Phase IIIb VOLITION Trial Shows Strong Patient Preference for Long-Acting HIV Therapy After Rapid Suppression on Oral Treatment

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

Positive results from VOLITION trial shared at IAS 2025

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.

• Participants receiving DTG/3TC achieved rapid viral suppression, with a median time to suppression of 4.14 weeks.
• At the next study visit (Day of Choice), 89% (129 of 145) of eligible participants chose to switch to long-acting CAB+RPV, while 11% (16 participants) opted to remain on DTG/3TC.
• The top reasons for switching to the long-acting regimen were:
  • Avoiding daily dosing concerns (80%)
  • Not needing to carry medication (68%)

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.”

Trial design focused on choice and outcomes

• VOLITION is a Phase IIIb, multi-center, non-randomized, parallel-group, open-label, hybrid type I trial evaluating the efficacy, safety, implementation effectiveness, and patient-reported outcomes of oral DTG/3TC once-daily.²
• The patient population is comprised of individuals living with HIV-1 who have not been previously treated with any antiretroviral therapies.
• The trial is evaluating two 2-drug regimens for HIV-1 treatment:
  • Oral DTG/3TC
  • Long-acting CAB+RPV LA
• All participants started on daily DTG/3TC, and once they achieve virologic suppression (HIV-1 RNA <50 copies/mL), they will have the option to either continue DTG/3TC or switch to CAB+RPV LA.
• The study is assessing time to viral suppression on DTG/3TC, antiviral effectiveness at 11 months post-switch to CAB+RPV LA, as well as safety, implementation outcomes, and patient-reported experiences with each regimen.

Real-world data supports long-acting therapy’s utility

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:

• Out of 3,304 participants, 11% (368 individuals) started treatment with detectable viral load (>50 copies/mL).
• Among those with follow-up data, 88% (277 of 313) achieved viral suppression (<50 copies/mL) during the study period.
• A separate subgroup analysis of 105 women who began CAB+RPV LA with viremia showed that 92% (85 of 92) achieved suppression at some point during follow-up.
• Confirmed virologic failure in this population was rare, demonstrating the regimen’s effectiveness in diverse patient groups.
• Additionally, these findings highlighted CAB+RPV LA’s ability to address challenges related to daily oral pills.

References

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