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.
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Córdova Ezequiel, Rolle Charlotte-Paige, Hove Kai, Felizarta Franco, Johnson Marc, Cuevas Tascón Guillermo, Molina Jean-Michel, Bravo Urbieta Joaquin, Hocqueloux Laurent, Lupo Sergio, Perez Carlos M, Ole Jensen Björn-Erik, Jonsson-Oldenbüttel Celia, Zamora Vargas Francisco Xavier, Szabo Jason, Cahn Pedro, Antinori Andrea, López Bernaldo de Quirós Juan Carlos, Castagna Antonella, Bui Monika, Grove Richard, Wang Kehui, St Clair Marty, Moodley Riya, Radford Jacob, Priest Julie, Gutner Cassidy A, Jacob Ian, Chatterjee Avishek, Somvanshi Suryakant, Kolobova Irina, Trehan Rekha, Polk Christopher, Patel Parul, de Los Rios Patricia, DiMondi Paul, Gordon Lori A, Brown Kimberley, Garges Harmony P, Jones Bryn, van Wyk Jean
Аннотация
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+ cell count categories. At Day of Choice (DoC), 85% (n = 129/151) of eligible participants chose to switch to CAB+RPV LA. At M11, 113/129 (88%) participants maintained suppression with CAB+RPV LA; 1 participant had confirmed virologic failure with resistance (integrase strand transfer inhibitor and non-nucleoside reverse transcriptase inhibitor). Both regimens were well tolerated, with no new safety signals observed. Treatment satisfaction improved after DoC and remained high with CAB+RPV LA.
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.