We are very grateful to the Irish Haemophilia Society for organising a weekend conference in Malahide, near Dublin, to look at Hepatitis and Bleeding Disorders in Europe. There are almost 11,000 people in Europe with a bleeding disorder and Hepatitis C so this is one of the major issue facing the Bleeding Disorders community across the continent.
Hepatitis C contaminated with Factor VIII
The early factor concentrate products were 100% infective for Hepatitis C. Professor Michael Makris, from Sheffield, explained that, on a molecular level, it was less of case of having vials of Factor VIII contaminated with Hepatitis C and more a case of having a vial of Hepatitis C virus contaminated with Factor VIII.
Liver related deaths
The EUHASS project has been looking at adverse effects following treatment. We heard that their data show that the number one cancer in people with bleeding disorders is liver cancer. Also, liver failure kills more people with bleeding disorders than inter cranial haemorrhage and is the number one cause of death in people with a Bleeding Disorders and Hepatitis C.
It is now widely acknowledged that Hepatitis C causes damage well beyond the liver. It was interesting to learn that “brain fog” can be due to the liver not being able to sufficiently clean blood before it circulates to the brain.
Liver transplants are often the last resort for people with bleeding disorders and Hepatitis C. However, it is reassuring to hear how successful they can be. The Milan Criteria is used to work out when people are no longer suitable for a transplant. To satisfy the criteria your liver cannot have a single tumour of more than 5cm or up to three tumours larger than 3cm. The widespread use of these criteria underlines the importance of seeking treatment early. It is important to remember that transplants are less successful for people who have not cleared the virus.
Who Should Be Treated First?
The conference also considered the debate about who should be treated first with the new, interferon free, treatments. These treatments are know as Direct Acting Antivirals (DAAs). This is often present as a choice between treating people who are most likely transmit the virus (often typified as injecting drug users) on one hand or trying to identify people with advanced fibrosis and treating them before their liver decompensates on the other. In Scotland priority access to the new treatment has been given on the basis of clinical need but a lot of the work to identify new patients has focuses on drug services. There is a different dimension to this discussion in the case of Bleeding Disorders; the cost of clotting factor cover during surgery or treatment for varices can mean it is much more cost effective to treat earlier. The are a lot of strong arguments in favour of treating people before their liver starts to deteriorate fast
High Success Rates & Avoiding Resistance
The information about the effectiveness of the new treatments continues to be very good. For most patients there are treatment options with around a 95% success rate. However, for some genotypes such as genotype 3, success rates are lower – especially for people with cirrhosis. The success rate can be improved by adding interferon but many people with bleeding disorders who are still infected in Scotland do not tolerate interferon well. This means there is a powerful argument for treating people before cirrhosis, especially for genotype 3.
Data shows that there is limited benefit in treating people with the same regime again if they have been unsuccessful once. This maybe because of resistant mutations. This means that drugs that are still in development, that are more effective for these mutations, will be very important for anyone who isn’t successful on the new treatments that are already available. The advice to clinicians is to select treatment options carefully to try and avoid resistance for the future. Their is an increasing amount of published data on the success rates of DDAs which informs the decision about which treatment regime is most appropriate.
The most common side effects of the new treatments are fatigue, headaches, and nausea. However, Haemophilia Scotland members who have been through, or are on, treatment tell us that the side effects they have experienced have been manageable – especially compared to older treatments including interferon. However, if you are considering treatment it is important to understand that there may be side effects and to prepare for them.
Access Around Europe
One of the most interesting parts of the meeting was hearing from countries all over Europe, and Canada, about how their health system work and what access to the new treatments the have got at the moment. There is a very large range across Europe, both in terms of the prices for the treatment and who can access the treatments. Dan Farthing-Sykes reported from Haemophilia Scotland. Although there is more work to do in Scotland it was clear that we are ahead of the curve and among the countries with the better access to the new therapies for people with bleeding disorders. In both Scotland and Ireland the importance of having good access to a supportive Government Minister was highlighted. The meeting was shocked to hear about the situation in England where NHS England has taken the highly unusual step of delaying the implementation of the National Institute for Clinical Excellence (NICE). Other countries reporting included Poland, Ireland, France, Denmark, and Serbia.
Advocating For Treatment
There were also sessions on advocating for treatment and access to DAAs. The seriousness of Hepatitis C means that that access to treatment is one of the most important advocacy challenges facing patient organisations in Europe. It’s important that the bleeding disorders community are well informed so that they know what questions to ask and can push for the treatment. In addition, it is vital to collect relevant data to support arguments to provide the new treatments.
The economic case for not delaying treatment is important too. Often if treatment is delayed then factor costs will go up. Providing cover for procedures such as liver transplants and other interventions can be much more expensive than any of the new treatment regimes. Also, because of the rate that at transplanted liver can deteriorate it is particularly important to push for access to treatment for people who have had a transfusion. Treatment for everyone with a Bleeding Disorders and Hepatitis C, and eradicating the disease, is an achievable objective for Europe.
Hepatitis C Database
In Ireland data on people infected through blood or blood products is held on a National Hepatitis C Database. Their database was set up in 2004 and patient support groups are represented on its steering group. The database doesn’t include names and has full ethical approval. The data is collected from medical records so patients aren’t contacted directly although consent is required. The latest round of collection covers 2010 – 2013. The database provides a very clear picture of state infected Hepatitis in Ireland.
The finally session of the conference was about how patient organisations can support our members with Hepatitis C. It is important to make sure that people who are just beginning to think about treatment have the information they need and have someone they trust to talk to. It can be very helpful to speak to someone with experience of going through the treatment. This is why Haemophilia Scotland recently ran a Hepatitis C Information for people who are considering treatment, on treatment, or had finished treatment to get up to date and to meet each other. It was great to learn from the Irish experience about how we can do this work better in the future. If you are in Scotland and on the new treatments, considering treatment, or just have questions, please contact Dan Farthing-Sykes.