Not an actual patient.
Bleed protection for adults and adolescents ages 12+
BASIS study objectives—with or without inhibitors
The primary objective was to evaluate the annualized bleed rate (ABR) of treated bleeds vs on-demand factor-based treatment without inhibitors, vs factor-based prophylaxis without inhibitors, and vs on-demand bypassing treatment with inhibitors after 12 months on HYMPAVZI.
The secondary objective of the study included evaluation of HYMPAVZI prophylaxis (compared with on-demand factor-based treatment without inhibitors, routine prophylaxis treatment without inhibitors, and on-demand bypassing treatment with inhibitors) based on the occurrences of treated joint bleeds, treated target joint bleeds, treated spontaneous bleeds, and total bleeds.
Frequency and severity of adverse events and serious adverse events observed with HYMPAVZI were also studied.
The phase 3 BASIS study was designed to include the following objectives about HYMPAVZI: (1) if 12 months of HYMPAVZI treatment works better than previous on-demand factor treatments to reduce bleeding (ie, is HYMPAVZI superior?), (2) if 12 months of HYMPAVZI treatment works better than previous on-demand bypassing agent treatments to reduce bleeding (ie, is HYMPAVZI superior?), and (3) if 12 months of HYMPAVZI treatment to reduce bleeding is just as effective as routine factor-based prophylaxis treatments in patients without inhibitors (ie, is HYMPAVZI noninferior?).
HYMPAVZI delivered proven bleed protection
BASIS study results—without inhibitors (n=116)
Without Inhibitors
Primary objective:
Reduced treated bleeds
12 months of HYMPAVZI reduced the number of treated bleeding episodes.
ABR of treated bleeds with HYMPAVZI:
lower
lower than on-demand
(3.2 ABR vs 39.9 ABR)
lower
lower than on-demand
(5.1 ABR vs 7.9 ABR)
Secondary objective:
Reduced joint bleeds
ABR of joint bleeds with HYMPAVZI:
lower
lower than on-demand
(2.9 ABR vs 34.5 ABR)
lower
lower than on-demand
(4.1 ABR vs 5.7 ABR)
Reduced target joint bleeds
If a joint has had 3+ bleeds in a span of 6 months, it's considered a target joint.
ABR of target joint bleeds with HYMPAVZI:
lower
lower than on-demand
(1.8 ABR vs 24.4 ABR)
lower
lower than on-demand
(2.5 ABR vs 3.4 ABR)
Reduced spontaneous bleeds
ABR of spontaneous bleeds with HYMPAVZI:
lower
lower than on-demand
(2.5 ABR vs 32.6 ABR)
lower
lower than on-demand
(3.8 ABR vs 5.9 ABR)
Reduced total bleeds
Total bleeds included treated and untreated bleeds.
ABR of total bleeds with HYMPAVZI:
lower
lower than on-demand
(7.4 ABR vs 50.0 ABR)
lower
lower than on-demand
(6.0 ABR vs 8.9 ABR)
BASIS study results—with inhibitors (n=48)
With Inhibitors
Primary objective:
Reduced treated bleeds
12 months of HYMPAVZI reduced the number of treated bleeding episodes.
ABR of treated bleeds with HYMPAVZI:
lower
lower than on-demand
(1.4 ABR vs 19.8 ABR)
Secondary objective:
Reduced joint bleeds
ABR of joint bleeds with HYMPAVZI:
lower
lower than on-demand
(1.1 ABR vs 15.2 ABR)
Reduced target joint bleeds
If a joint has had 3+ bleeds in a span of 6 months, it's considered a target joint.
ABR of target joint bleeds with HYMPAVZI:
lower
lower than on-demand
(0.8 ABR vs 6.3 ABR)
Reduced spontaneous bleeds
ABR of spontaneous bleeds with HYMPAVZI:
lower
lower than on-demand
(0.9 ABR vs 15.3 ABR)
Reduced total bleeds
Total bleeds included treated and untreated bleeds.
ABR of total bleeds with HYMPAVZI:
