Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lotivibart (LVB)
VH3810109 · 3 trials · 1 indication
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
| Arm | Type | Description |
|---|---|---|
| Part 1A: Participants Receiving VH3810109 Formulation 1 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 formulation 1 intravenously (IV) and Cabotegravir intramuscularly (IM) every month (QM). Participants from this arm will either transition to Part 2A or discontinue from the study and enter the LTFU period. |
| Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 plus rHuPH20 via subcutaneous (SC) infusion and Cabotegravir IM. This arm was discontinued following preliminary results. Participants from this arm will either transition to Part 1A at the next dosing visit or withdraw from the Investigational Product (IP) and enter the LTFU. |
| Part 1C: Participants Receiving SOC ART | ACTIVE_COMPARATOR | Participants in this arm will either transition to Part 2B or Part 2C or discontinue from the study. |
| Part 2A: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir Q2M | EXPERIMENTAL | Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M). Participants from this arm will either transition to Part 3A or discontinue from the study and enter the LTFU period. |
| Part 2B: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M. Participants from this arm will either transition to Part 3A or discontinue from the study and enter the LTFU period. |
| Part 2C: Participants continuing SOC ART | ACTIVE_COMPARATOR | Participants in this arm will either transition to Part 3B or discontinue from the study. |
| Part 3A: Participants continuing VH3810109 Formulation 2 plus Cabotegravir Q2M | EXPERIMENTAL | Participants will continue to receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M). |
| Part 3B: Participants receiving VH3810109 Formulation 2 plus Cabotegravir | EXPERIMENTAL | Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M. |
| Participants receiving SOC INSTI-based ART in Randomized Intervention Phase (Step 1) | ACTIVE_COMPARATOR | - |
| Participants receiving SOC INSTI-based ART+VH3810109 in Randomized Intervention Phase (Step 1) | EXPERIMENTAL | - |
| Participants receiving SOC INSTI-based ART+VH3810109+FTR in Randomized Intervention Phase (Step 1) | EXPERIMENTAL | - |
| Participants receiving VH3810109 in ATI Phase (Step 2) | EXPERIMENTAL | - |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | EXPERIMENTAL | Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. |
| Part 2 Group: VH3810109 60 mg/kg [IV] | EXPERIMENTAL | Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks. |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | EXPERIMENTAL | Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| VH3810109 | BIOLOGICAL | VH3810109 will be administered. |
| Cabotegravir | DRUG | Cabotegravir will be administered. |
| Standard of care (SOC) | DRUG | Pre-baseline SOC antiretroviral therapy (ART) will be administered. |
| rHuPH20 | BIOLOGICAL | rHuPH20 will be administered. |
| Fostemsavir (FTR) | DRUG | Fostemsavir will be administered. |
| SOC INSTI-based ART | DRUG | A SOC INSTI-based ART regimen will be administered. |
Inclusion criteria Age 1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Must be on uninterrupted current regimen for at least 6 months prior to Screening. Any prior switch, defined as a chang...
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| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
VH3810109 is an investigational monoclonal antibody being developed for the treatment of HIV infections. It is being studied both as a component of antiretroviral therapy regimens and as an agent to reduce the size and activity of the viral reservoir in people living with HIV.
VH3810109 is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. The company is the sponsor of the clinical program evaluating the antibody in HIV infections.
VH3810109 is in Phase 2 clinical development. The Phase 2 study is evaluating virologic efficacy and safety of VH3810109 plus cabotegravir compared with standard of care in adults living with HIV. The drug is investigational and has not been approved by the FDA.
Three trials have evaluated VH3810109. NCT05996471 is a Phase 2 study of VH3810109 plus cabotegravir versus standard of care in 185 adults. NCT07053384 is a Phase 1 study with or without fostemsavir in 107 participants. NCT05291520 was a completed Phase 1 pharmacokinetics study in 24 healthy adults.
Yes, VH3810109 is also known as GSK3810109. The two names refer to the same monoclonal antibody, and the alternate designation appears in the Phase 1 study NCT05291520, which evaluated a single dose given subcutaneously with rHuPH20 or intravenously in healthy adult participants.
Across the three clinical trials of VH3810109, total enrollment is 316 participants. The Phase 2 study NCT05996471 enrolled 185 adults, the Phase 1 study NCT07053384 enrolled 107 participants, and the completed Phase 1 study NCT05291520 enrolled 24 healthy adults.