• Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) for HIV treatment and assess experiences of using Apretude (cabotegravir long-acting (CAB LA) for PrEP) in range of populations
• New phase IIIb data look at preferences among treatment-naive adults offered the choice to switch to CAB+RPV LA after attaining rapid viral suppression with Dovato (DTG/3TC) daily oral therapy
• Interim data from wave three of the Positive Perspectives study demonstrate impact of joint decision-making on HIV treatment satisfaction and health outcomes

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of abstracts from its innovative HIV treatment and prevention portfolio at the International AIDS Society 2025 Conference (IAS 2025) in Kigali, Rwanda. Key data will highlight the long-term effectiveness of Vocabria & Rekambys, (branded as Cabenuva in the US, Canada and Australia) the company’s complete long-acting injectable regimen for treatment; evaluate patient preference for long-acting injectables compared to daily oral therapy; and measure benefits of long-acting injectables in tackling common challenges associated with taking daily pills, including stigma and adherence.

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:

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.

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