The Programme Development Group (PDG) took account of a number of factors and issues when developing the recommendations.
3.1 The PDG felt that awareness-raising in the general population was a very important issue. While it was always intended that the guidance would make specific recommendations for awareness-raising in professionals and in populations at increased risk, the group decided that it would also be helpful to raise awareness generally.
3.2 The PDG was aware of the potential benefit of educating all healthcare professionals about hepatitis B and C but was pragmatic in its approach, focusing on those who were likely to be providing services to people at increased risk of infection.
3.3 Recent developments in the treatment of hepatitis B and C are not reflected in the qualitative literature on the barriers and facilitators to testing. This is because much of the research was undertaken before the newer drugs (see section 7) were available. The Group felt that awareness of more effective treatments may have a positive impact on the uptake of testing.
3.4 The need for awareness-raising and training on hepatitis C for healthcare professionals was a key theme in the qualitative review, and was in accord with PDG members' experiences. The Group heard reports of people with hepatitis C having to ask for testing for viral hepatitis and liver function and being left with misinformation and confusion about their diagnosis, its consequences and treatment pathways. The Group felt it important that professionals working in this area had the ability to help people make informed choices.
3.5 The PDG considered there was a need for targeted education programmes for health and social care professionals, such as those produced by Hepatitis Scotland and the Royal College of General Practitioners (RCGP). An outline of requirements on Hepatitis C workforce education development (NHS Education for Scotland 2010) has been produced as part of the Hepatitis C Action Plan for Scotland (Scottish Executive 2006, 2008). The RCGP programme is aimed at generalist clinicians such as GPs and nurses working in primary care, and covers detection, diagnosis and management of hepatitis B and C in primary care.
3.6 The PDG felt education programmes might cover, depending on the role of the health and social care professional, some or all of the following:
epidemiology, public health impact and clinical consequences of hepatitis B and C infection
risk factors for hepatitis B and C and population groups at increased risk of infection
detection and diagnosis of hepatitis B and C
factors to consider in a pre- and post-test discussion and how these discussions should be conducted
the importance of repeat testing and harm reduction interventions for people who remain at risk of infection, including hepatitis B vaccination
social and cultural barriers to testing and treatment (for example, stigma)
local testing, treatment and referral pathways
the main features of treatment for hepatitis B and C, in line with current best practice guidelines
tests used to monitor liver health
the benefits and risks of current treatment options, including their effectiveness, adverse events and barriers and facilitators to treatment adherence.
3.7 There are many barriers to testing for hepatitis B and C for groups at increased risk of infection and many are similar for both infections. They include:
Fear of being stigmatised, whether by healthcare professionals, sexual partners, family or friends.
Knowledge and awareness in relation to the transmission of infection and the treatments available. The PDG was aware of a general lack of knowledge about hepatitis B and C, including among people promoting tests for these infections. Members felt that this contributed to the low uptake of testing among people at increased risk of infection and to the stigma surrounding these infections. It was noted that lack of awareness among people at increased risk of infection may result from lack of access to statutory services.
Parental fears that they will not be able to cope with the issues their child may face if the child is found to have hepatitis B or C. (This is especially the case if appropriate information and care pathways have not been discussed with parents.)
3.8 People who have injected drugs in the past may not want to disclose drug-using history. This may be a barrier to hepatitis B and C testing and treatment. The PDG felt that positive messages about the effectiveness of treatment and attempts to 'normalise' testing might help reach these people.
3.9 The PDG was keen for the guidance to convey the improvement in health outcomes associated with early identification of hepatitis C in people for whom treatment is indicated. However, they acknowledged that personal circumstances may influence the timing of testing, and that economic, social or other health needs may be a higher priority for some people.
3.10 The PDG recognised the important role that family, partners and friends may play in encouraging people to get tested and complete treatment. The Group also recognised a role for the peers of people at increased risk in promoting hepatitis B and C testing and supporting people who are diagnosed positive.
3.11 The PDG noted that it was important to ensure people are not stigmatised by the way information on hepatitis B and C is delivered.
3.12 The PDG was mindful that combining awareness-raising campaigns for hepatitis B and C with other health promotion campaigns, such as those for HIV, may risk alienating some populations at increased risk. For example, the PDG was made aware that some migrant populations are unlikely to engage with a campaign that associates hepatitis B with sexually transmitted infection. The need to target awareness-raising campaigns to different audiences was felt to be of considerable importance to the PDG.
3.13 Transmission of hepatitis B from mother to child may be considered normal among some minority ethnic communities. Although this suggests there is less stigma associated with infection among these communities, the Group felt that acceptance of infection may adversely impact on the uptake of testing and treatment. It noted a lack of qualitative evidence about this route of transmission, suggesting a lack of awareness and the need for preventive education.
3.14 Employment-based screening and subsequent discrimination against workers who test positive for hepatitis B in countries where there is a high prevalence of hepatitis B may discourage voluntary testing among migrants from those countries.
3.15 The PDG noted that people who inject drugs and have hepatitis C could be stigmatised by the injecting drug community, as a diagnosis of hepatitis C suggests a history of sharing injecting equipment.
3.16 The PDG was mindful that offering universal testing in certain settings may help reduce the stigma associated with hepatitis B and C.
3.17 Access to dried blood spot testing or a specialist phlebotomist can reduce pain and embarrassment associated with the difficulties of taking blood samples from people with poor vascular access – typically associated with long-term injecting or poor injecting technique.
3.18 The PDG discussed the need to train all healthcare staff who are involved in hepatitis testing to carry out pre- and post-test discussions with people at increased risk of hepatitis B and C infection.
3.19 The PDG were mindful of the sensitivities of discussing people's sexuality and potential sexual exposure to hepatitis B or C.
3.20 The PDG noted the importance of all blood samples that test positive for hepatitis C antibody being routinely tested for hepatitis C virus, for example, by PCR. In addition, further consideration of and research on the use of PCR for initial testing in current injecting drug users, with follow-up antibody testing for people who test PCR positive, may be warranted to enable rapid diagnosis of recent infections.
3.21 While venepuncture samples remain the gold standard, the PDG noted that dried blood spot tests for hepatitis B and C have a high test sensitivity and specificity and can be useful in certain settings for people with poor venous access and where there may be no facilities or expertise to take venous blood samples (for example, in specialist drug treatment services or prisons).
3.22 The PDG recognised that the use of dried blood spot testing for diagnosis may be more acceptable to some of the target populations than taking a blood sample from a vein, especially if there is poor venous access or the person is needle phobic. In addition, more staff would probably be able to carry out such tests, so helping to increase the number of people who are tested. The PDG noted the success of the Scottish Hepatitis C Action Plan in place since 2008 (Scottish Executive 2006, 2008). Preliminary evidence from this programme suggests that hepatitis C testing in specialist drug clinics increased after the introduction of dried blood spot testing and wide-scale training of healthcare workers in hepatitis C.
3.23 The PDG recognised that oral fluid testing may be more acceptable to some people because it is less invasive than taking blood from a vein, but that oral fluid testing has a lower sensitivity and specificity than tests for hepatitis B and C performed on blood. If an oral fluid sample was used, a blood sample would then be needed to confirm the initial positive results, and for PCR testing to diagnose chronic hepatitis C.
3.24 The PDG acknowledged that different populations are at increased risk of hepatitis B and C. However, there is some overlap between them, and it would simplify delivery if testing for both infections at the same time was recommended in people who are at increased risk of either.
3.25 The PDG felt that the point of entry into a hepatitis B vaccination programme also provides an opportunity to offer testing to people considered to be at increased risk for hepatitis B and C infection.
3.26 The Group was aware of cases where people had repeatedly been vaccinated against hepatitis B (for example in the prison setting) but not tested for infection, and had later been found to have chronic infection and subsequent liver damage. Nonetheless, the PDG felt that it is important for testing to be offered after vaccination, so as not to impede the success of the vaccination programme.
3.27 In line with the Green book, the PDG felt that drug services should offer hepatitis B vaccination to all service users who inject or have injected drugs and people with a risk of progression to injecting, for example people who are currently smoking heroin and/or crack cocaine, and heavily dependent amphetamine users, as well as non-injecting users who are living with current injectors.
3.28 The PDG felt that despite the focus of this guidance on primary and secondary care there may be a role for routine testing for hepatitis B and C in some tertiary clinical services (such as liver clinics, haemodialysis, rheumatology, cancer and fertility services) and as such staff should have access to appropriate training and a role in awareness-raising. The PDG was aware that evidence regarding the effectiveness of routine testing in tertiary clinical services has not been adequately considered in the development of this guidance, but felt this area should be acknowledged.
3.29 The PDG felt that there may be merit in commissioners considering a range of venues for hepatitis B and C testing in order to improve accessibility. Mechanisms would need to be in place to ensure access to laboratory testing services, delivery of results and referral of people who test positive into the care pathway. In addition, venues would need to ensure adequate measures were taken to ensure infection control and privacy. The PDG acknowledged that there is encouraging evidence from pilot schemes where community pharmacists provide dried blood spot testing for hepatitis. Although the evidence is not strong enough to uniformly recommend that all community pharmacists provide this service, the PDG felt that it would be worthwhile considering extending pilot programmes. This extension could be considered for pharmacists already engaged with people at increased risk of hepatitis B and C, such as pharmacists providing needle exchange and NHS health checks.
3.30 The PDG noted that abnormal liver function tests, such as raised ALT (alanine aminotransferase) can occur for a variety of reasons (for example, as a consequence of alcohol consumption and fatty liver, or use of statins). In primary care there is a requirement to investigate the cause of an abnormal liver function test, including testing for hepatitis. In secondary care, however, hepatitis tests should only be conducted if the cause of an abnormal liver function test is not known.
3.31 Active contact tracing for people who test positive for hepatitis C is not recommended, given low transmission rates to both sexual and household contacts. The PDG acknowledged that it would be sensible to discuss with people who test positive whether any of their contacts may have been exposed to infection, including the children of mothers with hepatitis C infection. Testing of identified contacts would be offered at clinical discretion.
3.32 There was little published evidence on effective or cost-effective interventions to promote and offer testing to people at increased risk of hepatitis B. There was also a lack of corresponding evidence for interventions addressing hepatitis C testing among migrants. The PDG, therefore, largely drew on economic modelling and other evidence presented to the PDG in order to formulate the recommendations.
3.33 The PDG was concerned about people who have previously injected drugs but are no longer doing so, and other groups at increased risk, because there was limited evidence on how to reach them effectively. This includes, for example, commercial sex workers and men who have sex with men. The group felt that the principles of the recommendations may apply to these groups.
3.34 The mapping review provided limited evidence of existing good practice on testing among people at increased risk of hepatitis B and C in England. The Hepatitis C Action Plan for Scotland, however, does provide a model for improving testing and treatment for hepatitis C (Scottish Executive 2006, 2008).
3.35 The PDG recognised the potential risk of hepatitis C transmission among people who inject performance and image-enhancing drugs (PIEDs) such as anabolic steroids (for non-medical reasons). However, there is a lack of published evidence on the extent of risk in this group or on their contribution to overall hepatitis C prevalence.
3.36 The PDG recognised and understood the potential risks associated with the transmission of hepatitis C via sharing straws to snort drugs (in theory, if nasal passages were bleeding a straw could transfer infected blood to others using the same straw), but there was a lack of strong biological evidence on which to base recommendations. The key risk was considered to be through sharing injecting equipment.
3.37 The PDG noted a lack of evidence specific to the role of peer support in promoting the uptake of testing and treatment for hepatitis B and C. Evidence of its positive effect on attitudes, knowledge and behavioural practices relating to prisoners' sexual health was considered. Based on this evidence, the PDG considered it logical that peer support could be beneficial for the groups of interest identified in the guidance.
3.38 The way hepatitis B and C are transmitted among different groups at greatest risk varies by group. For example, in the UK 90% of hepatitis C infections are attributed to sharing injecting equipment among people who inject drugs. Among migrant groups from medium- and high-prevalence countries, adult-to-adult transmission of hepatitis B within the UK is responsible for only about 5–10% of chronic cases. The main transmission routes for hepatitis B are from mother to baby and between children through exposure to contaminated blood. The majority of chronic infections of hepatitis B are acquired in the country of origin. The modelling analyses took these differences into account.
3.39 There was a lack of data on interventions to increase rates of case-finding and treatment in prison, and on continuity of treatment from prison into the community. This meant it was difficult to judge the cost effectiveness of such interventions and treatment rates following diagnosis. Modelling showed that if continuity of treatment (for a prisoner deemed appropriate for treatment) between prisons, from outside to inside prison, or from inside prison to release is at least 40% of the treatment rate of people diagnosed in the community then the treatment would be estimated to be cost effective.
3.40 The migration modelling was also severely hampered by lack of data on the prevalence of chronic hepatitis B among minority ethnic groups, the cost of finding infected people within these groups and treatment rates. Nevertheless, modelling showed that provided that the prevalence of chronic hepatitis B in migrants from minority ethnic groups was at least 2%, then it was estimated that it would be cost effective to find, test and treat within such communities.
3.41 The cost effectiveness of primary care interventions to promote testing for hepatitis B and hepatitis C among men who have sex with men was not formally evaluated. The PDG acknowledged the existence of other NICE guidance promoting testing for HIV among this group. Modelling for that guidance showed that, where there is a reasonably high prevalence of undiagnosed cases of hepatitis B and C, adding a test for these infections when testing for HIV would be cost effective.
3.42 The PDG discussed the possibility of testing all people between the ages of 40 and 65 or 70 for hepatitis C infection. Three recent studies have been carried out in the USA to estimate the cost effectiveness of hepatitis C screening in several different cohorts of people born between 1945 and 1975 (that is, people who were between 37 and 67 years of age in 2012). These studies estimate that such testing would be cost effective, and have led to a recommendation for cohort testing in the USA. The PDG was aware that it was not possible in the time available to carry out modelling for an equivalent cohort in England. The PDG does note, however, that the estimated prevalence of chronic hepatitis C infection in England for that part of the population that does not currently inject drugs would be substantially lower than the 1.6% assumed for the US cohort (Harris et al. 2012). This suggests that a comprehensive testing programme for people born between 1945 and 1975 is unlikely to be cost effective if it were carried out independently of other programmes.
3.43 The PDG discussed the possibility of linking a cohort testing programme for hepatitis C to the Health Check programme currently being introduced for people between 40 and 70 years in England. However, given that a potential extension of the Health Check programme had not been mentioned in the draft guidance sent for consultation, and that there was uncertainty about whether cohort testing offered as part of the Health Check programme would be cost effective, the PDG believed that it would be preferable to wait for more information before making a substantive recommendation in this area.
3.44 The PDG noted a lack of evidence on interventions to promote testing for hepatitis B and C in specific settings, for example, prisons. Expert testimony was sought to address these gaps.
3.45 Given the prevalence of hepatitis B and the history of injecting drug use among the prison population, the PDG recognised the importance of prison as a setting for promoting and offering hepatitis B and C vaccination and testing. It also acknowledged that the established hepatitis B vaccination programme in prisons provides an opportunity for discussing the benefits of testing. The PDG felt testing should be offered in prisons after vaccination, so as not to hamper the success of the vaccination programme.
3.46 The PDG was aware of problems with transferring medical records and information between prison and community settings. However, it was beyond the remit of this guidance to make recommendations about sharing health data between custodial and community providers.
3.47 The PDG recognised the barriers to continuity of care when someone enters or is released from prison. However, the Group felt that these barriers should not prevent testing for hepatitis B and C being offered to prisoners.
3.48 Testing for hepatitis C in prisons, with prisoners' informed consent, is cost effective if there is continuity of care when someone who is infected is referred to, from or between prisons and treatment is at least 40% of the treatment rate of people diagnosed in the community. The PDG felt that prison testing would also help ensure that prisoners' right to the same access to healthcare as the general population would be met, and so address health inequalities.
3.49 The PDG was aware that a key factor affecting treatment outcomes was the length of someone's remaining stay in prison following diagnosis – many prisoners only live at one site for short periods of time, for example when on remand.
3.50 The PDG was aware that treatment success rates are greater when treatment is based on an 'in-reach' model of care in prisons (where healthcare services are brought into the prison rather than providing escorted outpatient treatment). However, the Group acknowledged that the necessary security arrangements in prison could act as a barrier to this approach.
3.51 The PDG recognised the importance of immigration removal centres as a setting for promoting and offering hepatitis B and C testing. Many of the people detained in these centres originate from medium and high prevalence countries and so are at increased risk of hepatitis B and C infection. In 2011, approximately 27,000 migrants entered detention. Although the majority of immigration detainees are held for less than 2 months, many are held for 2 to 6 months, and some are held for more than 1 year.
3.52 The PDG acknowledged the limitations and challenges of current surveillance systems for hepatitis B and C (for example, data on the number of people completing treatment successfully are not available). The Group considered that the collection and collation of robust, service-level data on testing and treatment services was important for both monitoring and developing services.
3.53 The PDG discussed the need for hepatitis B and C databases holding details on people who have been tested and treated. The importance of collecting data on treatment uptake and the need for this data collection to be built into the pathway at every point was noted. It considered that an integrated system, bridging different healthcare providers and capturing a range of data, was the ideal. However, it was felt that there needed to be a balance between the burden of collecting data and the value of those data. The Group acknowledged that it would be resource-intensive.
3.54 It may not always be easy to identify people from groups at increased risk of hepatitis B or C infection. Examples include: children born to parents who inject drugs, and who may later be placed in care or adopted, or children who have been adopted from a country with a medium or high background prevalence.
3.55 Other smaller groups at increased risk of hepatitis B and C infection include people who:
have received medical or dental procedures, including renal dialysis, in countries where infection control may be inadequate
have been exposed to unsterile needles (for example, by having non-professional tattoos, body or ear piercing, or acupuncture, or through vaccination in a developing country)
are jaundiced or have abnormal liver function tests.
3.56 The PDG was aware of the need to test candidates for chemotherapy or immunosuppressive therapy for hepatitis B prior to treatment. In people with hepatitis B, chemotherapy or immunosuppressive therapy can result in a flare-up of liver disease and death by fulminant liver failure.
3.57 To increase testing in primary care the PDG considered recommending that GPs review patient notes to identify people at increased risk and invite them in for discussion and testing. However, there was insufficient evidence on which to decide whether such an approach would be effective or cost effective.
3.58 The PDG noted the importance of verifying the identity of people testing for hepatitis B and C. Members were made aware of instances where NHS cards have been passed on or sold to illegal migrant workers. In some cases medical information had, as a result, been linked to the wrong people.
3.59 The PDG emphasised existing hepatitis B vaccination recommendations (as detailed in the Green book) because although hepatitis B vaccination was beyond the scope of this guidance, case-finding may identify contacts of infected individuals who should be offered vaccination.
3.60 In addition, the Group was aware of the complexities and the importance of the hepatitis B vaccination schedule for babies born to infected mothers. Adherence to the vaccination schedule provides an opportunity to prevent chronic infection in babies. The Group was aware that the current system is failing to ensure babies receive a full course of vaccination and are tested for hepatitis B surface antigen (HBsAg) at 12 months to exclude infection.
3.61 Staff working in drugs services have a diverse mix of skills. As a result, it would not be possible to adopt a universal approach to training them in hepatitis B and C testing. However, the PDG felt that all staff should be capable of encouraging people to be vaccinated against hepatitis B and test for hepatitis B and C infection.
3.62 The PDG focused on people who inject drugs and migrants from medium- and high-prevalence countries. The Group noted that effective vaccination and testing for hepatitis B has already been implemented for other groups at increased risk, including men who have sex with men and people with multiple sexual partners. For example, see the Royal College of General Practitioners' Guidance for the prevention, testing, treatment and management of hepatitis C in primary care (Appendix 5) for information on hepatitis B vaccination in men who have sex with men and other groups at increased risk. For other populations at increased risk there was no evidence that infection rates were sufficiently high to warrant a recommendation for case-finding amongst these groups. (These groups include people who have been exposed to unsterile needles, for example, by having non-professional tattoos, body or ear piercing, or acupuncture.)