In an editorial in the Journal Haemophilia this week, the editor and the leaders of WFH discuss their view of the Global ramifications of Covid-19 in Haemophilia. They are of the view that the pandemic will have direct and indirect consequences on the management of haemophilia worldwide. They state that the consequences may include:
– Interruption of access to supply chains
– Decrease in supply of plasma derived factor concentrates
– Difficulty in access to treatment centres
– Interruption of clinical research programmes including clinical trials
– Cancellation of many educational meetings and events
– Possible future impact on funding for haemophilia due to financial crisis
I will briefly discuss these issues and try to place them in context for Ireland.
There is a concern globally about access to treatment because of interrupted supply chains. Many countries do not have home delivery systems. Countries who are almost totally reliant on the treatment provided by the WFH Humanitarian aid programme will face particular difficulties as the WFH will have difficulty sending the products by air at the current time. In Ireland, we are fortunate that we have in place a robust home delivery service and an additional two weeks supply has been delivered or is in the process of delivery to all on home treatment.
Production of recombinant factor concentrates and other non-blood products such as Hemlibra should not be adversely affected. The situation is more complex for plasma derived factor concentrates as their production relies on the collection of plasma. Plasma donations may be adversely affected if donors become unwell with Covid-19 or if donors stop donating due to the requirement for social distancing and staying at home. There has already been a small decrease in plasma donation in the countries who supply most of the plasma for fractionation (USA, Germany, Austria, Hungary and Czech Republic). However, in these European countries, plasma collection has been designated as part of the critical health infrastructure which should help to maintain donations.
There is no concern in regard to the potential for transmission of Covid-19 through plasma derived factor concentrates. Covid-19 is a lipid enveloped virus which is readily inactivated by the viral inactivation methods currently in use. We have a reasonable supply of plasma derived FVIII (for von Willebrand’s) and FX in the country and indeed our reserve supply was increased last year due to concerns about Brexit.
The situation in our hospitals is changing daily. To date, we have not had any problems with access to haemophilia treatment centres and it must be restated that if any person with haemophilia or an inherited bleeding disorder needs to attend their centre in case of a major bleeding episode or emergency, they should attend. However, do contact the centre first by phone.
The centres are open and operational. Some adjustments in infrastructure have been made. In St. James’s Hospital, out-patients who attend with bleeding episodes now go to the National Coagulation Centre (NCC) and not the H and H ward. These arrangements may change which is why it is important that you phone the centre before attending. Physical locations for treatment may change but we do not anticipate any major interruption of service. Elective surgeries have been postponed but other procedures which are required are going ahead as planned.
We have not seen an impact here on our participation in clinical trials. The FIX Gene Therapy trial has proceeded as planned and the three individuals due to be treated have been treated and are currently being monitored. Other individuals continue on clinical trials for the subcutaneous therapy Fitusiran. Clearly, we do not anticipate the centres starting participation in any new clinical trials until the pandemic crisis has diminished and some other clinical trials have postponed treatment for new individuals abroad. The pandemic may delay the completion of clinical trials and the consequent licencing of some of the new therapies.
There will be a major impact on international educational conferences on Haemophilia. The World Federation of Hemophilia Conference scheduled for June of this year has been cancelled. The International Society for Thrombosis and Haemostasis Conference will become a virtual meeting. These are the two largest and most important Conferences on Haemophilia. The European Haemophilia Consortium conference in October this year is scheduled to go ahead. We anticipate seeing more virtual meetings over the coming year and indeed this may become a continuing trend.
From the Irish Haemophilia Society, our October members conference is scheduled to proceed at present. Some of our smaller meetings have been cancelled or postponed. Next week, we have organised two separate virtual meetings for members using the Zoom platform. If these are successful, we will look at organising further virtual meetings in the coming weeks for members on different topics and for different demographic groups within our community. Indeed, such virtual meetings may well offer an opportunity for the future- not to replace face to face events – but to supplement our interaction with members.
The financial cost to the country of Covid-19 will be massive. However, now is not the time to focus on this. We must focus on staying well, on avoiding Covid-19 infection for ourselves, for our families and for our community. There will be time later to look at the financial consequences. It is reassuring to state that our formal involvement together with our treating Doctors in the procurement process for haemophilia medications has been one of the most effective, efficient and cost-effective procurement systems not only in the Irish health system but in the global haemophilia world. There is no waste in our procurement system and we will continue to work to ensure optimum access to the safest and most effective treatments in the future.
Other Covid-19 Updates:
There has been a lot of media coverage on potential treatments for Covid-19. They have speculated on the possible use of the anti-malarial drug Hydroxychloroquine, various antiviral medications such as Redemisvir and the potential protective impact of the BCG vaccination. Time and ongoing work will tell if these have validity or limited, or no use. It is reassuring to see so many clinical trials progressing on different approaches to treating Covid-19 and indeed the relatively slow pace at which such trials are normally approved, particularly by ethics boards, has been considerably accelerated.
There is interesting work progressing on the possible use of Convalescent plasma to treat Covid-19. The plasma of those who have recovered from Covid-19 may be used as a possible treatment for those with severe Covid-19 infection. Small scale trials have demonstrated some beneficial effect. Yesterday (April 8th), the US Food and Drug Administration (FDA) issued guidelines for investigational use of Convalescent plasma in Covid-19. Convalescent plasma for other conditions has been used in the past as a treatment for those conditions. It is encouraging to see this work progressing as we await the availability of a vaccine for Covid-19.
Covid-19 in Blood
Covid-19 virus RNA has been found in the blood of a very small number of blood donors in China. In a sample of 2.430 donations, viral RNA was found in 4 samples. The presence of viral RNA does not necessarily signify infectivity. There is, to date, no evidence of transmission of Covid-19 via blood or plasma and indeed, when we had the outbreak of the earlier Coronavirus, SARS, in 2003, there was no transmission by blood. However, these current findings should lead to more proactive work by blood establishments to screen out donors who may be at higher risk of Covid-19 and in looking at the development of screening tests for the virus in blood donors.
Reported case of Covid-19 in Haemophilia
Earlier this week, the Journal The Lancet published the first journal reported case of Covid-19 in a person with Haemophilia. This was in a 35-year-old man with haemophilia in China. His normal haemophilia treatment was on demand. He developed mild pneumonia and was treated with immune globulins (often used for primary immune deficiency). He recovered well. He had no bleeding due to his Covid-19 infection.