ViiV Healthcare, majority owned by GSK Plc (NYSE: GSK), with Pfizer Inc (NYSE: PFE) and Shionogi Limited as
shareholders, uncovered data from an interim analysis of the LATITUDE phase 3 trial.
Exceptional Efficacy of Long-Acting Injectable HIV Treatment
Evidence emerged that long-acting injectable antiretroviral treatment (ART), Cabenuva (cabotegravir + rilpivirine),
surpasses daily oral therapy in maintaining viral load suppression for individuals with adherence challenges.
Study Results and Comparative Analysis
During the trial, 146 participants received monthly LA-ART, while 148 remained on the standard of care (SOC). The
primary goal was to compare regimen failure between arms.
24.1% on LA-ART faced regimen failure, a notable drop from 38.5% on SOC (difference -14.4).
Although the primary endpoint did not meet the stringent predefined criteria, significant secondary endpoints
of virologic failure and treatment-related failure favored the LA-ART regimen.
The study’s Data Safety Monitoring Board (DSMB) confirmed the overall superior efficacy of long-acting ART over
daily oral standard care.
Safety Measures and Adverse Events
Adverse events were comparable in both treatment arms. Few participants in the LA-ART group reported serious
injection site reactions, resulting in one discontinuation.
Confirmed virologic failures with new resistance-associated mutations occurred in both arms.
Future Prospects with Investigational Formulation
ViiV Healthcare unveiled findings from a phase I study indicating that an investigational formulation of
cabotegravir, known as cabotegravir ultra long-acting (CAB-ULA), may be dosed every four months.
Market Reaction and Stock Movement
Pfizer stock surged by 4.26% to close at $27.19 following this groundbreaking update.
The promising data from ViiV Healthcare’s research unveils a new horizon in HIV treatment, marking a pivotal
shift towards more effective and accessible therapies for individuals facing adherence challenges.