase strand transfer inhibitor cabotegavir, which was developed by ViiV, and the non-nucleoside reverse transcriptase inhibitor rilpivirine, which was developed by J&J’s Janssen. Cabotegavir works by blocking HIV DNA replication, while rilpivirine stops the virus from multiplying.
Cabenuva first won the FDA’s approval in January 2021 as a monthly injection for HIV-1. In February 2022, the regulator allowed Cabenuva’s dosing to be cut in half, approving its use once every two months. Then, in March 2022, the FDA expanded Cabenuva’s label, making an oral lead-in period optional.
In February 2023, ViiV and GSK unveiled positive 12-month data from the Phase IIIb SOLAR study, which put Cabenuva up against Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in HIV-1. The head-to-head study found that the bimonthly injectable schedule was non-inferior to the daily oral regimen and was preferable to 90% of the participants who switched treatment arms.
LATITUDE is ongoing and is being conducted across 31 sites in the U.S. It is led by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, a global clinical trials network funded by the National Institutes of Health. LATITUDE is also being supported by ViiV and J&J’s Janssen.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
