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

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:

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

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GSK plc ViiV Healthcare Limited

No. 3888792 No. 06876960

Registered Office:

79 New Oxford Street ViiV Healthcare Limited

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United Kingdom

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References

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