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.

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+ 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.