ViiV Healthcare Showcases Extensive Long-Acting HIV Portfolio with Over 60 Abstracts at EACS 2024 and IDWeek 2025
ViiV Healthcare, the global specialist HIV company majority-owned by GSK with Pfizer and Shionogi as shareholders, has announced the presentation of more than 60 scientific abstracts at two major international infectious disease conferences this October. These include the 20th European AIDS Conference (EACS), taking place in Paris, France from 15–18 October 2024, and IDWeek 2025, held in Atlanta, Georgia, USA from 19–22 October. The breadth and depth of data underscore ViiV Healthcare’s continued leadership in long-acting HIV treatment and prevention, featuring pivotal studies on cabotegravir long-acting (CAB LA), lenacapavir (LEN), and innovative combination approaches.
Among the most anticipated presentations is the initial data from the phase I CLARITY crossover study—the first head-to-head comparison of the acceptability and tolerability of single-dose CAB LA and LEN injections in HIV-negative adults. This study marks a significant step forward in understanding patient and provider preferences between two leading long-acting injectable antiretrovirals, offering critical insights that could shape future clinical decision-making and regimen selection.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, emphasized the importance of this research: “The breadth of our data presented at EACS and IDWeek reinforces 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.”
CLARITY Study: A First-of-Its-Kind Comparison
The CLARITY study is a randomized, crossover phase I trial involving 63 HIV-negative adults who received single intramuscular injections of both CAB LA and LEN in a randomized sequence, with a washout period in between. Primary endpoints include participant-reported acceptability and tolerability, with a specific focus on injection site reactions (ISRs). Early findings indicate clinically relevant differences in the frequency, severity, and duration of ISRs between the two agents. These data are particularly valuable as both CAB LA and LEN represent the next generation of long-acting HIV prevention tools, and understanding tolerability profiles can significantly influence adherence and long-term uptake.
Real-World Evidence Strengthens CAB LA for PrEP
At IDWeek 2025, ViiV Healthcare will present multiple real-world studies evaluating the implementation and impact of CAB LA (branded as Apretude in the U.S., Canada, and Australia) for HIV pre-exposure prophylaxis (PrEP). The PrEPFACTS study will shed light on U.S. HIV testing patterns and seroconversion rates among individuals using CAB LA, providing context for its effectiveness in routine clinical settings. Complementing this, data from the OPERA cohort will detail how CAB LA and oral PrEP are being administered in real-world practice, highlighting gaps and opportunities for optimizing HIV prevention strategies.
Additionally, interim results from the phase IV EBONI study will offer crucial perspectives from Black women—a population disproportionately affected by HIV in the U.S., accounting for nearly half of all new HIV diagnoses among women. The EBONI study explores their experiences with CAB LA, including access, adherence, satisfaction, and perceived barriers, ensuring that equity remains central to HIV prevention innovation.
Reinforcing the Role of CAB+RPV LA in Diverse Populations
Long-acting cabotegravir plus rilpivirine (CAB+RPV LA), marketed as Cabenuva in several countries and as Vocabria + Rekambys in others, continues to demonstrate strong real-world performance. At EACS, a comprehensive meta-analysis pooling data from 26 studies involving over 7,000 virologically suppressed people living with HIV (PLHIV) will present robust evidence on the regimen’s effectiveness, adherence, and tolerability across varied demographics and healthcare settings.
Further reinforcing its durability, IDWeek will feature a four-year analysis from the OPERA cohort examining how long patients remain on CAB+RPV LA and their sustained virologic outcomes across different age groups. These long-term data are essential for clinicians considering long-acting regimens as a standard of care for stable patients seeking alternatives to daily oral therapy.
VOLITION Study: Provider Perspectives on Early Switch Strategies
The phase III VOLITION study, to be presented at EACS, will report healthcare providers’ views on an early switch strategy to CAB+RPV LA following rapid viral suppression with Dovato (dolutegravir/lamivudine, or DTG/3TC) in treatment-naïve adults. This approach aims to streamline care by transitioning eligible patients to long-acting therapy sooner, potentially improving long-term adherence and quality of life. The findings build upon earlier VOLITION results that demonstrated high efficacy, safety, and patient satisfaction when individuals were given the choice between continuing Dovato or switching to CAB+RPV LA based on personal preference.
Advancing Two-Drug Regimens: DTG/3TC Data Across Populations
ViiV Healthcare will also present new long-term efficacy and safety data for its foundational two-drug regimen, DTG/3TC (Dovato). At EACS, 96-week results from PASO DOBLE—the largest head-to-head randomized trial comparing DTG/3TC with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)—will be unveiled. The study evaluates not only virologic suppression but also metabolic outcomes, such as lipid profiles and bone mineral density, which are increasingly important in aging PLHIV populations.
Complementing this, the DOLCE study—sponsored by Fundación Huésped—will report findings on DTG/3TC use in virologically suppressed adults with low CD4 counts (<200 cells/mL), a historically challenging subgroup. Additionally, the global retrospective REGAL study will compare DTG/3TC and BIC/FTC/TAF in older adults (aged 50+) across multiple regions, offering real-world insights into regimen performance in an aging HIV population.
