Thanks to new Direct-Acting Antiviral treatment (DAA), hepatitis c could be dead and buried. But before that day arrives, NHS rationing threatens a death sentence for thousands of patients. A mixture of anger and optimism at the Addaction World Hepatitis Day conference 28th July. By Harry Shapiro
Not for nothing is viral hepatitis dubbed the silent killer. A single injecting episode could result in a positive HCV diagnosis twenty years later with the individual being entirely asymptomatic. But the silence goes beyond the stealth trajectory of the disease itself. While diseases like HIV, ebola and zika virus have captured the media headlines and the attention of politicians and the global health community, viral hepatitis has been pretty much ignored despite the fact that it is the world’s seventh biggest killer, with 1.4 million deaths a year and 400 million people infected.
Yet only this year is there now a global commitment from some 194 governments to eradicate the disease by 2030 while combatting viral hepatitis now features as one of the UN Sustainable Development Goals in recognition of the fact that, as Raquel Peck of the World Hepatitis Alliance explained, eliminating the disease has implications for development far beyond dealing with the medical condition itself.
The UK is one of those 194 governments signed up to the pledge, but figures show how far we have to go. We have around 200,000 people with HCV, only about 50% have a diagnosis and of those only 3% receive treatment. There is no central monitoring of treatment and no real idea of prevalence. I am reminded of a conversation I had way back in the early 90s with the late and sadly missed Dr Tom Waller, a substance misuse specialist GP who conducted the first survey of HCV prevalence in the UK. From the treatment services who responded, it emerged that 60% of injecting drug users were HCV positive. Dr Waller said to me that the Regional Health Authority in which he worked did not want to do blanket HCV testing, “because they would be scared of what they would find”. The point was underlined at the conference by Professor Mark Thursz from Imperial College, London whose infographic demonstrated the UK shortfall regarding diagnosis and treatment rates compared to many other western countries while emphasising that ignorance of infection status was the greatest barrier to control of morbidity, mortality and prevalence. And if any further proof was needed that the UK had a lot of catching up to do regarding the prevention of viral hepatitis, Paul Desmond from the Hep B Foundation made the point that the UK does not vaccinate children against the disease unlike two hundred other countries despite the fact the Foundation receives thousands of calls each year from people in just about every walk of life concerned about their risk of becoming infected.
And finally on the subject of silence, the drug using community itself has been relatively quiescent. One BBV consultant was quoted at the conference as saying that if haemophiliacs has been denied life-saving treatment they would have made a huge fuss. But the low self-esteem and the shroud of discrimination and prejudice that hangs off the shoulders of especially injecting drug users has stilled the voices. Until now. There was outrage, powerfully articulated by patient activists at the conference, at the decision by the NHS to ration the new and highly effective hepatitis C treatments. So what’s it all about?
For many years, the standard treatment for hepatitis C has been interferon, a brutal drug regime with devastating side effects as the drug suppresses the whole immune system and is not targeted at the specific virus. Then along came Direct-Acting Antivirals (DAA) which have proved extremely effective without any of the distressing side-effects. Not only that, the National Institute for Health and Care Excellence (NICE) has deemed the treatment cost effective which in theory should mean that the 90,000 patients currently in need of this treatment should get it on the NHS. Except the NHS has decided that just because a drug is cost effective, doesn’t mean it is affordable. So what they have done is to restrict treatment to 10,000 patients a year. The Hep C Trust wrote to the NHS to request they review the decision which the NHS has refused to do and so the Trust is planning to seek a judicial review on the the grounds that the NHS decision is illegal. There is a feeling among activists, said Rachel Halford of the Trust, that this could be the thin edge of the wedge, suggesting the NHS is seeing if they can get away with this by piloting it with drug users to try and slip it under the radar initially with a group of patients few care about.
The treatment cap is being organised under the auspices of Operational Development Networks (ODN) of which there are 21 in England. The stated purpose of the ODN is “ coordinating patient pathways between providers over a wide area to ensure access to specialist support”. What practitioners see is essentially a cost-cutting exercise making the ODN jump through hoops to get the money to help clients.. For a start the allocation for HCV payments depends on where you live. So if you live in a region with high HCV prevalence, your chances of treatment are reduced. Then for the ODN to receive its full allocation, it has to stay within very tight budgetary parameters, opt for the cheapest drugs (in NHS-speak “lowest acquisition cost”); only treat those in dire need (which makes reaching any elimination target very difficult); and make sure it has reinfection rate data on at least 85% of patients treated in the previous 60 weeks. All of which prompted consultant heptologist Dr Ashley Brown to urge services to meet with their ODN lead; make sure key-workers and clients know about new treatments and restrictions; start to collect data and request a fibroscan clinic for the non-invasive assessment of liver damage. He also urged managers to attend the multidisciplinary team meetings to advocate for clients and emphasised the importance of treatment adherence and long-term follow-up while ending by encouraging a positive approach.
Helping services develop an intervention which helps increase diagnosis and access to treatment is the current work of virologist Will Irving of Nottingham University. Although the study (cutely named HepCatt) is not complete, the preliminary results indicate, not surprisingly given treatment worker caseloads, that the best results results can be achieved by having a designated post. In this study,the employment of a half time nurse facilitator for a year assisted in the education of local drug workers, coordination of a buddy system with the Hep C Trust, encouraged testing, streamlined onward referral and assisted in the coordination of HCV treatment with OST. The study has revealed the importance of close liaison between the treatment and secondary health services made the more easier if the client was seeing the same person in both settings.
Dr Brown’s call to positive thinking despite all the challenges was picked up by Dr Emily Finch. There were key messages for commissioners to make sure that service specifications were clear about the need for services to be able to deliver on viral hepatitis vaccinating and testing and supporting service users into treatment and then only commission those services who could demonstrate their capability. And for services it was all about embedding vaccination and testing systems into organisational processes and keeping the systems under review, collecting adequate data and providing high quality information for service users. More specifically, trials using contingency management for HBV treatment compliance had proved very successful, but the overall message was that drug treatment services have the responsibility to be the lead agencies in the fight against viral hepatitis.
The starting point for Dr Magdalena Harris from the London School of Hygiene and Tropical Medicine was that a growing body of evidence demonstrated the redundancy of the argument that it was pointless treating active drug users. Through her qualitative research with service users, she too emphasised the critical role of treatment services in the elimination agenda through prevention (harm reduction interventions); enabling users to overcome fears about testing; and assisting in creating supportive environments for peer support (the importance of which was emphasised by patient advocates Mick Grant and Tony Gillham).
On 7th July in a written House of Lords question, Baroness Randerson asked what the government was doing to contribute to the elimination of viral hepatitis by 2030. In her reply on behalf of the Department for International Development, Baroness Verma ran through a number of international initiatives that the government ‘supports’ (in ways unspecified) and said the UK was the largest donor to the Vaccine Alliance aiming to increase vaccination access for low income countries. All very commendable, but what about the UK itself? Exactly what is the government doing centrally to tackle the problem right here?