2025 Articles

Fixed dosing versus weight-based dosing of HIV-1 prophylactic monoclonal antibodies in adults: a post-hoc, cross-protocol pharmacokinetics modelling study

Zhang, Lily; Gelderblom, Huub; Seaton, Kelly E.; Yates, Nicole L.; Paez, Carmen A.; Karuna, Shelly T.; Andrew, Philip; Gamble, Theresa; Robinson, Samuel Thomas; Ledgerwood, Julie E.; Hyrien, Ollivier; Walsh, Stephen R.; Gay, Cynthia L.; Gwira, Jane A.; Spiegel, Hans M. L.; Sobieszczyk, Magdalena E.; Mannheimer, Sharon B.; Edupuganti, Srilatha; Hurt, Christopher B.; Stephenson, Kathryn E.; Yu, Chenchen; Kelley, Colleen F.; Mahomed, Sharana; Siegel, Marc; Yacovone, Margaret; Pensiero, Michael N.; Donnell, Deborah; Cohen, Myron S.; Corey, Lawrence; Gilbert, Peter B.; Koup, Richard A.; Tomaras, Georgia D.; VRC 605 Study Team; HVTN 127/HPTN 087 Study Team; HVTN 130/HPTN 089 Study Team; HVTN 136/HPTN 092 Study Team; HVTN 140/HPTN 101 Study Team

For HIV-1 prophylactic mAbs, a fixed-dose approach, possibly banded by weight categories may be advantageous over weight-based dosing, as it offers increased operational efficiency while maintaining comparable pharmacokinetics and inter-individual consistency.

Keywords: HIV prevention; Dosing strategy; Exponent of body weight; Two-compartment; Population pharmacokinetics model; Variability in exposure