HCV infectionin prison. From individualcare to viral ... · Hosted by Jim Gauthier, Senior Clinical Advisor, Diversey 4 Overview of the WHO Care Continuum for Viral Hepatitis and

HCVInfection inPrison.FromIndividual CaretoViral Eradication StrategyDr.RobertoRanieri&Dr.RuggeroGiulliani,Penitenciary Regional Health Unit

SanPaoloUniversity Hospital,Milano,ItalyAWebberTrainingTeleclass

HostedbyJimGauthier,SeniorClinicalAdvisor,Diverseywww.webbertraining.com

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HCVinfection inprison.Fromindividual caretoviraleradication strategy:abenefitforthecommunity

R.RanieriMDR.GiulianiMD

Infectious Diseases ServicePenitenciary Regional HealthUnitSanPaoloUniversity Hospital

Milano,Italy

www.webbertraining.com November15,2019

Hosted byJim GauthierSeniorClinical Advisor,Diversey

Key pointsofthetalk• HCVincommunityandprisons

• What about Italian andMilanoprisons?

• What is thestateofartofHCVtreatmentinprisons?

• Reallifeexperience ofour group

• What about reinfection?

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2

HCVincommunityandprisons

3

WHOVision:EliminateViralHepatitisasaMajorHealthThreatby2030• WHOglobalhealthsectorstrategyonviralhepatitis2016–2021.Availableat:http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en/.

90%reductioninnewchronicHCV

infections

Treatmentof80%ofeligiblepersonswithchronicHCV

infection

65%reductioninmortalityrates

“Aworldwhereviralhepatitistransmissionishaltedand everyonelivingwithhepatitishasaccesstosafe,affordableandeffectivecareandtreatmentservices”

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3

0

50,000

100,000

150,000

200,000

250,000

300,000

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

TreatedPa

tients

TotalNumberofPatientsTreatedinEU1

TheChangingParadigmofHCVTreatmentHasLedtoaSignificantIncreaseintheNumberofPatientsBeingTreated

1.AdaptedfromthePolarisObservatory.Availableat:http://cdafound.org/polaris-hepC-graphs/;2. WHO Global Hepatitis Report, 2017. Available at: http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/;

3. CDCHepatitisC:25yearssincediscovery.Availableat:https://www.cdc.gov/knowmorehepatitis/media/pdfs/hepc-timeline.pdf.

Introductionofall-oralDAAs3

CumulativenumbertreatedforHCVgloballyin2015:5.5million(only0.5millionreceivedDAAs)2

5

AllPatientsAreNowPrioritizedforTreatment

1. WHO guidelines for the screening, care and treatment of persons with chronic HCV infection.Availableat:http://apps.who.int/iris/bitstream/10665/205035/1/9789241549615_eng.pdf?ua=1;

2.AASLDrecommendationsfortesting,managingandtreatinghepatitisC.Availableat:http://www.hcvguidelines.org/full-report-view;3.EuropeanAssociationfortheStudyoftheLiver.JHepatol 2018;inpress.Availableat:https://doi.org/10.1016/j.jhep.2018.03.026.

PWID,peoplewhoinjectdrugs;TN,treatmentnaive.

AllpatientswithHCV infectionmustbeconsideredfortherapy,includingTNpatientsandindividualsthatfailedtoachieveSVRafterpriortreatment

EASL3LastupdatedApril2018

Alladultsandchildren withchronic

HCVinfection,including PWID

WHO1

LastupdatedApril2016

Allpatientswithchronic HCVinfection,exceptthosewithshortlifeexpectanciesthatcannotberemediated

AASLD2

LastupdatedSeptember2017

Treatmentisindicatedfor:

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4

OverviewoftheWHOCareContinuumforViralHepatitisandtheAssociatedChallengesEncounteredWhenAimingtowardWHOEliminationTargets

HeffernanA.,etal.OpenForumInfectDis 2018;5:ofx252.

1. ProvisionofHBVbirth-dosevaccinationwithin24hoursofbirth topreventmother-to-childtransmission

2. Expansionofhemovigilanceschemesandsafeinjectionpracticestoreduceiatrogenictransmission

3. Adoptionofpoint-of-caretestingtoexpanddiagnosticcoverageandstrengthenlinkagetocare

4. Integrationofscreeningintoexistingcaredeliverymodelsforat-riskpopulationstoincreasetheiraccesstoandengagementwithviralhepatitiscare

5. MaintenanceoftreatmentforallcirrhoticHBV-infectedpatientsindefinitelytominimizeriskofdiseaseprogression

6. ProcurementofaffordableDAAsto enableuniversalaccesstotreatmentforHCV

Reachedbypreventionservices

Tested

Awareofstatus

Enrolledincare Initiatedtreatment

Treatmentcompleted(HCV)ormaintained

(HBV)Achievedcure(HCV)orviral

suppression(HBV)Popu

latio

nswith

inth

ecare

continuu

mfo

rvira

lhep

atitis

Care continuum forviralhepatitis

Currentchallengeswithinthecarecontinuumforviralhepatitiswith

referencetoachievingWHOeliminationtargets

Prevention ScreeningandLinkagetoCare Treatments

7

ScreeningMustBeLinkedtoCare

CDC.TestingforHCVinfection:Anupdateofguidanceforcliniciansandlaboratorians.MMWR2013;62. Availableat:https://www.cdc.gov/hepatitis/hcv/pdfs/hcv_flow.pdf.

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5

High-RiskPopulationsFaceUniqueChallengeswithLinkagetoCare…

1.YapL,etal.PLoSOne2014;9:e87564;2.GrebelyJ,etal.JIntAIDSSoc 2017;20:22146;3.Sacks-DavisR,etal.JIntAIDSSoc 2018;21(Suppl2):e25051.

MSM,menwhohavesexwithmen;PWID,peoplewhoinjectdrugs.

Substanceabuse1,2Lackofadditionalsupport,i.e.harm-reductionservices2

PWID MSMPrisoners

Stigmaanddiscrimination1–3

LackofHCVawareness in

patients andHCPs1–3

Socioeconomicfactors1,2

Lack of specialists/coverageofservices1,2

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BenefitsofTargetingHCVinPrisons

PrisonSystem§ DecreasedriskofHCVtransmissionwithintheprison

§ Improvedhealthofinmates§ Deceased‘risk’tocustodialstaff

BENEFITSOFHCV

TREATMENT

Community§ DecreasedriskofHCVtransmissionbyprisonersfollowingrelease

§ Long-termcostsavings

IncarceratedIndividual§ CuredofHCV§ Decreasedriskofliverfailureandlivercancer

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6

BenefitsofTreatmentinPrison

HeT,etal.AnnInternMed 2016;164:84–92.

F0,nofibrosis;F1,portalfibrosiswithoutsepta;F2,portalfibrosiswithfewsepta;F3,numerousseptawithoutcirrhosis; F4,compensatedcirrhosis.DC,decompensatedcirrhosis;HCC,hepatocellularcarcinoma;LT,livertransplants;LRD,liver-relateddeaths.

• Risk-basedandopt-outscreeningandtreatment

• Preventnewinfections–90%inthecommunity!

• Highlycost-effective• Butwouldrequireincreaseinhealthcarebudget

• PotentialtodecreaseHCVinprison• Andinthecommunity!!

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Percentage unwareofHCVinfection :25%to35%

GlobalandRegionalPrevalenceofHepatitisCinPrisonInmatesPublishedBetween2005and2015

DolanK,etal.Lancet2016;388:1089–1102. 12




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Anti-HCVPrevalenceamongPeopleinPrisonacrosstheEU/EEA

FallaAM,etal.BMCInfectDis2018;18:79.

Allbut4estimates(Germany,France,

Hungary,Croatia)wereabove10%prevalence

Coun

try,prevalenceestim

ate(95%

CI),

samplesize(N

)

Anti-HCVprevalence0% 60% 70% 80% 90%40% 50%10% 20% 30% 100%

Luxembourg86.3%(79.0‒91.8)N=122

Finland45.8%(40.8‒51.0)N=383

Italy38.0%(35.0‒41.2)N=973

Portugal34.4%(26.9‒42.6)N=151

Bulgaria(pooled)26.3%(23.5‒29.3)N=1156

Spain25.3%(noCIavailable)N=N/R

Spain22.7%(18.3‒27.1)N=N/R

Bulgarian(juvenile)20.5%(15.8‒26.0)N=258

Spain(pooled)20.3%(18.9‒21.7)N=3062

UK(pooled)17.4%(16.4‒18.4)N=5450

Croatia(pooled)13.3%(12.5‒14.2)N=6696

Ireland12.9%(10.6‒15.4)N=777

Germany(juvenile)8.6%(7.0‒10.4)N=1125

France(pooled)6.3%(6.1‒6.5)N=68797

Hungary4.9%(4.3‒5.6)N=4894

Croatia(juvenile)4.3%(1.6‒9.1)N=140

EU/EEA,EuropeanUnion/EuropeanEconomicArea.13

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15

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What about Italian andMilanoprisons?

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9

Italian Penitenciary System september 2018

[www.giustizia.it]

• N.ofcorrectional housesà 190

• Totalcapacity à 50.544p/l

• Totalpresents à 58.087p/l

• Overcrowding à +15%

• Foreigners à 19.818 =34%

• Women à 2.441=4,2%

• PWUD à 19.752=34,1%

• Pris.inLombardiaà 8.527=14.3%

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Newcomers in2017 (47.342)High turnover and short stay

[www.giustizia.it]

0

10.000

20.000

30.000

40.000

50.000

24.419 19.534

1.8211.568

55,4% 44,6%

Italians Foreigners

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10

In2008penitenciary healthmanagementwas transferred fromMinistry ofJusticetoMinistry of Health.

Every region adopted its own way:most have choosen territorialmanagementthrough Local Health Authorities.

Lombardiahas attributed health careactivities tolocal hospitals.

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Distributionofthe19correctional housesinLombardia20

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PRISONHEALTHSYSTEM

.

Region LombardiaHealth Department

LocalHospitalHealth

Department

PenitenciaryHealth Unit:regional

supervision

Penitenciary HealthSystem

21

21

.San Paolo HospitalHealth

Department

Prison Health System

Model of Milano

San Paolo Hospital

PenitenciaryUnit (24 beds)

San Paolo Hospital

Pharmacy

4 Correctional houses: Opera, San Vittore, Bollate, Beccaria average 3500 prisoners daily

PRISON HEALTH SYSTEM 22

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There is aattenuatesurveillance section dedicated tomothers andchildren

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24

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13

CesareLari

CRBollate,is similar toOpera,has acapacity of1100beds,hostsboth males andfemales,generally at theendoftheir sentences andonthewayofsocialrehabilitation (programs forjobs,study,ecc)

IstitutoBeccariais ajuvenile prison formaleadolescents andyoungadults (until 26years ),has acapacity of50beds.

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Based onthecharacteristic ofeach facilitythere aredifferent levels ofhealth assistance: MilanoOpera,SanVittore,Bollateprovide amultispecialistic integratedassistance:

Generalphysicians 24h/dailyNurses 24h/dailyRadiology (daily):chest,skeleton ,abdomen,ultrasound (visceral andvascular)Laboratory foranalysis (daily)Newcomers service(24h/daily)Firstaid service(24h/daily)DigestiveEndoscopy serviceDrug addiction ServicePharmacy (depending onCentralPharmacy)Multispecialistic service:psychiatrics,psycologists,infectious diseasesconsultants,otolaryngologists,ophthalmologists,pneumologists,orthopaedics,endocrinologists,dentists,surgeons,dermatologists,pediatricians,gynecologists,neurologist,cardiologists,physioterapists

Outside services:es.CT,NMR,hospitaladmissions areprovided bySanPaoloHospital 26




14

OperaandSanVittorehost aClinical Centerforadmissions ofpatients affected byserious diseases(i.e.decompensated diabetes,cardiomiopathy,COPD,AIDS,cirrhosis).

Overall 120beds with24h/daily assistance4beds forinfectious isolation (i.e. TB) Operais considered anitalian hub forcomplexpathologies andparticularly forinfectious diseasesmonitoringandtreatment.

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What is thestateofartoftheHCVtreatmentinprisons?

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15

HCVTreatmentinPrisonsintheInterferonera

Studysite N Male,%

Meanage

Treatment CompletedRx,%

OverallSVR,%

RhodeIsland 90 96 38 IFN/RBV 46 29

Virginia 59 83 41 IFN/RBV NR 36

Canada 114 100 38 IFN/RBV NR 52

Italy 39 98 36 PegIFN/RBV 26 13

Connecticut 68 85 41 PegIFN/RBV 69 47

RhodeIsland 71 100 41 PegIFN/RBV 46 28

Chew KW, et al. J Clin Gastrenterol. 2009;43:686-691.

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1.BrandoliniM,etal.BMCPublicHealth2013;13:981.

RESULTS:• 2012HCV+prevalence:22%• HCV-RNApositivity:86%• Eligiblefortreatment:26%• OverallSVR48:43%• Main causesforineligibilityortreatment

discontinuation:judiciaryconcerns

What’s our experience

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16

HepatitisCManagementinPrisonsintheeraofDAAs

FoschiA,etal.Hepatology2016;64(5)).

DAAregimensareasafe,shortdurationtreatmentstrategyinprisons.WeneedtodedicatefurthereffortstostrengthenthecontinuityofcareandimproveHCVmanagementinprisonsforbothindividualandpublichealth.

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18

35

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in

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IncreasingInvolvementofNon-specialists

1.HajarizadehB,etal.JViralHepat 2018;25;2.DoreGJ&HajarizadehB.InfectDisClinNorthAm 2018;32:269–279.

GP,generalpractitioners;ID,infectiousdiseasesphysicians.

Gastroenterologists ID Other specialists GP Other

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

Individu

alsInitia

tingDA

ATreatm

ent(%)

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20

39

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Thereal lifeexperience ofour group

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21

¹InfectiousDiseases Service,Penitentiary HealthSystem,SanPaoloUniversity Hospital,Milano,Italy²PenitentiaryHealthUnit,SanPaoloUniversity Hospital,Milano,Italy³Pharmacy,SanPaoloUniversity Hospital,Milano,Italy4ClinicalofInfectious Diseases,SanPaoloUniversity Hospital,Milano,Italy5DepartmentofClinical Research,LondonSchoolofHygieneandTropical Medicine,London,UK.6NationalTuberculosisReferenceLaboratory,ResearchCentreBorstel,Borstel,Germany

HCV-freeprisons:Reallifeexperiencetowardsmicro-eliminationinMilanopenitentiaryservices.

RuggeroGiuliani¹,TeresaSebastiani¹,FrancescaIannuzzi¹,ElisabettaFreo¹,CesareLari²,CinziaD’Angelo³,FrancescaBai4,KatarinaKranzer5,AntonellaD’ArminioMonforte4,RobertoRanieri¹

Submitted toJournalofHepatology 41

WepresentourexperienceofalmosteradicatingHCVinfectionsinMilanoprisonsandcomingclosetothe2030WHOtargetsofdiagnosisandtreatment.

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InterventiontoscaleupHCVcareinprison

In2014SanPaoloUniversityHospitaldecidedtostrengthentheHepatologyservicesofferedintheprisonswiththeobjectivetoreachandmaintainhighcoverageofHCVscreeningamongnewlyadmittedprisonersandtoallowfastHCVtreatmentwithDAAinHCVinfectedinmates.Theprogramincludedi)strategiestoachieveuniversalHCVscreening,ii)broadenedtreatmenteligibilitycriteria,iii)provisionofcontinuoustreatmentacrossandoutsideprisonandiv)informationandeducationforinmatesandhealthcarestaff.

HCVScreening.InVITallnewlyadmittedinmateswereofferedoptoutHCVscreeningalongwithotherSTItests.HCVantibodytestingwasperformedonvenousbloodwithaturn-aroundtimeof48hours.FromMarch2017onwards,prisonersopting-outscreeningatadmissionwerecounseledbyInfectiousDisease(I.D.)specialistsandofferedrapidoraltest.AllpositiveoraltestswereconfirmedbyHCVserologytesting.InOPEavailabilityofpreviousscreeningresultswerecheckedatthetimeoftransferfromotherprisons;ifresultswerenotaccessibleorolderthan2yearsold,counselingandtestingwasofferedbyhealthprofessionalswithinamonthoftransfer.RegularHCVtestingcatch-upcampaignswereconductedtoincreasecoveragetargetingpatientswhohadpreviouslyrefusedthetest.

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Eligibility

Duringthepre-DAASera(until2013)lessthanonethirdofinmateswereeligiblefortreatmentwithdepressionbeingonthemainreasonforineligibility.Forthisreason,integrationofinfectiousdiseasesandpsychiatricserviceswithjointclinicalconsultationandstrengthenedpsychiatricsupportwasofferedtopatientsinneed.In2014,whenthefirstgenerationDAAs(telapravir)becameavailable,nursesunderwentintensivetrainingonadministrationofdirectlyobservedtherapy,earlyidentificationandmanagementofsideeffectstogetherwithmotivationalcounseling.InitiallyDAAswereonlyavailableforindividualswithadvanceddisease(liverfibrosisstagedF3F4withmetavir score).ThenationalhealthcaresystemchangedtheeligibilitycriteriainApril2017.AllHCVviremic individualsregardlessofthestageofdiseaseandco-morbiditiesbecameeligibleforDAAsresultinginamassiveincreaseofeligibleindividuals.Tocopewiththenewdemandeligibilityassessmentwasstreamlined.AllinmateswithHCVantibodiesunderwentHCVRNAandHCVgenotypetestingaswellasultrasoundsandelastometry tostudyseverityoftheliverdisease.RegularmultidisciplinarycasediscussionswereimplementedtooptimizetreatmentforHCVinfectedinmateswithco-morbiditiestakingintoaccountpotentialdruginteractionsandswitchingconcomitanttreatmenttowardssaferregimens.Stafffromthejusticesystemwasinvitedtoattendthesemeetingstodiscussjudicialaspectsthatcouldhamperthetreatment,likedurationofsentence,possibilityoftransfertootherprisonsorallocationincorrectionalregimesalternativetodetention)

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Informationandeducation

OPEintroducedspecificinformativesessionfornewlyadmittedprisonersonriskoftransmissionofHCVandprevention,HCVdiagnosisandtreatmentoptions,aswellasmoregeneralinformationaboutinfectiousdiseasesandriskoftransmissionduringdetention,perceptionofriskandconsequencesonmentalhealthTrainingandsensitizationsessionswerealsoofferedtothedetentionofficersandnon-medicalstaffatriskforinfectionatwork.Provisionofcontinuoustreatment.In2014anationalITdatabasewasintroducedtomonitorandguideprescriptionofDAAs.The databasestrengthenedthelinkbetweencorrectionalfacilities,hospitalsandprisonpharmacyguarantyingpromptsupplyanddeliveryofmedications.ThejudiciarysystemagreedtopostponewhenpossibletransferofHCVinfectedinmatestocorrectionalfacilitieswheretreatmentwasnotavailableoncetreatmentwascompleted.AlistofinmatesonHCVtreatmentwasthusregularlysharedbetweenmedicalandadministrativestaffwithinprisons.Incaseofunexpectedrelease,properwrittenreferraltospecificIDclinicintownwasensuredandindividualswerecounselledaboutthefollowingstepstobetakenbythepatient.CollaborationwiththelocalcentersfortreatmentofsubstanceandIDclinicsintownwasstrengthened.

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Across-sectionalsurveybasedonchartreviewswasperformedamongallinmatesontheinOctober-November2017.InformationwascollectedregardingHCVscreening,prevalenceofHCVantibodypositivity,HCVRNAprevalence,HCVtreatmenthistoryandoutcome.Thefollowingvariableswererecorded:demographicdata(sex,countryoforigin,pre-incarcerationdruguse,durationofdetention),HCVtestingoffered,HCVvirologicaltesting(HCVRNAandGenotype),HBVorHIVco-morbidities,eligibilitydata.ForinmateswhoinitiatedHCVtreatmentpre-treatmentfibrosis,previoustreatmenthistory,typeofregimen(DAAsvsIFNbasedregimens),location(prisonvscommunity)anddateoftreatmentinitiationwererecorded.ForHCV-infectedinmateswhodidnotstarttreatmentreasonsforineligibilitywerereported.Datawasextractedandenteredintoanaccessdatabase.ThesurveywasperformedonrequestofMinistryofHealthatlocallevel.MinistryofJusticeapprovedthestudyandgrantedawaiveroninformedconsent.Datawerecollectedinaccordancewiththenationalethicalstandards.Nospecificconsentwasrequiredsincedatawerecollectedinanonymousandaggregateform.

StatisticalanalysisAllanalysiswasperformedusingStataversion14(Stata-Corp,TX,USA).Proportionswerecalculatedforcategoricalvariablesandmedianandinterquartilerangesforcontinuousvariable.AssociationsbetweennotundergoingHCVtestingandHCVantibodypositivityandexplanatoryvariablesuchasage,gender,pre-incarcerationdruguse,countryoforiginanddurationofdetentionwereinvestigatedusingunivariateandmultivariatelogisticregression.

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TotalHCV-Abtested HCV- AbNottested

UnivariateOddsRatio(95%CI) MultivariateOddsratio(95%CI)

N(%) N(%)

PRISON(OPE) 1335 1234(92.4%) 101(7.6%) 1 1

JAIL(VIT) 1031 861(83.5%) 170(16.5%) 2.41(1.86-3.13) 2.05(1.53-2.74)

Men 2261 1996(88.3%) 265(11.7%) 1 1

Women 105 99(94.3%) 6(5.7%) 0.46(0.20-1.05) 0.27(0.12-0.63)

NonItalian 1017 856(84.2%) 161(15.8%) 1 1

Italian 1349 1239(91.9%) 110(8.2%) 0.47(0.36-0.61) 0.73(0.54-0.99)

<35years 772 640(82,9%) 132(17,1%) 1 1

>35years 1594 1455(91,3%) 139(8,7%) 0.46(0.36-0.60) 0.62(0.46-0.83)

NoDrugUsers 1266 1098(86.7%) 168(13.3%) 1 1

DrugUsers 1100 997(90.6%) 103(9.4%) 0.68(0.52-0.88) 0.62(0.47-0.80)

Characteristics of Inmates tested and not for HCV Antibodies47

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TotalHCVantibodynegative HCVantibodypositive

UnivariateOddsRatio(95%CI) MultivariateOddsRatio(95%CI)N(%) N(%)

PRISON(OPE) 1234 1104(89.5%) 130(10.5%) 1

JAIL(VIT) 861 779(90.5%) 82(9.5%) 0.89(0.67-1.20)

Men 1996 1794(89.9%) 202(10.1%) 1

Women 99 89(89.9%) 10(10.1%) 1.00(0.51-1.95)

NonItalian 856 820(95.8%) 36(4.2%) 1 1

Italian 1239 1063(85.8%) 176(14.2%) 3.77(2.61-5.46) 2.19(1.46-3.28)

Agegroup

<35years 640 628(98.1%) 3(1.9%) 1 1

>35years 1455 1255(86.3%) 200(13.8%) 8.34(4.62-15.05) 7.40(4.03-13.59)

NoDrugusers 1098 1047(95.4%) 51(4.6%) 1 1

Drugusers 997 836(83.9%) 161(16.2%) 3.95(2.85-5.49) 4.92(3.52-6.89)

HIV-Abnegative 1941 1781(91.8%) 160(8.2%) 1

HIV-Abpositive 66 22(33.3%) 44(66.7%)22.26(13.02-

38.08)

HIVnotdone 88 80(90.9%) 8(9.0%) 1.11(0.53-2.34)

AssociationbetweenHCV-Abpositivityandriskfactorsb

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N(%) N

HCVRNANEGATIVEpts 151

TreatedwithDAAs 77(51%) 15 Treatmentongoing

22 ReachedEOTR

40 ReachedSVR12

PreviouslytreatedwithIFN 36(24%)

Notreatmenthistory 38(29%)

HCVRNAPOSITIVEpts 41(21%)

Eligibilityongoing 8(20%)

EligibleforDAAs 21(51%) 14 DAAsTreatmentinitiated

7 DAAsTreatmentrequested

RelapsetoDAAs 1(2%)

Notreatment(relevantco-morbidities,refusals) 11(27%)

Characteristics of patients with HCV RNA available

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HCV Treatment Cascade in Milano Penitentiary FacilitiesMilanoprisons HCVcascade ofcare

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Discussion

ThissurveywasconductedtoevaluatetheimpactofabundleofinterventionsaimedatenhancingandexpandingHCVcareinprisonconsideringitastrategicvenuefortreatmentofaffectedindividualsotherwiseneglectedwithoverallbenefitsforthegeneralcommunity.AsshownbyMartinN.K.etal.eliminationofHCVinPWIDcouldbeveryeffectivetoreduceHCVinthegeneralcommunity.

HighHCVtestingcoverage(88%)wasachievedbyusingacombinedapproachofofferingopt-outHCVtesting,eitherbloodororaltests,repeatindividualcounselingforthosewhodidnotwanttotestandeducationandinformationtoincreaseawarenessbothamonginmatesaswellasstaff.Opt-outtestingHCVtestinginprisonhasbeenproventobeacost-effectivestrategytoreducetransmissioninthecommunity,neverthelessspecialcaremustbetakenwhenrunninguniversalprogramwithinacommunityofindividualswhoselibertyhasbeenrestrictedoftenwithstressingeffectsonmentalconditionthatmightleadtorefusaltotestatfirstentrance.Inourexperienceadditionalstrategieswereneededtoensurealso“difficult”andmarginalizedpatientswouldadheretothescreeningofferandovercomedistrusttowardsmedicalpersonnel,e.g.youngoffenderswithbehavioraldisorders,longcoursedruguserswithconcomitantpsychiatricproblemsandhomeless.Atailoredapproacharoundthepatientswhooptoutneedtobedevelopedtoensuretoreachhighcoverageandincludedonetoonecounseling,repeatcontactwiththesamepersonalongthedetentionperiodandcounsellingfromdifferentproviders,aswellaslessinvasivemethods.InourexperienceoraltestswerefoundtobemoreacceptableamongillegalimmigrantsofAfricanoriginandyoungoffendersandledtoidentificationofnewcases.

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The prevalence of HCV infection in our cohort was 10,1%, slightly lower than previously reported in a similar cohort in Italy and Spain

[18,19], that might be explained by improved access to rehabilitation program in the community for offenders with substance abuse

problems that are sentenced for minor crimes. Over 90% of HCV positive inmates underwent further evaluation to determine their

eligibility, with very few that missed this opportunity due to judicial issues, like unexpected transfer or quick release. Such high

proportion of onward referral and linkage to HCV care was possible because all HCV positive inmates were referred to ID specialist by

the general practitioners or straight by the laboratory in case of new infections. This in turn enabled post-test counseling, rapid eligibility

assessment, prompt start of treatment and completion within a short period of time.

Among the patients with undetectable viral load the majority was as such as a result of a previous treatment received while in prison.

DAAs, that were used in our experience in 75% of the cases, are indeed particularly suitable to the prison setting due to easy

administration, lack of side effects and short duration of treatment that overcome the possibility of interrupt treatment due to unexpected

transfers and release Besides, several trials had shown similar efficacy among active drug users receiving DAAs who were on

substitution therapy and who had admit concomitant substance abuse .Up to date in our experience, till now over 200 only one patient

had relapsed, that was started on treatment while in the community before entering the prison. Results were similar in short and long-

stay facilities because of the prompt treatment of all eligible individuals as soon as identified.

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27

ComparingourexperiencetoarecentlypublishedHCVtestandtreattrialconductedinaSpanishprison(18)thatwereabletoreach0prevalenceofviremic infection,themainpracticalchallengeswerethecontinuousnewadmissionfromthecommunityofnewHCVpositiveinmatesoftenunawareoftheirconditionandtherefusaltotreatespeciallyincaseofasymptomaticinfectionsorduetotheirmentalconditionorpsychological/emotionalsituation.InrelationtoourexperiencethemainlimitationintermofexportabilitytootherItalianprisonsandothercountriesistheavailabilityofspecialistswithintheprison,aswellasultrasoundsservice,whilepharmacyordersandlaboratoryresultsareeasilyavailablebywebfrominsidetheprison.Treatmentaspreventionprogramintheprisonhavebeenalreadyfoundtobecost[23]effective:despitetheextracostforhavingspecialistcareinsidetheprisonmightnothavebeenconsideredinsuchcalculation,itisunlikelytochangetheoverallbenefitandsuchavailabilityappearsmorelinkedtopoliticalendorsementofaHCVeliminationprogram.Regardingthesurveymainlimitationsconcernthemethod:datawereextractedretrospectivelyfromclinicalfilessothatsomevariables,inparticularlythecounselingapproachwasnotproperlyrecordedandtheconcomitantpsychiatricconditionanddiagnosiswasnotalwaysclear,whenpresent.Alsovariablesuchassubstanceabusewasself-reportedanddidn’talwaysdifferentiatebetweenendo-venousororalabuse.Lastly,itwasnotpossibletocomparetheinterventionwithabaselinesassessment,inparticulartheprevalenceofviremicinfectionbeforethetreatmentthusitisdifficulttoassesshowmuchoftheeffectwasduetotheinterventionbundle. 53

Conclusions

ImplementationinprisonoftestandtreatprogramofferanuniquepossibilityofdetectionandcureofHCVinaspecialatriskpopulationthatisoftensufferingfromreducedaccesstocareoncefreeinthecommunity,withbenefitsthatgobeyondtheindividualandreachtheoverallcommunity.Ourprogrambasedonsystematicscreeningofallnewinmatesfollowedbyfasttrackandprompttreatmentofeligiblecasesistheresultofaneliminationstrategythathasbeentailoredtorespondtothespecificcharacteristicandchallengesofoursettingandthathasbeenbuiltoverthetimewithamultidisciplinaryapproachandstrongcoordinationbetweenhealthandnon-healthprofessionals,includingpatientsandjudiciarysystem.Despitethepositiveimpactofthisstrategy,stillitremainsasmallgroupofpersonsdifficulttoengageincareduetoimportantco-morbidities,especiallypsychiatricconditionsordiseases,thatrequireadedicatedindividualstrategy.

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CaseStudy– 1

Data presented here are the speaker’s own. There arenoreferencespublishedforthese.Datapresentedareinternalonlyandnodistributionisallowed

• DM, 49 years old italian male

• IDU (heroin & cocaine). Followed by a Drug Addiction Service since 1987 and taking opioid substitution treatment (methadone)

• Alcoholabuser(dailyalcoholintake3lts)

• Heavy cigarette smoker (40 c. a day)

• Never submitted to blood borne diseases screening

• 1989: Admitted in hospital for pneumonia. Diagnosis of PCP AIDS (C3 Atlanta) : CD4 cell count nadir 1/mmc

• Referred to Infectious Disease Unit of San Paolo Hospital

• Started on dual and then triple drug regimen therapy according to guidelines. Throughout the years an optimal virological status wasachieved (January 2018 CD4 1248/mmc, 24% HIV-RNA undetectable)

• 1991: Diagnosis of HCV genotype 1b infection

• 1992: Liver biopsy Chronic HCV Hepatitis Ishak score: 7

• Comorbidities: COPD, arterial hypertension, ischemic heart disease (MI due to cocaine abuse with PTCA), epilepsy treated withphenobarbital

DM,demographic;IDU,injectiondruguse;PCP,pneumocystispneumonia;COPD,chronicobstructivepulmonarydisease;MI,myocardialinfarction;PTCA,percutaneoustransluminalcoronaryangioplasty. 55

CaseStudy– 2

Remaining data presented here are the speaker’s own. There arenoreferencespublishedforthese.Datapresentedareinternalonlyandnodistributionisallowed

• 2001: first detention in Milano prison due to a three year sentence

• ALT 96 IU, AST 88 IU, HCV-RNA 1,288,000 IU, PT INR 0.97, albumin 4.5 g/dl, total bilirubin0.7 mg/dl CD4 count 720/mmc HIV RNA undetectable

• Liver biopsy: Ishak 7 (same as before)

• Liver ultrasound: fatty liver, neither signs of portal hypertension or hepatic nodules

• Treatment started in March 2003

• 2004 NEJM increased treatment efficacy in coinfected people is shown

ALT,alaninetransferase;IUPTINR,internationalunitsprothrombintimeinternationalnormalizedratio;RVR,rapidvirologicresponse;EVR,earlyvirologicresponse 55




29


• July 2003 - unexpected release in freedom, without being referred in time to Service for Drug Addiction and InfectiousDisease Unit

• Relapsed in drug and alcohol abuse

• August 2003 therapy was discontinued with HCV breakthrough

• In spite of drug abuse, the patient keeps the link with the Infectious Disease Unit and goes on taking antiretroviraltherapy. HIV-RNA always suppressed. No further treatment for HCV is started.

• July 2017: new detention with a two-year sentence

• August 2017: ALT 91 UI, AST 68 UI, tot bilirubin 1.1 mgs/dl, PT INR 0.95, albumin 4.7 g/dl, HCV-RNA genotype 1b, HCV-RNA 1801568, CD4 1248/mmc, 24% HIV-RNA undetectable

• Current ART: Elvitegravir + cobicistat + TAF + emtricitabine

• Liver elastography (fibroscan): grade 2 fibrosis

• Liver ultrasonography: fatty liver, no signs of portal hypertension or hepatic nodules

• Patient eligible for treatment with DAAsALT,alanineaminotransferase;;ART,antiretroviraltherapy;PTINR,prothrombintimeinternationalnormalizedratio;TAF,tenofoviralafenamide;DAA,directactingantiviral

CaseStudy– 3

57


CaseStudy– 4

What issuesshouldbeconsidered?Whatisyouropinion?

Issuestobeconsidered:

• Durationoftreatment

• Durationofsentence

• Otherjudiciaryconcerns:transfertootherprison,unexpectedrelease

• Drug‒druginteractions(antiretroviral,cardiovascular,anti-epyleptic,psichiatric)

• Linkagetocareafterrelease

58




30


CaseStudy– 5

Whatdidwedo?Short-duration HCVtreatment

• Anagreementwithjudiciarysystemwasachievedtoensuretreatmentcompletionavoidingtransferbeforeendoftheschedule

• TreatmentstartedinearlyDecember2017andendedinearlyFebruary2018

• BothEOTRandSVR12werereached

• Attheendoftreatmentadocumentincludingdiagnosis,drugregimen,outcomeandindicationformedicalfacilitywasgiventothepatientaimingtoensurelinkagetocarewhenreleased

59

60

EASLrecommendations

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31

AMatchedComparisonStudyofHepatitisCTreatmentOutcomesinthePrisonandCommunitySetting,andanAnalysisoftheImpactofPrisonReleaseorTransferDuringTherapy

AspinallEJ,etal.JViralHepatology2016;23(12):1009–1016.61

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ConclusionsandRecommendations• Detentionisanopportunityfortesting,diagnosisandcareforHCVinfectedinmates,mainlyifunawareof

thisinfection

• Extensivebloodborne disease screeningisstronglyrecommendedinhighriskpopulations

• Eligibilitypathandtreatmentcould beentirelyperformedinsideprisonbyamulti-specialistteamwithanurseprotocol

• Anagreementwithjudiciarysystemhastobereachedinordertokeepthepatientsinthesameinstitutionforthewholedurationoftreatment

• Adocumentincludingdiagnosis,drugregimen,outcomeandindicationformedicalfacilityhastobegiventothepatientaimingtoensurelinkagetocareafterrelease

• InmateshavetobereferredtoInfectiousDiseases/GastroenterologyUnitforfollow-upandtopreventlivercomplicationsorreinfections

63

Acknowledgements

Infectiousdiseasesspecialist:• RuggeroGiuliani,TeresaSebastiani,ElisabettaFreo,FrancescaIannuzzi• FrancescaBaj,AntonellaD’ArminioMonforte

• Psychologists andpsychiatrists

• Pharmacists

• Nurses

• Prison officers

• Magistrates

• SanPaoloHospitalHealthDepartment

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