Clinical review of the impacts of hepatitis C

2. Executive Summary: Conclusions and Recommendations

2.1 Characteristics of Members of the Scottish Blood Support Scheme (Term of Reference 1)

• As at March 2018, 328 people were members of SIBSS and belonged to the Chronic HCV application category; 305 were primary infectees, 11 were secondary infectees and 12 were widows, widowers or civil partners. The average age of the primary infectees was 58 and 170 (60%) were male.

The following estimates apply to primary infectees as at September 2017.

• Half were diagnosed before 1996; two thirds and one third acquired the infection through blood transfusion and blood factor respectively.
• Approximately 70% had received a course of therapy (this proportion is probably an under-estimate due to missing information) and, of those who had been treated, just under one third had received two or more courses; just over 80% of those treated had been given a course of interferon.

2.2 Impact of Hepatitis C on Health, Wellbeing and Quality of Life (Term of Reference 2)

• People with hepatitis C, regardless of liver disease status, are at an increased risk of a number of extrahepatic diseases; most of these are relatively uncommon and usually not life threatening. Renal disease due to Membranoproliferative Glomerulonephritis ( MPGN) and B-cell Lymphoma (currently an advanced HCV-defining disease) are exceptions.

• Key Recommendation
  Accordingly, Renal Disease due to Membranoproliferative Glomerulonephritis ( MPGN) should be added to the advanced HCV eligibility criteria as it is a condition known to cause a considerable negative impact on life expectancy.

• Other conditions such as sporadic porphyria cutanea tarda and rheumatoid arthritis are more common in people with hepatitis C, but any causal link with reduced life expectancy is not clear cut.
• Interferon-based therapies (used between 1994 and 2016 in Scotland) invariably cause adverse effects which are debilitating over long periods; in contrast, the direct acting antiviral ( DAA) agents, now used for all patients, are safe (note: long-term follow-up studies of recipients of DAAs will be undertaken for completeness) and very well tolerated.
• Evidence from the scientific literature -indicating that the mental health (particularly depression, anxiety and self-worth), and thus the quality of life, of people with hepatitis C, regardless of liver disease status, is impaired considerably - is compelling; this evidence is strongly supported by testimonials given by SIBSS beneficiaries.
• Evidence from the scientific literature indicates a relatively small reduction in general physical health due to hepatitis C among people without advanced liver disease; the exception applies to people who have relatively uncommon extrahepatic manifestations of hepatitis C.
• While testimonials from SIBSS beneficiaries generally support these findings, individuals often reported that periods of fatigue and general malaise were due to their hepatitis C in full or in part. It is possible that the physical health impact of hepatitis C is more pronounced in people infected through blood factor/transfusion who often have other chronic disease conditions (e.g. blood factor disorders), but the evidence base associated with this specific group of individuals is insufficient to say.
• There is no appreciable evidence to indicate that hepatitis C or the number/amount of exposure(s) influences health and wellbeing outcomes.
• While hepatitis C in those without advanced liver disease is not life threatening, it is life changing; this is particularly applicable to people who acquired it through blood factor or blood transfusion, not least because of the “additional blow” conveyed to them by NHS procedures/treatments.
• Hepatitis C, particularly in the context of the source of infection being an NHS one, changed lives because of its negative effects on family, relationships in general, ambition, employment, self-esteem and general mental wellbeing; these effects stem from a number of factors including the stigma associated with hepatitis C and the recalibrating effects of being diagnosed with an infection that, according to their healthcare attendants, would likely reduce the quality and quantity of one’s life.
• Most individuals with chronic HCV who are registered with SIBSS were aware of their infection for many years, most lived with the uncertainty surrounding its consequences and most attributed, fully or in part, any ill health to it.
• For those diagnosed more recently, there has been less uncertainty due to improved knowledge and better treatment; however, the failure to have been offered a test decades before (and the disadvantages of a later diagnosis) has caused resentment.
• While the majority have been treated successfully, the legacy of their infection manifests, commonly, in the reflection – “...if I hadn’t been infected with hepatitis C what would my life have been like...”
• While some infected people welcome action in the form of Inquiries, Reviews and Reports, most are stressed by them and yearn for closure – a time when they are free from hepatitis C in their bodies, but also free from hepatitis C in their minds.
• In the context of the life changing impacts of hepatitis C on infected individuals, the burden on many of their partners and the widows/widowers/partners of those deceased—a burden which was particularly evident in conversations with SIBSS beneficiaries - must be recognised.

2.3 Impact of Hepatitis C on Mortality (Term of Reference 3)

• People who have advanced HCV disease are at considerably greater risk of death than the general population.

• At the population level, people without advanced HCV disease have much the same risk of death as people who are uninfected with Hepatitis C and have similar underlying health characteristics. This does not exclude the possibility of Hepatitis C contributing to the death of an infected individual who does not have advanced HCV (e.g. death associated with mental health problems).

• The recording of hepatitis C on the death certificate is unreliable and, when it occurs, cannot be used to differentiate between hepatitis C having made a contribution to death or not in instances where the person has died from non-advanced HCV defining diseases/conditions.

2.4 Assessment of the Impact of Hepatitis C at the Individual Level (Term of Reference 4)

• At the individual level, an overall assessment of impact is almost impossible i) because of the complexity of teasing out the contribution of ill-health to hepatitis C among people of varying ages who usually have other conditions (co-morbidities), ii) because it spans over many years, iii) because so much of the impact is unrecorded in patient files due to the absence of any comprehensive, systematic and ongoing assessment (i.e. ”no-one asked us!”), iv) because some patient records are no longer available and v) because, in many instances, patients did not disclose, in particular, the psycho-social impacts of hepatitis C to their attending healthcare professionals due to, for example, embarrassment, feeling uncomfortable, stoicism or self-denial.
• Patients’ representatives, and the patients themselves through the conversations as described in this Report, were of the view that any form of “means testing” would be unfair, enormously stressful to both patients and their healthcare assessors, and would compromise the ethos of SIBSS beneficiaries supporting and caring for each other - an ethos that has been nurtured over many years.
• It was, however, recognised by the Clinical Review Group that, while the great majority of people with chronic HCV had been affected by their infection, some had not been appreciably affected and, for those who had been affected, there had been a spectrum of impact – both clinical and-non clinical (e.g. employment, ambition, relationships). Accordingly any assessment which was just clinically-based would ignore the very considerable non clinical impacts as described in this Report.

• Key Recommendations
  From an award perspective, the Clinical Review Group appreciated the dilemma of the unfairness, impracticality, divisiveness and stress of formal individual assessment on the one hand and the failure of a non-differentiating “blanket approach” to recognise differences in hepatitis C impact on the other. To address this dilemma, the Clinical Review Group favours, unanimously, the following approach:
• People with chronic HCV (including those who have cleared their virus through treatment), or their widows, widower or partners, who are currently SIBSS beneficiaries or who become eligible to be SIBSS beneficiaries in the future, should be asked to self-declare hepatitis C impact in the following simple way.
  • If they themselves considered that their (or their spouse’s/partner’s) hepatitis C had not appreciably affected their life, they would not be eligible for a chronic HCV annual payment award; however if the situation changed in the future and they considered that hepatitis C was now affecting their life, they could apply for a chronic HCV award as below.
  • If they themselves considered that their (or their spouse’s/partner’s) hepatitis C had seriously affected and continued to affect their life, they would be eligible for a chronic HCV award at a higher level.
  • If they themselves considered that their (or their spouse’s/partner’s) hepatitis C had affected and continued to affect their life, but not seriously, they would be eligible for a chronic HCV award at a lower level.
• Accordingly, those applying for a chronic HCV award would have to declare themselves in one of two categories. A definition of ‘serious’ would be provided to assist the decision making; this definition would be to the satisfaction of the Clinical Review Group. There would be no requirement for the applicant to justify the application and the category they declared themselves in. The process would be entirely based on trusting the judgement of the potential applicant. There would be no requirement for a healthcare professional to be involved.
• In the context of the available evidence as outlined in this report and the vast collective experience of its members , the Clinical Review Group deemed this approach to be optimal for the following reasons:
  • It has patient and healthcare professional support, it is simple to administer, it aims to ensure that those with the greatest need receive the greatest benefit, it avoids patient/healthcare professional conflict and any need for an appeals process, it reduces stress among applicants to a minimum, it is person-centred recognising that the individual’s perception of hepatitis C is critical, it promotes both individual and collective responsibility and it sends out a loud and clear message saying “you are trusted to make the appropriate declaration”.

2.5 Relativity of the Hepatitis C Infection Impacts among Chronic and Advanced HCV Individuals (Term of
Reference 5)

2.5.1 Overall Contextual Conclusions Encompassing those from Terms of Reference 2-4 as above

• In many instances, people with advanced hepatitis C will have their lives shortened by the impact of infection; while certain people without advanced hepatitis C may have their lives shortened by the impact of infection (for example hepatitis C being a factor in a cycle of depression and addictions), the overall impact of hepatitis C on mortality among this group as a whole (i.e. at a population level) is not appreciable. That said, survival among infected people with underlining bleeding disorders and other serious chronic conditions is compromised when compared with survival among the general population.
• For people with hepatitis C, regardless of whether or not they have advanced hepatitis C, the impact on their mental health and way of life, often over decades, has been profound. The mental health effects – especially those manifesting themselves in depression, anxiety and stress – are incontrovertible; such certainty stems from comprehensive and high quality evidence from the scientific literature, supported by illuminating testimonials from a random sample of SIBSS members.
• Just as critical are the notable losses sustained by most infected individuals. Such losses relate to relationships with family and friends, employment and financial security, and stem from many factors; these include i) the stigma of hepatitis C because of its association with injecting drug use and the fear of transmission to others, ii) the loss of ambition and self-esteem from knowing one has a life-threatening, generally untreatable, condition, iii) the debilitating effects of antiviral treatment and iv) the constant, long standing, reminder through news bulletins that one is the victim of an NHS “scandal and disaster”, the scale and intensity of which is unprecedented.
• Any physical impacts of hepatitis C on people without advanced hepatitis C are difficult to characterise and quantify, not least because the underlying bleeding disorders and chronic disease associated with this group, and the mental health effects as described above, could themselves influence, for example, energy levels and cognitive ability. Nevertheless, what is undisputed is the self-perception that hepatitis C was, is or might have been the cause of such difficulties.
• While the hepatitis C impacts among those without advanced disease, generally, are not life threatening, they are life changing; and such life changing effects have not just been confined to the affected person. The effects also apply to their spouses/partners and children and parents.

2.5.2 Conclusions Concerning the Relative Impacts of Hepatitis C

With respect to the relativity of hepatitis C impacts associated with chronic infection and advanced hepatitis C, the consensus of the Group is as follows:

• The impacts of hepatitis C on the great majority of SIBSS members, regardless of their chronic hepatitis C/advanced hepatitis C status, have been very considerable and the characteristics and intensity of these impacts have varied among people and within the same person over long periods of time.
• While the impacts of hepatitis C, generally, are greater among people with advanced hepatitis C, there are instances of people with such advanced disease who have been less affected than those with chronic hepatitis C; in other words, there is a considerable overlap in terms of impact – one which reflects the different ways people manage adversity on account of differences in their underlying mental and physical health and their living circumstances, particularly those relating to financial and human (family and friends) resources.
• The impacts of hepatitis C on many spouses or partners of those living and widows/ widowers/civil and long-term partners of those deceased are very substantial, regardless of chronic hepatitis C/advanced hepatitis C status.
• Sharing a life with an infected person with chronic hepatitis C means sharing the fallout – particularly in the context of that fallout relating to mental ill health and notable losses.
• Accordingly, assessing the relativity of the impacts of hepatitis C among those with and without advanced hepatitis C is complex and challenging. The Clinical Review of the Impacts of Hepatitis C Group consider that this complexity is, at present, not factored into the decision making around awards but should be.

• Key Recommendation
  The Group recognises that there is a gap between the awards made to those with and without advanced hepatitis C, but is of the view that the extent of the difference between the current awards – a difference which was accentuated by the Financial Review Group ( FRG) recently - is inconsistent with the difference between the cumulative past (and future) lifetime impacts of hepatitis C experienced by those with and without advanced hepatitis C. The Group considers that this inconsistency is unfair and inappropriate, and should be addressed commensurately.

• Key Recommendation
  The Group recommends, for the purposes of consistency and fairness, that any new arrangements for the chronic HCV category of individuals should incorporate the same approach to widows, widowers and partners as that currently in operation for those belonging to the advanced HCV category.

• Key Recommendation
  In circumstances where an individual with chronic HCV dies as a consequence of HCV, their widow, widower or partner may apply to SIBSS for consideration of an advanced HCV award for widows, widowers or partners.

• Key Recommendation
  Given the impact of hepatitis C and interferon-based therapies on individuals’ mental health (particularly depression, anxiety, self-worth) and quality of life, the Group considers that specialist psychological support be made available to those who belong to the chronic HCV category (including widows, widowers and partners) and who want it; this measure will address the justified perception that their needs have not been taken as seriously as they should have been.