HAVEN 1 and HAVEN 2 efficacy data

HEMLIBRA was studied in 2 pivotal, multicenter, open-label studies, HAVEN 1 and HAVEN 2, in adults, adolescents, and children with hemophilia A with factor VIII inhibitors. HEMLIBRA subcutaneous dosing: 3 mg/kg by subcutaneous injection QW for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg.

HAVEN 1: a randomized, multicenter, open-label, phase III study of patients with hemophilia A with FVIII inhibitors aged 12 to 75 years weighing >40 kg (n=109, all males). Efficacy was evaluated based on the ABR requiring BPAs for a minimum of 24 weeks or date of discontinuation.

HAVEN 2 interim analysis: a single-arm, multicenter, open-label study of patients with hemophilia A with FVIII inhibitors aged <12 years and 12 to 17 years weighing <40 kg (n=63, all males). The interim efficacy analysis examined a reduction in treated bleed rate in 59 children aged <12 years taking HEMLIBRA for at least 12 weeks.

HAVEN 1

HAVEN 2

BPAs=bypassing agents; CI=confidence interval; FVIII=factor VIII; Haem-A-QoL=Haemophilia Quality of Life Questionnaire for Adults; IQR=interquartile range; NE=nonevaluable; QW=every week.
ABR=annualized bleed rate. ABR calculated with a negative binomial regression model, which accounts for different follow-up times. 15
*Defined as bleeds treated with bypassing agents based on an adaptation of standard criteria defined by the International Society on Thrombosis and Haemostasis (ISTH). 15
Categorized number of bleeds and ABR; all bleeds (treated patients aged <12 years). 

Efficacy in Patients Without Inhibitors

Learn about the primary and secondary results for patients without FVIII inhibitors

Adverse Reactions

Adverse reactions from pooled clinical studies with HEMLIBRA

Dosing Calculator 

Help calculate the dosage for your HEMLIBRA patient