Antiviral Effect, Safety, and Tolerability of Oral VH4011499 (VH-499), a New HIV-1 Capsid Inhibitor: Proof-of-Concept Trial

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ID: 322877
2026
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Ranked #208 of 635 articles by views in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

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Abstract
Abstract Background Innovative HIV-1 therapies, especially those with infrequent dosing, are a promising approach to advance progress toward the UNAIDS goal of ending HIV-1 transmission. VH4011499 (VH-499) is a new capsid inhibitor in development as a long-acting antiretroviral agent for HIV-1 treatment. We present the antiviral effect, pharmacokinetics, safety, and tolerability of oral VH-499 from a proof-of-concept phase 2a trial in people with HIV-1. Methods The randomized, double-blind, placebo-controlled CINNAMON trial evaluated oral VH-499 monotherapy in adults naive to antiretroviral therapy (ART) with viremia. During a 10-day monotherapy period, participants received VH-499 25, 100, or 250 mg or placebo on Days 1 and 6. After monotherapy, participants initiated locally sourced standard-of-care ART starting on Day 11. The primary endpoint was maximum change from baseline in viral load through Day 11. Secondary endpoints included exposure-response relationship, safety, and tolerability. Results Twenty-three participants were enrolled (VH-499, n=20; placebo, n=3). Viral load decreased through Day 11 for all VH-499 dose groups (mean [SD] maximum decline: 25 mg, −1.8 [0.5]; 100 mg, −1.8 [0.5]; 250 mg, −2.2 [0.4]). Increasing VH-499 exposures were associated with greater viral load declines. Ninety-five percent (19/20) of participants had no emergent genotypic resistance-associated mutations. Adverse events (AEs) were mild or moderate in severity, and no serious AEs or AEs leading to withdrawal were reported. Conclusions VH-499 monotherapy demonstrated highly potent antiviral activity, was well tolerated, and had a favorable safety profile. These results support further development of VH-499 as part of a complete long-acting regimen for HIV-1 treatment (ClinicalTrials.gov, NCT06039579).
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Authors Rulan Griesel, Sebastián A. Núñez, Ezequiel Córdova, Alma Minerva Pérez Ríos, Verónica Lacal Ridilenir, Clara Lehmann, Jihad Slim, Carmen Busca, Jason Szabo, Pedro Cahn, Frank A. Post, Amy Pierce, Matthew J. Pestrak, Jerry L Jeffrey, Nilay Thakkar, Bronagh Shepherd, Veronica Bainbridge, Konstantinos Angelis, Carlye McMillan, Paul Benn
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Journal Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Year 2026
DOI
10.1093/cid/ciag452
URL
https://doi.org/10.1093/cid/ciag452
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