Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol)

Matthew Hickman, John F Dillon, Lawrie Elliott, Daniela De Angelis, Peter Vickerman, Graham Foster, Peter Donnan, Ann Eriksen, Paul Flowers, David Goldberg, William Hollingworth, Samreen Ijaz, David Liddell, Sema Mandal, Natasha Martin, Lewis J Z Beer, Kate Drysdale, Hannah Fraser, Rachel Glass, Lesley GrahamRory N Gunson, Emma Hamilton, Helen Harris, Magdalena Harris, Ross Harris, Ellen Heinsbroek, Vivian Hope, Jeremy Horwood, Sarah Karen Inglis, Hamish Innes, Athene Lane, Jade Meadows, Andrew McAuley, Chris Metcalfe, Stephanie Migchelsen, Alex Murray, Gareth Myring, Norah Palmateer, Anne Presanis, Andrew Radley, Mary Ramsay, Pantelis Samartsidis, Ruth Simmons, Katy Sinka, Gabriele Vojt, Zoe Ward, David Whiteley, Alan Yeung, Sharon J Hutchinson

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Abstract

Introduction Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/ incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV ‘Treatment as Prevention’ (TasP) in PWID. Methods and analysis We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome – chronic HCV prevalence in PWID – is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a ‘virtual cohort’ of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. Ethics and dissemination Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials. gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.
Original languageEnglish
Number of pages12
JournalBMJ Open
Volume9
Issue number9
DOIs
Publication statusPublished - 24 Sep 2019

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Hepatitis C
Hepacivirus
Antiviral Agents
Pharmaceutical Preparations
Population
Therapeutics
Scotland
Chronic Hepatitis C
England
Ethics
Needles
Incidence
Pharmaceutical Databases
Pharmacies
Prisons

Keywords

  • Hepatitis C
  • people who inject drugs
  • antiviral treatment
  • protocol

Cite this

Hickman, Matthew ; Dillon, John F ; Elliott, Lawrie ; De Angelis, Daniela ; Vickerman, Peter ; Foster, Graham ; Donnan, Peter ; Eriksen, Ann ; Flowers, Paul ; Goldberg, David ; Hollingworth, William ; Ijaz, Samreen ; Liddell, David ; Mandal, Sema ; Martin, Natasha ; Beer, Lewis J Z ; Drysdale, Kate ; Fraser, Hannah ; Glass, Rachel ; Graham, Lesley ; Gunson, Rory N ; Hamilton, Emma ; Harris, Helen ; Harris, Magdalena ; Harris, Ross ; Heinsbroek, Ellen ; Hope, Vivian ; Horwood, Jeremy ; Inglis, Sarah Karen ; Innes, Hamish ; Lane, Athene ; Meadows, Jade ; McAuley, Andrew ; Metcalfe, Chris ; Migchelsen, Stephanie ; Murray, Alex ; Myring, Gareth ; Palmateer, Norah ; Presanis, Anne ; Radley, Andrew ; Ramsay, Mary ; Samartsidis, Pantelis ; Simmons, Ruth ; Sinka, Katy ; Vojt, Gabriele ; Ward, Zoe ; Whiteley, David ; Yeung, Alan ; Hutchinson, Sharon J. / Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol). In: BMJ Open. 2019 ; Vol. 9, No. 9.
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title = "Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol)",
abstract = "Introduction Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40{\%} among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90{\%}) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/ incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV ‘Treatment as Prevention’ (TasP) in PWID. Methods and analysis We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62{\%} (from 26{\%} to 10{\%}) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome – chronic HCV prevalence in PWID – is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a ‘virtual cohort’ of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. Ethics and dissemination Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials. gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.",
keywords = "Hepatitis C, people who inject drugs, antiviral treatment, protocol",
author = "Matthew Hickman and Dillon, {John F} and Lawrie Elliott and {De Angelis}, Daniela and Peter Vickerman and Graham Foster and Peter Donnan and Ann Eriksen and Paul Flowers and David Goldberg and William Hollingworth and Samreen Ijaz and David Liddell and Sema Mandal and Natasha Martin and Beer, {Lewis J Z} and Kate Drysdale and Hannah Fraser and Rachel Glass and Lesley Graham and Gunson, {Rory N} and Emma Hamilton and Helen Harris and Magdalena Harris and Ross Harris and Ellen Heinsbroek and Vivian Hope and Jeremy Horwood and Inglis, {Sarah Karen} and Hamish Innes and Athene Lane and Jade Meadows and Andrew McAuley and Chris Metcalfe and Stephanie Migchelsen and Alex Murray and Gareth Myring and Norah Palmateer and Anne Presanis and Andrew Radley and Mary Ramsay and Pantelis Samartsidis and Ruth Simmons and Katy Sinka and Gabriele Vojt and Zoe Ward and David Whiteley and Alan Yeung and Hutchinson, {Sharon J}",
note = "Acceptance from webpage OA article",
year = "2019",
month = "9",
day = "24",
doi = "10.1136/bmjopen-2019-029538",
language = "English",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
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}

Hickman, M, Dillon, JF, Elliott, L, De Angelis, D, Vickerman, P, Foster, G, Donnan, P, Eriksen, A, Flowers, P, Goldberg, D, Hollingworth, W, Ijaz, S, Liddell, D, Mandal, S, Martin, N, Beer, LJZ, Drysdale, K, Fraser, H, Glass, R, Graham, L, Gunson, RN, Hamilton, E, Harris, H, Harris, M, Harris, R, Heinsbroek, E, Hope, V, Horwood, J, Inglis, SK, Innes, H, Lane, A, Meadows, J, McAuley, A, Metcalfe, C, Migchelsen, S, Murray, A, Myring, G, Palmateer, N, Presanis, A, Radley, A, Ramsay, M, Samartsidis, P, Simmons, R, Sinka, K, Vojt, G, Ward, Z, Whiteley, D, Yeung, A & Hutchinson, SJ 2019, 'Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol)', BMJ Open, vol. 9, no. 9. https://doi.org/10.1136/bmjopen-2019-029538

Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol). / Hickman, Matthew; Dillon, John F ; Elliott, Lawrie; De Angelis, Daniela; Vickerman, Peter; Foster, Graham; Donnan, Peter; Eriksen, Ann; Flowers, Paul; Goldberg, David; Hollingworth, William; Ijaz, Samreen; Liddell, David ; Mandal, Sema; Martin, Natasha; Beer, Lewis J Z; Drysdale, Kate; Fraser, Hannah; Glass, Rachel; Graham, Lesley; Gunson, Rory N; Hamilton, Emma; Harris, Helen; Harris, Magdalena; Harris, Ross; Heinsbroek, Ellen; Hope, Vivian; Horwood, Jeremy; Inglis, Sarah Karen; Innes, Hamish; Lane, Athene; Meadows, Jade; McAuley, Andrew; Metcalfe, Chris; Migchelsen, Stephanie; Murray, Alex; Myring, Gareth; Palmateer, Norah; Presanis, Anne; Radley, Andrew; Ramsay, Mary; Samartsidis, Pantelis; Simmons, Ruth; Sinka, Katy; Vojt, Gabriele; Ward, Zoe; Whiteley, David; Yeung, Alan; Hutchinson, Sharon J.

In: BMJ Open, Vol. 9, No. 9, 24.09.2019.

Research output: Contribution to journal › Article

TY - JOUR

T1 - Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol)

AU - Hickman, Matthew

AU - Dillon, John F

AU - Elliott, Lawrie

AU - De Angelis, Daniela

AU - Vickerman, Peter

AU - Foster, Graham

AU - Donnan, Peter

AU - Eriksen, Ann

AU - Flowers, Paul

AU - Goldberg, David

AU - Hollingworth, William

AU - Ijaz, Samreen

AU - Liddell, David

AU - Mandal, Sema

AU - Martin, Natasha

AU - Beer, Lewis J Z

AU - Drysdale, Kate

AU - Fraser, Hannah

AU - Glass, Rachel

AU - Graham, Lesley

AU - Gunson, Rory N

AU - Hamilton, Emma

AU - Harris, Helen

AU - Harris, Magdalena

AU - Harris, Ross

AU - Heinsbroek, Ellen

AU - Hope, Vivian

AU - Horwood, Jeremy

AU - Inglis, Sarah Karen

AU - Innes, Hamish

AU - Lane, Athene

AU - Meadows, Jade

AU - McAuley, Andrew

AU - Metcalfe, Chris

AU - Migchelsen, Stephanie

AU - Murray, Alex

AU - Myring, Gareth

AU - Palmateer, Norah

AU - Presanis, Anne

AU - Radley, Andrew

AU - Ramsay, Mary

AU - Samartsidis, Pantelis

AU - Simmons, Ruth

AU - Sinka, Katy

AU - Vojt, Gabriele

AU - Ward, Zoe

AU - Whiteley, David

AU - Yeung, Alan

AU - Hutchinson, Sharon J

N1 - Acceptance from webpage OA article

PY - 2019/9/24

Y1 - 2019/9/24

N2 - Introduction Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/ incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV ‘Treatment as Prevention’ (TasP) in PWID. Methods and analysis We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome – chronic HCV prevalence in PWID – is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a ‘virtual cohort’ of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. Ethics and dissemination Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials. gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.

AB - Introduction Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/ incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV ‘Treatment as Prevention’ (TasP) in PWID. Methods and analysis We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome – chronic HCV prevalence in PWID – is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a ‘virtual cohort’ of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. Ethics and dissemination Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials. gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.

KW - Hepatitis C

KW - people who inject drugs

KW - antiviral treatment

KW - protocol

U2 - 10.1136/bmjopen-2019-029538

DO - 10.1136/bmjopen-2019-029538

M3 - Article

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

ER -

Hickman M, Dillon JF, Elliott L, De Angelis D, Vickerman P, Foster G et al. Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol). BMJ Open. 2019 Sep 24;9(9). https://doi.org/10.1136/bmjopen-2019-029538

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