ViiV Healthcare announces data from Phase IIIb VOLITION study

ViiV Healthcare, the HIV company majority owned by GSK (GSK), with Pfizer (PFE) and Shionogi (SGIOY) as shareholders, announced data from the phase IIIb VOLITION study demonstrating that 89% of eligible treatment-naive people living with HIV opted to switch to long-acting injectable Vocabria + Rekambys following rapid viral suppression with daily Dovato. Additional real-world data from other studies reinforce CAB+RPV LA’s effectiveness across a broad range of populations. Data summary from ViiV Healthcare and partner studies at IAS 2025: Empowering choice: 89% of treatment-naive people with HIV opt for CAB+RPV LA after achieving rapid viral suppression: These new data from the phase IIIb VOLITION study evaluate the experience of treatment-naive individuals who initiated treatment with daily DTG/3TC pills and were subsequently offered the choice to switch to CAB+RPV LA after achieving viral suppression. Study results showed that participants achieved rapid viral suppression with DTG/3TC, following which they were offered to switch. At the immediate next study visit, 89% of eligible participants chose to switch to CAB+RPV LA, while 11% opted to continue DTG/3TC. The most common reasons cited for choosing CAB+RPV LA were not having to worry about missing a dose each day and not having to carry medication.These findings underscore the efficacy and tolerability of DTG/3TC as a rapid suppression option, and demonstrate the value of offering CAB+RPV LA as a treatment option to meet individual needs and preferences. CAB+RPV LA delivers sustained effectiveness and enhanced patient experience in real-world settings: Data from multiple real-world observational studies, including the two-year BEYOND study in the US, the CARLOS study in Germany, the COMBINE-2 cohort across seven European countries, and the OPERA study, consistently reinforce the high effectiveness, favourable outcomes and patient satisfaction associated with CAB+RPV LA. BEYOND is a two-year prospective observational study enrolling people with HIV following the decision to switch to CAB+RPV LA across 27 U.S. sites.2 Among the 308 participants, 97% maintained virologic suppression at Month 24, with infrequent discontinuations due to injection reactions and no new confirmed virologic failures after Month 6. Participants reported reduced stigma and improved treatment satisfaction. Similarly, the real-world CARLOS study of 351 participants in Germany, showed 77.5% virologic suppression at Month 24, with high adherence and clinically meaningful improvements in treatment satisfaction.4 97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation. In Europe, the COMBINE-2 study, evaluating real-world outcomes for 956 virologically suppressed people with HIV initiating CAB+RPV LA across seven European countries, reported 99% virologic suppression at last measured viral load, with low rates of confirmed virologic failure and high persistence. Real-world evidence focused on the effectiveness of CAB+RPV LA outside the labelled indication in viraemic patients: The large-scale OPERA study further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Among the 3,304 participants, 11% initiated with baseline viremia of these, 88% achieved viral suppression to less than50 copies/mL. A separate analysis also showed that among a diverse group of 105 women initiating CAB+RPV LA with viremia, most achieved viral suppression with confirmed virologic failure being rare.6,7 Through these findings, CAB+RPV LA was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control..