Trial reportOpen forum infectious diseases2026
Rapid Virologic Suppression With Dolutegravir Plus Lamivudine Facilitates Early Switch to Long-Acting Cabotegravir Plus Rilpivirine for Treatment-Naive People With HIV-1: Month 11/12 Outcomes From the Phase 3b VOLITION Study.
Trial report in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05917509 (A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1), which is not on this map. Not yet cited in PubMed.
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A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1
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Abstract
Background: Long-acting cabotegravir plus rilpivirine (CAB+RPV LA) and dolutegravir plus lamivudine (DTG/3TC) are HIV-1 antiretroviral therapy regimens with different administration routes and dosing frequencies, allowing for greater choice.plus. Methods: VOLITION is a phase 3b, multicenter, nonrandomized, parallel-group, open-label implementation-effectiveness study (NCT05917509) evaluating viral suppression on DTG/3TC for up to 16 weeks, followed by a participant-determined optional switch to CAB+RPV LA dosed Q2M or continuation of DTG/3TC through Month (M) 11/12. Co-primary endpoints were the time to virologic suppression with DTG/3TC and the proportion of participants with HIV RNA < 50 copies/mL per the Snapshot algorithm at M11 with CAB+RPV LA. Safety and participant experience were also assessed. Results: One hundred and seventy-one participants initiated DTG/3TC. Median time to suppression on DTG/3TC was 4.1 weeks (95% confidence interval: 4.1-4.3), with 98% (n = 167/171) achieving virologic suppression and similar rates observed across baseline viral load and CD4 Conclusions: Providing treatment-naive participants with the option to switch to CAB+RPV LA as soon as virologic suppression was achieved on daily oral therapy allowed them to choose a treatment to meet their individualized needs while maintaining virologic suppression, which is essential for long-term treatment success and optimized quality of life. Clinical Trial Registration: NCT05917509.
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