ViiV Healthcare, the global specialist HIV company majority owned by GSK with Pfizer and Shionogi as shareholders, announced positive 12-month interim efficacy and tolerability data from the phase 2b EMBRACE study. In adults living with HIV on stable therapy, a regimen of lotivibart (N6LS), a broadly neutralising antibody, administered intravenously every four months combined with monthly intramuscular long-acting cabotegravir (CAB LA), maintained viral suppression in 94% of participants. Subcutaneous administration achieved 82%, compared with 88% in the standard of care group.

These results reinforce lotivibart’s ultra long-acting potential, supporting study progression to evaluate a twice-yearly IV dosing interval. The findings were presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.

Kimberly Smith, 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.”

At the 12‑month interim analysis, confirmed virologic failure was observed in two participants (4%; n=2/50) from the IV group and three participants (6%; n=3/49) in the SC group, compared with one (4%; n=1/26) receiving daily oral standard of care. Lotivibart was generally well tolerated, with mean perception of injection (PIN) scores for “bother of ISRs,” “physical impact,” “sleep” and “acceptability” remaining “very acceptable” to “totally acceptable” through month 12. Adverse events related to lotivibart were less common in the IV group (24%; n=12/50) than the SC group (53%; n=26/49), with higher grade (3-4) infusion-site reactions reported in 16% (n=8/49) of SC participants, while none occurred in the IV group.

The 12-month data build on six-month EMBRACE results presented at CROI 2025, which first showed that lotivibart combined with CAB LA effectively maintained an undetectable viral load in adults on stable therapy. The regimen’s ultra long-acting profile could offer patients more convenient dosing intervals, potentially improving adherence and long-term viral suppression.