ViiV Healthcare Advances Ultra Long-Acting HIV Pipeline with Third-Generation Integrase Inhibitor VH184 Data at CROI 2026
核心洞察
ViiV Healthcare presents first-in-human data for VH184, the first third-generation integrase (搜索) inhibitor with potential for four-month or longer dosing intervals, marking a significant advancement in ultra long-acting HIV (搜索) treatment.
The phase IIb EMBRACE study reports 12-month data on HIV (搜索) suppression and safety with investigational lotivibart (搜索) (N6LS) administered every four months in combination with monthly cabotegravir.
Clinical data from the VOLITION study shows Month 11 outcomes for treatment-naïve adults switching to long-acting cabotegravir + rilpivirine immediately after achieving viral suppression.
ViiV Healthcare, the global specialist HIV (搜索) company majority owned by GSK, announced comprehensive data presentations from its innovative HIV treatment and prevention portfolio at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado from February 22-25, 2026. The presentations highlight significant progress in the company's ultra long-acting pipeline and established therapies.
Breakthrough Third-Generation Integrase Inhibitor Shows Ultra Long-Acting Potential
The most significant development centers on VH184, the first third-generation integrase (搜索) inhibitor (INSTI), with first-in-human data from an ongoing phase I study of injectable long-acting formulations. According to Jean van Wyk, Chief Medical Officer at ViiV Healthcare, VH184 "has the potential to extend dosing intervals to four months or longer – beyond what is available today for HIV (搜索) treatment."
An additional analysis evaluates VH184's in-vitro resistance profile compared to bictegravir, demonstrating enhanced resistance characteristics that could address current treatment limitations. The data represents a major advancement in ViiV's legacy of integrase (搜索) inhibitors and ultra long-acting regimen development.
EMBRACE Study Demonstrates Long-Term Efficacy of Novel Antibody Combination
The phase IIb EMBRACE study interim analysis reports 12-month data on HIV (搜索) suppression and safety with lotivibart (搜索) (N6LS), an investigational broadly neutralising antibody administered every four months, in combination with monthly long-acting cabotegravir (CAB LA) for HIV treatment. This combination represents a potential pathway toward ultra long-acting dosing intervals that could transform HIV care.
Expanding Evidence for Established Long-Acting Therapies
Cabenuva Shows Promise in Treatment-Naïve Population
Late-breaking results from the phase IIIb VOLITION study provide Month 11 outcomes among antiretroviral therapy (ART)-naïve adults who chose to switch to cabotegravir + rilpivirine (CAB+RPV) LA immediately after achieving virologic suppression on once daily Dovato (dolutegravir/lamivudine). This approach could significantly simplify treatment pathways for newly diagnosed patients.
Real-world analyses from the OPERA cohort report virologic outcomes by body mass index categories for individuals suppressed at CAB+RPV LA initiation and four-year follow-up results for individuals initiating CAB+RPV LA with viral loads ≥50 vs <50 copies/mL, providing crucial insights for clinical practice.
PrEP Advances Show Real-World Impact
Data from the OPERA cohort outline Apretude (CAB LA for PrEP) effectiveness over three years, as well as coverage versus oral PrEP in routine care. Particularly significant are twelve-month real-world effectiveness and acceptance data for CAB LA for PrEP among Black women, a group disproportionately impacted by HIV (搜索), demonstrating high effectiveness and acceptance rates.
An updated analysis from the phase I CLARITY study provides detail on acceptability, visibility and size of injection-site reaction nodules following single-dose lenacapavir and cabotegravir injections, supporting informed patient choice between available long-acting options.
Dolutegravir-Based Regimens Show Continued Efficacy
Several analyses from PASO DOBLE, described as the largest head-to-head randomised clinical trial of DTG/3TC versus bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), provide insights on differential metabolic impact including steatotic liver disease and adipose tissue at 96 weeks. The first efficacy meta-analysis between DTG/3TC versus DTG three-drug regimens in ART-naïve people with high or very high viral load and/or low CD4 will also be presented.
Results from the SUNGURA study include safety and efficacy data in virally suppressed older people living with HIV (搜索) (≥60 years), switching to DTG/3TC from BIC/FTC/TAF, addressing an important population with specific treatment considerations.
Pediatric Treatment Advances
Week 96 and end-of-study results for adolescents from IMPAACT 2017 (MOCHA) and first safety and pharmacokinetics data for children <20 kg from IMPAACT 2036 (CRAYON) illustrate CAB+RPV LA treatment strategies in younger age groups. Results from PENTA 21 explore non-inferiority of the simplified oral regimen DTG/3TC versus 3-drug ART in treating children.
Pipeline Development Continues
Additional presentations illustrate data for the injectable HIV (搜索)-1 capsid (搜索) inhibitor VH499, informing dosing and ultra long-acting feasibility. The phase I CAB ULA 012 study explores dose selection of cabotegravir ULA to support administration every four months, informing expanded prevention choices.
Van Wyk emphasized that "listening to the needs of the HIV (搜索) community shapes our research and development, and the breadth of clinical and real-world data we are presenting at CROI 2026 reflects our commitment to delivering long-acting therapies that people impacted by HIV need and want."
The comprehensive data package represents ViiV Healthcare's continued leadership in long-acting HIV (搜索) therapeutics, with potential to extend dosing intervals beyond current standards and improve treatment adherence across diverse patient populations.