Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half-life factor VIII concentrates

Abstract

Background: BAY81-8973 (Kovaltry; Bayer, Berkeley, CA, USA) was reported with enhanced pharmacokinetic (PK) profiles compared with some other standard half-life (SHL) factor VIII (FVIII) concentrates. Limited head-to-head comparative studies were conducted in a real-world setting. Objective: To make head-to-head comparisons of PK and clinical outcomes between Kovaltry and three other SHL FVIII concentrates. Methods: Forty-seven boys with severe hemophilia A were enrolled and divided into three groups according to their previously used FVIII concentrates (Kogenate FS, N = 22; Advate, N = 14; GreenMono, N = 11). Two separate PK tests were conducted in each participant with a five-point assay during the study period from 6 months before switching to 6 months after switching. FVIII levels were detected by one-stage assay, and PK profiles were calculated by noncompartmental assay. Annualized bleeding rates were collected through participant’ bleed logs. Results: Longer half-life time (Kogenate FS group: 14.4 vs 11.9 hours, P