HIV competitive landscape: Viiv Phase 2a Trial with VH184 in TN PLWH Initiated

A new ViiV-sponsored Phase 2a trial investigating the efficacy, safety, tolerability, and PK of VH4524184 (VH184), ViiV’s ‘third generation’ INSTI, as a monotherapy in TN PLWH has been listed (NCT06214052). Route of administration was not disclosed, but it is likely being delivered orally.

Key Details:

• The trial started on January 16, 2024 and aims to recruit 28 participants with a PCD and SCD of August 8, 2024
• The sole primary outcome measure is VH184 antiviral activity at 10 days with secondary measures including AEs, PK parameters, and phenotypic resistance
• The study record does not disclose route of administration or dosing
• 26 study sites have been listed in the US, Argentina, Canada, Italy, Mexico, and Spain

Assessment:

• VH184 is a ‘third generation’ pipeline INSTI, which ViiV management shared is being developed as a potential option for their Q6M treatment and Q2M-Q3M self-administration treatment programs, in combination with either N6LS (bNAb), VH280/VH499 (capsid inhibitors), or VH937 (maturation inhibitor, self-administration only) pipeline assets. It is also a potential option for their Q6M prevention program.
• Despite the RoA being undisclosed in the trial record, this trial is likely assessing oral administration. It follows VH184’s Ph1 trial (NCT05631704), which investigates an oral formulation in healthy volunteers. However, in ViiV’s recent Meet the Management presentation, it was stated that an injectable formulation of VH184 will enter the clinic “soon,” which is assumed to be in 2024.
• The Ph1 trial reached its PCD on August 31, 2023, but data has yet to be presented. This is also expected in 2024.