ViiV Healthcare presents new data demonstrating positive real-world impact of its innovative long-acting injectables for HIV at IAS 2025
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: 'Our extensive real-world insights about CAB+RPV LA for HIV treatment and CAB LA for HIV prevention demonstrate how long-acting injectables are redefining the way we approach HIV care and management in broad populations. The new real-world and implementation data at IAS 2025 further reinforce their effectiveness, safety and tolerability, and underscore our commitment to delivering therapies that meet the evolving needs of people impacted by HIV, offering flexibility and choice beyond daily oral treatment.'
Key data to be presented at IAS 2025 by ViiV Healthcare and its study partners include:
New data assessing preference and choice to switch to CAB+RPV LA after attaining rapid viral suppression: First data from the phase IIIb VOLITION study assessed preferences and experiences among ART-naive adults offered the option to switch to CAB+RPV LA after achieving rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). 1
Growing body of real-world effectiveness data for CAB+RPV LA in broad range of populations: New data will be presented on outcomes including effectiveness, adherence, and satisfaction with CAB+RPV LA, from several real-world studies, including COMBINE-2, and two-year data from CARLOS and BEYOND. 2,3,4,5 In addition, two analyses from the OPERA cohort will focus on the effectiveness of CAB+RPV LA in real-world settings for treatment-experienced adults with viremia at therapy initiation. 6,7
New implementation data on acceptability and benefits of CAB LA for PrEP: Data from the PILLAR and EBONI implementation studies will focus on participant experiences with CAB LA implementation among men who have sex with men and transgender men, as well as healthcare provider experiences implementing CAB LA for Black women, respectively. 8,9
New effectiveness data for DTG/3TC in different populations: New data from VOLITION evaluate the efficacy of DTG/3TC in achieving rapid virologic suppression in a diverse treatment-naive population. 10 Data from investigator-led, ViiV Healthcare-supported studies, D2ARLING and SUNGURA will also be presented, including D2ARLING's comparison of DTG/3TC effectiveness to other regimens in the presence of transmitted resistance mutations, and an analysis from the SUNGURA study including safety and efficacy data in virally suppressed older people living with HIV switching to DTG/3TC from BIC/FTC/TAF. 11,12
Positive Perspectives wave three data highlighting the importance of community perspectives in treatment outcomes: Interim results from wave three of the Positive Perspectives study will be presented, showing how shared decision making and treatment satisfaction are linked to treatment outcomes and self-rated health in specific sub-group analyses. 13 Additionally, the continued need to improve awareness, belief and confidence in U=U will be presented. 14
ViiV Healthcare-sponsored or supported studies to be presented at IAS 2025:
Title
Presenting author
Presentation
CAB+RPV LA
J. Scherzer
Poster Exhibition TUPEB035
15 July 2025
12:00 PM – 13:00 PM CAT
Clinical outcomes among women in the OPERA Cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL
V. Vannappagari
Poster Exhibition WEPEB036
16 July 2025
12:00 PM – 13:00 PM CAT
Perspectives of people with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND)
C. Garris
Poster Exhibition THPEB036
17 July 2025
12:00 PM – 13:00 PM CAT
The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in newly diagnosed people living with HIV
C. Gutner
E-Poster EP0170
High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe
A. Pozniak
E-Poster EP0171
Clinical Outcomes at Month 24 After Initiation of Cabotegravir and Rilpivirine Long Acting (CAB+RPV LA) in an Observational Real-World Study (BEYOND)
G. Blick
E-Poster EP0178
CAB LA for PrEP
One-Year Implementation Outcomes of Cabotegravir Long-Acting Injectable PrEP in Men who Have Sex with Men (MSM) & Transgender Men (TGM): Findings from the PILLAR Study
D. Dandachi
Poster Exhibition TUPEE116
15 July 2025
12:00 PM – 13:00 PM CAT
Health Care Provider Experiences After 12 Months of Implementing Cabotegravir Long-Acting Injectable PrEP (CAB LA) for Black Women: Results from the EBONI Study
Z. Tims-Cook
Poster Exhibition THPEE096
17 July 2025
12:00 PM – 13:00 PM CAT
DTG/3TC
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
B. Jones
Poster Exhibition WEPEB033
16 July 2025
12:00 PM – 13:00 PM CAT
Efficacy of dolutegravir plus lamivudine in treatment-naïve people with HIV with baseline transmitted drug-resistance mutations: a subanalysis of the D2ARLING study
E. Cordova
E-Poster EP0172
Positive Perspectives
Treatment Satisfaction was Linked to Improved Adherence, and Mental, Physical, Sexual and Overall Health Among People Living with HIV in the Positive Perspectives 3 Study
R. Patel
Poster Exhibition WEPED080
16 July 2025
12:00 PM – 13:00 PM CAT
Data from the Positive Perspectives 3 Study Highlights the Continued Need for Expansion of Awareness, Belief and Confidence in Undetectable Equals Untransmittable (U=U)
N. Nwokolo
E-Poster EP0597
Joint Patient-Provider Decision Making was Associated with Improvements in Quality of Life and Treatment Satisfaction for People Living with HIV in the Positive Perspectives 3 study
R. Patel
E-Poster EP0608
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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. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.
Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection
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 as a complete regimen to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg in the EU, and weighing at least 25 kg in the US, with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.
Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets.
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 Q1 Results for 2025.
References
__________________________________________
1 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.
2 A. Pozniak, et al. High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
3 C. Wyen, et al. 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
4 F. Felizarta, et al. Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
5 G. Blick, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
6 R. Hsu, et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
7 J. Altamirano, et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
8 D. Dandachi, et al. One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
9 Z. Tims-Cook, et al. Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
10 B. Jones, 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.
11 E. Cordova, et al. Efficacy of dolutegravir plus lamivudine in treatment-naïve people with HIV with baseline transmitted drug-resistance mutations: a subanalysis of the D2ARLING study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
12 L.A. Ombajo, et al. Efficacy and safety of switching to dolutegravir/lamivudine dual therapy from bictegravir/emtricitabine/tenofovir alafenamide among virally suppressed older adults ≥60 years: week 24 results from the Sungura study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
13 R. Patel, et al. Treatment satisfaction was linked to improved adherence, and mental, physical, sexual and overall health among people living with HIV in the Positive Perspectives 3 study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
14 R. Patel, et al. Data from the Positive Perspectives 3 Study highlights the continued need for expansion of awareness, belief and confidence in undetectable equals untransmittable (U=U). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
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