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ViiV HEALTHCARE SHOWCASES LONG-ACTING HIV INNOVATION AND POTENTIAL OF ULTRA LONG-ACTING PIPELINE, INCLUDING NEW DATA FOR FIRST THIRD-GENERATION INTEGRASE INHIBITOR AT CROI 2026
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•First-in-human data for long-acting formulations of VH184, the first third-generation integrase inhibitor, and early data for capsid inhibitor VH499 to be presented, highlighting progress in ViiV's ultra long-acting pipeline
•12-month data to be presented for investigational lotivibart (N6LS) + cabotegravir long-acting, evaluating feasibility of ultra long-acting dosing intervals
•Clinical data and real-world evidence from ViiV's innovative portfolio include insights for established INSTI-based long-acting Cabenuva (cabotegravir + rilpivirine LA) and 2-drug regimen Dovato (dolutegravir/lamivudine
London, 17 February 2026 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced data presentations from its innovative HIV treatment and prevention portfolio and integrase inhibitor (INSTI)-led pipeline at the 33rdConference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado from 22-25 February.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "We are making major advances towards new ultra long acting regimens that build on ViiV's legacy of integrase inhibitors, including pipeline assets such as VH184 that have the potential to extend dosing intervals to four months or longer - beyond what is available today for HIV treatment. Listening to the needs of the HIV 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."
Key data to be presented at CROI 2026 by ViiV Healthcare and study partners include:
Advancing the next generation of ultra long acting (ULA) HIV treatment candidates: For VH184, the first third-generation INSTI, data from the ongoing first-in-human phase I study of injectable long-acting formulations will provide insights into its ULA potential in future regimens,1 while an additional analysis evaluates its in-vitro resistance profile vs bictegravir.2
Additionally, an interim analysis from the phase IIb EMBRACE study will report long-term data on HIV suppression and safety at 12 months with lotivibart (N6LS), an investigational broadly neutralising antibody administered every four months, in combination with monthly long-acting cabotegravir (CAB LA) for HIV treatment.3 Additional presentations illustrate data that will inform dosing and ULA feasibility of the injectable HIV 1 capsid inhibitor, VH499.4,5
Exploring longer interval HIV prevention with cabotegravir ULA: The phase I CAB ULA 012 study explores dose selection of cabotegravir ULA, to support administration every four months, and informs the path toward expanded prevention choices.6
Expanding evidence across different populations for Cabenuva (cabotegravir + rilpivirine LA), the only complete long-acting injectable HIV treatment: Late-breaking results from the phase IIIb VOLITION study will provide an update on Month 11 outcomes among ART-naïve adults who chose to switch to cabotegravir + rilpivirine (CAB+RPV) LA (branded as Vocabria + Rekambys outside the US, Canada and Australia) immediately after achieving virologic suppression on once daily Dovato(dolutegravir/lamivudine (DTG/3TC)).7 Additionally, analyses from the real-world OPERA cohort will 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.8,9
New evidence supporting CAB LA for PrEP and understanding PrEP uptake: An updated analysis from the phase I CLARITY study will provide detail on acceptability, visibility and size of injection site reaction nodules following single-dose lenacapavir and cabotegravir injections, supporting informed choice.10 Data from the OPERA cohort will outline Apretude (CAB LA for PrEP) effectiveness over three years, as well as coverage vs oral PrEP in routine care, providing important insights to guide implementation and adherence support.11,12 Twelve-month real-world effectiveness and acceptance data for CAB LA for PrEP among Black women, a group disproportionately impacted by HIV, will also be presented.13
Strengthening evidence for dolutegravir-based treatment across populations: The first efficacy meta-analysis between DTG/3TC vs DTG three drug regimens in ART-naïve people with high or very high viral load and/or low CD4 will be presented.14 Several analyses from PASO DOBLE, the largest head-to-head randomised clinical trial of DTG/3TC vs bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), will provide insights on the differential metabolic impact including steatotic liver disease and adipose tissue at 96 weeks.15,16,17 Results from the SUNGURA study including safety and efficacy data in virally supressed older people living with HIV (≥60 years), switching to DTG/3TC from BIC/FTC/TAF will also be presented.18
Advancing paediatric treatment with LA options and DTG-based regimens: Week 96 and end-of-study results for adolescents (IMPAACT 2017; MOCHA), and first safety and pharmacokinetics data for children <20 kg (IMPAACT 2036; CRAYON) - from two of our registrational supported collaborative studies - illustrate CAB+RPV LA treatment strategies in younger age groups.19,20 Findings from an additional study from Southern Africa will describe viral suppression in children aged ≤5 years on DTG, highlighting its role in paediatric treatment.21 Results from PENTA 21 will explore non-inferiority of the simplified oral regimen DTG/3TC vs 3-drug ART in treating children.22
Full press release pdf attached
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