Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.
Related links:
HAVEN 3 demonstrated significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. episodic FVIII2
HAVEN 3 was a randomised, multicentre, open-label, phase III study in 152 adult and adolescent males with severe congenital haemophilia A (endogenous FVIII activity, <1%) without inhibitors, ≥12 years; treated with episodic FVIII or FVIII prophylaxis in the prior 24 weeks.2,3
In the HAVEN 3 study, treated annualised bleed rate (ABR; primary efficacy endpoint) was 38.2 with episodic FVIII (95% CI, 22.9–63.8; Arm C, n=18) compared with:2
- 1.5 with HEMLIBRA 1.5 mg/kg/QW, a 96% reduction (95% CI, 0.9–2.5; Arm A, n=36; p<0.001)
- 1.3 with HEMLIBRA 3.0 mg/kg/Q2W, a 97% reduction (95% CI, 0.8–2.3; Arm B, n=35; p<0.001)
56% and 60% of patients had zero treated bleeds with HEMLIBRA QW (95% CI, 0–18; Arm A, n=20/36) and HEMLIBRA Q2W (95% CI, 42–76; Arm B, n=21/35) vs. 0% with episodic FVIII (95% CI, 0–18; Arm C, n=0/18).2
Significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. prior FVIII prophylaxis (intra-individual comparison of patients from non-interventional study, Arm D)2
Treated ABR was 4.8 with prior FVIII prophylaxis (95% CI, 3.2–7.1) compared with:2
- 1.5 with HEMLIBRA 1.5 mg/kg/QW, a 68% reduction (95% CI, 1.0–2.3; Arm D, n=48; risk ratio 0.32; 95% CI, 0.20–0.51; p<0.001)
54% of patients had zero treated bleeds with HEMLIBRA QW (95% CI, 39–69; n=26/48) vs. 40% with prior FVIII prophylaxis (95% CI, 26–55; Arm D, n=19/48).2
For further details of the intra-individual study please see Study designs
For full study details please refer to the HAVEN 3 publication
HAVEN 1 demonstrated significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. episodic bypassing agents (BPAs)4
HAVEN 1 was a randomised, multicentre, open-label, phase III study in 109 adult and adolescent males with congenital haemophilia A with FVIII inhibitors ≥12 years, ≥40 kg; treated with episodic BPAs or BPA prophylaxis in the prior 24 weeks.4,5
In HAVEN 1, treated ABR (primary efficacy endpoint) was 23.3 with episodic BPAs (95% CI, 12.3–43.9, Arm B, n=18) compared with:4
- 2.9 with HEMLIBRA 1.5 mg/kg/QW, an 87% reduction (95% CI, 1.7–5.0; Arm A, n=35; p<0.001)
62.9% of patients had zero treated bleeds with HEMLIBRA QW (95% CI, 44.9–78.5; Arm A, n=22/35) vs. 5.6% with episodic BPAs (95% CI, 0.1–27.3; Arm B, n=1/18).4,5
For details on how efficacy is maintained over time please see Long-term efficacy
For details of the HAVEN 2 and HAVEN 4 non-randomised trials please see Efficacy non-RCTs
For details on safety please see Safety
For full study details please refer to the HAVEN 1 publication
ABR, annualised bleed rate; BPA, bypassing agent; CI, confidence interval; FVIII, Factor VIII; QW, every week; Q2W, every 2 weeks; RCT, randomised controlled trial.
References:
- HEMLIBRA Summary of Product Characteristics.
- Mahlangu J et al. N Eng J Med 2018;379:811–22.
- Mahlangu J et al. N Eng J Med 2018;379:811–22 [Supplementary Appendix].
- Oldenburg J et al. N Eng J Med 2017;377:809–18.
- Oldenburg J et al. N Eng J Med 2017;377:809–18 [Supplementary Appendix].
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Date of preparation: September 2021
