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:

About Apretude (cabotegravir LA)

Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.

Please consult the full Prescribing Information here.

About Cabenuva (cabotegravir + rilpivirine)  

Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.

Please consult the full Prescribing Information here.

About Dovato (dolutegravir and lamivudine) 

Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

Please consult the full Prescribing Information here.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. 

About GSK   

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2024. 

References

1. Khan T, et al. PILLAR 12 Month Clinical Results: Zero HIV acquisition and High Persistance with CAB LA for PrEP. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
2. Grinsztejn B, et al. ImPrEP CAB Brasil: Enhancing PrEP coverage with CAB_LA in Young Key Populations. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA              
3. Sax P, et al. Outcomes on Cabotegravir + Rilpivirine in Suppressed People with HIV (PWH) in TRIO Health US Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
4. Sension M, et al Long-term CAB+RPV LA Effectiveness in Virologically Suppressed Individuals in the OPERA Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
5. Altamirano J, et al. Clinical outcomes Among Virologically Suppressed Women Receiving CAB=RPV LA in the OPERA Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
6. Kityo C, et al. Randomized Trial of Cabotegravir and Rilpivirine Long-Acting in Africa (CARES): Week 96 Results. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
7. Tiraboschi JM, et al. Switch to DTG/3TC vs BIC/FTC/TAF (PASO-DOBLE study): Efficacy and Weight Changes by Predefined Subgroups. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
8. Taiwo B, et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
9. Rogg L, et al. Proof-of-Concept Trial of VH4524184 (VH-184), a Third-Generation Integrase Strand Transfer Inhibitor. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA
10. Griesel R, et al. Proof-of-Concept Trial of Oral VH4011499 (VH-499), a New HIV-1 Capsid Inhibitor. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA