Aim for zero: Most people on HEMLIBRA didn’t have any bleeds that needed treatment with additional therapy
Percentage of people with zero bleeds in our studies*†
WITHOUT factor VIII inhibitors: HAVEN 3 Study (adults and young adults)
WITH factor VIII inhibitors: HAVEN 1 Study (adults and young adults)
WITH factor VIII inhibitors: HAVEN 2 Study (children)
WITH or WITHOUT factor VIII inhibitors: HAVEN 4 Study (adults and young adults)
*The need to treat was determined by the
individual or the trial physician.
†Individuals did not receive prophylactic bypassing therapy.
Adults: 18 years or older.
Young adults (adolescents): 12 to less than 18 years.
Children: less than 12 years.
People who were included in HAVEN 1 and HAVEN 3 were in the study for at least 24 weeks. People in HAVEN 2 were in the study for at least 52 weeks. People in HAVEN 4 were in the study for at least 24 weeks.
The median time on HEMLIBRA was 31 weeks (HAVEN 3), 29 weeks (HAVEN 1), 58 weeks (HAVEN 2), and 26 weeks (HAVEN 4). A median is a numeric middle. That means that in a list of numbers, the median is the number in the middle.
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Decrease in bleed rate in a study of adults and young adults without factor VIII inhibitors‡
People who switched from taking factor VIII to prevent bleeds (prophylaxis) to HEMLIBRA had 68% fewer bleeds that needed treatment.
Median observational period of 34 weeks.
‡This is a “before and after” (intra-patient) analysis.
§95% CI; prior factor VIII (n=48): 4.8 (3.2; 7.1); HEMLIBRA (n=48): 1.5 (1.0; 2.3).
HEMLIBRA was also studied in children without FVIII inhibitors
A study in Japan called HOHOEMI measured the annualized bleed rate (ABR) in children without factor VIII inhibitors using HEMLIBRA. This was a descriptive study with a small patient population (13 children). In a descriptive analysis, researchers are simply looking at what happened in the clinical trial, without determining a definitive benefit.
Children who were included in HOHOEMI were in the study for at least 24 weeks.
The median time on HEMLIBRA every 2 weeks and HEMLIBRA every 4 weeks was 39 weeks and 32 weeks, respectively.
More than 6100 people have been treated with HEMLIBRA worldwide
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