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 -