ViiV’s Lotivibart Hits 94% HIV Control at 12 Months EMBRACE Data

ViiV Healthcare, a specialist in HIV treatments and majority-owned by GSK (with Pfizer and Shionogi as shareholders), shared promising 12-month data from the phase IIb EMBRACE study (NCT05996471) at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.

The study tested lotivibart (N6LS), a broadly neutralizing antibody (bNAb) designed to target HIV broadly, combined with monthly intramuscular (IM) long-acting cabotegravir (CAB LA a next-generation integrase inhibitor already approved for HIV prevention and treatment).

This regimen was given to adults with HIV who were already virally suppressed on stable therapy, aiming to reduce dosing frequency from daily pills to ultra long-acting injections every four months or more.

The results were strong: 94% of participants receiving intravenous (IV) lotivibart every four months plus monthly CAB LA maintained viral suppression (HIV RNA <50 copies/mL), compared to 82% in the subcutaneous lotivibart group and 88% in the daily oral standard-of-care group.

Confirmed virologic failure meaning detectable virus rebound was low across arms 4% (2/50) in IV, 6% (3/49) in SC, and 4% (1/26) in standard care. These outcomes build on six-month data from CROI 2025, reinforcing lotivibart’s potential for twice-yearly IV dosing in the ongoing trial.

Safety and tolerability were also favorable. Lotivibart was generally well-tolerated, with high participant acceptability scores (mean Perception of Injection scores rated “very acceptable” to “totally acceptable” for injection-site reactions (ISRs), physical impact, sleep, and overall use).

Adverse events linked to lotivibart occurred in 24% of the IV group versus 53% in the SC group. Notably, no grade 3-4 (severe) infusion-site reactions happened in the IV arm, while 16% (8/49) in the SC arm reported them highlighting IV as a potentially smoother option.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV, emphasized that “These positive 12-month data from EMBRACE strengthen the evidence that lotivibart has the potential to be a part of an ultra-long-acting HIV treatment regimen and support our efforts to evaluate lotivibart in a twice-yearly dosing interval. These results build on our legacy of developing innovative long-acting options for HIV treatment that offer greater choice for people living with HIV.”

This advances ViiV’s pipeline of long-acting HIV therapies, like CAB LA, addressing adherence challenges where daily oral pills see real-world discontinuation rates of 20-50% within 6-24 months. If validated in later trials, lotivibart + CAB LA could transform maintenance therapy for the 40.8 million people living with HIV globally.

Reference

ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen, 25 February 2026, ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen | GSK

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) (EMBRACE), ClinicalTrials.gov ID NCT05996471, https://clinicaltrials.gov/study/NCT05996471

HIV, The Global Health Observatory, World Health Organization, https://www.who.int/data/gho/data/themes/hiv-aids

Global HIV & AIDS statistics — Fact sheet, UNAIDS, https://www.unaids.org/en/resources/fact-sheet