ViiV Healthcare showcases breadth of clinical and real-world evidence at EACS and IDWeek 2025

• Data from the CLARITY study will provide insights on acceptability and tolerability of single-dose cabotegravir and lenacapavir long-acting injections
• Four-year analysis from the OPERA cohort examines continued use of Vocabria + Rekambys and virologic outcomes across age groups
• 96-week virological efficacy data for Dovato vs Biktarvy will be presented from the PASO DOBLE head-to-head study
• Safety and tolerability results from the phase IIb EMBRACE study will be presented for VH109 (N6LS), an investigational broadly neutralising antibody administered every four months, in combination with cabotegravir long-acting for HIV treatment

LONDON--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of more than 60 abstracts, including data from its industry-leading long-acting HIV treatment and prevention portfolio, at the 20^th European AIDS Conference (EACS) in Paris, France from 15-18 October, and at IDWeek 2025 in Atlanta, Georgia, US from 19-22 October.

Highlights include initial data from the phase I CLARITY crossover study, the first comparing the acceptability and tolerability of cabotegravir long-acting (CAB LA) and lenacapavir (LEN) injections after a single dose.¹ New effectiveness and tolerability data for Vocabria + Rekambys (cabotegravir + rilpivirine LA; branded as Cabenuva in the US, Canada and Australia), Apretude (CAB LA for PrEP), and pipeline data on innovative combination approaches in HIV treatment, reinforce ViiV Healthcare’s leadership in HIV long-acting innovation.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “The breadth of our data presented at EACS and IDWeek reinforce the effectiveness of our therapies, the potential promise of our pipeline and our unwavering commitment to meeting the evolving needs of those impacted by HIV. The CLARITY study, comparing single dose injections of cabotegravir and lenacapavir, offers critical insights into patient and provider preferences, empowering informed decisions and building on our substantial body of real-world evidence in long-acting HIV treatment and prevention.”

Key data to be presented at EACS and IDWeek by ViiV Healthcare and study partners include:

New clinical data assessing acceptability and tolerability of single-dose CAB LA and LEN injections: At EACS, initial data from a primary analysis of the phase I CLARITY study – a randomised crossover study of long-acting injectable antiretrovirals in 63 HIV-negative adults – will highlight acceptability and tolerability of CAB LA vs LEN following a single dose.¹ The study will show clinically relevant differences in injection site reactions (ISRs) experienced by participants following administration.

New real-world evidence for CAB LA for PrEP: At IDWeek, a range of studies will provide insights into the real-world data of CAB LA in HIV prevention including: the PrEPFACTS study, which will reveal US testing patterns and evidence of HIV; US data on HIV testing from the OPERA cohort, which will report on how CAB LA or oral PrEP is administered in the real world to help support optimal HIV care; interim findings from the phase IV EBONI study on Black women’s experiences of CAB LA, providing insights from a group that accounts for approximately half of new HIV diagnoses among women in the US.^2,3,4,5

Reinforcing the established data for HIV treatment with cabotegravir + rilpivirine (CAB+RPV LA) in a broad range of populations: At EACS, a meta-analysis of 26 studies involving more than 7,000 virologically suppressed people living with HIV will provide real-world effectiveness, adherence and tolerability data for CAB+RPV LA.⁶ At IDWeek, a four-year analysis from the OPERA cohort of length of time people stay on CAB+RPV LA and their virologic outcomes across age groups provides insights into its use and effectiveness over time.⁷

Phase III study of healthcare providers’ perspectives on treatment optimisation: At EACS, the phase III VOLITION study will report perspectives from healthcare providers on early switch to CAB+RPV LA after rapid suppression in ART-naive adults with Dovato (dolutegravir/lamivudine (DTG/3TC)).⁸ The findings build on previous VOLITION data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes from participants who had the option to choose between these two regimens based on individual preference.^9,10

New long-term efficacy data for ViiV Healthcare’s two-drug regimen DTG/3TC: At EACS, 96-week results from PASO DOBLE, the largest head-to-head randomised clinical trial of DTG/3TC vs bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), will explore virological efficacy and metabolic outcomes.¹¹ In addition, findings will be presented from the Fundación Huésped-sponsored DOLCE study that assessed DTG/3TC in virologically suppressed adults with low CD4 counts (<200 cells/mL).¹² At EACS and IDWeek, the retrospective real-world global REGAL study will compare DTG/3TC and BIC/FTC/TAF in older people living with HIV.^13,14,15

Advancing innovative approaches in HIV treatment: At EACS, new data will be presented from the phase IIb EMBRACE study of N6LS, an investigational broadly neutralising antibody (bNAb) in combination with CAB LA for HIV treatment.^16,17,18,19 Presentations will include safety and tolerability results from intravenous and subcutaneous administration in Part 1 of the study, pharmacokinetic parameters in virologically suppressed adults, and perspectives from people living with HIV and clinical staff on using N6LS with CAB LA injections.

Key ViiV Healthcare sponsored or supported studies to be presented at EACS 2025:

Title	Presenting author	Presentation
CAB+RPV LA
The Power of Choice: Perspectives From Healthcare Providers on Early Switch to CAB+RPV LA After Rapid Suppression With DTG/3TC	C. A. Gutner	Oral presentation (RO2.5) October 17 2025 12:30 PM - 1:30 PM CEST
Real-World Effectiveness and Tolerability of Cabotegravir + Rilpivirine Long-Acting in People Living with HIV-1: A Meta-Analysis of Real-World Evidence	C. Orkin	ePoster exhibition (eP103) October 16 2025
Real-World Utilization of Cabotegravir/Rilpivirine Long-Acting Injectable: An Observational Analysis of Adherence and Persistence using a Patient Support Program in Canada	J. F. Fortin	ePoster exhibition (eP106) October 16 2025
CAB LA for PrEP
Opportunities to Prevent Human Immunodeficiency Virus (HIV) Acquisition: Global Survey Results on Sexual Health Engagement in Newly Diagnosed People Living With HIV From the VOLITION Study	C. A. Gutner	ePoster exhibition (eP456) October 16 2025
Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover Study of Long-Acting Injectable Antiretrovirals	K. Brown	Moderated ePoster (MeP20.4.LB) October 17 2025 2:05 PM - 2:25 PM CEST
DTG/3TC
PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine in Europe (PAIRED Europe): Primary Analysis	E. Fernvik	ePoster exhibition (eP095) October 16 2025
The European REGAL Cohort: A Retrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment Regimens DTG/3TC Compared to BIC/FTC/TAF in Older Persons Living with HIV	M. Jesus Perez Elías	ePoster exhibition (eP115) October 16 2025
Real-world Effectiveness of DTG+3TC in PLHIV With Previous ART Experience but no Genotype Testing: The “AReTi” Study Results	D. Athanasopoulos	ePoster exhibition (eP104) October 16 2025
CARAVEL: evaluation of real-world antiviral effectiveness and sustainability of the 2-drug regimen Dolutegravir/ Lamivudine fixed dose combination in treatment-naïve adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France	P. Philibert	ePoster exhibition (eP049) October 16 2025
TR-DOLA: Real-world data on the use of Dolutegravir (DTG) + Lamivudine (3TC) in treatment-experienced people living with HIV in TURKIYE	T. Demirdal	ePoster exhibition (eP117) October 16 2025
Subgroup Analysis of Dolutegravir/ Lamivudine-in ART-Naïve Adults Living with HIV with CD4 counts below 200 cells/mL: Results from the DOLCE Study	C. Brites	ePoster Exhibition (eP134) October 16 2025
Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial	E. Martínez	Oral presentation (RO3.8.LB) October 17 2025 12:30 PM - 1:30 PM CEST
VH109 (N6LS)
Cutoff for Baseline Phenotypic Sensitivity to VH3810109 (N6LS) Did Not Impact Occurrence of Confirmed Virologic Failure in the Phase 2b EMBRACE Study	M. Gartland	ePoster exhibition (eP127) October 16 2025
Safety and Tolerability of N6LS Administered Intravenously or Subcutaneously: Promising Results From Part 1 of the EMBRACE Study	P. Leone	Oral Presentation (PS09.1) October 17 2025 11:00 AM – 12:00 PM CEST
Evaluation of VH3810109 (N6LS) and Cabotegravir Long-Acting, Dual Modality, Injections for HIV Treatment: People With HIV and Staff Perspectives	C. A. Gutner	ePoster exhibition (eP131) October 16 2025
Population Pharmacokinetics, Antidrug Antibodies and Exposure-Response of VH3810109 (N6LS) in Virologically Suppressed Adults Living With HIV From the Phase 2b EMBRACE Study	A. Yin Edwards	ePoster Exhibition (MeP10.1) October 16 2025 3:35 PM – 3:40 PM CEST

Key ViiV Healthcare sponsored or supported studies to be presented at IDWeek 2025:

Title	Presenting author	Presentation
CAB+RPV LA
Few differences in persistence and virologic outcomes across age groups among CAB+RPV LA users: Findings from the OPERA Cohort	M. Sension	Poster Session (P-371) October 20 2025 12:15 PM – 1:30 PM ET
PREFER-LA: People with HIV (PWH) in the United States with prior adherence challenges with oral antiretroviral therapy (ART) prefer cabotegravir + rilpivirine long-acting (CAB+RPV LA) therapy after switch	Z. Henry	Poster session (P-396) October 20 2025 12:15 PM – 1:30 PM ET
PREFER-LA: Improved adherence and viral control in real-world study of people with HIV (PWH) in the United States with adherence challenges on oral antiretroviral therapy (ART) switching to cabotegravir + rilpivirine long-acting (CAB+RPV LA)	W. Short	Oral Session (575) October 22 2025 11:06 AM – 11:18 AM ET
CAB LA for PrEP
Associations between Intersectional Stigma and Long-Acting Injectable PrEP (LAI-PrEP) Willingness and Preference among Gay, Bisexual, and other Men who have Sex with Men (GBMSM)	J. Glick	Poster Session (P-306) October 20 2025 12:15 PM – 1:30 PM ET
Characteristics associated with HIV pre-exposure prophylaxis persistence among men who have sex with men in the United States: results from the American men’s internet survey (AIMS) 2023-24	D. Islek	Poster Session (P-300) October 20 2025 12:15 PM – 1:30 PM ET
Screening Practices for HIV and Sexually Transmitted Infections During Cabotegravir Long Acting or Daily Oral Pre-Exposure Prophylaxis Use in the US	S. Barnett	Poster Session (P-332) October 20 2025 12:15 PM – 1:30 PM ET
Black Women’s Experiences on Long-Acting Cabotegravir for PrEP: Interim Patient Findings from the EBONI Study	K. Nelson	Poster Session (P-313) October 20 2025 12:15 PM – 1:30 PM ET
Human Immunodeficiency Virus (HIV) Testing and Evidence of HIV among Real-World Long-Acting Pre-Exposure Prophylaxis (PrEP) Users in a United States Claims Database: Results from the PrEPFACTS Study	A. Metzner	Oral Session (574) October 22 2025 10:54 AM – 11:06 AM ET
DTG/3TC
The US REGAL cohort: a retrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment regimens DTG/3TC compared to BIC/FTC/TAF in older persons living with HIV	O. Ogbuagu	Poster Session (P-376) October 20 2025 12:15 PM – 1:30 PM ET
The Global REGAL cohort: A REtrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment reGimens DTG/3TC compAred to BIC/FTC/TAF in older persons Living with HIV	J. Fraysse	Poster Session (P-357) October 20 2025 12:15 PM – 1:30 PM ET
Real-world Effectiveness and Safety Outcomes in People with HIV-1 Switching to Dolutegravir + Lamivudine (DTG + 3TC) with Unknown Prior Genotype: a Systematic Literature Review and Meta-analysis	J. Boulos	Poster Session (P-360) October 20 2025 12:15 PM – 1:30 PM ET

About Apretude (cabotegravir long-acting)

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 Vocabria (cabotegravir)

Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.

Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:

• oral lead-in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
• oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.

Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.

Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets

About Rekambys (rilpivirine)

Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection

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 35 kg 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 US 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 35 kg 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 in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q2 Results for 2025.

Registered in England & Wales:
GSK plc ViiV Healthcare Limited
No. 3888792 No. 06876960

Registered Office:
79 New Oxford Street ViiV Healthcare Limited
London GSK Medicines Research Centre
WC1A 1DG Gunnels Wood Road, Stevenage
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References

____________________

1 J. Boles, et al. Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover Study of Long-Acting Injectable Antiretrovirals. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

2 A. Metzner, et al. Human Immunodeficiency Virus (HIV) Testing and Evidence of HIV among Real-World Long-Acting Pre-Exposure Prophylaxis (PrEP) Users in a United States Claims Database: Results from the PrEPFACTS Study. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

3 S. Barnett, et al. Screening Practices for HIV and Sexually Transmitted Infections During Cabotegravir Long Acting or Daily Oral Pre-Exposure Prophylaxis Use in the US. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

4 K. Nelson, et al. Black Women’s Experiences on Long-Acting Cabotegravir for PrEP: Interim Patient Findings from the EBONI Study. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

5 Kaiser Family Foundation. The impact of HIV on women in the United States. 2024 Dec 16. Available: https://www.kff.org/hiv-aids/the-impact-of-hiv-on-women-in-the-united-states/ Accessed: October 2025

6 C. Orkin, et al. Real-World Effectiveness and Tolerability of Cabotegravir + Rilpivirine Long-Acting in People Living with HIV-1: A Meta-Analysis of Real-World Evidence. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

7 M. Sension, et al. Few differences in persistence and virologic outcomes across age groups among CAB+RPV LA users: Findings from the OPERA Cohort. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

8 C. Jonsson-Oldenbütel, et al. The Power of Choice: Perspectives From Healthcare Providers on Early Switch to CAB+RPV LA After Rapid Suppression With DTG/3TC. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

9 E. Cordova, et al. Rapid virologic suppression with DTG/3TC facilitates early switch to CAB+RPV LA for treatment-naive people living with HIV: suppression phase outcomes from the Phase 3b VOLITION study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

10 F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

11 M. Masia, et al. Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

12 C. Brites, et al. Subgroup Analysis of Dolutegravir/Lamivudine-in ART-Naïve Adults Living with HIV with CD4 counts below 200 cells/mL: Results from the DOLCE Study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

13 M. Jesus Perez Elías, et al. The European REGAL Cohort: A Retrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment Regimens DTG/3TC Compared to BIC/FTC/TAF in Older Persons Living with HIV. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

14 J. Fraysse, et al. The Global REGAL cohort: A REtrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment reGimens DTG/3TC compared to BIC/FTC/TAF in older persons Living with HIV. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

15 O. Ogbuagu, et al. The US REGAL Cohort: A Retrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment Regimens DTG/3TC Compared to BIC/FTC/TAF in Older Persons Living with HIV. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

16 Leone P, et al. Safety and tolerability of N6LS administered intravenously or subcutaneously: promising results from Part 1 of the EMBRACE study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

17 C. A. Gutner, et al. Evaluation of VH3810109 (N6LS) and Cabotegravir Long-Acting, Dual Modality, Injections for HIV Treatment: People With HIV and Staff Perspectives. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

18 M. Gartland, et al. Cutoff for Baseline Phenotypic Sensitivity to VH3810109 (N6LS) Did Not Impact Occurrence of Confirmed Virologic Failure in the Phase 2b EMBRACE Study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

19 A. Yin Edwards, et al. Population Pharmacokinetics, Antidrug Antibodies and Exposure-Response of VH3810109 (N6LS) in Virologically Suppressed Adults Living With HIV From the Phase 2b EMBRACE Study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

 

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