ViiV Healthcare’s investigational four-monthly HIV drug maintains viral suppression at 12 months in a Phase IIb trial.
In the EMBRACE trial (NCT05996471), lotivibart, a broadly neutralising antibody, administered every four months combined with monthly intramuscular (IM) long-acting cabotegravir (CAB LA), maintained viral suppression in 94% of patients who received the drug intravenously (IV) and 82% subcutaneously (SC), compared with 88% in the standard of care (SOC) group.
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Confirmed virologic failure was 6% in the SC group, while the IV group was 4% – the same as those receiving a daily oral SOC.
The drug remained well tolerated at the 12-month mark, with higher-grade (Grade 3-4) infusion-site reactions reported in 16% of patients in the SC group, while none were reported in the IV group.
Dr Kimberly Smith, head of R&D 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.”
Results were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.
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By GlobalDataThese 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.
Earlier pipeline shows promise
ViiV, majority owned by GSK, with Pfizer and Shionogi as shareholders, also presented data from its earlier stage pipeline, including two twice-yearly HIV treatments, at CROI 2026.
In a Phase I study of long-acting formulations in adults without HIV, VH184 was given as a single SC or intramuscular (IM) injection in one of two formulations. Both formulations demonstrated long-acting properties, with one maintaining steady drug levels through month seven, indicating the potential for twice-yearly dosing.
VH184 also demonstrated an improved virology profile, specifically an enhanced resistance profile compared with bictegravir when evaluated against HIV with mutations linked to resistance to second-generation INSTIs.
ViiV is also investigating VH499, an HIV-1 capsid inhibitor, which has also shown potential for twice-yearly dosing. In an ongoing Phase I study in adults without HIV, VH499 was given as a single IM or SC injection between 100mg and 1200mg. Both injection routes maintained stable drug levels for a prolonged period, indicating that injectable VH499 has the potential for dosing intervals up to six months.
The company also touted data from its approved product Dovato (dolutegravir/lamivudine (DTG/3TC)), which showed lower cases of steatotic liver disease compared to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) after 96 weeks of treatment. Dovato was first approved by the US Food and Drug Administration (FDA) in April 2019.
While ViiV is a well-regarded company in HIV medication, Gilead is also a leader in the space, especially since the approval of its twice-yearly pre-exposure prophylaxis (PrEP) drug Yeztugo (lenacapavir). Data show that 99.9% of participants who received Yeztugo in the Phase III PURPOSE 1 and PURPOSE 2 trials remained HIV negative.
The HIV market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is forecast to grow at a compound annual growth rate (CAGR) of 1.9% from $26.5bn in 2023 to $32.1bn in 2033, forecasts GlobalData.
