Drug information

Audio
Download files:
VH3810109.mp3
Pronounce:
VH3810109
Other Names
N6LS; GSK3810109A; VRC-HIVMAB091-00-AB; GSK3810109 and N6 (parent bNAb)
Drug Class
Broadly Neutralizing Antibodies
Organization:
ViiV Healthcare; National Institute of Allergy and Infectious Diseases (NIAID); GlaxoSmithKline
Phase of Development

VH3810109 is in Phase 2b development as a broadly neutralizing antibody for HIV treatment. (VH3810109 has also been studied for HIV prevention.)

(Compound details obtained from Treatment Action Group Pipeline Report 2024,1 ViiV Healthcare press release,2 and Treatment Action Group Pipeline Report 20223)

What is VH3810109? What is VH3810109?

What is VH3810109?

VH3810109 is an investigational drug that is being studied as a possible strategy to treat people with HIV. VH3810109 belongs to a group of HIV drugs called broadly neutralizing antibodies (bNAbs).1,4

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

Researchers have also studied VH3810109 for HIV prevention.3 This record focuses on the study of VH3810109 as a treatment for HIV.

Select clinical trials of VH3810109 Select clinical trials of VH3810109

Select clinical trials of VH3810109

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 evaluate the antiviral activity, safety, and tolerability of a single intravenous or subcutaneous infusion of VH3810109 administered at various dose levels in treatment-naive adults.9
Selected Study Results: Results presented at EACS 2023 and CROI 2024 showed that monotherapy with a single intravenous or subcutaneous infusion of VH3810109 was capable of producing a substantial reduction in viral load levels from baseline in treatment-naive participants. The antiviral response was dependent on the dose of VH3810109. Subcutaneous dosing led to lower drug exposure and lower antiviral response compared to intravenous dosing. Infusions of VH3810109 were safe and well tolerated.10,11
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 evaluate the safety and efficacy of VH3810109, given either intravenously or subcutaneously with recombinant human hyaluronidase PH20 (rHuPH20), in combination with intramuscular long-acting cabotegravir. (rHuPH20 is a manufactured enzyme that helps injected drugs get distributed and absorbed in the body.) Experimental interventions will be compared to standard-of-care antiretroviral therapy (ART).12
Selected Study Results: Results presented at CROI 2025 indicated that VH3810109 given either intravenously or subcutaneously with rHuPH20 every 4 months, in combination with monthly long-acting cabotegravir, was effective in controlling viral load levels in most of the participants. The proportion of participants maintaining viral suppression through Month 6 was 96% in the intravenous VH3810109 group and 88% in the subcutaneous VH3810109 plus rHuPH20 group. In comparison, 96% of participants in the oral standard-of-care group maintained viral suppression through Month 6. Study investigators noted that based on results, intravenous VH3810109 administered every 6 months, in combination with long-acting cabotegravir, was selected for further evaluation in the second part of the EMBRACE study.13


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

Additional studies of VH3810109 have also been conducted, including the following Phase 1 trials:

  • SPAN (NCT05291520): A study that evaluated the safety, tolerability, and pharmacokinetics of VH3810109 plus rHuPH20 in healthy participants without HIV. This study has been completed, and results are available from CROI 2024.14,15
  • VRC 609 (NCT03538626): A study that evaluated the safety and pharmacokinetics of VH3810109 administered with or without rHuPH20 in healthy adults without HIV. This study has been completed, and results are available from CROI 2023 and Lancet HIV (2025).16-18

What side effects might VH3810109 cause? What side effects might VH3810109 cause?

What side effects might VH3810109 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of VH3810109 listed above.

BANNER (NCT04871113)

In the BANNER study, 62 participants received a single intravenous infusion of VH3810109 monotherapy. Thirteen participants experienced drug-related side effects, all of which were mild or moderate. The most common drug-related side effects included headache, injection site pain, injection site bruising, and abdominal pain. Seven participants had mild injection-site reactions that lasted a maximum of 10 days. No severe drug-related side effects were reported.9,19

EMBRACE (NCT05996471)

In the EMBRACE study, 50 participants received intravenous VH3810109 and 49 participants received subcutaneous VH3810109 plus rHuPH20, each in combination with long-acting cabotegravir. Over 60% of the participants in each of the VH3810109 arms had a side effect related to either VH3810109 or cabotegravir. In the intravenous VH3810109 arm , none of the participants had a severe side effect related to the study drugs or a serious side effect. Also, none of the participants receiving intravenous VH3810109 withdrew from the study due to a side effect. In the subcutaneous VH3810109 group, eight participants had a severe side effect related to the study drugs, three participants had a serious side effect, and three participants withdrew from the study because of a side effect.12,13

Four participants in the intravenous VH3810109 group reported a total of four injection site reactions related to VH3810109, all of which were mild and went away within 3 days. Twenty-five participants in the subcutaneous VH3810109 group reported a total of 70 injection site reactions related to VH3810109; the injection site reactions ranged from mild to severe in intensity. In both groups, there were no serious injection site reactions related to VH3810109 and no injection site reactions resulting in study discontinuation.13

Because VH3810109 is still being studied, information on possible side effects of the drug is not complete. As testing of VH3810109 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying VH3810109? Where can I get more information about clinical trials studying VH3810109?

Where can I get more information about clinical trials studying VH3810109?

More information about VH3810109-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. Jefferys R. Antiretroviral therapy. Treatment Action Group Pipeline Report 2024. Accessed March 21, 2025
  2. ViiV Healthcare: Press release, dated November 21, 2019. ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational “bNAb” with potential for long-acting HIV treatment and prevention. Accessed March 21, 2025
  3. Jefferys R. HIV vaccines & passive immunization. Treatment Action Group Pipeline Report 2022. Accessed March 21, 2025
  4. Treatment Action Group website. Research toward a cure trials. Accessed March 21, 2025
  5. Snow B. The rise of broadly neutralizing antibodies. AIDS Vaccine Advocacy Coalition (AVAC). Published May 17, 2018. Accessed March 21, 2025
  6. HIV Vaccine Trials Network (HVTN). Using antibodies for HIV prevention. Accessed March 21, 2025
  7. National Institute of Allergy and Infectious Diseases (NIAID). Sustained ART-free HIV remission. Accessed March 21, 2025
  8. National Institute of Allergy and Infectious Diseases (NIAID). Future directions for HIV treatment research. Accessed March 21, 2025
  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 March 21, 2025
  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 March 21, 2025
  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 March 21, 2025
  12. 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 March 21, 2025
  13. 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 March 21, 2025
  14. 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 March 21, 2025
  15. Win B, Leone P, Losos J, et al. High-dose VH3810109 (N6LS) ± recombinant human hyaluronidase PH20: Phase I SPAN study safety results. Abstract presented at: Conference on Retroviruses and Opportunistic Infections; March 3-6, 2024; Denver, CO. Abstract 639. Accessed March 21, 2025
  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 March 21, 2025
  17. Wu RL, Houser KV, Happe M, et al. N6LS with rHuPH20 enables safe high-dose monoclonal antibody subcutaenous delivery. Poster presented at: Conference on Retroviruses and Opportunistic Infections; February 19-22, 2023; Seattle, WA. Poster 499. Accessed March 21, 2025
  18. Wu RL, Houser KV, Gaudinski MR, et al. Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults. Lancet HIV. Published online May 20, 2025:S2352-3018(25)00041-4. doi:10.1016/S2352-3018(25)00041-4. Accessed July 7, 2025

  19. Leone P, Cahn P, Rolle CP, et al. Safety and tolerability of VH3810109 (N6LS) among antiretroviral therapy–naive adults living with HIV-1: results from the monotherapy phase of the Phase 2a BANNER study. European AIDS Conference; October 18-21, 2023; Warsaw, Poland. Accessed March 21, 2025

Last Reviewed: July 7, 2025