BSG supported STOPAH study shows a lack of evidence for drug treatments
Wednesday, 29 April 2015 08:22
The survival of patients with alcohol-related hepatitis is not being significantly improved by the main drugs currently widely used in treatment of this condition, according to a major new National Institute for Health Research sponsored study supported by members of the British Society of Gastroenterology.
Senior health professionals are highlighting an 'urgent need' for investment into research for the prevention and treatment of alcohol-related liver disease. Documented in the New England Journal of Medicine¸ a trial of over 1,000 patients using prednisolone and pentoxifylline did not achieve a statistically significant reduction in mortality after 28 days, 90 days, or a year.
The alarming findings come at a time when the incidence of alcohol-related liver disease is rapidly increasing, however the report does also show that the overall mortality has fallen compared to studies done in the past which suggests that specialist in hospital care of these very sick people can improve outcomes, and what could be achieved more widely contrasting with the 2013 NCEPOD report on the care of cirrhosis where care was often found to be lacking.
Commenting, British Society of Gastroenterology Vice President (Hepatology), Dr Stephen Ryder, said:
"STOPAH has answered some key questions in the treatment of alcohol-related hepatitis and highlighted the urgent need for research into the prevention and treatment of alcohol-related liver disease, which is on the rise.
Whilst the study does suggest that patients are receiving better care than reported in previous reviews, unfortunately it also shows that neither steroids or pentoxifylline are effective treatments and there is no real indication now for their use.
The stark finding in STOPAH remains the high late mortality related to resumption of alcohol intake and emphasises the need for universal implementation of the BSG recommendations on alcohol care teams, that seems likely to be a far more effective intervention than any medical therapy for the acute episode.
One of the great successes of this study was to show that UK hepatologists and gastroenterologists from over 50 UK centres can collaborate to deliver important large scale clinical studies aimed at improving outcomes for patients with liver disease."
Consensus Meeting on Therapy for Chronic Hepatitis C
Friday, 17 April 2015 09:46
London, March 3 2015
The treatment options for patients with chronic hepatitis C are expanding rapidly. To guide clinicians and commissioners the national societies (BASL, BHIVA BIA, BSG, BVHG) representing clinicians with an interest in this area convened a meeting to provide evidence based treatment and management recommendations.
A nominated individual outlined the background data (both published and outcome data from the English early access program) and presented proposals for therapy. These were discussed by the 80 attendees and a consensus was reached. This document outlines the consensus recommendations.
Dr Stephen Ryder, BSG Vice-president Hepatology, April 2015.
Report from Liver section for BSG Council
Thursday, 26 March 2015 11:29
Dr S Ryder, VP Hepatology.
There are two major areas where BSG has had a significant profile, introduction of new drugs for hepatitis C and the future of liver services via input into the Lancet commission.
The new hepatitis C drugs now have approval by NICE and commissioning intent from NHS England, these agents are SMC approved and in use in Scotland although there are restrictions on use. BSG co-hosted a recent consensus meeting in London for the exact regimens to be established for use in England. Patients with cirrhosis will be able to access treatment with the new agents from April with more widespread use in the summer. The BSG strongly supported the plan for networks of care to deliver HCV therapy in England. The delivery of these treatments in the Early access programme (for patients with decompensated cirrhosis) has worked very well with excellent results in over 700 patients treated (SVR rates >65%) and £38 million of investment from NHS England which shows a substantial level of commitment to liver disease. The next steps will be establishing the mechanism by which medicines are distributed and outcomes monitored. It seems likely that there will be steps required with use of the existing EAP systems initially to deliver therapy to patients with cirrhosis and later more formalised networks established.
Changes in HCV therapy - approval of Sofosbuvir
Friday, 30 January 2015 13:55
Dr Stephen Ryder, BSG Vice-President Hepatology & Dr Andrew Austin, Chair BSG Liver Section
There are two major changes in HCV therapy which now have NICE and/or NHSE approval for use. The first is that commissioning guidance for the use of Simiprevir is published (http://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-a/a02/). This allows G1 patients without Q80K to access triple therapy now using Simiprevir instead of Boceprevir or Telaprevir.
The second and probably more significant development is the approval of Sofosbuvir. The approval can be summarised as below:
Sofosbuvir in combination with pegylated interferon + ribavirin (Peg-IFN+RBV)
|HCV genotype||Adult patient population|
|Genotype 3||Treatment-naïve with cirrhosisa|
|Genotype 4, 5, or 6||Treatment-naïve & experienced with cirrhosisa|
Sofosbuvir in combination with RBV
|HCV genotype||Adult patient population|
|Genotype 3||Treatment-naïve with cirrhosisb|
|Treatment-experienced with cirrhosisb|
The NHSE approval is for cirrhotic patients to access treatment in April with non-cirrhotic patients from July.
There is a meeting at Barts on 3rd March 2015 (advertised by BVHG) to establish clinical guidelines as to who to treat with what when. It is highly likely that by July other agents approvals will make the interferon component of the regimen outdated. NHSE will establish a process by which the drugs will be distributed shortly but it would seem prudent for centres to enter local negotiations now in order all are ready to prescribe when we are given the approvals. It is pretty certain that similar data gathering will be required as for EAP.
Liver Section News Update Winter 2014
Wednesday, 07 January 2015 10:02
Stephen D Ryder, BSG Vice-president, Hepatology
There are a number of themes to the development of hepatology. The future of specialised commissioning and what that may mean for liver services, the recently released Lancet Commission into liver disease, new drugs for hepatitis C and how they may be managed probably being the most pressing. I apologise if the following has a very English rather than UK flavour but the devolved nations, particularly Scotland, are well ahead of England in their strategic approach to liver disease and most of the new structures and changes are England specific. I will attempt, in future, to give some feedback on how things may work in Wales and Northern Ireland.
The Hepatobiliary Clinical Reference Group (CRG), which advises NHS England on specialised services, met again in October. There has been a 3 month "pause" to most workstreams in NHS England while Simon Stevens assessed the future strategy of the NHS. The exception to this pause was the hepatitis C programme which continued recognising the magnitude of new developments and the implication for patients.
The Early Access Programme to Sofosbuvir (with either Daclatasvir or Ledipasvir) continues and represents a strong commitment from NHS England to fund HCV therapy for those in greatest need (in this case patients with decompensated cirrhosis). There are now 550 patients who have started therapy across the Country and the outcomes will be monitored through HCV UK where almost all patients are registered.
The early access programme (EAP) set the framework for how high cost drugs may be allocated by NHS England in future with a bidding process for coordinating centres working with networks of clinicians delivering care locally. At the present time it is not clear how NHSE will deal with Sofosbuvir post NICE (the review should be finalised this month) and it seems clear that existing mechanisms for drug application, which vary markedly across England, will need to continue in 2015/16 as there is little time now for a bidding process similar to the EAP to be staged. We continue to await NHSE guidance on Simeprevir, the Scottish as usual are ahead in approving this with a "cost per cure" approach. We do not yet know what NHSE wish to do although replacing Telaprevir/Boceprevir with Simeprevir seems a sensible and relatively low cost option which may take some of the pressure off the Sofosbuvir debate.
The EAP has been regarded as a significant success by NHSE and the principles of networked arrangements really should guide us in how liver services in areas other than HCV should develop.
The NHS Forward View (in my view one of the most sensible documents to emerge from NHSE in the post-Lansley era) details new models for how care could be provided in future (www.england.nhs.uk/ourwork/futurenhs/). These include:
- allowing GP practices to join forces into single organisations that provide a broader range of services including those traditionally provided in hospital;
- creating new organisations that provide both GP and hospital services together with mental health, community and social care;
- helping patients needing urgent care to get the right care, at the right times, in the right place, by creating urgent care networks that work seven days a week;
- sustaining local hospitals where this is the best solution clinically and is affordable and has the support of local commissioners;
- concentrating services into specialist centres where there is a strong relationship between numbers of patients and the quality of care.
The BSG will need to respond to this in how it frames its plans but it does seem to fit well with hepatology and emphasises the networked principles and moving care out of hospital that we know have to happen if we are to turn round the epidemic of cirrhosis.
The Lancet Commission on liver disease was launched on 26th November and provides a template for changes we need to make for service delivery. The report will help in producing a series of workstreams which will try to address specific areas from primary care education through to liver transplant services. The BSG will be a key partner in taking these programmes forward.
Public Health England have a very functional infrastructure and have identified their priorities regionally. This is likely to be another very powerful lever for change if you are in an area where liver disease is a priority. PHE have published data on prevalence of liver disease nationally (http://fingertips.phe.org.uk/profile/) which is vital reading for your local authority areas. I do not know nationally how this has translated into local priorities for PHE and as yet how many areas have liver disease as a key part of Joint Strategic Needs Assessments, this is a key step for ensuring that the whole community is linked together and has a common aim. This will be the focus of a future update.
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