In the interim review of the Phase 3 LATITUDE study, performed by the Data Safety Monitoring Board (DSMB), the long-acting injectable HIV treatment Cabenuva showed superior efficacy in maintaining viral load suppression compared to daily oral therapy
Cabenuva packaging and product. (Credit: Business Wire)
GSK’s majority-owned HIV therapeutics unit ViiV Healthcare has announced positive results for its long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine), from an interim analysis of the Phase 3 LATITUDE clinical trial.
In the study, ViiV’s antiretroviral treatment (ART) showed superior efficacy in maintaining viral load suppression compared to daily oral therapy in people with ART adherence issues.
LATITUDE is an ongoing clinical trial across 31 sites in the US, implemented through ACTG.
ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) is an NIH-funded clinical trials network focused on HIV and other infectious diseases.
The participants with issues taking daily oral ART were screened to ensure the HIV in their blood was not resistant to the study drugs and that they met other health and safety criteria.
Upon enrolling, the participants were given adherence support while taking the three-drug regimen oral ART, including dolutegravir and bictegravir, to achieve viral suppression.
The participants were then randomised to receive either long-acting injectable ART (cabotegravir+rilpivirine) every four weeks or continue with oral ART.
The planned interim review of the Phased 3 LATITUDE study was performed by the Data Safety Monitoring Board (DSMB), last week.
DSMB considered the totality of all the study endpoints and concluded that the evidence indicated superior efficacy of long-acting ART over the daily oral standard of care.
Also, the board recommended that all eligible participants should be offered long-acting injectable cabotegravir + rilpivirine.
ViiV Healthcare R&D head Kimberly Smith said: “The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome.
“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.
“Optimising therapy for all people living with HIV, including those with adherence challenges, is critical to the effort to end the HIV epidemic.”
The LATITUDE study is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
ACTG is conducting the study with support from the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare and Janssen.