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 two 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).

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

HEMLIBRA COMPARED WITH PRIOR PROPHYLACTIC FACTOR VIII THERAPY

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

  • First took 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

Main goal of trial: HEMLIBRA delivered a substantial reduction in treated bleeds*

HEMLIBRA COMPARED WITH ON-DEMAND (NO PROPHYLAXIS) FACTOR VIII THERAPY

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

The majority of people taking HEMLIBRA had zero treated bleeds*

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

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

Compared with prior prophylactic factor VIII therapy

54% of people who took HEMLIBRA once weekly had zero bleeds (n=48) vs. 40% when they took 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

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Treating Breakthrough Bleeds

Making a plan