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TREATMENT-NAÏVE* STUDIES

VPRIV is a first-line option for your treatment-naïve patients1,2

The recommended starting dose for treatment-naïve patients 4 years of age and older is 60 U/kg once every other week as a 60-minute IV infusion.1 VPRIV should be administered under the supervision of a healthcare professional.1

male VPRIV patient hero blob

*Treatment-naïve: patients who had not received disease-specific treatment for at least 30 months prior to starting VPRIV3

STUDY 032 DESIGN (N=25)3

R
(N=25)

VPRIV 45 U/KG
EOW
(n=13)
VPRIV 60 U/KG
EOW
(n=12)

PRIMARY OBJECTIVE

Change in hemoglobin concentration from baseline to 12 months in the 60 U/kg treatment group.3

SECONDARY OBJECTIVES

Included changes from baseline to 12 months in hemoglobin concentration in the 45 U/kg treatment group; and changes from baseline to 12 months in platelet count, and spleen and liver volumes, for both treatment groups.3

At 12 months, VPRIV improved hemoglobin concentration with clinically relevant differences from baseline observed. Differences from baseline were observed for secondary objectives.3

PRIMARY OBJECTIVE

HEMOGLOBIN CONCENTRATION

  • Mean hemoglobin concentration at baseline: 10.6 g/dL1
  • Mean change at 12 months: +2.4 g/dL ± 0.3 (SE)1,3
Hemoglobin

SECONDARY OBJECTIVES

PLATELET COUNT

  • Mean platelet count at baseline: 97 × 109/L1
  • Mean change at 12 months: +51 × 109/L ± 12 (SE)1,3
Platelet

SPLEEN VOLUME

  • Mean spleen volume at baseline: 2.9% of body weight1
  • Mean change at 12 months: −1.9% ± 0.5 of body weight1
Damaged Spleen

LIVER VOLUME

  • Mean liver volume at baseline: 3.6% of body weight1
  • Mean change at 12 months: −0.84% ± 0.33 of body weight1
Liver

Mean change (%) from baseline3

Chart legend
Up arrow

Increasing hemoglobin and platelet counts

Down arrow

Decreasing spleen and liver volumes

HEMOGLOBIN
CONCENTRATION
PLATELET COUNT
SPLEEN VOLUME
LIVER VOLUME

+23%

n=12

+66%

n=12

−50%

n=12

−17%

n=12

This decrease was not
statistically significant
after adjusting for
multiple tests

100

50

0

0

−50

−100

EOW, every other week; R, randomized; SE, standard error

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.