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lotivibart.m4a

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Lotivibart
Other Names
LVB; VH3810109; N6LS; GSK3810109A; VRC-HIVMAB091-00-AB; GSK3810109 and N6 (parent bNAb)
Drug Class
Broadly Neutralizing Antibodies
Registry Number
2851892-98-1 (CAS)
Organization:
ViiV Healthcare
Phase of Development

Lotivibart is in Phase 2b development as a broadly neutralizing antibody for HIV treatment.

(Compound details obtained from PubChem,1 Treatment Action Group Pipeline Report 2025,2 and ViiV Healthcare website3)

What is lotivibart? What is lotivibart?

What is lotivibart?

Lotivibart is an investigational drug that is being studied as a possible strategy to treat people with HIV. Lotivibart belongs to a group of HIV drugs called broadly neutralizing antibodies (bNAbs).2,4

To learn how investigational drugs are tested during clinical trials, read the HIVinfo What is an investigational HIV Drug? and HIV and AIDS Clinical Trials fact sheets.

How do broadly neutralizing antibodies work? How do broadly neutralizing antibodies work?

How do broadly neutralizing antibodies work?

Antibodies are proteins that the immune system makes to fight infection. A person with HIV produces specific antibodies against HIV. However, most of these antibodies do not stop HIV from multiplying in the body.5,6

Some people with HIV naturally produce rare types of HIV antibodies called broadly neutralizing antibodies (bNAbs). bNAbs are powerful antibodies that can work against different HIV strains. bNAbs can block HIV from entering healthy cells and activate other immune cells to help destroy infected cells.6–8

Researchers are investigating whether giving bNAbs to people with HIV can help them maintain undetectable levels of HIV without the need for daily antiretroviral therapy. Additionally, some bNAbs are being studied because they may be able to reduce the size of the latent HIV reservoir.7,8

Select clinical trials of lotivibart Select clinical trials of lotivibart

Select clinical trials of lotivibart

Study Names: BANNER Study; NCT04871113

Phase: 2a
Status: This study has been completed.
Locations: United States, Argentina, Brazil, Canada, Mexico, and Peru
Purpose: The purpose of this trial was to see whether a single intravenous or subcutaneous infusion of lotivibart given at various dose levels is safe and tolerable in adults who have never received HIV medicines before. Researchers also looked at how well lotivibart works to reduce viral load in the body.9
Selected Study Results: Results were presented at the European AIDS Clinical Society conference (EACS 2023) and the Conference on Retroviruses and Opportunistic Infections (CROI 2024) and published in the J Infect Dis (2025). Researchers found that a single intravenous or subcutaneous infusion of lotivibart could substantially reduce viral load levels in participants. Lotivibart given intravenously worked better to reduce viral load levels than lotivibart given subcutaneously. Lotivibart was safe and well tolerated by participants.10–12
Additional Published Material:

Study Names: EMBRACE; NCT05996471

Phase: 2b
Status: This study is ongoing, but not recruiting participants.
Locations: United States and Puerto Rico
Purpose: The purpose of this study is to look at whether intravenous or subcutaneous lotivibart given with long-acting cabotegravir is safe and can maintain control of viral load levels in adults with viral suppression.13
Selected Study Results: Results were presented at CROI 2025 and showed that lotivibart given with long-acting cabotegravir worked to maintain control of viral load levels in most of the participants. Intravenous lotivibart worked just as well as standard oral antiretroviral therapy in controlling viral load and was more easy to tolerate than subcutaneous lotivibart.14
Additional Published Material:


For more details on the studies listed above, see the Health Professional version of this drug summary.

Additional studies evaluating lotivibart for HIV treatment have also been completed or are currently being conducted, including the following Phase 1 trials:

  • SPAN (NCT05291520) was a study that evaluated intravenous and subcutaneous lotivibart in healthy adults without HIV. Investigators looked at how the body handles lotivibart and whether lotivibart is safe and tolerable. This study has been completed, and results are available from CROI 2024 and Antimicrob Agents Chemother (2025).15
  • VRC 609 (NCT03538626) was a study that looked at how the body handles intravenous and subcutaneous lotivibart and whether these forms of lotivibart are safe in healthy adults without HIV. This study has been completed, and results are available from CROI 2023 and Lancet HIV (2025).16
  • ENTRANCE (NCT07053384) is a study looking at the use of lotivibart with or without fostemsavir in adults with HIV. All participants are also receiving a standard antiretroviral therapy regimen. Researchers are looking at whether this combination of medicines can reduce the size and activity of the HIV reservoir. This study is ongoing, but not recruiting participants.17

What side effects might lotivibart cause? What side effects might lotivibart cause?

What side effects might lotivibart cause?

One goal of HIV research is to identify safe new drugs that have fewer side effects. The following side effects were observed in some of the studies of lotivibart listed above.

BANNER (NCT04871113)

In the BANNER study, 62 participants received a single intravenous or subcutaneous infusion of lotivibart. Thirteen participants had mild or moderate side effects related to lotivibart. The most common drug-related side effects included headache, abdominal pain, and pain at the infusion site. Seven participants had mild reactions at the infusion site that lasted a maximum of 10 days. There were no severe side effects related to lotivibart, and none of the participants withdrew from the study because of a side effect.12

EMBRACE (NCT05996471)

In the EMBRACE study, 50 participants received intravenous lotivibart plus long-acting cabotegravir and 49 participants received subcutaneous lotivibart plus long-acting cabotegravir. Results through Month 12 of the study showed that 12 participants in the intravenous lotivibart group and 26 participants in the subcutaneous lotivibart group had side effects related to lotivibart treatment. Most of the lotivibart-related side effects were mild or moderate. Three participants withdrew from the study because of drug-related side effects—two participants withdrew due to cabotegravir-related injection site reactions, and one participant withdrew due to lotivibart/cabotegravir-related anxiety and depression.13,18,19

Infusion site reactions were more common with subcutaneous lotivibart than intravenous lotivibart. Eight participants had severe infusion site reactions after receiving subcutaneous lotivibart. With intravenous lotivibart, all infusion site reactions were mild and lasted two days at most.18,19

Because lotivibart is still being studied, information on possible side effects of the drug is not complete. As testing of lotivibart continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying lotivibart? Where can I get more information about clinical trials studying lotivibart?

Where can I get more information about clinical trials studying lotivibart?

More information about lotivibart-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in clinical trials is right for you. For more information, visit NIH Clinical Research Trials and You.

References References

References

  1. National Center for Biotechnology Information. PubChem substance record for SID 507427715, lotivibart, Source: FDA Global Substance Registration System (GSRS). Accessed August 4, 2026
  2. Jefferys R. The antiretroviral therapy pipeline 2025. Treatment Action Group Pipeline Report 2025. Accessed August 4, 2026
  3. ViiV Healthcare website. HIV medicines in development. Accessed August 4, 2026
  4. Treatment Action Group website. Research toward a cure trials. Accessed August 4, 2026
  5. Snow B. The rise of broadly neutralizing antibodies. AIDS Vaccine Advocacy Coalition (AVAC). Published May 17, 2018. Accessed August 4, 2026
  6. HIV Vaccine Trials Network (HVTN). Using antibodies for HIV prevention. Accessed August 4, 2026
  7. National Institute of Allergy and Infectious Diseases (NIAID). Sustained ART-free HIV remission. Accessed August 4, 2026
  8. National Institute of Allergy and Infectious Diseases (NIAID). Future directions for HIV treatment research. Accessed August 4, 2026
  9. ViiV Healthcare. A Phase 2a multicentre, randomized, open-label, two-part adaptive design study to evaluate the antiviral effect, safety and tolerability of GSK3810109A, an HIV-1 specific broadly neutralizing human monoclonal antibody in antiretroviral-naïve HIV-1-infected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 28, 2021. NLM Identifier: NCT04871113. Accessed August 4, 2026
  10. Edwards AY, Ashraf W, Zweers T, et al. Pharmacokinetics/pharmacodynamics and virological activity of VH3810109 (N6LS) in antiretroviral-naive viremic adults from the Phase 2a BANNER study. European AIDS Conference; October 18-21, 2023; Warsaw, Poland. Conference reports for National AIDS Treatment Advocacy Project (NATAP); 2023. Accessed August 4, 2026
  11. Leone P, Ferro A, Lupo S, et al. VH3810109 (N6LS) in antiretroviral therapy-naive adults with HIV-1: Phase 2a BANNER efficacy data. Conference on Retroviruses and Opportunistic Infections; March 3-6, 2024; Denver, CO. Conference reports for National AIDS Treatment Advocacy Project (NATAP); 2024. Accessed August 4, 2026
  12. Leone PA, Ferro A, Rolle CP, et al. VH3810109 efficacy, safety, pharmacokinetics, and incidence of antidrug antibodies in adults with HIV-1 naive to antiretroviral therapy: BANNER study results. J Infect Dis. 2025;232(6):e1022-e1032. doi:10.1093/infdis/jiaf450. Accessed August 4, 2026
  13. ViiV Healthcare. A Phase 2b multicenter, randomized, open-label study comparing the efficacy, safety, PK, and tolerability of VH3810109, administered either intravenously or as a subcutaneous infusion with rHuPH20, in combination with CAB LA to standard of care in virologically suppressed adults living with HIV. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 9, 2023. NLM Identifier: NCT05996471. Accessed August 4, 2026
  14. Taiwo B, Leone P, Gartland M, et al. VH3810109 (N6LS) efficacy and safety in adults who are virologically suppressed: the EMBRACE study. Conference on Retroviruses and Opportunistic Infections (CROI); March 9-12, 2025; San Francisco, CA. Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2025. Accessed August 4, 2026
  15. ViiV Healthcare. A Phase 1, open-label, single-dose study of the safety and pharmacokinetics of a human monoclonal antibody, GSK3810109, administered either subcutaneously or intravenously with recombinant human hyaluronidase PH20 (rHuPH20) to healthy adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 16, 2022. NLM Identifier: NCT05291520. Accessed August 4, 2026
  16. National Institute of Allergy and Infectious Diseases (NIAID). VRC 609: A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of a human monoclonal antibody, VRC-HIVMAB091-00-AB (N6LS), administered intravenously or subcutaneously with or without recombinant human hyaluronidase PH20 (rHuPH20) to healthy adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 24, 2018. NLM Identifier: NCT03538626. Accessed August 4, 2026
  17. ViiV Healthcare. An exploratory Phase 1b, multicenter, randomized, open-label study to investigate the impact of the administration of intravenous VH3810109 with or without oral fostemsavir in combination with integrase inhibitor-based antiretroviral therapy on the viral reservoir in adults living with HIV-1. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 26, 2025. NLM Identifier: NCT07053384. Accessed August 4, 2026
  18. Rolle C-P, Luetkemeyer AF, Bettacchi C, et al. Maintenance of HIV suppression at 12 months with VH3810109 (N6LS) Q4M + CAB LA QM: the EMBRACE study. Webcast presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2026; Denver, CO. Accessed August 4, 2026
  19. Rolle C-P, Luetkemeyer AF, Bettacchi C, et al. Maintenance of HIV suppression at 12 months with VH3810109 (N6LS) Q4M + CAB LA QM: the EMBRACE study. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2026; Denver, CO. Abstract 178. Accessed August 4, 2026

Last Reviewed: August 4, 2026