New data from the VOLITION study reveal that 89% of treatment-naïve individuals with HIV chose to switch to long-acting cabotegravir and rilpivirine after achieving viral suppression with oral DTG/3TC, with real-world evidence further supporting its effectiveness across diverse populations.
ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has announced positive data from the Phase IIIb VOLITION (NCT05917509) clinical trial. Data show that 89% of eligible treatment-naïve people living with HIV elected to switch to long-acting injectable Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additionally, real-world data of CAB+RPV LA, which is branded as Cabenuva, reinforced its effectiveness across a wide range of populations.1
Presented at IAS 2025, findings from VOLITION highlighted the experience of treatment-naïve individuals who initiated treatment with daily DTG/3TC pills and were then offered to switch to CAB+RPV LA after achieving viral suppression.
In a press release, Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, said: “Data from the VOLITION study highlight how providing choice in HIV care empowers individuals to choose medicines that meet their evolving everyday needs. ViiV pioneered long-acting injectables for HIV, and we now have over three years of robust real-world evidence demonstrating the impact our portfolio is having today across a broad range of settings and populations. Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.”
ViiV also shared data from OPERA, a large-scale, real-world evidence study which further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Results showed:
1. ViiV HEALTHCARE DATA SHOW 89% OF TREATMENT-NAÏVE PEOPLE WITH HIV CHOOSE TO SWITCH TO LONG-ACTING INJECTABLE VOCABRIA + REKAMBYS FROM DAILY PILLS AFTER ACHIEVING RAPID VIRAL SUPPRESSION. News release. ViiV Healthcare. July 14, 2025. Accessed July 17, 2025. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/july/daily-pills-after-achieving-rapid-viral-suppression/
2. A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (VOLITION). ClinicalTrials.gov. Updated July 17, 2025. Accessed July 17, 2025. https://clinicaltrials.gov/study/NCT05917509
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
Imugene’s Azer-Cel Shows Promise in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
July 16th 2025Results from a Phase Ib trial (NCT03666000) show that azer-cel demonstrated a 75% overall response rate and a 55% complete response in patients with relapsed/refractory diffuse large b-cell lymphoma.
