ViiV Healthcare continues to deliver long-acting injectable HIV innovation with late-breaking data and real-world insights across pipeline and portfolio at CROI 2025

Real-world and implementation data highlight effectiveness of Cabenuva (cabotegravir + rilpivirine LA) and Apretude (cabotegravir LA (CAB LA) for PrEP), the only approved long-acting injectable therapies for HIV treatment and prevention, among broad range of communities Late-breaking phase IIb data demonstrate the potential of an investigational new long-acting broadly neutralising antibody (bNAb)/CAB LA combination treatment Two proof-of-concept studies on an investigational third-generation integrase strand transfer inhibitor (INSTI) and a capsid inhibitor highlight the opportunity for further research into these assets as long-acting antiretrovirals GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will be presenting abstracts from its innovative HIV treatment and prevention portfolio and research pipeline at the Conference on Retroviruses and Opportunistic Infections (CROI 2025). Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Our long-acting injectable portfolio is being showcased at CROI 2025 with data on real-world outcomes, demonstrating the impact our industry-leading portfolio is having today. We’re also sharing early data from our transformative pipeline, including results from our third-generation integrase inhibitor and partner assets. These assets have the potential to increase dosing intervals beyond what's currently available, aiming to deliver what the community of people living with HIV tells us they want and need.” Key data to be presented at CROI 2025 by ViiV Healthcare and its study partners include: Portfolio New data assessing Apretude (CAB LA for PrEP) in HIV prevention: Latest data from the PILLAR implementation study, which is assessing strategies for delivering CAB LA at 17 sites in the US, will be presented; clinical assessments will include HIV incidence, HIV diagnostic testing, persistence, and safety and tolerability of CAB LA over 12 months1.Findings from the ImPrEP CAB Brazil implementation study will include PrEP coverage and HIV incidence among young, key populations who were given the choice of CAB LA or oral PrEP2. Long-term real-world and clinical trial data in diverse populations on Cabenuva (cabotegravir + rilpivirine long-acting (CAB+RPV LA)): New data on the utilisation and effectiveness of CAB+RPV LA in people living with HIV in the US will be presented from the Trio Health study3. Long-term follow-up data from the real-world OPERA study will include CAB+RPV LA effectiveness in individuals through two years4, as well as clinical outcomes in women receiving CAB+RPV LA5. Long-term data on the efficacy, safety and tolerability of CAB+RPV LA in people living with HIV in sub-Saharan Africa will be presented from the CARES study6. PASO-DOBLE week 48 subgroup analysis: New data from the largest head-to-head randomised clinical trial of DTG/3TC vs BIC/FTC/TAF, looked at efficacy and clinically meaningful weight changes (>5% from baseline) across different subgroups, including but not limited to sex at birth, age groups ethnicity and prior antiretroviral therapy7. Pipeline Late breaking data for a new therapeutic option: A new phase IIb study with VH3810109 (VH109), an investigational, broadly neutralising antibody (bNAb) offers efficacy and safety findings of the bNAb (subcutaneous and IV administration) in combination with CAB LA8. New findings from our next generation of INSTIs: A proof-of-concept clinical study with VH4524184 (VH184), an investigational third-generation integrase inhibitor with potential for long-acting dosing, assessed the drug’s exposure-response relationship to HIV-1 at multiple doses and shows findings that support further development9. Proof of concept data of a partner asset to INSTIs: A proof-of-concept clinical trial provides insights into the antiviral effects, pharmacokinetics, safety, and tolerability of VH4011499 (VH499), a new, highly potent investigational capsid inhibitor and one of several partner asset options being evaluated for development into long-acting treatment HIV regimens10. ViiV Healthcare-sponsored or supported studies to be presented at CROI 2025:

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