ViiV Healthcare reports positive 12-month data showing investigational bNab lotivibart maintains high levels of viral suppression in long-acting HIV treatment

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.

At the 12‑month interim analysis, lotivibart combined with CAB LA maintained viral suppression in a high proportion of adults living with HIV on stable therapy, with confirmed virologic failure observed in two participants (4%; n=2/50) from the IV group and three participants (6%; n=3/49) in the SC group, compared to one (4%; n=1/26) receiving a daily oral standard of care.

Lotivibart was generally well tolerated, with participants in both groups reporting high acceptability through month 12. Mean perception of injection (PIN) scores for “bother of ISRs,” “physical impact,” “sleep” and “acceptability” remained “very acceptable” to “totally acceptable” throughout the study in both groups. Adverse events related to lotivibart were less common in the IV group (24%; n=12/50) compared with the SC group (53%; n=26/49). Higher grade (grade 3-4) infusion-site reactions were reported in 16% (n=8/49) of participants in the SC group, while none were reported in the IV group.

These findings build on the six-month EMBRACE data presented at CROI 2025, which first showed that lotivibart, administered every four months in combination with monthly CAB LA, effectively maintained an undetectable viral load in adults living with HIV on stable therapy.