ViiV Healthcare announces Phase 1 data at CROI 2026: VH184 (3rd-gen INSTI) shows twice-yearly potential and superior resistance vs. Bictegravir; VH499 capsid inhibitor supports 6-month dosing. Ultra long-acting HIV innovations from GSK-majority owned specialist.
Written By: Karthik Teja, PharmD
Reviewed By: Pharmacally Editorial Team
GSK announced that ViiV Healthcare majority owned by GSK with Pfizer and Shionogi as shareholders presented early data at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado, on two pipeline drugs advancing ultra long-acting (ULA) HIV therapies: VH184, a third-generation integrase strand transfer inhibitor (INSTI), and VH499, an investigational capsid inhibitor.
VH184: Potential Twice-Yearly INSTI with High Resistance Barrier
In a phase 1 study of long-acting formulations in adults without HIV, single subcutaneous (SC) or intramuscular (IM) injections of VH184 maintained steady drug levels through Month 7 in one formulation, supporting twice-yearly dosing.
The drug was generally well tolerated, with most adverse events limited to mild grade 1 injection site reactions (ISRs) like erythema, pain, and nodules consistent with approved INSTIs.
Separate in-vitro data showed VH184’s superior potency and resistance profile versus bictegravir against HIV strains with second-generation INSTI mutations, retaining activity across resistant viruses. This positions VH184 as a potential high-barrier option for phase 2b studies to optimize twice-yearly regimens.
VH499: Capsid Inhibitor Supports Six-Month Dosing
In an ongoing phase 1 study, single IM or SC doses (100mg–1200mg) of VH499 in HIV-negative adults sustained stable levels for prolonged periods, indicating ULA potential up to six months. Safety was favourable, with primarily mild-to-moderate grade 1/2 injection site reactions as a pain; no serious adverse events or withdrawals occurred. These results build on 2025 proof-of-concept data, informing future dosing optimization.
Kimberly Smith, Head of R&D at ViiV Healthcare, emphasized: “Our efforts focus on best-in-class, long-acting therapies to make HIV treatment less frequent. VH184 and VH499 data highlight progress toward the first INSTI-based twice-yearly regimen, addressing patient needs.”
Reference
ViiV Healthcare presents pipeline data for two investigational HIV treatment therapies with potential for twice-yearly dosing, 25 February 2026, ViiV Healthcare presents pipeline data for two investigational HIV treatment therapies with potential for twice-yearly dosing | GSK
About Writer
Karthik Teja, Pharm.D
He is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.