ViiV Healthcare Advances HIV Treatment with Potential for Twice-Yearly Dosing

New data presented showcase ViiV Healthcare’s progress in developing long-acting HIV therapies, potentially reducing treatment frequency to as little as twice a year. These advancements aim to improve the lives of people living with HIV and contribute to the goal of ending the HIV epidemic.

Breakthroughs in Long-Acting HIV Treatment

ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, is pioneering the development of ultra-long-acting HIV regimens. Recent findings from Phase IIa proof-of-concept studies of investigational antiretroviral therapies VH4524184 (VH184) and VH4011499 (VH499) presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) demonstrate promising results. Business Wire

VH184: A Third-Generation Integrase Inhibitor

VH184, a potent investigational third-generation integrase inhibitor (INSTI), has shown strong antiviral activity and positive safety results across multiple dose levels in people with HIV-1. Data suggests the potential for dosing intervals of up to twice yearly. In a Phase 1 study involving adults without HIV, VH184, administered as a single subcutaneous (SC) or intramuscular (IM) injection, demonstrated long-acting properties, with one formulation maintaining steady drug levels through Month 7. Business Wire

The VH184 formulations were generally well-tolerated, with most side effects limited to mild grade 1 injection site reactions (ISRs) such as erythema, pain, and nodules. The safety profile is consistent with previous studies and similar to that of approved INSTIs. Business Wire

VH184 demonstrated an improved virology profile, exhibiting enhanced resistance compared to bictegravir against HIV with mutations linked to resistance to second-generation INSTIs. It retained activity against a broad range of resistant virus strains, indicating a potentially higher barrier to resistance. Business Wire

VH499: A Highly Potent Capsid Inhibitor

VH4011499 (VH499), a promising, highly potent investigational capsid inhibitor, shows positive antiviral activity and excellent safety findings for the treatment of HIV-1, supporting further development as a long-acting antiretroviral. Early results suggest potential for dosing every six months. Business Wire

ViiV Healthcare’s Commitment to Innovation

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, emphasized the company’s dedication to delivering best-in-class, long-acting therapies. Business Wire “Our R&D efforts are built around delivering best-in-class, long-acting therapies that challenge the status quo and help craft HIV treatment a smaller, less frequent part of people’s lives,” she stated. Business Wire

ViiV Healthcare’s pipeline, with INSTIs at its core, showcases continued leadership in long-acting injectable innovation. The company aims to introduce the first INSTI-based, twice-yearly regimen for people with HIV. Business Wire

“It’s clear long-acting injectable medicines deliver on unmet patient need and will play a critical role in achieving our ambition of ending HIV and AIDS,” added Dr. Smith. ViiV Healthcare