ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen

Key Terms

broadly neutralising antibody medical

A broadly neutralising antibody is a laboratory-identified immune protein that can block infection by many different strains or variants of a virus because it targets parts of the virus that stay the same across versions — like a master key that fits many locks. For investors, these antibodies signal higher commercial potential and longer-lasting therapies or prevention, reducing the need for frequent reformulation and increasing chances of regulatory approval, partnerships, and durable revenue.

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subcutaneously medical

Given or delivered beneath the skin into the fatty layer just under the surface, usually by injection or a small device. For investors, whether a medicine is given subcutaneously affects how easy it is for patients to use, how often doses are needed, and the cost and complexity of manufacturing and regulation—think of it like placing a slow-release patch under a carpet instead of pouring medicine on top of it, which changes convenience and ongoing demand.

intramuscular medical

A way of giving a medicine or vaccine by injecting it deep into a muscle, typically using a syringe and needle so the drug is absorbed into the bloodstream more steadily than a skin shot but faster than swallowing a pill. Investors care because this delivery method affects how quickly and reliably a treatment works, the type of manufacturing and packaging needed, clinical trial design and regulatory requirements, and patient or provider preferences that influence market uptake.

injection-site reactions medical

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phase IIb medical

Phase IIb is a mid-stage clinical trial that tests whether an experimental treatment works and what dose is best by studying it in a larger group of patients than early tests. For investors, Phase IIb results are important because they substantially reduce uncertainty about a drug’s effectiveness and safety, and positive or negative outcomes often drive company valuation, partnership interest, and the likelihood of advancing to the large, costly Phase III trials.

long-acting medical

A long-acting product is a drug or treatment designed to work for an extended period after a single dose, reducing how often it must be taken or administered. For investors, longer-lasting therapies can increase patient convenience and adherence, lower treatment costs over time, and create competitive advantages or pricing power—similar to a single charge lasting days instead of hours—potentially boosting market demand and revenue predictability.

• 94% of adults on stable therapy maintained viral suppression with intravenous lotivibart dosed every four months in combination with long-acting cabotegravir
• These phase IIb results reinforce lotivibart’s ultra long-acting potential, with the trial progressing to evaluate a twice-yearly intravenous dosing interval

LONDON--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced positive 12-month interim efficacy and tolerability data from the phase IIb EMBRACE study.¹ In adults living with HIV on stable therapy, a regimen of lotivibart (N6LS), a broadly neutralising antibody, administered every four months combined with monthly intramuscular (IM) long-acting cabotegravir (CAB LA), maintained viral suppression in 94% of participants receiving lotivibart intravenously (IV) and 82% subcutaneously (SC), compared with 88% in the standard of care group.

These favourable data reinforce lotivibart’s ultra long-acting potential (dosing every four months or longer) and support the progression of the study, which will evaluate a twice-yearly IV dosing interval for lotivibart.

Results were presented today at the 33^rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.

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.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q4 Results for 2025.

Registered in England & Wales:
GSK plc		ViiV Healthcare Limited
No. 3888792		No. 06876960
Registered Office:
79 New Oxford Street		ViiV Healthcare Limited
London		GSK Medicines Research Centre
WC1A 1DG		Gunnels Wood Road, Stevenage
		United Kingdom
		SG1 2NY

*On 20 January 2026, GSK plc and Shionogi & Co., Ltd announced that they have reached agreement together with Pfizer Inc. for the economic interest in ViiV Healthcare Limited currently held by Pfizer to be replaced with an investment by Shionogi. Completion of the transaction is subject to certain regulatory clearances in relevant markets, and is expected to occur during the first quarter of 2026.

References

¹ CP. Rolle et al. Maintenance of HIV Suppression at 12 Months With VH3810109 (N6LS) Q4M + CAB LA QM: The EMBRACE Study. Presented at the 33^rd Conference on Retroviruses and Opportunistic Infections (CROI). February 2026.

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Source: ViiV Healthcare