ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the presentation of more than 60 abstracts, including data from its industry-leading long-acting HIV treatment and prevention portfolio, at the 20th 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. 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 supressed 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.
For more information, read the original press release.
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