ViiV's lotivibart-cabotegravir combo returns to AIDS 2026 with patient-experience data
The poster follows a 12-month interim readout that already put viral suppression on record, making this AIDS 2026 update a second look at how patients tolerate switching to the long-acting regimen, not a fresh efficacy verdict.
Executive Summary
- ViiV Healthcare will present a poster on patient experience switching to its long-acting cabotegravir-lotivibart combination at the AIDS 2026 conference, building on efficacy data already disclosed earlier in the year from this Phase 2 trial.
- The regimen has already shown it can maintain viral suppression comparably to standard oral therapy, so the open question this trial still has to settle is tolerability, specifically how the subcutaneous and intravenous delivery routes compare on patient-reported experience and injection-site reactions.
- The trial sits in a target-indication pairing with essentially no other active Phase 2 competitor, which reflects a sparse, not crowded, field around this specific neutralizing-antibody-plus-integrase-inhibitor mechanism in HIV treatment switching.
- Enrollment reached its target of 185 participants with the trial now active and not recruiting, and its primary completion date has moved forward from an original 2024 target after a design change; the trial is proceeding as a multi-part study rather than showing distress.
The catalyst
ViiV Healthcare plans to present a poster titled around participant experience with switching to cabotegravir long-acting (CAB LA) and lotivibart, an investigational HIV-1 neutralizing antibody also known as N6LS or VH3810109, at AIDS 2026 in Rio de Janeiro on July 29. The poster draws on EMBRACE, a Phase 2 trial registered as NCT05996471 that is testing whether switching stable, virologically suppressed adults from daily oral antiretroviral therapy to an every-few-months injectable regimen holds viral suppression. The trial enrolled 185 adults across United States and Puerto Rico sites and is randomized and open-label, running eight arms comparing intravenous and subcutaneous lotivibart doses paired with cabotegravir against standard-of-care oral therapy. ViiV+1ViiV Healthcare to present phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults; alongside INSTI-powered long-acting injectable innovation at AIDS 2026Jul 21, 2026A 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)NCT05996471
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial has already shown
ViiV disclosed a 12-month interim readout from EMBRACE at CROI 2026 on February 25, showing lotivibart plus cabotegravir long-acting maintained viral suppression, defined as HIV-1 RNA below 50 copies per milliliter, in 94% of participants on the intravenous dose and 82% on the subcutaneous dose, versus 88% on daily oral standard of care. Tolerability was described as consistent with the drugs' known profiles, though the subcutaneous arm carried higher related adverse events and Grade 3-4 injection-site reactions than the intravenous arm. An earlier six-month readout at CROI 2025 had shown suppression of 96% (intravenous lotivibart), 88% (subcutaneous lotivibart), and 96% (standard of care). The AIDS 2026 poster extends that evidence base into participant-reported experience with the switch, rather than introducing a new efficacy endpoint. ViiVViiV Healthcare to present phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults; alongside INSTI-powered long-acting injectable innovation at AIDS 2026Jul 21, 2026
The trial's design and completion path
EMBRACE's primary endpoint measures the number of participants with plasma HIV-1 RNA at or above 50 copies per milliliter at month 6, assessed by the FDA Snapshot algorithm, across the trial's three parts. Enrollment grew from an original 150-participant target to 185 over the trial's life, with the primary completion date moving several times before settling at May 22, 2026, most recently confirmed in a March 2026 registry update. The trial's operational-risk model, which is a registry-churn proxy rather than a scientific-instability judgment, flags multiple protocol edits, but the enrollment growth itself falls within the routine band the model uses to flag cuts against target, and the trial's overall completion path, from enrollment to primary completion this spring to conference readouts now, has tracked without slipping the presentation calendar. NCT05996471A 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)NCT05996471
Where this sits in the field
EMBRACE is the only Phase 2 trial in the HIV-1 Integrase by Human Immunodeficiency Virus target-indication pairing that ViiV's own competitive landscape identifies, with the field's broader activity in this integrase target declining relative to prior years. Cabotegravir itself is an approved integrase inhibitor, marketed by ViiV as part of Cabenuva for HIV-1 treatment and as Apretude for HIV pre-exposure prophylaxis; lotivibart, the neutralizing antibody component, remains investigational. The nearest modality precedent is AbbVie's budigalimab, a monoclonal antibody tested in a separate Phase 2 HIV trial, though it targets PD-1 rather than the integrase-antibody combination EMBRACE is built around, making it a modality neighbor rather than a direct comparator. NCT05996471A 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)NCT05996471
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.