ViiV Healthcare Advances Twice-Yearly HIV Treatment at Conference on Retroviruses and Opportunistic Infections 2026

ViiV Healthcare Advances Twice-Yearly HIV Treatment at Conference on Retroviruses and Opportunistic Infections 2026

By, Admin 3 March 2026

The future of HIV treatment may require just two doses per year. At CROI 2026 in Denver, ViiV Healthcare unveiled early-stage data on two investigational long-acting agents — VH184 and VH499 — both showing potential for twice-yearly dosing.

For a company built around long-acting innovation, this marks another step toward reducing HIV treatment frequency even further.

VH184: A Third-Generation Integrase Inhibitor

VH184 is positioned as the first third-generation integrase strand transfer inhibitor (INSTI) in development for HIV.

What the Phase 1 Data Show?

In a phase 1 study involving adults without HIV:

  • Participants received a single subcutaneous (SC) or intramuscular (IM) injection
  • Two long-acting formulations were tested
  • One formulation maintained steady drug levels through Month 7
  • Results support the potential for twice-yearly dosing

Safety Profile

VH184 was generally well tolerated:

  • Most adverse events were mild grade 1 injection site reactions
    • Erythema
    • Pain
    • Nodules
  • Fewer grade 2 or 3 injection site reactions
  • No unexpected safety signals
  • Profile consistent with approved INSTIs

Resistance Advantage Over bictegravir

In a separate in-vitro study presented at CROI:

  • VH184 demonstrated improved potency
  • Showed an enhanced resistance profile compared with bictegravir
  • Retained activity against HIV strains with:
    • Multiple INSTI-associated mutations
    • Resistance to second-generation INSTIs

These findings suggest a potential higher barrier to resistance, a key consideration in long-term HIV management. Phase 2b studies will now refine dosing and further assess its potential as a twice-yearly regimen.

VH499: A Long-Acting Capsid Inhibitor

ViiV also presented phase 1 data on VH499, an investigational capsid inhibitor.

Key Findings

In adults without HIV:

  • Single IM or SC injections ranging from 100 mg to 1200 mg
  • Both routes maintained stable drug levels for extended periods
  • Data support potential ultra long-acting (ULA) dosing up to six months

Tolerability

  • Most common adverse events: injection site reactions
  • Primarily grade 1 or 2 injection site pain
  • Mild to moderate and short-lived
  • No serious adverse events
  • No discontinuations due to adverse events

These data build on proof-of-concept findings presented at CROI 2025.

A Broader Ultra Long-Acting Strategy

According to Kimberly Smith, Head of R&D at ViiV Healthcare, the company’s strategy centers on delivering:

  • Best-in-class long-acting therapies
  • High resistance barriers
  • Reduced treatment frequency
  • More discreet and convenient care options

VH184 and VH499 form part of a broader ultra long-acting pipeline that also includes lotivibart (N6LS), all aimed at reducing the need for daily HIV treatment.

The long-term goal: introduce the first INSTI-based twice-yearly regimen for people living with HIV.

Why Twice-Yearly Dosing Matters?

For people living with HIV, reducing dosing frequency can:

  • Lower treatment burden
  • Improve adherence
  • Reduce stigma
  • Increase quality of life

Long-acting therapy has already transformed HIV care. Moving from monthly or bimonthly dosing to twice-yearly regimens would mark another major shift.

About ViiV Healthcare

Founded in 2009 by GSK and Pfizer, with Shionogi joining as a shareholder in 2012, ViiV Healthcare is dedicated exclusively to HIV treatment and prevention.

The company focuses on advancing innovative therapies designed to meet the evolving needs of people living with HIV and those who could benefit from prevention.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!