NATIONAL REGISTER OF HEPATITIS 'C' VIRUS

The Hepatitis C National Register is an ongoing national public health surveillance programme established in 1998 to provide epidemiological information on the clinical course and outcomes of hepatitis C infection in the UK.

The UK Health Security Agency (UKHSA), an executive agency of the Department of Health and Social Care (DHSC) is the data controller for the Hepatitis C National Register and is responsible for its operation and management. Historically, the register came under the responsibility of Public Health England (PHE) but following its disestablishment in September 2021, Data Controllership now comes under DHSC.

The HCV National Register contains data on one of the largest cohorts of patients in Europe who acquired their hepatitis C virus (HCV) infections on a known date and provides a facility for the monitoring and long-term assessment of HCV infection within the UK.

Most people within the HCV National Register were traced during the national Hepatitis C Lookback Programme that commenced in 1995 to identify recipients of blood or blood components derived from potentially infected donations prior to the introduction of routine screening of the blood supply for HCV. The HCV National Register also holds information for a group of anti-HCV negative transfusion recipients (approximately 475 controls), who were traced during the UK HCV Lookback Programme. These data are treated in the same way as the HCV cases enrolled in the register.

The Register also holds data on: (i) other patients who acquired their infections in childhood or adolescence (recruited via the Institute of Child Health’s British Paediatric Surveillance Unit’s active surveillance of HCV and prospectively from Birmingham Children’s Hospital; St James͛ University Hospital, Leeds; Kings College Hospital, London; Royal London Hospital; and Great Ormond Street Hospital, London), and (ii) individuals who have seroconverted for antibodies to hepatitis C between blood donations (identified via the UKHSA (historically Public Health England)/NHS Blood and Transplant (NHSBT) Infection Surveillance Scheme). Recruitment of new paediatric cases will also be sought via the Paediatric Operational Delivery Networks (PODNs) in the future.

Registry data are processed in the exercise of UKHSA’s official authority to protect and improve the nation’s health and wellbeing, and to reduce health inequalities.

In looking at the justification of processing the data under UK GDPR Article 6(1)(e), UKHSA's responsibilities include collecting and using information on communicable diseases, including HCV, to help prevent the spread of infection and improve the treatment and care of those affected, a task carried out in the public interest (Article 6(1)(e)). Processing data held in the HCV National Register will enable UKHSA to learn about the clinical course of HCV infection because the individuals in the Register are unique in having acquired their infections on known dates. It is rare to know the date individuals acquired their infection because HCV is usually asymptomatic in the early years and there are no reliable, routinely used, HCV tests that identify new/acute infection. The objective for processing the data in the Register is to enable UKHSA to find out which groups of patients with HCV are at greatest risk of developing liver disease and also to compare the death rates among patients who acquired their HCV infection via a blood transfusion with others who received a transfusion but were not infected with HCV. This information will help UKHSA to understand how HCV-related liver disease develops, including the effects and response to treatment. Information on the progression of disease is used to inform mathematical models that help UKHSA to predict the current and future burden of HCV-related disease on health care services. These models are used to inform strategies that will help UKHSA to meet the World Health Organization goals to eliminate HCV as a major public health threat by 2030 (Article 9(2)(i) and Part 2 of Schedule 1 of the Data Protection Act 2018).

A data privacy impact assessment has been undertaken and a privacy notice is publicly available. The HCV National Register was subject to review by the Public Health England Research Ethics and Governance Group (REGG) in April 2021 to ensure that it was fully compliant with all current regulatory requirements, and no regulatory or ethical issues were identified.

The data requested from NHS England enables the HCV National Register to know whether the patients enrolled in the register have: (i) died, and if so, to obtain full details of the cause of death to establish whether it was HCV-related or not; (ii) been registered with cancer, and if so, obtain details of this cancer to establish whether it was HCV-related or not.

Civil Registration Death and Cancer data received from NHS England, for flagged patients enrolled in the HCV National Register, will be linked to existing longitudinal clinical data in the National HCV Register database via their unique patient identifier and used to define disease progression (including identifying risk factors for progressive disease) and to update the outcome (morbidity) and survival (mortality) of patients enrolled in the HCV register compared to an HCV-negative transfused control population. UKHSA will also be looking to link HCV National Register data with UKHSA chronic hepatitis surveillance systems. These findings are used to inform statistical modelling work on the current and future burden of HCV infection in the UK, which is used to inform healthcare utilisation, national policy on how best to tackle hepatitis C infection, and monitoring of the progress of HCV elimination strategies (WHO Global Health Sector Strategy to eliminate hepatitis C as a major public health threat by 2030) that the UK government is signed up to.

Registered individuals are monitored over the long-term from infection/exposure to death (from any cause). Every 3-5 years a follow-up of the patients’ clinical status is carried out. During this process follow-up letters and forms are sent from UKHSA to the patients’ current GP/consultants asking for an update on their patients’ health. In some cases, where hospitals have a large number of patients enrolled in the Register, UKHSA staff will arrange a visit to the hospital to help complete the forms. In these cases, completion of the forms is undertaken electronically using UKHSA encrypted laptops. In addition, death and cancer data are requested from external organisations such as NHS England to update the individual records.

Data from NHS Central Registers are already held in the HCV National Register (supplied from 1998 to December 2019). This data contains information regarding deaths, cancers and exit and re-entries.

UKHSA only requires data for patients who reside in England. There are no less intrusive ways of obtaining these death and cancer events.

Other organisations from Northern Ireland (The General Register Office for Northern Ireland and Northern Ireland Death Registry), Scotland (NHS Central Register for Scotland and NHS Boards) and Wales (National Cancer Registry for Wales) will provide Cancer, Death, and Members and Postings data to UKHSA for patients enrolled in the Register who reside in other UK countries. These organisations have a DSA with UKHSA which outlines how their data is to be used and the security of their data.

Patient identifiable data requested from NHS England is kept to the minimum. UKHSA makes sure that the data added to the Register are accurate and correctly linked to individual patients, and only those identifiers that are necessary to achieve this are used. No Patient Identifiable Information is recorded in the Register that is no longer needed (e.g. patient names once flags are in place nor patient addresses).

DHSC is the sole Data Controller and UKHSA process the data for the purpose described in this agreement.

UKHSA will not onwardly share NHS England data with others unless it is aggregated with small numbers suppressed.

There are no external funders/commissioners involved in the study.

Data are processed to produce peer reviewed scientific publications, reports and presentations at scientific meetings on the natural history/outcome/burden of HCV infection. The results of some of these analyses are published in HCV in England national reports and in HCV in the UK reports. These annual reports have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk.

Clinicians͛ bulletins are produced for clinicians, clinical nurse specialists, GPs and histopathologists who have patients enrolled in the HCV National Register. The bulletins are sent to healthcare professionals who care for patients in the Register and are also released into the public domain on the HCV National Register webpage.

The HCV in England and HCV in UK reports are released into the public domain and there is a comprehensive communication strategy surrounding their dissemination to ensure all stakeholders are sighted on their publication (including DHSC, NHS England, Public Health (PH) leads in the Devolved Administrations, The National Strategic Group on Viral Hepatitis, the UKHSA Hepatitis Leads Group, UKHSA colleagues, patient organisations including The Hepatitis C Trust and the British Liver Trust, the British Association for the Study of the Liver, the European Centre for Disease Control and the WHO, along with communication bundles to Directors of Public Health and Integrated Care Boards).

The HCV in England report is released annually and Clinician Bulletin is released every 3-5 years.

In all these outputs, the data are aggregated, and disclosure policies and rules are adhered to before data are released into the public domain. No information that could identify individual patients are released. All outputs will contain only data that are aggregated with small numbers suppressed in line with the HES Analysis Guide.

Regarding yielded benefits, these data are critical for monitoring the health of people who acquired HCV infection via transfusion prior to the introduction of routine screening of the blood supply for HCV, and for UKHSA's modelling of the HCV epidemic in England. The data provided under this agreement have been used in the following ways:

(i) Undertaking regular survival analyses to compare the clinical and long-term outcomes of people who acquired HCV infection via transfusion with those without HCV infection. These findings have been, and continue to, help UK governments to assess the impact of transfusion acquired HCV infection and are used to inform decisions regarding compensation.

(ii) Public Health England HCV burden modelling employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. UKHSA use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. These models allow UKHSA to monitor levels of current HCV infection in England and to predict the future burden of HCV infection. This enables UKHSA to monitor national progress against the WHO targets to eliminate hepatitis as a serious public health concern by 2030 (a target that the UK is signed up to). These results are presented in a variety of papers and reports, including the annual Hepatitis C in England report, to help stakeholders identify the actions needed to tackle HCV infection.

Some examples of yielded benefits (published) are given below:

a. Data published in the HCV England reports (https://www.gov.uk/government/publications/hepatitis-c-in-the-uk) are used to generate public health recommendations to help tackle HCV infection in England. This helps stakeholders to identify the most appropriate interventions to prevent and control HCV. The national reports are released into the public domain and there is a comprehensive communication strategy surrounding their dissemination to ensure all stakeholders are sighted on their publication (including DHSC, NHS England, PH leads in the Devolved Administrations, The National Strategic Group on Viral Hepatitis, the UKHSA Hepatitis Leads Group, UKHSA colleagues, patient organisations including The Hepatitis C Trust and the British Liver Trust, the British Association for the Study of the Liver, the European Centre for Disease Control and the WHO, along with communication bundles to Directors of Public Health and Integrated care boards).

b. Data have been used to assess the impact of treatment with new direct acting anti-viral drugs on the burden of HCV disease in England. This has enabled UKHSA to identify the likely levels of treatment scale-up required to meet WHO targets to eliminate HCV by 2030 (Harris RJ. et al. 2019; Harris RJ et al., 2016; Harris RJ et al., 2014).

c. Data have been used to provide evidence that if infected populations are left untreated, the number of patients with severe HCV-related disease will continue to increase and will represent a substantial future burden on healthcare resources. These findings have supported the argument for increasing treatment uptake (Harris RJ, 2014). Since this time there has been 130% increase in the uptake of treatments. (Public Health England. HCV in England 2020 report).

d. Data have been used to assess the impact of currently available treatments such as Direct Acting Antivirals and their effect on patients with/without cirrhosis to investigate the most effective strategies for rolling out new HCV treatment to patients at different disease stages. These findings have assisted with the commissioning of treatment and care services in all UK countries. (Harris RJ et al., 2016).

e. Data have been used to assess whether there has been any excess morbidity and mortality attributable to HCV infection among individuals who acquired HCV following transfusion in the UK. This has helped to inform policy and compensation payments for those affected following receipt of HCV infected blood prior to the introduction of HCV screening of the blood supply. (Harris HE et al., 2006; Harris HE et al., 2002)

The current version of the Data Sharing Agreement has not been systematically edited at this stage to remove all references to PHE and will be amended in the next iteration of the Agreement.

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the Department of Health and Social Care to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The objective for processing the data is to describe the current biochemical, histological and clinically apparent liver disturbance in cases of Hepatitis C virus (HCV) infection, and to relate current status to the interval since presumed infection and other potential prognostic factors. These data are used to inform HCV disease burden modelling.

The HCV Register contains information on one of the largest cohorts of patients in Europe who acquired their HCV infections on a known date. These patients are unique as, unlike most people with HCV infection, PHE know the date that their infections were acquired. The HCV National Register was set up in 1998 and most people within it were traced during the national Hepatitis C lookback programme that commenced in 1995 to identify recipients of blood or blood components derived from potentially infected donations prior to the introduction of routine screening of the blood supply for HCV. The Register also holds data on other patients who acquired their infections in childhood or adolescence (recruited via the Institute of Child Health’s British Paediatric Surveillance Unit’s active surveillance of HCV and prospectively from Birmingham Children’s Hospital; St James’ University Hospital, Leeds; Kings College Hospital, London; Royal London Hospital; and Great Ormond Street Hospital. In addition, the Register recruits individuals who have seroconverted for antibodies to hepatitis C between blood donations; these donors are identified via the Public Health England (PHE) /NHS Blood and Transplant (NHSBT) Infection Surveillance Scheme.

When patients were first enrolled into the HCV National Register in 1998, the multi-centre research ethics committee approved that there was no formal requirement to gain patient consent; patient information was simply passed to the clinician to share with the patient and, if the patient was happy to join, the clinician enrolled them. Over the years guidelines regarding patient consent have changed, and from mid-2002 formal consent was introduced to enrol new patients into the Register. This was approved by the North Thames Multicentre Research Ethics Committee (MREC) and they advised that it was NOT necessary to retrospectively consent patients who were already enrolled. In May 2018, the register was granted approval to process patient identifiable information without consent under Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002.

Patient identifiable data requested from NHS Digital is kept to a minimum. PHE do not request patient names or addresses. The only data requested is information relating to the patients’ death or cancer events. Data from NHS Digital to PHE will contain the HCV National Register unique identifier, NHS number and date of birth which enables PHE to link the information to patients in the register. Patients enrolled in the register reside in both England and Wales, so PHE require data for both of these geographies.

NHS Digital data are linked to the records held in the National HCV Register to inform PHE when any of these patients have: (i) died, and if so, to obtain full details of the cause of death; (ii) been registered with cancer, and if so, obtain details of this cancer; and (iii) become lost to follow-up, so PHE can re-establish the link via the participant's current general practitioner to obtain follow-up clinical data on current HCV/health status. These data are linked to existing longitudinal clinical data in the National HCV Register via their unique patient identifier and then used to inform the natural history/outcome (morbidity and mortality) and risk factors for progressive HCV-related disease. These findings are used to inform national policy using mathematical modelling to predict the future burden of HCV-related disease.

Data from NHS Central Registers are already held in the HCV National Register (supplied from 1998 to April 2016). For existing patients who are already flagged with NHS Digital for notification of death/cancer and latest posting, PHE would require data from April 2016 to the present date to update their records in the Register. For newly recruited patients, information to flag patients (NHS number, HCV National Register number, Surname, Other initials, Date of birth, Date of death, Other surname, Sex) in in the NHS Central Registers will be securely shared with NHS Digital, and a historical search would be required from date of birth to the present date so that PHE have the most up-to-date information for these individuals.

There are no less intrusive ways of obtaining death and cancer events. PHE makes sure that the data added to the register are accurate and correctly linked to individual patients, and only those identifiers that are necessary to achieve this are used. No PII is recorded in the register that is no longer needed (e.g. patient names once flags are in place)

When the Register was established it was envisaged that researchers could apply to access data held within the Register and that it would serve as a national resource for use by those designing future studies. However, this process requires formal approval by the Register Steering Group and data would be anonymised; no data would be given out that could lead to the identification of any individual patient, either directly or via linkage to other data sources. These data are not shared with any third party in the format provided by NHS Digital.

The lawful basis for PHE to process this data under GDPR is Article 6(1)(e) 'task in the public interest' and Article 9(2)(i) 'public health'.

Data are processed to produce peer reviewed scientific publications, reports and presentations at scientific meetings on the natural history/outcome/burden of HCV infection. The results of some of these analyses are published in future HCV in England national reports and in HCV in the UK reports. These annual reports have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk.

In particular this year, HCV are using the mortality data to update the survival analyses to compare mortality of transfusion recipients with and without past HCV infection to help inform the Infected Blood Inquiry.

In all these outputs, the data are aggregated and disclosure policies and rules are adhered to before data are released into the public domain. No information that could identify individual patients are released.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

The results from the updated survival analysis will be submitted for publication in a peer-reviewed scientific journal and disseminated to scientists, patient organisations and shared with the Infected Blood Inquiry. The findings will be summarised in the HCV National Register’s Clinicians bulletin or via a link posted on the HCV National Register website.

Clinicians’ bulletins are produced for clinicians, clinical nurse specialists, GPs and histopathologists who have patients enrolled in the HCV National Register. Information in the bulletin gives updates on the HCV National Register; gives a summary of data and let clinicians know when the next follow up is due to take place. The bulletins are sent to each healthcare professional that cares for a patient in the register but is also released into the public domain on the HCV National Register webpage.

The HCV in England and HCV in UK reports are released into the public domain and are available here: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk. There is a comprehensive communication strategy surrounding their dissemination to ensure all stakeholders are sighted on their publication (including DHSC, NHS England, PHE leads in the Devolved Administrations, The National Strategic Group on Viral Hepatitis, the PHE Hepatitis Leads Group, PHE colleagues, patient organisations including The Hepatitis C Trust and the British Liver Trust, the British Association for the Study of the Liver, the European Centre for Disease Control and the WHO, along with communication bundles to Directors of Public Health and CCGs.

The HCV in England reports are released annually (published around September) and the HCV in the UK reports are released annually (published around December). The survival analysis is due to be released in 2022.

Clinician Bulletins are released every 3-5 years following a follow-up of patients.

HCV reports have been released at set target dates and peer-reviewed scientific papers published.

Reports that are available via this link:

https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

In addition to the recent publications in the above link, past publications are also listed in a supporting document (SD 7).

Regarding yielded benefits, these data are critical for monitoring the health of people who acquired HCV infection via transfusion prior to the introduction of routine screening of the blood supply for HCV, and for PHE's modelling of the HCV epidemic in England.

The data provided under this agreement have been used in the following ways:

(i) Undertaking regular survival analyses to compare the clinical and long-term outcomes of people who acquired HCV infection via transfusion with those without HCV infection. These findings have been, and continue to, help UK governments to assess the impact of transfusion acquired HCV infection and are used to inform decisions regarding compensation

(ii) PHE HCV burden modelling employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. PHE use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. These models allow The HCV National Register to monitor levels of current HCV infection in England and to predict the future burden of HCV infection. This enables The HCV National Register to monitor national progress against the WHO targets to eliminate hepatitis as a serious public health concern by 2030 (a target that the UK is signed up to). These results are presented in a variety of papers and reports, including the annual Hepatitis C in England report, to help stakeholders identify the actions needed to tackle HCV infection.

a. Data published in the HCV England reports (https://www.gov.uk/government/publications/hepatitis-c-in-the-uk) are used to generate public health recommendations to help tackle HCV infection in England. This helps stakeholders to identify the most appropriate interventions to prevent and control HCV. The national reports are released into the public domain and there is a comprehensive communication strategy surrounding their dissemination to ensure all stakeholders are sighted on their publication (including DHSC, NHS England, PH leads in the Devolved Administrations, The National Strategic Group on Viral Hepatitis, the PHE Hepatitis Leads Group, PHE colleagues, patient organisations including The Hepatitis C Trust and the British Liver Trust, the British Association for the Study of the Liver, the European Centre for Disease Control and the WHO, along with communication bundles to Directors of Public Health and CCGs.

b. Data have been used to assess the impact of treatment with new direct acting anti-viral drugs on the burden of HCV disease in England. This has enabled Public Health England to identify the likely levels of treatment scale-up required to meet WHO targets to eliminate HCV by 2030 (Ross J. 2019; Harris RJ, 2016; Harris RJ, 2014).

c. Data have been used to provide evidence that if infected populations are left untreated, the number of patients with severe HCV-related disease will continue to increase and will represent a substantial future burden on healthcare resources. These findings have supported the argument for increasing treatment uptake (Harris RJ, 2014). Since this time there has been 130% increase in the uptake of treatments. Public Health England. (HCV in England 2020 report).

d. Data have been used to analyse epidemiological data held in the register informing healthcare professionals about demographics of patients with HCV infection as well as the progression of disease over decades. The data enables healthcare professionals plan the appropriate care and treatment. As well as providing HCV patients with a source of information regarding HCV infection and the research work being undertaken in this field. (Public Health England, Clinicians Bulletins).

e. Data have been used to assess the impact of currently available treatments such as Direct Acting Antivirals and their effect on patients with/without cirrhosis and looking at strategies for rolling out new treatments to HCV patients at different stages of disease. These findings have assisted with the commissioning of treatment and care services in all UK countries. (Harris RJ, 2016)

The objective for processing the data is to describe the current biochemical, histological and clinically apparent liver disturbance in cases of Hepatitis C virus (HCV) infection, and to relate current status to the interval since presumed infection and other potential prognostic factors. These data are used to inform HCV disease burden modelling.

The HCV Register contains information on one of the largest cohorts of patients in Europe who acquired their HCV infections on a known date. These patients are unique as, unlike most people with HCV infection, PHE know the date that their infections were acquired. The HCV National Register was set up in 1998 and most people within it were traced during the national Hepatitis C lookback programme that commenced in 1995 to identify recipients of blood or blood components derived from potentially infected donations prior to the introduction of routine screening of the blood supply for HCV. The Register also holds data on other patients who acquired their infections in childhood or adolescence (recruited via the Institute of Child Health’s British Paediatric Surveillance Unit’s active surveillance of HCV and prospectively from Birmingham Children’s Hospital; St James’ University Hospital, Leeds; Kings College Hospital, London; Royal London Hospital; and Great Ormond Street Hospital. In addition, the Register recruits individuals who have seroconverted for antibodies to hepatitis C between blood donations; these donors are identified via the Public Health England (PHE)/NHS Blood and Transplant (NHSBT) Infection Surveillance Scheme.

When patients were first enrolled into the HCV National Register in 1998, the multi-centre research ethics committee approved that there was no formal requirement to gain patient consent; patient information was simply passed to the clinician to share with the patient and, if the patient was happy to join, the clinician enrolled them. Over the years guidelines regarding patient consent have changed, and from mid-2002 formal consent was introduced to enrol new patients into the Register. This was approved by the North Thames Multicentre Research Ethics Committee (MREC) and they advised that it was NOT necessary to retrospectively consent patients who were already enrolled. In May 2018, the register was granted approval to process patient identifiable information without consent under Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002.

Patient identifiable data requested from NHS Digital is kept to a minimum. PHE do not request patient names or addresses. The only data requested is information relating to the patients’ death or cancer events. Data from NHS Digital to PHE will contain the HCV National Register unique identifier, NHS number and date of birth which enables PHE to link the information to patients in the register. Patients enrolled in the register reside in both England and Wales, so PHE require data for both of these geographies.

NHS Digital data are linked to the records held in the National HCV Register to inform PHE when any of these patients have: (i) died, and if so, to obtain full details of the cause of death; (ii) been registered with cancer, and if so, obtain details of this cancer; and (iii) become lost to follow-up, so PHE can re-establish the link via the participant's current general practitioner to obtain follow-up clinical data on current HCV/health status. These data are linked to existing longitudinal clinical data in the National HCV Register via their unique patient identifier and then used to inform the natural history/outcome (morbidity and mortality) and risk factors for progressive HCV-related disease. These findings are used to inform national policy using mathematical modelling to predict the future burden of HCV-related disease.

Data from NHS Central Registers are already held in the HCV National Register (supplied from 1998 to April 2016). For existing patients who are already flagged with NHS Digital for notification of death/cancer and latest posting, PHE would require data from April 2016 to the present date to update their records in the Register. For newly recruited patients, information to flag patients (NHS number, HCV National Register number, Surname, Other initials, Date of birth, Date of death, Other surname, Sex) in in the NHS Central Registers will be securely shared with NHS Digital, and a historical search would be required from date of birth to the present date so that PHE have the most up-to-date information for these individuals.

There are no less intrusive ways of obtaining death and cancer events. PHE makes sure that the data added to the register are accurate and correctly linked to individual patients, and only those identifiers that are necessary to achieve this are used. No PII is recorded in the register that is no longer needed (e.g. patient names once flags are in place)

When the Register was established it was envisaged that researchers could apply to access data held within the Register and that it would serve as a national resource for use by those designing future studies. However, this process requires formal approval by the Register Steering Group and data would be anonymised; no data would be given out that could lead to the identification of any individual patient, either directly or via linkage to other data sources. These data are not shared with any third party in the format provided by NHS Digital.

The lawful basis for PHE to process this data under GDPR is Article 6(1)(e) 'task in the public interest' and Article 9(2)(i) 'public health'.

Data on disease progression and clinical outcome from the HCV National Register are used by PHE’s statisticians in mathematical models that help predict numbers of patients with HCV infection and the burden this will place on NHS health services. This is important for local planning of treatment and care services and to inform commissioners of the need to provide these services to the population. Information from these analyses are also used to monitor progress against WHO targets, that UK governments are signed up to, to eliminate HCV by 2030.

Data are processed to produce peer reviewed scientific publications, presentations at scientific meetings on the natural history/outcome/burden of HCV infection. These results of these analyses will be published in the HCV in the UK 2019 report (published around September 2019) and the HCV in England 2020 report (published around March 2020). These are both annual reports which have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

An updated survival analysis is planned once the data subject to this application are available, along with further analyses to inform HCV disease progression rates/outcomes (2019-2021).

Regarding yielded benefits, these data are critical for PHE's modelling of the HCV epidemic in England. Public Health England employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. PHE use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. Modelling results are presented in a variety of papers and reports, including the annual national HCV in England reports that are available via this link:

https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

In addition to the recent publications in the above link, past publications are also listed below, but it is important to note that most of the publications currently in preparation are being held up until this DSA is renewed, so PHE cannot currently update the survival analyses or respond to any requests in this area that are likely to come PHE's way from the government’s ongoing Infected Blood Enquiry.

Ross J. Harris HH, Sema Mandal, Mary Ramsay, Peter Vickerman, Matthew Hickman, Daniela De Angelis. Monitoring the hepatitis C epidemic in England and evaluating intervention scale-up using routinely collected data. Journal of Viral Hep.2019;00:1-12.

Hepatitis C: Estimating Disease Burden. Updated November 2018.

https://www.gov.uk/government/publications/hepatitis-c-commissioning-template-for-estimating-disease-prevalence

Harris RJ, Martin, N. K., Rand E, Mandal S, Mutimer D, Vickerman P, Ramsay ME, et al. New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England. Journal of Viral Hepatitis. 2016(8):631-43.

Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: Modelling the predicted impact of treatment under different scenarios. Journal of Hepatology 2014; 61: 530-7.

Hepatitis C in England/the UK, annual reports from 2005-2019

(https://www.gov.uk/government/publications/hepatitisc-in-the-uk)

Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; 2012 Oct;140(10):1830-7

The impact of mode of acquisition on biological markers of paediatric hepatitis C virus infection. Journal of Viral Hepatitis. 2011; 18: 533-541.

Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. Journal of Medical Virology 2011; 83: 1338-1344.

Harris HE, Costella A, Amirthalingam G, Alexander G, Ramsay ME, Andrews N; the UK HCV National Register Collaborators. Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; Nov 29:1-8.

The burden of Hepatitis C in England. Journal of Viral Hepatitis 2007; 14 (8): 570576.

Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis 2007; 14: 213-220.

Harris HE, Mieli-Vergani G, Kelly D, Davison S, Gibb D and Ramsay ME. A national sample of individuals who acquired their hepatitis C virus infections in childhood/adolescence – risk factors for advanced disease. Journal of Paediatric Gastroenterology and Nutrition 2007; 45 (3); 335-341.

H.E. Harris, K.P. Eldridge, S. Harbour, G. Alexander, C.-G. Teo, M.E. Ramsay and The HCV National Register Steering Group. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis March 2007; 14 (3):213-20.

Survival of a national cohort of hepatitis C virus infected patients, 16 years after exposure Epidemiology and Infection 2006; 134: 472-477.

Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment. Journal of Clinical Epidemiology 2006; 59: 144-152.

Sweeting MJ, De Angelis D, Neal KR, Ramsay ME, Wright M, Brant L, Harris HE and the Trent HCV Study Group. Estimating progression to cirrhosis in three UK hepatitis C cohorts: the effect of recruitment bias. Journal of Clinical Epidemiology 2006; 59: 144-152.

Pathways of care and resource utilization in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-626.

Harris HE, Ramsay ME, Andrews NJ. Survival of a national UK cohort of hepatitis C virus infected patients 16 years after exposure. Epidemiology and Infection 2006; 134: 472-7.

Harris HE, Ramsay ME, Andrews NJ - Epidemiology and Infection 2006; 134: 472-7 (PDF, 98 KB) © Cambridge University Press 2005

Cambridge Journals Online - Epidemiology and Infection

Brant L, Harris HE, Ramsay ME, Grieve, R, Roberts J on behalf of the HCV national register steering group. Pathways of care and resource utilisation in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-26.

Helen E Harris, Mary E Ramsay, Nick Andrews, Keith P Eldridge on behalf of the HCV National Register Steering Group. Clinical course of hepatitis C virus during the first decade of infection: cohort study. BMJ 2002; 324:1-6.

H. E. Harris, M. E. Ramsay, J. Heptonstall, K. Soldan, K. P. Eldridge, on behalf of the HCV National Register Steering Group. The HCV National Register: towards informing the natural history of hepatitis C infection in the UK. Journal of Viral Hepatitis November 2000; 7 (6): 420-7.

The objective for processing the data is to describe the current biochemical, histological and clinically apparent liver disturbance in cases of Hepatitis C virus (HCV) infection, and to relate current status to the interval since presumed infection and other potential prognostic factors. These data are used to inform HCV disease burden modelling.

The HCV Register contains information on one of the largest cohorts of patients in Europe who acquired their HCV infections on a known date. These patients are unique as, unlike most people with HCV infection, PHE know the date that their infections were acquired. The HCV National Register was set up in 1998 and most people within it were traced during the national Hepatitis C lookback programme that commenced in 1995 to identify recipients of blood or blood components derived from potentially infected donations prior to the introduction of routine screening of the blood supply for HCV. The Register also holds data on other patients who acquired their infections in childhood or adolescence (recruited via the Institute of Child Health’s British Paediatric Surveillance Unit’s active surveillance of HCV and prospectively from Birmingham Children’s Hospital; St James’ University Hospital, Leeds; Kings College Hospital, London; Royal London Hospital; and Great Ormond Street Hospital. In addition, the Register recruits individuals who have seroconverted for antibodies to hepatitis C between blood donations; these donors are identified via the Public Health England (PHE)/NHS Blood and Transplant (NHSBT) Infection Surveillance Scheme.

When patients were first enrolled into the HCV National Register in 1998, the multi-centre research ethics committee approved that there was no formal requirement to gain patient consent; patient information was simply passed to the clinician to share with the patient and, if the patient was happy to join, the clinician enrolled them. Over the years guidelines regarding patient consent have changed, and from mid-2002 formal consent was introduced to enrol new patients into the Register. This was approved by the North Thames Multicentre Research Ethics Committee (MREC) and they advised that it was NOT necessary to retrospectively consent patients who were already enrolled. In May 2018, the register was granted approval to process patient identifiable information without consent under Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002.

Patient identifiable data requested from NHS Digital is kept to a minimum. PHE do not request patient names or addresses. The only data requested is information relating to the patients’ death or cancer events. Data from NHS Digital to PHE will contain the HCV National Register unique identifier, NHS number and date of birth which enables PHE to link the information to patients in the register. Patients enrolled in the register reside in both England and Wales, so PHE require data for both of these geographies.

NHS Digital data are linked to the records held in the National HCV Register to inform PHE when any of these patients have: (i) died, and if so, to obtain full details of the cause of death; (ii) been registered with cancer, and if so, obtain details of this cancer; and (iii) become lost to follow-up, so PHE can re-establish the link via the participant's current general practitioner to obtain follow-up clinical data on current HCV/health status. These data are linked to existing longitudinal clinical data in the National HCV Register via their unique patient identifier and then used to inform the natural history/outcome (morbidity and mortality) and risk factors for progressive HCV-related disease. These findings are used to inform national policy using mathematical modelling to predict the future burden of HCV-related disease.

Data from NHS Central Registers are already held in the HCV National Register (supplied from 1998 to April 2016). For existing patients who are already flagged with NHS Digital for notification of death/cancer and latest posting, PHE would require data from April 2016 to the present date to update their records in the Register. For newly recruited patients, information to flag patients (NHS number, HCV National Register number, Surname, Other initials, Date of birth, Date of death, Other surname, Sex) in in the NHS Central Registers will be securely shared with NHS Digital, and a historical search would be required from date of birth to the present date so that PHE have the most up-to-date information for these individuals.

There are no less intrusive ways of obtaining death and cancer events. PHE makes sure that the data added to the register are accurate and correctly linked to individual patients, and only those identifiers that are necessary to achieve this are used. No PII is recorded in the register that is no longer needed (e.g. patient names once flags are in place)

When the Register was established it was envisaged that researchers could apply to access data held within the Register and that it would serve as a national resource for use by those designing future studies. However, this process requires formal approval by the Register Steering Group and data would be anonymised; no data would be given out that could lead to the identification of any individual patient, either directly or via linkage to other data sources. These data are not shared with any third party in the format provided by NHS Digital.

The lawful basis for PHE to process this data under GDPR is Article 6(1)(e) 'task in the public interest' and Article 9(2)(i) 'public health'.

Data on disease progression and clinical outcome from the HCV National Register are used by PHE’s statisticians in mathematical models that help predict numbers of patients with HCV infection and the burden this will place on NHS health services. This is important for local planning of treatment and care services and to inform commissioners of the need to provide these services to the population. Information from these analyses are also used to monitor progress against WHO targets, that UK governments are signed up to, to eliminate HCV by 2030.

Data are processed to produce peer reviewed scientific publications, presentations at scientific meetings on the natural history/outcome/burden of HCV infection. These results of these analyses will be published in the HCV in the UK 2019 report (published around September 2019) and the HCV in England 2020 report (published around March 2020). These are both annual reports which have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

An updated survival analysis is planned once the data subject to this application are available, along with further analyses to inform HCV disease progression rates/outcomes (2019-2021).

Regarding yielded benefits, these data are critical for PHE's modelling of the HCV epidemic in England. Public Health England employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. PHE use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. Modelling results are presented in a variety of papers and reports, including the annual national HCV in England reports that are available via this link:

https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

In addition to the recent publications in the above link, past publications are also listed below, but it is important to note that most of the publications currently in preparation are being held up until this DSA is renewed, so PHE cannot currently update the survival analyses or respond to any requests in this area that are likely to come PHE's way from the government’s ongoing Infected Blood Enquiry.

Ross J. Harris HH, Sema Mandal, Mary Ramsay, Peter Vickerman, Matthew Hickman, Daniela De Angelis. Monitoring the hepatitis C epidemic in England and evaluating intervention scale-up using routinely collected data. Journal of Viral Hep.2019;00:1-12.

Hepatitis C: Estimating Disease Burden. Updated November 2018.

https://www.gov.uk/government/publications/hepatitis-c-commissioning-template-for-estimating-disease-prevalence

Harris RJ, Martin, N. K., Rand E, Mandal S, Mutimer D, Vickerman P, Ramsay ME, et al. New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England. Journal of Viral Hepatitis. 2016(8):631-43.

Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: Modelling the predicted impact of treatment under different scenarios. Journal of Hepatology 2014; 61: 530-7.

Hepatitis C in England/the UK, annual reports from 2005-2019

(https://www.gov.uk/government/publications/hepatitisc-in-the-uk)

Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; 2012 Oct;140(10):1830-7

The impact of mode of acquisition on biological markers of paediatric hepatitis C virus infection. Journal of Viral Hepatitis. 2011; 18: 533-541.

Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. Journal of Medical Virology 2011; 83: 1338-1344.

Harris HE, Costella A, Amirthalingam G, Alexander G, Ramsay ME, Andrews N; the UK HCV National Register Collaborators. Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; Nov 29:1-8.

The burden of Hepatitis C in England. Journal of Viral Hepatitis 2007; 14 (8): 570576.

Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis 2007; 14: 213-220.

Harris HE, Mieli-Vergani G, Kelly D, Davison S, Gibb D and Ramsay ME. A national sample of individuals who acquired their hepatitis C virus infections in childhood/adolescence – risk factors for advanced disease. Journal of Paediatric Gastroenterology and Nutrition 2007; 45 (3); 335-341.

H.E. Harris, K.P. Eldridge, S. Harbour, G. Alexander, C.-G. Teo, M.E. Ramsay and The HCV National Register Steering Group. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis March 2007; 14 (3):213-20.

Survival of a national cohort of hepatitis C virus infected patients, 16 years after exposure Epidemiology and Infection 2006; 134: 472-477.

Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment. Journal of Clinical Epidemiology 2006; 59: 144-152.

Sweeting MJ, De Angelis D, Neal KR, Ramsay ME, Wright M, Brant L, Harris HE and the Trent HCV Study Group. Estimating progression to cirrhosis in three UK hepatitis C cohorts: the effect of recruitment bias. Journal of Clinical Epidemiology 2006; 59: 144-152.

Pathways of care and resource utilization in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-626.

Harris HE, Ramsay ME, Andrews NJ. Survival of a national UK cohort of hepatitis C virus infected patients 16 years after exposure. Epidemiology and Infection 2006; 134: 472-7.

Harris HE, Ramsay ME, Andrews NJ - Epidemiology and Infection 2006; 134: 472-7 (PDF, 98 KB) © Cambridge University Press 2005

Cambridge Journals Online - Epidemiology and Infection

Brant L, Harris HE, Ramsay ME, Grieve, R, Roberts J on behalf of the HCV national register steering group. Pathways of care and resource utilisation in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-26.

Helen E Harris, Mary E Ramsay, Nick Andrews, Keith P Eldridge on behalf of the HCV National Register Steering Group. Clinical course of hepatitis C virus during the first decade of infection: cohort study. BMJ 2002; 324:1-6.

H. E. Harris, M. E. Ramsay, J. Heptonstall, K. Soldan, K. P. Eldridge, on behalf of the HCV National Register Steering Group. The HCV National Register: towards informing the natural history of hepatitis C infection in the UK. Journal of Viral Hepatitis November 2000; 7 (6): 420-7.

The objective for processing the data is to describe the current biochemical, histological and clinically apparent liver disturbance in cases of Hepatitis C virus (HCV) infection, and to relate current status to the interval since presumed infection and other potential prognostic factors. These data are used to inform HCV disease burden modelling.

The HCV Register contains information on one of the largest cohorts of patients in Europe who acquired their HCV infections on a known date. These patients are unique as, unlike most people with HCV infection, PHE know the date that their infections were acquired. The HCV National Register was set up in 1998 and most people within it were traced during the national Hepatitis C lookback programme that commenced in 1995 to identify recipients of blood or blood components derived from potentially infected donations prior to the introduction of routine screening of the blood supply for HCV. The Register also holds data on other patients who acquired their infections in childhood or adolescence (recruited via the Institute of Child Health’s British Paediatric Surveillance Unit’s active surveillance of HCV and prospectively from Birmingham Children’s Hospital; St James’ University Hospital, Leeds; Kings College Hospital, London; Royal London Hospital; and Great Ormond Street Hospital. In addition, the Register recruits individuals who have seroconverted for antibodies to hepatitis C between blood donations; these donors are identified via the Public Health England (PHE)/NHS Blood and Transplant (NHSBT) Infection Surveillance Scheme.

When patients were first enrolled into the HCV National Register in 1998, the multi-centre research ethics committee approved that there was no formal requirement to gain patient consent; patient information was simply passed to the clinician to share with the patient and, if the patient was happy to join, the clinician enrolled them. Over the years guidelines regarding patient consent have changed, and from mid-2002 formal consent was introduced to enrol new patients into the Register. This was approved by the North Thames Multicentre Research Ethics Committee (MREC) and they advised that it was NOT necessary to retrospectively consent patients who were already enrolled. In May 2018, the register was granted approval to process patient identifiable information without consent under Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002.

Patient identifiable data requested from NHS Digital is kept to a minimum. PHE do not request patient names or addresses. The only data requested is information relating to the patients’ death or cancer events. Data from NHS Digital to PHE will contain the HCV National Register unique identifier, NHS number and date of birth which enables PHE to link the information to patients in the register. Patients enrolled in the register reside in both England and Wales, so PHE require data for both of these geographies.

NHS Digital data are linked to the records held in the National HCV Register to inform PHE when any of these patients have: (i) died, and if so, to obtain full details of the cause of death; (ii) been registered with cancer, and if so, obtain details of this cancer; and (iii) become lost to follow-up, so PHE can re-establish the link via the participant's current general practitioner to obtain follow-up clinical data on current HCV/health status. These data are linked to existing longitudinal clinical data in the National HCV Register via their unique patient identifier and then used to inform the natural history/outcome (morbidity and mortality) and risk factors for progressive HCV-related disease. These findings are used to inform national policy using mathematical modelling to predict the future burden of HCV-related disease.

Data from NHS Central Registers are already held in the HCV National Register (supplied from 1998 to April 2016). For existing patients who are already flagged with NHS Digital for notification of death/cancer and latest posting, PHE would require data from April 2016 to the present date to update their records in the Register. For newly recruited patients, information to flag patients (NHS number, HCV National Register number, Surname, Other initials, Date of birth, Date of death, Other surname, Sex) in in the NHS Central Registers will be securely shared with NHS Digital, and a historical search would be required from date of birth to the present date so that PHE have the most up-to-date information for these individuals.

There are no less intrusive ways of obtaining death and cancer events. PHE makes sure that the data added to the register are accurate and correctly linked to individual patients, and only those identifiers that are necessary to achieve this are used. No PII is recorded in the register that is no longer needed (e.g. patient names once flags are in place)

When the Register was established it was envisaged that researchers could apply to access data held within the Register and that it would serve as a national resource for use by those designing future studies. However, this process requires formal approval by the Register Steering Group and data would be anonymised; no data would be given out that could lead to the identification of any individual patient, either directly or via linkage to other data sources. These data are not shared with any third party in the format provided by NHS Digital.

The lawful basis for PHE to process this data under GDPR is Article 6(1)(e) 'task in the public interest' and Article 9(2)(i) 'public health'.

Data on disease progression and clinical outcome from the HCV National Register are used by PHE’s statisticians in mathematical models that help predict numbers of patients with HCV infection and the burden this will place on NHS health services. This is important for local planning of treatment and care services and to inform commissioners of the need to provide these services to the population. Information from these analyses are also used to monitor progress against WHO targets, that UK governments are signed up to, to eliminate HCV by 2030.

Data are processed to produce peer reviewed scientific publications, presentations at scientific meetings on the natural history/outcome/burden of HCV infection. These results of these analyses will be published in the HCV in the UK 2019 report (published around September 2019) and the HCV in England 2020 report (published around March 2020). These are both annual reports which have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

An updated survival analysis is planned once the data subject to this application are available, along with further analyses to inform HCV disease progression rates/outcomes (2019-2021).

Regarding yielded benefits, these data are critical for PHE's modelling of the HCV epidemic in England. Public Health England employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. PHE use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. Modelling results are presented in a variety of papers and reports, including the annual national HCV in England reports that are available via this link:

https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

In addition to the recent publications in the above link, past publications are also listed below, but it is important to note that most of the publications currently in preparation are being held up until this DSA is renewed, so PHE cannot currently update the survival analyses or respond to any requests in this area that are likely to come PHE's way from the government’s ongoing Infected Blood Enquiry.

Ross J. Harris HH, Sema Mandal, Mary Ramsay, Peter Vickerman, Matthew Hickman, Daniela De Angelis. Monitoring the hepatitis C epidemic in England and evaluating intervention scale-up using routinely collected data. Journal of Viral Hep.2019;00:1-12.

Hepatitis C: Estimating Disease Burden. Updated November 2018.

https://www.gov.uk/government/publications/hepatitis-c-commissioning-template-for-estimating-disease-prevalence

Harris RJ, Martin, N. K., Rand E, Mandal S, Mutimer D, Vickerman P, Ramsay ME, et al. New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England. Journal of Viral Hepatitis. 2016(8):631-43.

Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: Modelling the predicted impact of treatment under different scenarios. Journal of Hepatology 2014; 61: 530-7.

Hepatitis C in England/the UK, annual reports from 2005-2019

(https://www.gov.uk/government/publications/hepatitisc-in-the-uk)

Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; 2012 Oct;140(10):1830-7

The impact of mode of acquisition on biological markers of paediatric hepatitis C virus infection. Journal of Viral Hepatitis. 2011; 18: 533-541.

Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. Journal of Medical Virology 2011; 83: 1338-1344.

Harris HE, Costella A, Amirthalingam G, Alexander G, Ramsay ME, Andrews N; the UK HCV National Register Collaborators. Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; Nov 29:1-8.

The burden of Hepatitis C in England. Journal of Viral Hepatitis 2007; 14 (8): 570576.

Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis 2007; 14: 213-220.

Harris HE, Mieli-Vergani G, Kelly D, Davison S, Gibb D and Ramsay ME. A national sample of individuals who acquired their hepatitis C virus infections in childhood/adolescence – risk factors for advanced disease. Journal of Paediatric Gastroenterology and Nutrition 2007; 45 (3); 335-341.

H.E. Harris, K.P. Eldridge, S. Harbour, G. Alexander, C.-G. Teo, M.E. Ramsay and The HCV National Register Steering Group. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis March 2007; 14 (3):213-20.

Survival of a national cohort of hepatitis C virus infected patients, 16 years after exposure Epidemiology and Infection 2006; 134: 472-477.

Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment. Journal of Clinical Epidemiology 2006; 59: 144-152.

Sweeting MJ, De Angelis D, Neal KR, Ramsay ME, Wright M, Brant L, Harris HE and the Trent HCV Study Group. Estimating progression to cirrhosis in three UK hepatitis C cohorts: the effect of recruitment bias. Journal of Clinical Epidemiology 2006; 59: 144-152.

Pathways of care and resource utilization in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-626.

Harris HE, Ramsay ME, Andrews NJ. Survival of a national UK cohort of hepatitis C virus infected patients 16 years after exposure. Epidemiology and Infection 2006; 134: 472-7.

Harris HE, Ramsay ME, Andrews NJ - Epidemiology and Infection 2006; 134: 472-7 (PDF, 98 KB) © Cambridge University Press 2005

Cambridge Journals Online - Epidemiology and Infection

Brant L, Harris HE, Ramsay ME, Grieve, R, Roberts J on behalf of the HCV national register steering group. Pathways of care and resource utilisation in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-26.

Helen E Harris, Mary E Ramsay, Nick Andrews, Keith P Eldridge on behalf of the HCV National Register Steering Group. Clinical course of hepatitis C virus during the first decade of infection: cohort study. BMJ 2002; 324:1-6.

H. E. Harris, M. E. Ramsay, J. Heptonstall, K. Soldan, K. P. Eldridge, on behalf of the HCV National Register Steering Group. The HCV National Register: towards informing the natural history of hepatitis C infection in the UK. Journal of Viral Hepatitis November 2000; 7 (6): 420-7.