Clinical News

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 1 Treatment-naïvea
  Treatment-experienceda
Genotype 3 Treatment-naïve with cirrhosisa
  Treatment-experienceda
Genotype 4, 5, or 6 Treatment-naïve & experienced with cirrhosisa

 

Sofosbuvir in combination with RBV

HCV genotype Adult patient population
Genotype 2 Treatment-naïveb
Treatment-experienceda
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 It is highly likely that by July other agents approvals will make the interferon component of the regimen outdated.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.

Lancet liver recommendations must be implemented to address crisis

Tuesday, 25 November 2014 00:00

The British Society of Gastroenterology (BSG) has today urged for the Lancet Commission UK Liver Disease Publication recommendations to be pursued "without delay" to "address the UK liver disease crisis".

Liver Disease mortality rates have increased by 400% since 1970 and is the third most common form of premature death in the UK.

The most common form of liver disease is alcohol-related, followed by fatty liver disease caused by obesity. The steep rise in both alcohol consumption and obesity in recent decades has led to increases in both conditions.

Incidences of chronic viral hepatitis are also on the rise, with annual deaths from hepatitis C having quadrupled since 1996, and significant increases in hepatitis B infection.

The Lancet report calls for wide-reaching, joined-up action including:

  1. Better detection of early disease in primary care
  2. Improved support services in community settings
  3. The establishment of Liver Units in District General Hospitals
  4. A national review of liver transplantation services
  5. Strengthening of continuity of care for children with liver disease surviving into adult life
  6. A range of population-level measures such as a minimum unit price for alcohol
  7. Promotion of healthier lifestyles with clearer government messaging and new regulations on the food industry
  8. Eradication of chronic HBV and HCV infection from the country by 2020
  9. Greater provision of medical training in hepatology
  10. A national campaign led by NHS England to increase awareness of liver disease in the general population

NICE Evidence Update: Acute Upper Gastrointestinal Bleeding

August 2014

A summary of selected new evidence relevant to NICE clinical guideline 141 'Acute upper gastrointestinal bleeding: management' (2012)

This Evidence Update provides a summary of selected new evidence published since the literature search was last conducted for the following NICE guidance: Acute upper gastrointestinal bleeding. NICE clinical guideline 141 (2012) A search was conducted for new evidence from 23 September 2011 to 20 February 2014. A total of 6061 pieces of evidence were initially identified. After removal of duplicates, a series of automated and manual sifts were conducted to produce a list of the most relevant references.

ERCP – The Way Forward, A Standards Framework

Mark Wilkinson, (BSG Endoscopy, working party convenor and chairman) et al.

June 2014

Executive Summary:

To improve the quality and availability of ERCP in the UK, a working party was set up incorporating a number of stakeholders (Appendix 3) to make recommendations to achieve this goal. The attached framework document is the output of that process. It is recognised that not all changes can be achieved immediately, but that these are the standards to be aimed for. Though regulatory frameworks differ among the 4 nations of the UK (and delegates from Scotland, Wales and Ireland were represented on the working party) it is intended that this framework will be applicable to the whole of the UK.

In brief its recommendations are:

  1. ERCP should only be carried out in facilities dedicated to high standards of performance and safety, as measured by key performance indicators.
  2. That there should be a minimum of 75 cases per annum for ERCP endoscopists, and 150 cases minimum per facility, although we should be aiming for a minimum of 100 cases and 200 cases respectively.
  3. That ERCP services should work collaboratively in a regional or hub-and-spoke model, with simple and rapid referral pathways established.
  4. That facilities for urgent or emergency ERCP should be widely available.
  5. That minimum standards for independent practitioners should be based on intention to treat and include a >=85% cannulation rate of virgin papillae, CBD stone clearance for >=75% of those undergoing 1st ever ERCP, and for patients with an extra-hepatic stricture, successful stenting with cytology or histology where appropriate at 1st ERCP in >=80%.
  6. That performance criteria should be monitored by a detailed audit and feedback process via a strengthened JAG/GRS process, and be incorporated into consultant appraisal.
  7. That the organisation and standards for training for ERCP should follow from the above performance criteria.
  8. That newly appointed consultants are mentored to ensure a safe and effective transition from trainee to independent practitioner.
  9. That high quality performance in ERCP service and training should support high quality research.
  10. There should be a national registry of ERCP cases to monitor practice and outcomes which will aid a cycle of continuous improvement and provide research data to plan better care in the future.

Page 4 of 5