ViiV’s Lotivibart Shows Strong 12-Month HIV Viral Suppression In EMBRACE Phase IIb Study

GSK plc announced that ViiV Healthcare, the global HIV-focused company majority owned by GSK alongside Pfizer Inc. and Shionogi & Co., Ltd., reported positive 12-month interim results from the Phase IIb EMBRACE study. The trial evaluated lotivibart (N6LS), a broadly neutralising antibody, administered every four months in combination with monthly intramuscular long-acting cabotegravir (CAB LA) in adults living with HIV who were already on stable therapy.

At the 12-month interim analysis, viral suppression was maintained in 94% of participants receiving intravenous (IV) lotivibart and 82% of those receiving subcutaneous (SC) administration, compared with 88% in the daily oral standard-of-care group. Confirmed virologic failure occurred in two participants (4%) in the IV arm, three (6%) in the SC arm, and one (4%) in the oral therapy group.

Lotivibart demonstrated a generally favorable tolerability profile, with high acceptability reported across both treatment groups. Adverse events related to lotivibart were less frequent in the IV group (24%) than in the SC group (53%). Grade 3–4 infusion-site reactions were observed in 16% of participants in the SC arm, while none were reported in the IV arm. Patient-reported perception of injection scores remained in the “very acceptable” to “totally acceptable” range through month 12.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “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.” 

The results, presented at the Conference on Retroviruses and Opportunistic Infections in Denver, build on six-month EMBRACE data shared at CROI 2025. The findings further support lotivibart’s ultra long-acting potential, with the ongoing study set to evaluate a twice-yearly IV dosing schedule.