HEMLIBRA® was studied in people without factor VIII inhibitors

HAVEN 3 studied 152 adults and adolescents with hemophilia A (aged 12 and up, weighing at least 40 kg) without factor VIII inhibitors for a minimum of 24 weeks. 89 patients previously treated with on-demand therapy were randomized to receive HEMLIBRA prophylaxis 1.5 mg/kg once weekly (Group A), 3 mg/kg every 2 weeks (Group B), or no prophylaxis (Group C). 63 patients previously treated with prophylactic FVIII therapy received HEMLIBRA 1.5 mg/kg once weekly (Group D).

HEMLIBRA delivered a substantial reduction in treated bleeds*


Consistent reduction in ABR seen with HEMLIBRA once every 2 weeks (97%, n=35) vs. on-demand FVIII therapy (n=18).

Significant reduction in treated bleeds* compared with prior prophylactic factor VIII therapy


In this "before and after" comparison of prophylactic factor VIII therapy and HEMLIBRA, 48 people:

  • First used their routine prophylactic factor VIII therapy for at least 24 weeks and the results were measured
  • They then switched to HEMLIBRA once weekly for at least 24 weeks and the results were measured and compared
  • In this comparison, there were 68% fewer treated bleeds* on HEMLIBRA

The majority of people using HEMLIBRA had zero treated bleeds*

Compared with on-demand (no prophylaxis) factor VIII therapy

56% of people who used HEMLIBRA once weekly had zero bleeds (n=36) vs. 0% of those who used on-demand FVIII therapy (n=18). The majority of people who used HEMLIBRA once every 2 weeks also had zero bleeds (60%, n=35).

Compared with prior prophylactic factor VIII therapy

54% of people who used HEMLIBRA once weekly had zero bleeds (n=48) vs. 40% when they used their prior prophylactic FVIII therapy (n=48).

FVIII=factor VIII.
*The need to treat was determined by the individual or the trial physician.
Individuals did not receive prophylactic factor VIII therapy.
This is a “before and after” (intra-patient) analysis.

To learn more about HEMLIBRA for adults, adolescents, and children with factor VIII inhibitors, click here.

HEMLIBRA Results in Children

See study results for children with factor VIII inhibitors

Sign Up for Support

Stay informed with HEMLIBRA support and resources

Treating Breakthrough Bleeds

Making a plan