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2 With moderate haemophilia, no bleeds were observed with factor VIII levels over 10%, which now seems to become accepted as the “new normal”. This result is very similar to those presented earlier for long-term outcome in severe haemophilia on life-long prophylaxis. 9 At a median age of 37 years, the bleeding frequency in these patients was 2.0 (IQR 0.8-3.7) bleeds per year. In the search for the preferred level to prevent bleeding completely, the publication of a study on long-term bleeding in 75 patients with moderate haemophilia has received much attention. Moderate haemophilia, with factor VIII/IX levels between 1% and 5%, is an interesting “natural” model and therefore has recently received renewed attention. Interestingly, the Swedish prophylactic regimen of 20-40 IU/kg factor VIII 3 times a week, which for decades was perceived as too high and too costly, now, in the landscape of plenty, is considered inferior. Stakeholders now suggest that the current prophylactic dosing is too low. 7 Especially in the light of gene therapy, where a single infusion may give long-term cure, it is important to know which level to aim for.

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The justification for higher through levels came also from the notion that adult patients on full prophylaxis may still report bleeding. Parents might be persuaded that higher through levels with the same dosing and frequency of EHL is preferable.

It takes a long time before the deleterious effect of increased bleeding in children becomes visible. For haemophilia A, especially in children, reducing dosing should be done very cautiously. 5,6 Especially for haemophilia B, EHL products have a clear benefit because they enable once-weekly dosing. 4 It is important to better investigate the impact of high dosing in order to prevent unnecessary inhibitor development.Įxtended half-life (EHL) products became available only a few years ago and were developed to decrease the burden of infusions for patients and improve adherence to prophylaxis. 4 Although debate is ongoing regarding different risk profiles between products, the higher dosing which became possible after the introduction of recombinant products might have played an important role. The development of inhibitors in 25-30% of the patients during the first 50 exposure days is still a major side-effect of treatment. Some countries now even use up to 10 IU per capita, while the worldwide median per capita use is still only 0.83 IU.

Higher dosing for prophylaxis became possible for patients living in countries that could pay for the high costs. The first step that increased clotting product volumes was the introduction of recombinant products in the early nineties. The explosion of new products for the treatment of haemophilia will hopefully benefit all patients and change the current landscape from shortage, allowing only limited dosing in prophylactic regimens, to one of plenty. Now the landscape is changing dramatically. The Swedish and the Dutch groups have published the most comprehensive data on long term outcome with life-long prophylaxis. 1 Patients having access to primary prophylaxis are growing up without or with very limited joint problems. To prevent joint disease prophylaxis should be started very early, preferably after no more than 1-2 joint bleeds. Prophylaxis aimed at the prevention of bleeds is now globally accepted as the superior therapy. Only countries in the developed world with health-care systems that reimbursed the costs of treatment were able to start prophylaxis-based treatment regimens. Therefore, patients had no access to treatment at home and treatment was only delivered after long delays and more often not at all. It was therefore understandable that treatment choices were made based on shortage models. Even today many countries lack a continuously supply and patients are left without any choice. Introduction: Haemophilia treatment has long been hampered by the shortage of products. 00-Invited Presentation Summaries TU-PL-G – WFH VP Medical's Address New horizons within sight for haemophilia