Injectable HIV Treatment By ViiV Healthcare Outperforms Oral Therapy, Interim Data Shows

ViiV Healthcare, majority owned by GSK Plc GSK, with Pfizer Inc PFE and Shionogi Limited as shareholders, revealed data from a planned interim analysis of the LATITUDE phase 3 trial.

The data indicated that long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of ART adherence challenges.

Related Content: Pfizer/GSK-Backed ViiV Healthcare's HIV Drug Associated With Increased Resistance, WHO Report Says.

During the randomized phase of the study, 146 participants received monthly LA-ART, and 148 continued on SOC. 

The primary endpoint was a comparison of regimen failure, defined as a combination of virologic failures (VF) and regimen discontinuations between arms. 

24.1% of participants on LA-ART experienced regimen failure compared to 38.5% on SOC (difference -14.4).

Although the primary endpoint did not meet the strict predefined stopping criterion for the interim analysis, key secondary endpoints of virologic failure (7.2% LA-ART vs. 25.4% SOC (difference -18.2%) and treatment-related failure (9.6% LA-ART vs. 26.2% SOC (difference -16.6%) favored the LA-ART regimen. 

The study's Data Safety Monitoring Board (DSMB) considered the totality of all the study endpoints together and concluded that the evidence indicated superior efficacy of long-acting ART over daily oral standard of care. 

The rate of adverse events (AEs) was similar in both arms. Three participants in the LA-ART arm had serious injection site reactions (ISR), and one participant discontinued due to an ISR.

Two confirmed virologic failures in each arm had new resistance-associated mutations (RAMs), including at least two new integrase inhibitor RAMs in both LA-ART participants.

On Monday, ViiV Healthcare released findings from its phase I study that showed an investigational formulation of cabotegravir, known as cabotegravir ultra long-acting (CAB-ULA), can be dosed at intervals of at least four months. 

Price Action: PFE stock closed higher by 4.26% at $27.19 on Wednesday.

HIV/AIDS ribbon via Shutterstock