Strategies to Manage Dosing Deviations and Interruptions of Cabotegravir Long-Acting Intramuscular Injections.

ABSTRACT: Long-acting cabotegravir is approved for HIV treatment and prevention. To guide management of dosing deviations and interruptions, concentration-time profiles for monthly and every 2 months regimens were simulated using a population pharmacokinetic (PPK) model. Adequate exposure was defined as trough concentration (C_tau) >0.45 µg/mL (observed 5th percentile of first C_tau in pivotal studies) in >95% of subjects and maximum concentration (C_max) <13.1 µg/mL (highest observed median steady-state C_max in previous studies) in >50% of subjects. Simulations showed: (1) median C_max remained ≤6.35 µg/mL after doubled doses; (2) C_tau was suboptimal after half dose at first injection but recovered with a corrective dose; (3) injection d

SUBMITTER: Han K 

PROVIDER: S-EPMC12814316 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature