Sexual Health and Blood Borne Virus Framework 2015-2020 Update

Viral Hepatitis

Introduction

The original Framework set out separate sections on hepatitis B and hepatitis C. For the purposes of this update both hepatitis B and hepatitis C are addressed in this chapter on viral hepatitis.

Since the first Framework document much work has been done to better understand the epidemiology of hepatitis B in Scotland. That work has now been completed and we know that there is little transmission of hepatitis B in Scotland and the total number of infected individuals is low in comparison to hepatitis C, although the prevalence is much higher in populations from endemic areas. Hepatitis B remains an important infection and clinical care in Scotland is of the highest standard. Testing and diagnosis is vital in relation to both hepatitis B and hepatitis C, to ensure that individuals can access treatment and care as quickly as possible.

The introduction of new effective therapies for hepatitis C is a watershed moment and we can now look forward to a Scotland where hepatitis C is no longer a public health concern. Despite these new therapies, prevention of new blood borne virus infections remains key and it is vital that we do not reduce our prevention resources and infrastructure.

Key Progress since 2011

• As a result of investment in prevention strategies there has been a reduction in the annual number of new hepatitis C infections in Scotland - from 1,500 new infections in 2007 to 700 new infections in 2013.
• Testing/diagnosis: Significant increases in testing for hepatitis C have been observed, particularly in GP practices, addictions services and prisons. More than 55% of the estimated hepatitis C infected population in Scotland was diagnosed in 2013, compared with only 38% in 2007.
• A report on the prevalence and incidence of hepatitis C amongst Scottish prisoners was published in May 2012.^[47] This study found that incidence of hepatitis C is very low among Scottish prisoners, including prisoners with a history of injecting.
• The number of people commenced on antiviral therapy for hepatitis C has increased significantly, from 470 in 2007/08 to 1,270 in 2014/15.
• With the development of new monitoring systems our understanding of the incidence, prevalence, and characteristics of, and thus public health challenges associated with, hepatitis B infection is very much greater than before.
• A great deal of activity takes place around World Hepatitis Day, co-ordinated by Hepatitis Scotland and the Hepatitis C Trust, with a particular focus on testing and awareness-raising.
• NHS Boards across Scotland have taken forward work with populations particularly vulnerable to viral hepatitis, including engaging directly with Mosques and employing Chinese-speaking staff for outreach.
• NHS Education for Scotland has developed educational resources 'Hepatitis B and C detection, diagnosis and management'. These resources have been developed for those who deliver programmes of CPD in relation to BBV and are aimed at primary care staff. The resources have been piloted and courses run with approximately 120 people attending, and a 'train the trainer' day for NHS Board staff has also been held.

Key Developments since 2011

• Prevention: during the first phase of the Framework the UK Government made changes to the list of items under the Misuse of Drugs Act which can be provided to injecting equipment provision service users such that it is now possible for IEP services to include foil within equipment provided to people who inject drugs. The provision of foil is an important harm reduction measure which advises/advocates smoking rather than the injecting of drugs.
• Treatment: the most significant development towards the end of the first phase of the Framework has been the emergence of highly effective new therapies (directly acting antivirals) for hepatitis C. The first such new therapy was approved for restricted use by the Scottish Medicines Consortium in late 2014, with approvals of other therapies occurring during the course of 2015. These new therapies mark an important moment in the treatment of hepatitis C, offering much more tolerable therapies which can achieve very high levels of viral clearance (which is considered a cure).
• The Penrose Inquiry into the transmission of hepatitis C and HIV via infected NHS blood and blood products was published on 25 March 2015. The report highlighted the importance of case-finding by the NHS and diagnosis of individuals who may have been infected for a number of years.
• The emergence of new psychoactive substances in recent years gives rise to a number of issues relevant to the Framework, including the work of IEP services and the risks associated with injecting of NPS, but also the increased potential for risk-taking behaviours amongst individuals while using NPS.
• The UK National Screening Committee has published a review of screening for hepatitis B and C among ethnic minorities born outside UK. This document was last updated in 2011^[48].

Key Priorities to 2020

Prevention

Significant developments have occurred in the field of treatment for hepatitis C in recent years, and this will have an impact on the next five years as set out below, but prevention must remain our priority. This update to the Framework restates the importance of prevention of viral hepatitis, particularly because it is vital that the developments in treatment do not distract us from this work. An effective vaccination against hepatitis C is not yet available but other effective prevention strategies are available. Prevention remains a priority for all blood borne viruses and all NHS Boards and partners should ensure efforts continue to prevent infections.

As a result of the Hepatitis C Action Plan, the Scottish Government published Guidelines for Services Providing Injecting Equipment^[49] in 2010. This document set out best practice for injecting equipment service providers and has been recognised internationally as a model of best practice. Since 2010 there have been a number of important developments - such as the provision of foil, the emergence of new psychoactive substances, the publication of guidance on needle and syringe programmes by NICE in March 2014^[50], and emerging evidence around performance and image enhancing drugs. Research, for example, from Public Health England in 2013 showed that men who inject PIEDS are at a much higher risk of hepatitis C.^[51] There is limited but growing scientific and anecdotal evidence of very risky injecting practices amongst small pockets of the MSM community, including in Scotland, and recent outbreaks of infections amongst injectors demonstrate that despite recent efforts there continues to be sharing of injecting equipment in Scotland. MSM living with HIV, particularly those using recreational drugs, are at risk of hepatitis C transmission through sex, as well as through injecting. The IEP guidelines should provide an evidence-informed approach taking into account new and emerging drug trends to ensure services are based on need, and with the twin aims of reducing infection risks and addressing the health needs of the user. The Scottish Government will provide funding to support a review and update of the IEP Guidelines, working with the Scottish Prevention Leads network. The review should take account of the NICE guidance in relation to young people to reflect any issues in relation to those under-16 who may be particularly vulnerable.

Hepatitis B vaccination is recommended for and available on the NHS in Scotland to those who are at particular risk of infection. Although there are very low levels of transmission of hepatitis B in Scotland, those at greater risk include people who inject drugs, those who change sexual partners frequently (including sex-workers) and prisoners. Provision of hepatitis B vaccination on the NHS for individuals at risk is available in sexual health and GUM clinics, via some addictions services and in prisons. Availability of hepatitis B vaccination via GP practices varies across Scotland. The Scottish Government's view is that, as with all vaccinations recommended for clinical reasons where there is no national vaccination programme, GPs are expected to apply General Medical Council's guidance on Good Medical Practice by protecting people at risk from hepatitis B in the same way that they would provide treatments for other conditions and infectious diseases.

Vaccination against hepatitis B will be offered to all prisoners during the induction period in prison. Any course of treatment will continue throughout their sentence and upon release, and across NHS Health Boards. Those prisoners who are hepatitis C antibody positive will also be offered immunisation against hepatitis A.

Testing, Case-Finding and Diagnosis

Detecting those who have been infected with hepatitis C and diagnosing them as early as possible enables individuals to receive treatment as early as is possible, and can improve long term health outcomes. In the era of highly effective therapies it is more important than ever that everyone who has been infected is diagnosed and in contact with specialist services so that general and liver health can be monitored, and treatment can be provided when appropriate. The Penrose Inquiry also identified the possibility of there being a number of individuals who were infected with hepatitis C as a result of receiving NHS blood and blood products before 1991 remaining undiagnosed.

NHS Boards and Third Sector organisations should continue work to test high-risk groups and case-find those who may have been lost to follow-up (which may include individuals who were infected via blood or blood products). Hepatitis C Managed Care Networks should identify and prioritise initiatives to diagnose or re-diagnose those most likely to (i) have moderate to severe disease, or (ii) progress rapidly to severe disease. This includes those who may have been exposed to NHS blood and blood products pre-1999. Different parts of Scotland have trialled various approaches to this over the last five years and Boards should learn from good practice.

To make it easier for people with a drug problem to access testing, treatment and care, NHS Boards should consider innovative approaches to delivering services including peer support and buddying schemes, and/or integration with harm reduction/recovery services.

It is particularly important that efforts are made to target testing at groups which may be a higher risk of being exposed to infection. In the case of hepatitis C, prisoners are a particular risk group. A study funded by the Scottish Prison Service and published in 2012 showed that most prisoners who were also injecting drug users had been tested for hepatitis C and most received their last test while in prison. However the study also concluded that the hepatitis C prevalence rate among prisoners is estimated at 19%. As a result of this, coupled with the particular health inequalities of those likely to be incarcerated and the very good treatment outcomes for those who access treatment while in prison, the Scottish Government will work with NHS Boards and the Scottish Prison Service to introduce opt-out BBV testing (hepatitis B and C and HIV) for all new prisoners in Scotland during their induction period.

There are clear and unambiguous links between hepatitis C and factors related to health inequalities. These have been well articulated in the last Framework and in the Scottish Government's Hepatitis C Action Plan. Those who are infected with hepatitis C are more likely to live in the most deprived areas of Scotland and may not access healthcare routinely. In order to increase diagnoses amongst those most at risk the Scottish Government will work with Health Protection Scotland and representatives of the NHS Managed Clinical Networks to evaluate the potential and cost-effectiveness of a population-based case-finding approach (age-cohort or living in higher HCV prevalence areas). Such an approach would complement existing initiatives involving a targeted, risk factor based approach.

Treatment

Background

Ever since the publication of the Hepatitis C Action Plan in 2008, the Scottish Government has been recognised as a world-leader in its response to hepatitis C. We continue to be ambitious and in light of the emergence of highly-effective new therapies, the Scottish Government is committed to the elimination of hepatitis C as a public health concern in Scotland.

The Minister for Public Health established a Treatment and Therapies Group in late 2013 to consider the implications of new therapies on the Scottish Government's hepatitis C policy. This group included clinical leads from across the NHS, patient representatives and public health experts. The conclusions of this group were submitted to the Scottish Government in May 2015, and the group's report has been published in parallel with this document. The conclusions of this work inform the following comments and commitments.

Although new, highly effective therapies are now available, very considerable challenges still exist:

• Over the period 2008-2013 the annual number of new presentations of hepatitis C related liver failure or cancer increased from 125 to 194; approximately 50% occurred in people who had been diagnosed with hepatitis C within five years of presentation.

• 16,800 infected people, a high proportion of whom are older, former PWID with moderate or severe liver disease, remain undiagnosed.
• Most (75%) diagnosed hepatitis C-infected people are not, or have never been, in specialist care.
• Nearly 11,000 infected with hepatitis C people have either cirrhosis of the liver or are in the pre-cirrhotic stage and, thus, are in urgent need of therapy; most are undiagnosed or are not in specialist care.

Reducing Morbidity and Mortality

The aim of investing in hepatitis C services in Scotland is to reduce severe morbidity and mortality caused by infection. With the availability of highly effective direct acting antiviral therapies which can prevent liver disease progression even in those who already have advanced disease, there is the potential to see a dramatic reduction in the incidence of such severe morbidity and mortality in a similar way to that achieved with AIDS cases and deaths following the introduction of HIV combination antiviral therapy in 1996. Scotland should seek to reduce the number of people who develop HCV related liver failure, hepatocellular carcinoma (HCC) and the number of people who die from HCV related disease.

Decision-Making

It is essential that principles regarding decision-making around the administration of hepatitis C antiviral therapy should be equitable, made by both patient and attending clinician, and be driven principally by the patient's need and the effectiveness and safety of available drugs. How a patient acquired hepatitis C infection should never influence therapy decision-making.

Compelling evidence, based on Scottish and international data, indicates that the liver disease stage of the hepatitis C-infected patient strongly determines the short to medium term risk of developing severe hepatitis C-related liver disease; those with no or mild disease, for example, are very unlikely to progress to severe disease for many years. Nevertheless there is also compelling evidence that hepatitis C can cause serious non-liver related conditions and can have major psycho-social effects even in the presence of mild, or absence of, liver disease.

In the context of this evidence and the current high cost of the optimal therapies, prioritisation of such treatment - in terms of its timing - should be given to people at risk (imminently or in the next few years) of developing severe life threatening or seriously debilitating liver and/or non-liver hepatitis C related disease. This approach, coupled with the rigorous clinical monitoring of people not being offered therapy, is consistent with European Association for the Study of Liver (EASL) 2015 guidelines on the management of hepatitis C^[52].

The ultimate goal should be the offer, as soon as practically possible, of therapy to all people with chronic hepatitis C. Early treatment is likely to convey population benefits in terms of the prevention of onward transmission of infection (particularly among active PWID) and reduces the risk of infected people - lost to clinical monitoring (a common occurrence among those who have ever injected drugs) - presenting years later with end-stage liver disease. Early treatment also reduces the risk of people living for many years with debilitating symptoms and associated psycho-social consequences.

Hepatitis C infected patients should be offered optimal SMC-approved therapies (as judged by effectiveness and adverse effect profile): thereafter, the cost of therapy becomes an important consideration.

All hepatitis C infected individuals are eligible for treatment with optimal SMC accepted regimens. However, in view of the current high cost of these regimens and the high number of individuals infected in Scotland,^[53] priority, in terms of the timing of treatment, should be initially given to those patients with the highest need. This means, as a minimum:

• patients with F3/F4 hepatic fibrosis;
• and/or patients with severe extra-hepatic manifestations of hepatitis C;
• and/or patients with significant psychosocial morbidity as a consequence of hepatitis C.

Because the availability of new treatments and their pricing is changing rapidly, the above recommendations will be reviewed on an on-going basis. The Treatment and Therapies Group established by the Minister for Public Health, will continue to meet at least annually to do this.

Delivering Treatment

Scotland's Hepatitis C Action Plan achieved a rapid scale-up of therapy from 450 to approximately 1,050 initiates between 2007 and 2010; thereafter the numbers plateaued. The principal barriers to getting people treated have been sub-optimal effectiveness, adverse effects and the duration of Interferon-based therapeutic regimens. A further barrier has been the practice, in most instances for logistical reasons, of administering Interferon-containing therapy in the hospital setting. With the availability of easy-to-administer, safe, highly-effective, short-duration therapies, it is now practical to deliver treatment in community settings.

Scotland should aim to deliver hepatitis C therapy for most infected people in community settings (including prisons); such an approach must be overseen by the NHS Board Managed Care Network responsible for hepatitis C. This strategic change in service delivery should not preclude certain people receiving all or some of their management in a secondary care setting if their clinical status merits this.

Targets

The principal goal of the Scottish Government's commitment to Hepatitis C service development is the prevention of serious morbidity and mortality. Modelling work, undertaken by Health Protection Scotland and Glasgow Caledonian University, estimates that a minimum of 1,500 treatment initiates per year during 2015-2020 is required to stand a chance of reducing the number of new liver failure/cancer presentations from the current level of around 200 to 50 by 2020^[54].

As such, during 2015-2020 at least 1,500 people per year will be initiated onto antiviral therapy in Scotland. This represents a near 20% increase on the number of people treated in 2014^[55].

Assuming this treatment target is met, the Scottish Government is aiming for a 75% reduction in the annual number of people developing hepatitis C-related liver failure and/or liver cancer by 2020. This equates to a reduction from around 200 in 2013 to 50 in 2020.

Monitoring

The success of Scotland's Hepatitis C Action Plan has been achieved in part through the ability of service providers to monitor performance through a range of outcome indicators including numbers of people diagnosed, getting into specialist care, undergoing treatment and eliminating their infection. Accordingly, it is essential that outcome indicator data continue to be collected and made available. Scotland should continue to assess the impact of its investment in HCV infection and disease prevention through the monitoring of outcome indicators.

Research

This document recognises the importance of investment in research across the sexual health and blood borne virus field. The research dividend of Scotland's Hepatitis C Action Plan has been spectacular^[56]. Reports published in the world's leading liver disease journals have not only informed and evaluated policy and practice in Scotland, but internationally. Scotland should continue to lead the world in this way over the next five years, with a continued focus on research.

Three priority areas of research for hepatitis C have been identified:

• The cost, effectiveness and cost-effectiveness of different models of diagnosing, assessing and delivering of therapy to hepatitis C infected people
• Assessing the drivers and impact of alcohol consumption on hepatitis C case management and evaluating interventions to address the adverse impact of such consumption
• Evaluating the concept of the administration of antiviral treatment to people who actively inject drugs to prevent onward transmission of infection.