Drug information
Drug's link(s)
Not provided
Generic name
VH-184 and VH-499 (fremocapavir)
Brand name
investigational
Compound type
Small molecule
Drug class/category
INSTI (Integrase Strand Transfer Inhibitor), Capsid inhibitor — 3rd gen. integrase strand transfer inhibitor (INSTI) + capsid inhibitor (CI)
Lifecycle status
Active / In Development (Phase 1/2/3)
Summary
Investigational, potentially twice-yearly, complete long-acting injectable regimen pairing ViiV Healthcare's third-generation INSTI VH-184 with its capsid inhibitor VH-499 (fremocapavir). Both agents are being developed individually as injectables; ViiV describes VH-184 and VH-499 as potential components of future ultra long-acting treatment regimens, and states that the phase I data will inform its plans for a first INSTI-based twice-yearly regimen, without specifying the partner drug (ViiV press release, 25 Feb 2026). The pairing of the two agents as a single regimen is reported by TAG (Pipeline Report 2026). In phase I studies in adults without HIV, a single injection of VH-184 (formulation B) maintained flat plasma concentrations through month 7, and single IM or SC injections of VH-499 (100 to 1,200 mg) maintained stable concentrations supporting dosing intervals of up to six months. VH-184 retains activity against HIV with second-generation INSTI resistance substitutions in vitro, and VH-499 binds the CPSF6/nucleoporin pocket of the capsid with picomolar potency. No clinical trial co-administering the two agents had been registered a
Approval status
Investigational. Not approved in any jurisdiction. The combination has not yet entered clinical testing as a regimen; each component is in clinical development (VH-184: oral phase IIb INNOVATE, injectable phase I; VH-499: oral phase IIa CINNAMON completed, injectable phase I, phase IIb CINERGY with cabotegravir not yet recruiting) (last updated 30 September 2026)
Regulatory authorities
Not applicable (no regulatory submission).
Safety
Component data only. VH-184 LA (phase I, 39 participants, formulations A and B, SC or IM): injection site reactions mostly grade 1 (erythema, pain, nodules), fewer grade 2, two grade 3 ISRs; safety profile described as similar to marketed INSTIs. VH-499 LA (phase I, 48 participants at 100/200/400 mg IM or SC): AEs mostly grade 1 to 2, injection site pain in 27/36 (75%) VH-499 recipients, ISRs more frequent after SC (83 to 100%) than IM (33 to 83%), median ISR duration 1 to 3 days, no serious AEs, no withdrawals for safety.
Efficacy
No efficacy data for the combination. Component proof of concept: oral VH-184 monotherapy (phase IIa, ART-naive adults, 10/50/300 mg) produced dose-dependent viral load declines, maximum -2.69 log10 copies/mL at 300 mg; oral VH-499 monotherapy (phase IIa CINNAMON) showed potent antiviral activity over 10 days.
Evidence Summary
Not provided
