GSK plc announced that ViiV Healthcare has reported positive 12-month interim results from its phase IIb EMBRACE study, highlighting the potential of an ultra long-acting HIV treatment regimen built around the broadly neutralising antibody lotivibart (N6LS).
The data, presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, showed that a combination of lotivibart administered every four months together with monthly intramuscular long-acting cabotegravir (CAB LA) maintained viral suppression in the majority of participants living with HIV who were already stable on therapy.
Among adults receiving intravenous (IV) lotivibart, 94% maintained viral suppression at 12 months. In the subcutaneous (SC) group, 82% remained virally suppressed. This compared with 88% of participants in the daily oral standard-of-care group. Confirmed virologic failure occurred in two participants (4%) in the IV arm and three participants (6%) in the SC arm, versus one participant (4%) receiving oral therapy.
The findings reinforce lotivibart’s potential as part of an ultra long-acting HIV regimen, with dosing intervals of every four months or longer. The study will now continue to evaluate an even more extended schedule, exploring twice-yearly IV dosing of lotivibart.
Kimberly Smith, Head of Research and Development at ViiV Healthcare, said the 12-month results strengthen evidence that lotivibart could play a key role in future long-acting HIV treatment strategies. She noted that the company remains focused on expanding therapeutic options that provide greater flexibility and choice for people living with HIV.
In terms of safety and tolerability, lotivibart was generally well tolerated across both administration methods. Adverse events related to the drug were reported in 24% of participants in the IV group, compared with 53% in the SC group. Higher-grade (grade 3–4) infusion-site reactions were observed in 16% of participants receiving subcutaneous dosing, while none were reported in the IV arm.
Patient-reported outcomes also indicated high levels of acceptability. Mean perception of injection scores covering injection-site reactions, physical impact, sleep and overall acceptability remained in the “very acceptable” to “totally acceptable” range throughout the 12-month period.
The interim results build on six-month data previously presented at CROI 2025, which first demonstrated that lotivibart combined with monthly CAB LA could effectively maintain undetectable viral loads in adults with HIV on stable regimens.
If longer-term studies confirm durability and safety, lotivibart could further extend ViiV Healthcare’s portfolio of long-acting HIV therapies, potentially reducing dosing frequency to as little as twice per year and reshaping the standard of care for maintenance treatment.