Breakthrough HIV study reveals ultra-long-acting treatment with near-perfect suppression rates
Breakthrough HIV study reveals ultra-long-acting treatment with near-perfect suppression rates
Breakthrough HIV study reveals ultra-long-acting treatment with near-perfect suppression rates
ViiV Healthcare has released positive 12-month results from its phase IIb EMBRACE study of lotivibart, an ultra-long-acting HIV treatment. The data show strong efficacy and tolerability when combined with long-acting cabotegravir. Researchers now plan to test a twice-yearly intravenous (IV) dosing schedule for the drug.
The findings follow earlier six-month results presented at CROI 2025 and support further development of the treatment.
In the study, participants received lotivibart either intravenously every four months or subcutaneously (SC), alongside monthly intramuscular injections of long-acting cabotegravir. After 12 months, 94% of those in the IV group maintained viral suppression, compared with 82% in the SC group and 88% in the standard-of-care group.
Adverse events were less frequent in the IV group, with 24% reporting issues versus 53% in the SC group. Serious infusion-site reactions (grade 3-4) affected 16% of the SC group, while none occurred in the IV group. Overall, lotivibart was well tolerated, with high acceptability scores in both groups.
Virologic failure rates remained low, affecting 4% of the IV group and 6% of the SC group. Based on these results, ViiV Healthcare will now assess a twice-yearly IV dosing regimen for lotivibart.
The company also plans to advance lotivibart in combination with long-acting cabotegravir (Cabenuva) as a twice-yearly therapy. Phase III trials (potentially named LVDiV-1/2) are expected to begin in 2025, with a regulatory submission (BLA/MAA) targeted for 2028. If approved, the treatment could reach the market by 2029.
The EMBRACE study demonstrates that lotivibart, when combined with cabotegravir, maintains high rates of viral suppression with fewer side effects in the IV group. The next phase will test a twice-yearly IV dosing schedule, potentially simplifying HIV treatment further. ViiV Healthcare aims to submit the therapy for approval by 2028, with a possible launch the following year.