HCV in Cirrhosis - An Update on Treatment Access
Friday, 01 May 2015 11:53
Peter Moss (Chair HCV CRG) & Graham Foster (Vice Chairman HCV CRG)
We are writing to update you on access to treatment for patients with chronic HCV infection. As you know the first review of the Early Access Program was presented at EASL last week. These data show that therapy for patients with decompensated cirrhosis has been very successful and this program will continue.
NHS England has confirmed that access to treatment should be extended, and the CRG have completed a proposal for a new scheme to offer the best available oral antiviral therapy to all patients with cirrhosis. There is a formal sign off step to be completed but we anticipate that the scheme will be up and running by late May. However given the inevitable slippage in delivery times it may be prudent to advise patients that treatment may not commence until early June 2015. The precise details of how treatment will be delivered are still under discussion but we envisage a network approach, and details of centre selection will be circulated as soon as possible, probably within the next 10 days.
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.
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