Blood borne viruses and sexually transmitted infections. Scotland 2017.

Transcription

1 Blood borne viruses and sexually transmitted infections. Scotland 2017.

2 Health Protection Scotland is part of a Strategic Business Unit of NHS National Services Scotland. Health Protection Scotland website: Published by Health Protection Scotland, NHS National Services Scotland, Meridian Court, 5 Cadogan Street, Glasgow G2 6QE. First published December Health Protection Report written and prepared by: Blood Borne Virus and Sexually Transmitted Infection (BBVSTI) team, Health Protection Scotland and Glasgow Caledonian University. Reference this document as: Health Protection Scotland and Glasgow Caledonian University. Blood borne viruses and sexually transmitted infections: Glasgow: Health Protection Scotland, December Enquiries: NSS.HPSBBVSTI@nhs.net Health Protection Scotland has made every effort to trace holders of copyright in original material and to seek permission for its use in this document. Should copyrighted material have been inadvertently used without appropriate attribution or permission, the copyright holders are asked to contact Health Protection Scotland so that suitable acknowledgement can be made at the first opportunity. Health Protection Scotland consents to the photocopying of this document for professional use. All other proposals for reproduction of large extracts should be addressed to: Health Protection Scotland NHS National Services Scotland Meridian Court 5 Cadogan Street Glasgow G2 6QE Tel: +44 (0) NSS.HPSEnquiries@nhs.net Designed and typeset by: Graphics Team, Health Protection Scotland

3 Contents Abbreviations 1. Key Points 1 2. Introduction 4 3. Hepatitis C virus (HCV) Burden of HCV infection Monitoring impact Improving HCV treatment response Reducing HCV-related morbidity and mortality Morbidity Reducing the incidence of HCV-related ESLD/HCC Mortality Reducing deaths from HCV-related ESLD/HCC Reducing the number of new (incident) infections Estimated incidence of infection among people who inject drugs Monitoring service coverage Harm reduction Injecting equipment provision Opiate substitution therapy Testing and diagnosis Trends: general NHS boards Inequalities People who inject drugs (PWID) HCV treatment Trends: general Hepatitis B virus (HBV) Burden of infection Testing and diagnoses Prevalence of HBV infection Chronic HBV infection HBV: decrease in incidence and prevention successes Acute HBV Vaccination of population groups Prevention of mother to child transmission HBV treatment is successful and levels of HBV-related advanced liver disease are low HBV treatment success Outcomes of HBV infection and late diagnosis 24 iii i

4 5. Human immunodeficiency virus (HIV) Burden of infection HIV diagnoses and recent trends Epidemiology of HIV infection HIV infection in men who have sex with men (MSM) Heterosexually acquired HIV infection HIV infection in PWID New developments in HIV prevention HIV treatment and care provision is high quality for all Access to HIV treatment and care Late diagnosis of HIV HIV disease and outcomes HIV associated mortality HIV in Scotland: meeting global targets BBV Co-infection Sexually transmitted infection (STI) Sexually transmitted infections Chlamydia: decrease in diagnoses Gonorrhoea: increase in diagnoses Gonorrhoea diagnoses in women Gonorrhoea diagnoses in men Gonococcal antimicrobial resistance Infectious syphilis: increase in diagnoses among MSM MSM and sexually transmitted infection MSM: HIV and syphilis co-infection MSM: rectal bacterial sexually transmitted infections MSM: sexually transmitted enteric infections MSM: behavioural survey data STI prevention and control: challenges STI prevention and control in the heterosexual population STI prevention and control in the MSM population Acknowledgements References 49 ii

5 Abbreviations AIDS APT ART BASHH BBV BHIVA CAI DAA DBS ESLD EU GHSS HAV HBV HCC HCV HIV HPS HPV JCVI LGV MSM NAATs NATSAL NESI NHS NSS OST PrEP PLWH PN PWID Acquired Immune Deficiency Syndrome Accelerated partner therapy Antiretroviral therapy British Association for Sexual Health and HIV Blood Borne Virus British HIV Association Condomless anal intercourse Direct acting antivirals Dry blood spot End stage liver disease European Union Global Health Sector Strategy Hepatitis A Virus Hepatitis B Virus Hepatocellular carcinoma Hepatitis C Virus Human Immunodeficiency Virus Health Protection Scotland Human Papilloma Virus Joint Committee on Vaccination and Immunisation Lymphogranuloma venereum Men who have sex with men Nucleic acid amplification tests National Survey of Sexual Attitudes and Lifestyle Needle Exchange Surveillance Initiative National Health Service National Services Scotland Opiate substitution therapy Pre-exposure prophylaxis People living with HIV Partner notification People who inject drugs iii

6 SBSTIRL Scottish Bacterial Sexually Transmitted Infection Reference Laboratory SG Scottish Government SHBBV Sexual Health and Blood Borne Virus SIMD Scottish Index of Multiple Deprivation SMC Scottish Medicines Consortium SMMASH Social Media, MSM and Sexual Health SRE Sex and relationship education SRH Sexual and Reproductive Health STI Sexually Transmitted Infection STEI Sexually Transmitted Enteric Infection SVR Sustained viral response UK United Kingdom UNAIDS The Joint United Nations Programme on HIV/AIDS WHO World Health Organisation WoSSVC West of Scotland Specialist Virology Centre iv

7 1. Key Points Hepatitis C Virus (HCV) In 2016, an estimated 34,500 individuals were living with chronic HCV infection in Scotland, more than half of whom have been diagnosed. HCV testing and diagnosis remains strongly patterned by deprivation with numbers of cases highest in those most deprived and fewest in the least deprived. Of those aware of their infection, around a quarter are currently engaged in specialist treatment; approximately 1750 cases are treated per year. The numbers of new presentations of HCV-related end stage liver disease (ESLD) potentially peaked in Scotland in 2014 and have decreased by just over a third since then; this decrease coincides with the availability of highly effective Direct Acting Antiviral (DAAs) therapy and Scottish Government policy to prioritise, for treatment, those with moderate to severe liver disease over those with mild disease. New presentations of hepatocellular carcinoma (HCC) in Scotland continue to rise; while the DAAs prevent progression to liver failure when given to people with severe fibrosis or cirrhosis, their impact on cancer risk among such individuals is limited as the damage has already been done. Injecting drug use continues to be the most prominent risk factor for HCV infection in Scotland, accounting for over 90% of infections. The prevalence of HCV antibodies among people who inject drugs (PWID) in remains high at 58%. The incidence of Hepatitis C among PWID remains stable at 10% but the annual numbers of new infections are estimated to be in decline because the number of people starting to inject drugs is in decline. In , over a quarter of PWID who self-reported as HCV positive had received antiviral therapy for their infection. Almost two-thirds of HCV infected PWID accurately reported their HCV status in , the highest level since , suggesting that an increasing proportion of the HCV-infected PWID population are being diagnosed. Rates of HCV testing among PWID are at their highest levels since surveillance began in Rates of sharing of needles/syringes and other injecting equipment are low and stable, but the reported rate of re-use of one s own needle/syringe has increased. Public health priorities include: (i) Identifying those, particularly former infected PWID, who are currently undiagnosed; (ii) addressing the problem of those historically diagnosed with HCV, but lost to/never in clinical follow-up; and, (iii) increasing the numbers treated for their HCV particularly in primary care and other community settings. 1

8 Hepatitis B Virus (HBV) Of an estimated 9000 people living with chronic hepatitis B in Scotland, over half (55%) have been diagnosed; most originate from high HBV prevalence countries. An average of 360 diagnoses of chronic hepatitis B is made each year. Acute HBV infection is at its lowest level for several decades; this is due, in part, to the success of vaccination programmes in prisons and sexual health clinics. HBV treatment services are highly effective; 95% of those eligible to receive antiviral drugs are on treatment with 91% achieving an optimal response. HBV-related morbidity and mortality rates are low among those diagnosed and living with HBV; an average of 20 individuals per year during the past five years have died or progressed to advanced liver disease. A small number (<10 per year) are diagnosed at a late stage of HBV infection and progress to advanced liver disease within the year. Public health priorities include: (i) the identification of, in particular, infected people originating from high HBV prevalence countries, who remain undiagnosed; and, ii) addressing the problem of those historically diagnosed but lost to, or never in, clinical follow up. Human Immunodeficiency Virus (HIV) In 2016, the number of first time reports of HIV infection (316) fell to the lowest number since 2003; this is mainly due to a decrease in new diagnoses among men who have sex with men (MSM). MSM remain the group most at risk of HIV in Scotland; evidence from behavioural surveys and other infection data indicate that rates of casual unprotected sexual intercourse remain high. The availability of NHS-funded pre-exposure prophylaxis (PrEP) in 2017 for those at highest sexual risk of infection could appreciably reduce the incidence of HIV among MSM in particular. The recent outbreak of HIV among PWID in Glasgow reminds us that highly effective awareness raising initiatives and harm reduction measures, targeted at this population, are essential. In 2015/16, an estimated 13% (800 individuals) remained unaware of their infection. HIV treatment and care provision is excellent; 96% of those attending specialist services are receiving antiretroviral therapy (ART) with 96% achieving viral suppression. A small number are not attending for treatment and care and, of those newly diagnosed, approximately 40% have advanced HIV disease. 2

9 Public health priorities include: (i) improving opportunities for testing including widening the scope for testing in primary care and across all medical specialities in addition to home and self testing options; (ii) the implementation of HIV PrEP in clinical services; (iii) supporting and facilitating those who have been diagnosed into specialist treatment and care and onto therapy as early as possible; and, (iv) continuing to educate, raise awareness and drive the prevention messages. Sexually transmitted infection (STI) During 2015 and 2016 there have been sustained high levels of infectious syphilis and gonorrhoea diagnoses and a stable number of chlamydia diagnoses. In the heterosexual population, young people, particularly women aged under 25 are most at risk of being diagnosed with an STI. In the heterosexual population the incidences of gonorrhoea and infectious syphilis remain low and stable. Among MSM, diagnoses of infectious syphilis and gonorrhoea, particularly rectal gonorrhoea, have increased in the past couple of years, reaching the highest levels recorded for several decades. There has been an increase in sexually transmitted enteric infections (especially Hepatitis A Virus) among MSM elsewhere in the UK and across Europe an observation which has been seen in Scotland but, as yet, only minimally; raising awareness among both MSM and relevant health professionals is essential. Public health priorities, particularly for MSM, include: (i) safe sex education and condom provision, and effective and innovative communication tools to deliver prevention messages; (ii) regular testing and rapid access to treatment; and, (iii) effective partner notification initiatives. 3

10 2. Introduction The first Sexual Health and Blood Borne Virus Framework was published by the Scottish Government in The Framework brought together policy on sexual health and wellbeing, HIV and viral hepatitis for the first time. It set out five high-level outcomes and it sought to strengthen and improve the way in which the NHS, the Third Sector and Local Authorities supported and worked with individuals at risk of sexually transmitted infection (STIs) or blood borne virus (BBVs). The Framework was subsequently updated in 2015 covering the period through to Sexual Health and Blood Borne Virus Framework Outcomes: 1. Fewer newly acquired blood borne viruses and STIs; fewer unintended pregnancies. 2. A reduction in the health inequalities gap in sexual health and blood borne viruses. 3. People affected by blood borne virus(es) lead longer, healthier lives. 4. Sexual relationships are free from coercion and harm. 5. A society whereby the attitudes of individuals, the public, professionals and the media in Scotland towards sexual health and blood borne viruses are positive, non-stigmatising and supportive. The aim of this report is to provide an up to date epidemiological summary of the scale and response to BBVs and STIs in Scotland, highlighting key trends and identifying areas for priority action. 4

11 3. Hepatitis C virus (HCV) 3.1. Burden of HCV infection In 2016, an estimated individuals were living with chronic HCV infection in Scotland, more than half of whom have been diagnosed (Figure 1). Of those aware of their infection, around a quarter are currently engaged in specialist treatment and approximately 1750 cases are treated per year. Injecting drug use continues to be the most prominent risk factor for HCV infection in Scotland, accounting for over 90% of infections where data were available. In , results from the Needle Exchange Surveillance Initiative (NESI) showed that HCV antibody prevalence among people who inject drugs (PWID) remained high at 58%; 3 there were no major differences in HCV prevalence by gender or age-group over time, with rates in the younger ( 30 years) and older (>35 years) age-groups stable at around 40% and 65%, respectively. Figure 1: HCV care cascade as of 31 December Treated and optimal outcome Treated per year Attended and treatment eligible 3. Attended specialist care Diagnosed Living with chronic infection

12 3.2. Monitoring impact Improving HCV treatment response The optimal outcome of HCV treatment is known as a sustained viral response (SVR), and is widely regarded as tantamount to HCV cure. Recently available direct acting anti-viral (DAA) therapies have considerably improved the rate of achieving SVR among the treated population. Of patients commencing antiviral therapy in Scotland during 2015/16, 95% went on to achieve SVR (Figure 2). The highest proportion of SVR was among individuals who had been diagnosed with cirrhosis previous to receipt of antiviral therapy (97%; 95% CI: 96%-99%), and for those receiving interferon-free DAA regimens (96%; 95%CI: 95%-97%). SVR was lowest for individuals treated with interferon-based regimens (86% 95% CI: 80%-91%). Figure 2: Proportion of patients commencing therapy in Scotland that achieved a sustained viral response, i Percentage Overall Without cirrhosis With cirrhosis IFN-based therapy IFN-sparing therapy INF-free therapy Subgroup i Excluding individuals where SVR status is unknown/missing Reducing HCV-related morbidity and mortality Until recent years, morbidity and mortality related to HCV in Scotland have been increasing. This rise relates to those historically infected progressing to advanced liver disease and the limited effectiveness of interferon-based therapies. However, the new DAA therapy era and HCV treatment guidelines 4 outlined in the Framework [which target treatment at those with the most advanced liver disease] offers significant potential to reduce the burden of HCV-related morbidity and mortality in the coming years. Indeed, the Framework states that the Scottish Government is aiming for a 75% reduction in the annual number of people developing hepatitis C-related liver failure by

13 Morbidity Reducing the incidence of HCV-related ESLD/HCC Modelling work, undertaken by Health Protection Scotland and Glasgow Caledonian University, estimates that a minimum of 1500 treatment initiates with more advanced disease (i.e. F2-F4) per year during is required to reduce the number of new liver failure presentations from the current level of around 80 to 30 by The most recent estimates suggest that the numbers of new presentations for HCV-related end stage liver disease (ESLD) potentially peaked in Scotland in 2014 and is now beginning to decrease (Figure 3). This decrease coincides with the availability of highly effective Direct Acting Antiviral (DAAs) therapy and Scottish Government policy to prioritise, for treatment, those with moderate to severe liver disease over those with mild disease. In contrast, the number of HCV-related hepatocellular carcinoma (HCC) admissions has increased consistently. While the DAAs prevent progression to liver failure when given to people with severe fibrosis or cirrhosis, their impact on cancer risk among such individuals is limited as the damage has already been done. Figure 3: Number of incident ESLD/HCC hospital presentations among those diagnosed HCV RNA positive i at time of hospital presentation, Annual number of presentations ESLD i Deduced from available laboratory and clinic data. Year HCC

14 Mortality Reducing deaths from HCV-related ESLD/HCC The number of deaths from ESLD has stabilised in recent years and is expected to decline in the wake of the reduced incidence of new presentations with HCV-related liver failure (Figure 4). Deaths from HCC, generally, have continued to rise in alignment with the continuing increase in new HCC presentations, though the number observed in 2016 was lower than expected. Based on these data, the World Health Organization (WHO) Global Health Sector Strategy (GHSS) target for a reduction in HCV-related mortality of 10% by remains challenging for Scotland. Figure 4: Number of ESLD/HCC deaths among those diagnosed HCV RNA positive i at time of death, Annual number of deaths Year ESLD HCC i Deduced from available laboratory and clinic data Reducing the number of new (incident) infections One of the SHBBV Framework s five high-level outcomes is to reduce the number of newly acquired blood borne virus infections. Monitoring the impact of prevention measures on the incidence of infection remains a challenge as incident infection is difficult to measure directly. This is because, in the main, much of the acute infection is asymptomatic and undiagnosed. To address this, different methods are used to provide incidence estimates and each compared to assess consistency. 8

15 Estimated incidence of infection among people who inject drugs An indicator of recently acquired HCV infection is HCV prevalence among those who had recently commenced injecting: this is slightly higher in than observed in previous NESI surveys, with 21% (n=12), 30% (n=59) and 35% (n=129) prevalence among those who had been injecting for less than 1 year, 3 years and 5 years, respectively (Figure 5). However, it is also notable that these PWID with recent onset of infection are forming a declining proportion of the whole NESI sample over time. Data from NESI in also show that 18 respondents were found to be HCV RNA positive and HCV antibody negative, another indicator for recent infection. This translates into an incidence rate of 11.4 new HCV infections per 100 person-years (Figure 5); while this is higher than the HCV incidence rate of 6.1 per 100 person-years in , we cannot conclude that incidence is increasing as confidence intervals overlap. Nevertheless, HCV incidence is consistent with trends in HCV prevalence among recent onset injectors. Both estimates suggest that the WHO GHSS call to reduce newly acquired chronic HCV infections by 30% by 2020 and 80% by represents a significant challenge for Scotland. However, there is evidence to suggest that prevalence of injecting drug use in Scotland has decreased in recent years. Background epidemiology from NESI, drug treatment data 7, drugrelated hospital admissions 8 and drug-related deaths 9 suggests that PWID are an ageing cohort with fewer new injectors joining year on year. As a result, the overall number of incident infections occurring annually among PWID is likely to have decreased even though the incidence among this population over the last eight years has been relatively stable. Figure 5: Indicators of recently acquired HCV infection among NESI respondents, Percentage Year a) HCV incidence per 100 person-years b) HCV prevalence (among PWID with <1 yr since onset of injecting 9

16 3.3. Monitoring service coverage Harm reduction Provision of harm reduction interventions for PWID, including access to sterile injecting equipment and opiate substitution therapy, can prevent HCV among PWID and reduce the likelihood of onward transmission Injecting equipment provision The GHSS on viral hepatitis and the draft action plan for the health sector response to viral hepatitis in the WHO European region 10 call for a major global increase in provision of sterile needles and syringes, from an estimated baseline of 20 needles and syringes per PWID per year to 200 by 2020 and 300 by However, these estimates do not account for individual differences in need. To better reflect the adequacy of needle and syringe provision, data from NESI are presented on self-reported adequacy of needle and syringe provision. In this metric, needle and syringe provision is considered adequate when the reported number of needles received, met or exceeded the number of times the individual injected. In , the proportion of PWID reporting adequate provision of needles and syringes was suboptimal at 72%, its lowest level since NESI began in 2008 (Figure 6). Figure 6: Proportion of current PWID reporting adequate i needle and syringe provision, Percentage Among PWID who had injected in the past 6 months i reported number of needles received / number of times injected is greater than 1 [or percentage > 100%] 10

17 Levels of reported needle and syringe sharing in the past six months remained very low in NESI in (7%; n=147) and have now potentially reached a point of plateau (Figure 7). Similarly, reported sharing of injecting equipment (spoons/cookers, filters, and/or water) in the past six months has more than halved from 48% (n=988) in to 21% (n=458) in Figure 7: Proportion of current PWID reporting sharing of injecting equipment, Percentage Injected with a needle/syringe previously used by someone else Used other injecting equipment (either filters, spoons or water) that had previously been used by someone else Although the latest reported levels of sharing of needles and syringes and other equipment in NESI ( ) are low and have been decreasing in recent years, reported re-use of one s own needle/syringe has increased from 45% in to 54% in , with rates particularly high amongst the growing population of stimulant injectors. Additionally, the proportion of those interviewed reporting daily or more injecting (51%) in the past six months increased for the first time since Frequent injecting episodes (i.e. daily or more) are a particular feature of stimulant users, notably those reporting use of cocaine (60%), legal highs (67%) and crack (75%) Opiate substitution therapy Self-reported uptake of methadone has fluctuated, but remained high, over the five NESI surveys, with 77% (n=1699) of participants in , who were currently injecting (i.e. had injected in the last six months) reporting receipt of prescribed methadone in the last six months. When restricted to participants who were visiting the service to obtain sterile injecting equipment (on the occasion of their recruitment into the study), the proportion on prescribed methadone in the last six months decreased to 65%. Either way, these estimates far exceed the WHO European region calls for at least 40% of opioid dependent PWID to be receiving opiate substitution therapy (OST) by 2020 in its draft action plan for the health sector response to viral hepatitis

18 Testing and diagnosis Detecting those who have been infected with HCV and diagnosing them as early as possible enables individuals to receive treatment as early as possible, and can improve long term health outcomes. In the era of highly effective DAA 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 Trends: general Laboratory reports from Scotland s four largest NHS board areas suggest a consistent increase in the number of HCV tests undertaken in the past two decades, peaking at around in Over half of all testing in 2016 was conducted within hospitals (37%) and general practices (29%) (Figure 8). Since 2007, testing has increasingly been undertaken in drug treatment services, largely as a result of routine availability of DBS test kits, now accounting for ~ 5% of total tests conducted annually. Figure 8: Annual number of people tested for HCV in Scotland s four largest NHS board areas by setting, Annual number of people tested Year of HCV Antibody Test GP Hospital Drug Service GUM Clinic Prison Routine Screen ii Other / Not Known iii i Based on an individual s first test per year. ii Routine Screen includes Fertility/Assisted Conception, Occupational Health and Renal. iii Other includes Antenatal Clinic, Counselling Clinic, Family Planning, BTS. Prisoners are amongst the populations at greatest risk of HCV infection. 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 Sexual Health and Blood Borne Virus Framework update 2 stated: 12

19 In line with the WHO Guidelines, and reflecting the priority given to HIV testing, 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. This will provide an important opportunity to test and support a population who may otherwise not engage with health services. The SHBBV co-ordinators group have been developing standards in this area and there has been a focus on the importance of HCV testing in prison. NHS Greater Glasgow and Clyde introduced opt-out HCV testing for new prisoners in In the four largest NHS boards, HCV testing in prison increased from 587 individuals tested in 2013, to 1121 in 2014, and 2367 in More modest increases in HCV diagnoses in the prison setting were also observed from 66 in 2013, to 107 in 2014, and 137 in During January to December 2016, 1594 new cases of hepatitis C antibody-positivity (people with current or past infection) were diagnosed (Figure 9). This figure compares to 1940, 2022, and 1815 for 2013, 2014 and 2015 respectively. An average of 1866 cases were diagnosed per annum in the years , compared with 1908 from Two-thirds (66%) of new diagnoses in 2016 were male and almost two-thirds were aged years (64%). A cumulative total of cases of hepatitis C antibody-positivity had been diagnosed as at 31 December Figure 9: Persons in Scotland reported to be HCV antibody positive by year and setting, Annual number of persons Year GP Hospital Patients GUM Clinic Prison Drug Service Other Not Reported 13

20 Numbers of tests undertaken have risen by 45% between 2012 and 2016, and the proportion of people testing first time positive for anti-hcv declined from 2.7% in 2012 to 1.6% in 2016; this indicates that a higher proportion of individuals at relatively lower risk of infection are being tested (Figure 10). Figure 10: Annual number of people tested for HCV in Scotland s four largest NHS board areas and proportion testing first time positive, Annual number of people tested Proportion first time positive (%) Years 0.0 Annual number of people tested Proportion first time positive NHS boards Within NHS boards, the rate of people diagnosed and living with HCV varies and is more concentrated within cities (Figure 11). This observation is most apparent in NHS Greater Glasgow and Clyde, which has the highest number of HCV diagnoses in the country. Within this board there are postcode districts, all concentrated within the Glasgow City Council boundary, where there are more than 200 HCV diagnosed people living per 10,000 of the population representing the highest rates in the country. Similarly, within NHS Lothian, the highest diagnosis rates per population are within Edinburgh City and the surrounding areas. In NHS Grampian, only postcode districts that fall within the city of Aberdeen have rates of HCV diagnosed persons greater than 100 per 10,000 population Inequalities The Framework states the importance of health inequalities to BBVs, and much work has been done locally and nationally to reduce such inequalities. Despite this, HCV diagnosis remains strongly patterned by deprivation with numbers of diagnoses highest in those most deprived and fewest in the least deprived. This is largely influenced by prevalence of problem drug use in Scotland (including injecting), which is also strongly patterned by deprivation

21 Figure 11: Rate per 10,000 of population of hepatitis C antibody positive diagnosed individuals, not known to be dead, by postcode district of residence; data for four largest NHS boards to 31 December Tayside Grampian Dundee City Aberdeen City Greater Glasgow and Clyde Lothian City of Edinburgh Glasgow City Rate of HCV diagnosed persons by population < City bounderies based on Local Authorities. Postcode district available for 80% of Greater Glasgow and Clyde, 81% of Lothian, 81% Tayside and 87% Grampian. 15

22 When considering testing by deprivation, the most recent data highlight disparities between those tested from the most deprived areas and those from the least deprived (Figure 12). The likelihood of testing positive decreases across the index with those tested from the most deprived communities most likely to be infected with HCV. This again reflects the health inequalities which exist within HCV, with diagnosis strongly patterned by deprivation. However, it also further highlights the relatively high rates of testing among the least deprived who are at much lower risk of infection. Figure 12: Annual number of people tested for HCV in Scotland s four largest NHS board areas by SIMD quintile and proportion testing first time positive, % Annual number of people tested % 2.5% 2.0% 1.5% 1.0% 0.5% Proportion first time positive 0 1 (most deprived) (least deprived) Scottish Index of Multiple Deprivation (SIMD) 2016 quintile 0.0% Annual number of people tested Proportion first time positive People who inject drugs (PWID) Trends: general Uptake of HCV testing among PWID has increased slowly but steadily: the proportion of NESI respondents who reported recent testing (i.e. in the last 12 months) increased from 35% in to 48% in When those who reported that they had been diagnosed with infection from a past test (that is, prior to 12 months ago) were excluded, the percentage of respondents who had been tested for hepatitis C in the last year increased to 55%; this figure compares to 40%, 45%, 49% and 52% in , 2010, and , respectively. * * The rationale for excluding those diagnosed from a past test is that they would not be eligible for continued routine testing. From the NESI data it is however not possible to determine whether those who reported testing positive in the last 12 months had been diagnosed previously; therefore the figure of 55% may include some people who were ineligible for diagnostic testing in the last 12 months. 16

23 Awareness of HCV status In NESI in , among people who were positive for HCV antibodies on dried blood spot (DBS) testing, 42% self-reported that they were HCV positive and a further 21% self-reported that they had cleared their HCV infection (the latter is compatible with an HCV antibody positive DBS) (Figure 13). Thus, 63%, in total, reported that they were aware of their HCV status; this has increased from 46% in Figure 13: Proportion of current PWID testing positive for HCV antibodies, who are aware of their infection, Percentage Among PWID who had injected in the past 6 months The GHSS on viral hepatitis calls for a major global increase in the diagnosis of chronic HCV infection, with 30% of people infected knowing their status by 2020 and 90% by However, the draft WHO action plan for the European region sets relatively more ambitious targets of 50% diagnosed and aware of their infection by 2020 and 75% of those with latestage HCV-related liver disease diagnosed by Whilst the first target of 50% being diagnosed by 2020 may have already been reached in Scotland among PWID, more needs to be done to achieve the 90% target by The need to increase number of HCV diagnoses in Scotland is pressing given increasing numbers of individuals successfully being treated in the new DAA era HCV treatment Outcome three in the Framework focuses on ensuring that people affected by BBVs can access the best treatment and care and can lead a healthy life. New DAA therapies have the potential to transform the treatment landscape, offering shorter duration, increased tolerability and greater effectiveness to the majority who receive them. While prevention activity is crucial in reducing the rate of new infections, numbers already infected would remain high without effective HCV treatment. 17

24 Trends: general From the public health perspective, DAA therapy offers considerable advantages over previous HCV treatment which make community/outreach disbursement feasible, enabling increased contact with infected individuals. While the current high cost of DAAs represents a barrier to access in most countries worldwide, these medicines are currently prescribed in Scotland in accordance with national treatment and therapies guidelines and recommendations. 4 The treatment initiation target of 1500 people per year represented an almost 20% increase in the number treated in 2014/15, and remained for 2015/16. NHS board-level data highlights increases in people accessing treatment since 2013/14, exceeding 1700 in 2015/16 and 2016/17 (Figure 14), coinciding with the availability of DAA therapy. Heretofore, the number of new treatment initiations remained relatively static at around 1000 per year. As a result of this improved performance, The Scottish Government published a new national treatment target of 1800 treatment initiations for 2017/18. Figure 14: Estimated numbers initiating HCV treatment in Scotland vs. national treatment targets, Number / / / / / / / / / /17 Year Number of treatment initiations SG target 18

25 4. Hepatitis B virus (HBV) 4.1. Burden of infection A recent report describes the epidemiology of hepatitis B infection in Scotland using a combination of data sources. 12 Based on the analysis of laboratory data, a total of 4986 individuals had been diagnosed and were living with chronic hepatitis B infection at the end of December 2016 (Figure 15). This represents 55% of the estimated 9000 people living with hepatitis B in Scotland. 13 The pool of 9000 individuals living with HBV is influenced each year by an estimated steady state of who enter the pool through imported infection from high prevalence countries and new transmissions of infection, and a similar number who leave the pool through either death or migration from Scotland. Figure 15: HBV landscape: diagnoses and access to treatment and care, Scotland, 2015/2016. Death Exported Infection Chronically Infected New transmissions Imported Infection (High Prev. Countries) est est Diagnosed 4966 (55%) Undiagnosed 4034 (45%) In Specialist Care i 1951 (39%) Not in Specialist Care 3015 (61%) On treatment ii 362 (19%) Not on treatment 1589 (81%) Optimal Response iii 211/ 231 (91%, range %) i The data on those in specialist care and undergoing treatment are taken from a survey of the clinical units providing treatment during 2013/2014. ii Of those eligible for treatment according to guidelines. In the most recent survey of clinical services in 2015, 95% (362/383) of those eligible are receiving treatment and care with 91% (211/231) experiencing an optimal treatment response during iii Of those attending for treatment between January 2013 and December 2014 and treated with nucleo(s)tide analogues for >12 months and who achieved optimal response. 19

26 4.2. Testing and diagnoses There are an estimated 4000 infected individuals who may be undiagnosed at this time. Testing data indicate that almost 2% of the population received a diagnostic test for hepatitis B infection in 2015 with 40% and 36% of tests being performed in the hospital and primary care setting, respectively. Despite high levels of testing in clinical settings, there is a need for further case finding, targeting groups at risk, in an effort to identify those who would most benefit from specialist treatment and care. It is likely that a relatively small number will require antiviral treatment, based on the eligibility criteria in the treatment guidelines, but diagnosing and referring individuals into the specialist care pathway are key activities in reducing the likelihood of outcomes such as cirrhosis and hepatocellular carcinoma Prevalence of HBV infection The overall HBV prevalence is 0.4%, that is, 4 in 1000 of the population, similar to that at UK level. 14 There are slightly more diagnosed men than women (ratio 1.5:1); three quarters are aged between 25 and 54; and, over one third live in areas with the highest deprivation. Among the diagnosed cohort, 73% are of non-british ethnicity, and likely to originate from high HBV prevalence countries such as those in South and South East Asia. While this group comprises 4% of the population in Scotland, they are disproportionately affected by HBV and also more likely to be living in the most deprived communities in Scotland (Figure 16). If we wish to reduce health inequality gaps, [outcome 2 of the SHBBV framework] this area is worthy of attention. The majority (78%) of all HBV testing is performed on those of British ethnicity; there is, however, a tenfold higher positivity rate among those of non-british identity (2.2%) compared with 0.2% positive among those of British ethnicity. An increase in testing among those of South and South East Asian ethnicity is merited. Testing continues in public health screening settings such as that of the blood transfusion and antenatal services. Information collected at NHS board level indicates that there is a very high uptake of antenatal HBV screening; over 80% of women testing HBV positive were of non- British ethnicity and likely to originate from areas of high HBV prevalence. 20

27 Figure 16: Ethnic group i by deprivation quintile of the chronic HBV diagnosed cohort, Scotland, Number of diagnoses SIMD 1 SIMD 2 SIMD 3 SIMD 4 SIMD 5 Scottish Index of Multiple Deprivation (SIMD) Quintile British Non-British i Ethnic group is classified using name classification software. Approximately 5% of people with assigned British ethnicity will not be of British origin, while approximately 25% of people with assigned non-british ethnicity will indeed be British. Additionally, 5% of residents in the SIMD linked dataset either could not have their ethnicity classified by the name classification software or were classified as diaspora and as such, were assumed to be non-british. 21

28 Chronic HBV infection Diagnoses of chronic HBV infection have remained stable during the past five years with an annual average of 369 diagnoses between 2011 and In 2015, there were 411 new reports of chronic HBV infection (11.6 per 100,000 population) with 262 diagnoses in men (15.1 per 100,000) and 144 in women (8.0 per 100,000). Almost two thirds of diagnoses were made in those aged years (Figure 17). Unpublished data for 2016 indicate that there have been a further 385 diagnoses (10.9 per 100,000); this is in line with the five-year annual average number of diagnoses. The chronic cohort are characterised by 76% being non-british and, 58% being male. Figure 17: Laboratory diagnoses of chronic HBV in men and women by age group, Scotland, Men (n=262) Women (n=144) HBV: decrease in incidence and prevention successes Acute HBV During the first five years of the SHBBV framework, diagnoses of acute HBV infection have reduced to around 20 with 25, 18 and provisionally 23 in 2014, 2015 and 2016, respectively compared to 50 in 2011 (Figure 18). In the majority of instances, sexual transmission is the main route of transmission occurring among both the heterosexual (n=21) and, to a lesser extent, the men who have sex with men (MSM) (n=16) populations. The reduction in recent years is due, in part, to vaccination policy

29 Vaccination of population groups An effective vaccine has been available since the 1980s and recent data indicate successful coverage in both babies at risk of infection and in PWID, resulting in reductions in infection. A recent evaluation indicated that vaccine uptake among PWID has continued to increase since the introduction of prison inmate vaccination in 1999 with 74% of PWID reporting having received at least one dose of hepatitis B vaccine during 2015/16 and over 60% having received three or more doses. 16 This has complemented the achievement of other harm reduction tools introduced in the late 1980s when levels of acute HBV infection were higher than in recent years. There are limited data for the MSM population for whom the offer of vaccine in sexual health clinics is advised; however, an audit in 2010 showed that over 80% had commenced vaccination. 17 Figure 18: Annual number of probable acute diagnoses of hepatitis B infection, Scotland i Number i Year i provisional unpublished data. The data from 2007 to 2013 are based on probable acute infections extracted from the laboratory dataset. Since 2014, the data are based on information received using an enhanced surveillance approach Prevention of mother to child transmission Prevention of mother to child transmission is also noted to be successful: a survey of vaccine uptake among babies born to HBV infected mothers during 2013 indicated that 98% had received three doses of vaccine by their first birthday and 95% of those born during 2012 had received four vaccine doses by their second birthday. Thus, the combination of high levels of antenatal HBV testing and the subsequent vaccination of those at highest risk of horizontal transmission are successful public health interventions. Furthermore, the introduction of the hexavalent vaccine, which includes a hepatitis B component, into the childhood vaccination programme during 2017 will impact beneficially on acute and chronic hepatitis B incidence in the future

30 4.4. HBV treatment is successful and levels of HBV-related advanced liver disease are low The third outcome in the SHBBV framework is that individuals infected with BBVs lead longer healthier lives. Using data available at the time of the 2014 survey of HBV treatment centres in Scotland, an estimated 1951 (39%) individuals were attending services; 52% of whom represented an East Asian (Chinese/Hong Kong Chinese) or other Asian (Indian/Pakistani/ Bangladeshi) ethnicity. It is uncertain whether a further cohort is being monitored in a nonspecialist setting - this may be considered a reasonable approach where the viral load is low and there are no clinical indications requiring specialist care and/or treatment, but there remains a gap here potentially with regards to equity of care which needs to be addressed HBV treatment success Treatment is successful with 95% of those eligible, according to the current guidelines, 19,20 receiving antiviral drugs and, an optimal antiviral response is noted in 91% of those receiving treatment; the findings in 2014 were consistent with those in the previous survey in Note that, as with HIV, antiviral treatment is used to suppress viral replication, not to eradicate the virus, and that lifelong monitoring of individuals is required Outcomes of HBV infection and late diagnosis We observe small numbers of individuals in the chronically infected HBV cohort progressing to advanced liver disease or having died each year with an average of 20 per year during the past five years ( ). Indeed, there is evidence that infected individuals are presenting and being diagnosed late but this does not appear to be a large problem at this time. The data indicate that less than ten individuals per year, representing around 1.5% of the annual diagnoses, have progressed to advanced liver disease within a year of their HBV diagnosis. 24

31 5. Human immunodeficiency virus (HIV) 5.1. Burden of infection A total of 5271 individuals are diagnosed and living with HIV in Scotland at the end of September 2017 this includes all those who are not known to have died or to have left Scotland. During 2017, the database has been updated following an exercise to identify individuals who may not have engaged with healthcare services for more than one year and who may have left Scotland. There remain a number of non-attenders and if we consider that a further proportion of these may have left Scotland (allowing for outward migration of those who are non UK born), the estimated number of diagnosed individuals is closer to 5200 at this time. 21 For the purposes of this report we will describe the epidemiology of HIV in Scotland based on those who had been diagnosed by the end of December It should be noted that a proportion of individuals, an estimated one in eight (13%), according to 2016 UK estimates, remain undiagnosed; 22 this equates to almost 800 people in Scotland who may be unaware of their HIV infection and a total of approximately 6000 living with HIV in Scotland (Figure 19). The statistical modelling method to determine this proportion has been refined in recent years and will vary by risk group. The total of over 6000 estimated to be living with HIV is influenced each year by an estimated 300 who have acquired their infection either in Scotland (mainly MSM or PWID) or abroad (mainly heterosexuals from high prevalence countries) and around who either leave Scotland or have died from HIV and non HIV related causes (Figure 19). Figure 19: HIV landscape: diagnoses and access to treatment and care, Scotland, December 2016/2017. Death and Chronically New transmissions (MSM) Exported Infection Infected and Imported Infection (High Prev. Countries) est Diagnosed 5271 (87%) Undiagnosed 788 (13%) In Specialist Care i 4598 (87%) Not in Specialist Care 673 (13%) Treated 4414 (96%) Untreated 184 (4%) Optimal Response i 4239 (96%) Suboptimal Response 175 (4%) i Individuals recording viral suppression with an HIV viral load of 200 copies/ml or less at latest attendance. 25

32 5.2. HIV diagnoses and recent trends Epidemiology of HIV infection There were 366 reports of confirmed HIV infection in 2015 giving a rate of 10.4 per 100,000 population (aged 15 to 64 years) with a total 287 diagnoses among men (16.5 per 100,000) and 79 among women, (4.4 per 100,000). In 2016, the total number fell to 316, that is, 8.9 per 100,000 population with 248 diagnoses among men (14.2 per 100,000) and 68 among women (3.8 per 100,000). 21 In 2016, the majority (57%) of diagnoses were made in the two largest NHS boards, NHS Greater Glasgow and Clyde (35%) and NHS Lothian (22%). Two thirds (68%) of new diagnoses were made among individuals aged 25 to 49 (Figure 20). This is a similar observation to that in previous years. At the UK level, an increasing number of individuals over the age of 50 are being diagnosed, reaching 25% of new diagnoses in 2016 compared to 8% in 2007 and an average of 15% in the previous five years. Figure 20: New diagnoses of HIV by age group, Scotland, Percentage Year < >50 During the first five years of the SHBBV framework ( ), an annual average of 360 diagnoses of HIV were reported to Health Protection Scotland (HPS) each year; this steady number of reports reflects a combination of continued promotion of testing and new transmission of infection occurring in sub groups of the population. The latest data in 2016, however, indicate that the total has fallen to 316, the lowest annual total since This recent decrease is reflected in a decrease in both the number of reports among men who have sex with men (MSM) and those whose transmission risk was via heterosexual contact. Contemporaneously, there has been an increase in reports among people who inject drugs 26