Review Article

2014 UK Consensus Guidelines — Hepatitis C Management and Direct-acting Anti-viral Therapy

M. H. Miller; K. Agarwal; A. Austin; A. Brown; S. T. Barclay; P. Dundas; G. M. Dusheiko; G. R. Foster; R. Fox; P. C. Hayes; C. Leen; C. Millson; S. D. Ryder; J. Tait; A. Ustianowski; J. F. Dillon

Disclosures

Aliment Pharmacol Ther. 2014;39(12):1363-1375. 

In This Article

Abstract and Introduction

Abstract

Background Therapeutic options for the management of hepatitis C virus (HCV) infection have evolved rapidly over the past two decades, with a consequent improvement in cure rates. Novel therapeutic agents are an area of great interest in the research community, with a number of these agents showing promise in the clinical setting.

Aims To assess and present the available evidence for the use of novel therapeutic agents for the treatment of HCV, updating previous guidelines.

Methods All Phase 2 and 3 studies, as well as abstract presentations from international Hepatology meetings were identified and reviewed for suitable inclusion, based on studies of new therapies in HCV. Treatment-naïve and experienced individuals, as well as cirrhotic and co-infected individuals were included.

Results Sofosbuvir, simeprevir and faldaprevir, along with pegylated interferon and ribavirin, have a role in the treatment of chronic HCV infection. The precise regimens are largely dependent on the patient characteristics, patient and physician preferences, and cost implication.

Conclusions Therapies for chronic HCV have evolved dramatically in recent years. Interferon-free regimens are now possible without compromise in the rate of sustained viral response. The decision as to which regimen is most appropriate is multifactorial, and based on efficacy, safety and cost.

Introduction

The field of anti-HCV therapy is going through a period of rapid evolution, as numerous highly effective, but expensive, direct-acting anti-viral (DAA) drugs active against different targets become available. This welcome development requires a consensus guideline for treating physicians and health care providers. These expert guidelines are sponsored by the Scottish government and take representative opinion from the British Society of Gastroenterology Liver Committee, British Association for the Study of Liver, the Scottish Society of Gastroenterology, the Scottish Viral Hepatitis group, the Scottish Viral Hepatitis Nurses group and the British Viral Hepatitis group.

The aim of the guideline was to provide treating clinicians and health care providers with an expert opinion of the current best standard of care with available agents. It is anticipated that this advice will rapidly become outdated, but is based on the agents likely to be available in 2014 in the UK and these guidelines will be updated regularly as new agents become available. Over time, the simplest and most effective combinations of agents will become clearer. However any uncertainty over the best therapy or the possibility of better ones in the future is not a reason to defer patients from treatment. It is apparent from modelling and projection work together with empirical observation that we have cured far too few patients of their HCV infection to have an impact on the looming burden of chronic liver disease. Nonetheless annual budgets could limit the numbers of patients that can be treated per year and we may need to stratify patients for immediate treatment. The aim of these guidelines was to help clinicians identify those patients who can be treated efficaciously now and with which therapeutic agents.

We have not considered how much cost differential (i.e. in terms of numbers of patients treated within in a fixed budget) would justify using a cheaper regimen of similar efficacy containing interferon compared to an interferon-free regimen. A significant difference in cost per cure may cause some providers to favour regimens we have regarded as less tolerable for patients. It is hoped that these new efficacious drugs will allow sufficient number of patients to be treated to achieve the desired impact on HCV infection at a population level.

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