Building Momentum, Making the Case

Building Momentum, Making the Case World Hepatitis Summit 2015 meeting report 2 - 4 September 2015 Scottish Exhibition and Conference Centre (SECC) Glasgow, United Kingdom Contents 2015 m ee tin g r e port

5 Introduction 6 Executive summary 8 Glasgow declaration on viral hepatitis 10 The need for a global response 14 The need for comprehensive programming: evidence for action 14 Best practice in the prevention of hepatitis B 15 Best practice in the prevention of hepatitis C 16 Best practice in the treatment of hepatitis B and C 18 Best practice in HBV and HCV case finding 22 Countries move towards national programmes: early examples 26 Steps towards development of national viral hepatitis plans 26 The role of the community in catalysing and developing national plans 27 Simulation exercise 30 Parallel sessions on key national planning themes 30 Treatment and access to drugs 32 Strategic information for planning

Authored by: Keith Alcorn 34 Prevention 36 Service delivery 38 Universal health coverage, costing and prioritisation

40 Governance, ownership and partnership 42 Steps towards a global investment case 42 Cost-modelling of comprehensive global viral hepatitis prevention and treatment activities 44 Potential funding mechanisms for national programmes 46 Potential mechanisms for reducing drug costs 48 The global hepatitis community calls for access to life-saving hepatitis drugs 49 Operational research 52 Impact 2015 meeting report 4 • • • • • I

ntroduction based nationalplanningexercise. its keythemesandparticipateinascenario- Summit, providing anopportunity toreflect on national programme planning toolkitatthe The World HealthOrganizationlauncheda activities andfrom otherdisease areas. share from keylearning early countryscaleup The Summitalsooffered anopportunityto voice intheviralhepatitisresponse. planning andstrengthening ofthecommunity fordevelopmentofnational governments relationships betweencivilsocietyand The Summitoffered anopportunitytoforge 2016-2021 viralhepatitisstrategy. national planswithintheframeworkofWHO towards developmentofcomprehensive The Summitsoughttobuildmomentum and developamonitoringmechanism. B andCwithaviewtosettingglobaltargets to examinethefeasibilityofeliminatinghepatitis hepatitis strategies,aswellcallingonWHO to developandimplementnationalviral resolution, whichaskedWHOMemberStates to buildontheWorld HealthAssembly67.6 The World HepatitisSummitwasconvened

2015 port e r g tin ee m 5 2015 meeting report 6 • • • E treatment. key prevention interventions,diagnosisand through dramaticincreases incoverageof proposed. Thesetargetsmustbeachieved and a65%reduction by2030,hasalsobeen in deathsduetohepatitisBandCby2020, 2030. Amortalitytargetofa10%reduction B andCby2020,a90%reduction by 30% reduction innewinfections ofhepatitis global targetsforviralhepatitiscontrol ofa The World HealthOrganizationhasproposed development. to viralhepatitisasapublichealthissuefor combat hepatitis`,givinggreater prominence Sustainable DevelopmentGoalssetagoal`to with aviewtosettingglobaltargets.The2015 strategies for, eliminationofhepatitisBandC Organization toreview thefeasibility of,and Health Assemblyrequested theWorld Health hope ofeliminatinghepatitisC.The2014World majority ofhepatitisCinfectionshasoffered the development ofdrugswhichcancure thevast investment inviralhepatitiscontrol. Therecent Global momentumisbuildingtowards greater people developliverdisease. infected withhepatitisBorCgrows, andmore higher future costsasthenumberofpeople income countries.Inactiontodaywillresult in burden forhealthsystemsinlower- andmiddle- death worldwideandrepresents agrowing ranked seventhamongtheleadingcausesof of viralhepatitisannually. hepatitisisnow Viral Approximately 1.4millionpeopledieasaresult xecutive

summary • • • • affordable treatment andthe most effective for apublichealthresponse, advocatingfor role toplayinmobilisingpoliticalsupport hepatitis andtheiradvocateshaveanimportant Community organisationsofpeoplewithviral lower-income countries. cost ofHCVtreatment for middle-income and Mechanisms are beingexplored toreduce the up oftreatment. secure muchlowerdrugprices toachievescale voluntary licensingagreements willneedto products fortreatment ofHCVundercurrent countries whichdonothaveaccesstogeneric up ofprevention andtreatment. Middle-income need donorsupportinorder toachievescale burden ofdisease.Lower-income countrieswill and treatment scaleupgradually reduce the beginning todeclineastheeffects ofprevention approximately $11billiona yearin2025before these globaltargetswouldneedtogrow to Modelling showsthatfinancingtoachieve treatment isavailableandaffordable. aregovernments ready toactwheneffective Gambia andUgandademonstratethatnational treatment. Examplesfrom Egypt,Georgia,The price reductions facilitatetheexpansionof rapid movementtowards scaleupwhen of countryplanningshowthepotentialfor catalyse nationalcommitment.Earlyexamples order toscaleupservices,mobilisefundingand health sectorsandcivilsocietywillbeneededin through consultationbetweengovernments, Comprehensive nationalplansdeveloped • •

to achieveitsaims. Declaration andworkatnationallevel this report todisseminatetheGlasgow all stakeholders.We urgeallwhoread and programmes inpartnershipwith develop comprehensive national plans to Hepatitis Summitforgovernments endorsed bydelegatesattheWorld The GlasgowDeclarationisacall up ofprevention andtreatment. effectiveness ofinvestments inscale in research inorder tomaximisethe Greater investmentwillbe needed forms ofservicedeliveryandtreatment. the mosteffective andcost-effective will playacriticalrole inidentifying Operational andpublichealthresearch as apublichealthissue. and totheprioritisationofviralhepatitis prevention, diagnosisand treatment by delegatesasamajorobstacleto viral hepatitis.Stigmawasidentified challenging thestigmaassociatedwith organisations playacentralrole in treatment andcare. Community the designofeffective prevention, of peoplewithviralhepatitisand improved understandingoftheneeds viral hepatitisplan,deliveringan partners indevelopmentofanational Community organisationsare key evidence-based prevention measures.

2015 port e r g tin ee m 7 2015 meeting report 8 G agree onrealistic yetaspirationalglobaltargetsforprevention, testing,diagnosis, care andtreatment. Assembly Resolution67.6and,incollaborationwiththeWorld HealthOrganization,todefineand hepatitis plansandprogrammes inpartnershipwithallstakeholdersandlinetheWorld Health inalljurisdictionstodevelopandimplementcomprehensive,upon governments fundednational Weas agoaltheeliminationofbothhepatitisBandCpublichealthconcerns. therefore call The participantsoftheinauguralWorld HepatitisSummitbelieveitispossibleandessentialtoset promoting accesstoandaffordability oftheseservicesistheresponsibility ofallstakeholders, Because universalaccesstoprevention, diagnosis,care andtreatment isahumanrightand effective treatments thatcansuppress hepatitisBvirusreplication andcure hepatitisCinfection, Because there are highlyeffective measures toprevent newhepatitisBandCinfectionshighly deaths canbeprevented, Because 1.4millionpeopledieeveryyearfrom complicationsofviralhepatitisyetmostthese Because there isalackofglobalawareness andmost personswithhepatitisremain undiagnosed, region unaffected, Because there are 400millionpeoplelivingwithhepatitis BorhepatitisCinfectionwithnocountry/ lasgow

declaration

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hepatitis “World HepatitisSummit: A voicetodealwith hepatitis #E Glasgow Declaration 186 on 4September2015 asathreat intheworld tweetstohashtagatlaunchof liminate elimination of H ” ep

2015 port e r g tin ee m 9 2015 meeting report 10 3 2 1 epidemiological transition.Lancet. 2015,epubAug27. disability-adjusted lifeyears(DALYs) for306diseasesandinjuries andhealthylifeexpectancy(HALE)for188countries,1990-2013: quantifyingthe review of data publishedbetween1965and 2013.Lancet.2015,epubJul28. vaccination. Vaccine. 2009;27(47):6550-7 rganization. O Health World rogramme, P Hepatitis Global and Department middle incomecountriesinmorbidityandmortalityattributabletoviralhepatitishasnarrowed since1990. T edical Director, Liver Liver Director, edical M Center/ esearch R Liver edicine/Director, M of rofessor P Jia, Ji-Dong rofessor P London; College and Mongolia(>3.5%)thegreatest numericalburden ofchronic infectionintheWesternPacific region East Asia.Thehighestprevalence ofHCVisfoundinNorthAfrica,theMiddleEast,CentralAsia,China blood products priortotheintroduction ofscreening) andincertainregions, notablyAfricaandCentral HCV. HepatitisCisconcentratedinspecificpopulations (peoplewhoinjectdrugs,people received infection worldwide,andaround 500,000peopledieeachyearfrom liverdiseasecausedby The World HealthOrganizationestimatesthat130-150millionpeoplehavechronic hepatitisC worldwide in2010. between 1965and2013.Approximately 248million peoplewere estimatedtobeHBsAgpositive Western Pacific region and8.83%in theAfrican region, according tosystematic review ofdatapublished Global prevalence ofhepatitis Bisestimatedtorangefrom 0.81%intheAmericasto5.26% holdstrueforcirrhosis. similar pattern attributable tohepatitisBhaverisenby4.8%since2005,anddueC35.1%2005.A mperial I of deathworldwide,compared totenthin1990.Disability-adjustedlifeyearslostduelivercancer Diseases, Global Burden ofDiseasestudyshowedthatviralhepatitiswasrankedseventhamongtheleadingcauses nfectious I in Lecturer In 2013approximately 1.4millionpeoplediedworldwideasaconsequenceofviralhepatitis.The2013 Senior Clinical Cooke, Graham Dr by: presentations from messages Key T 0.96% in2006,compared toprevalence of8.57%inadultsaged15-59. China, India,Egypt,MozambiqueandT and 2013are correlated withdeclinesinHBsAgprevalence inseveralcountries inAsiaandAfricaincluding LiangX,BiS,Yang W, Wang L,CuiG,F, etal.Epidemiologicalserosurvey ofhepatitisBinChina--declining HBVprevalence due tohepatitis J,MikolajczykRT SchweitzerA,Horn GBD2013DALYs andHALECollaborators,MurrayCJ,Barber RM, ForemanO KJ,zgoren AA,Abd-AllahF, etal.Global,regional, andnational DS DS I V/A I H Director, Hirnschall, Gottfried Dr University; edical M Capital Hospital, Friendship Beijing rogram, P ransplant he

need 2 Improvements innationalcoverage ofinfanthepatitisBimmunizationbetween1990 , KrauseG,OttJJ.Estimationsofworldwideprevalence ofchronic hepatitisBvirusinfection:asystematic

for 1 Thegapbetweenhigher- andupper-middle incomeandlower-and- anzania. InChinaprevalence ofHBsAg inchildren aged1-4was

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• • • • • Achievement oftheproposed targetswillbefacilitatedthrough: opportunity tomakesubstantialprogress towards eliminationofviralhepatitis transmission. Highly effective prevention andtreatment interventionsnowexistforviral hepatitis,offering the (62 million). 4 proposed thefollowingtargets: Health Assembly, theWorld HealthOrganizationhas viral hepatitis,forconsiderationbythe2016World As partofitsGlobalHealthSectorStrategyon B andCwithaviewtosettingglobaltargets. of, andstrategiesfor, eliminationofhepatitis Health Organizationtoreview thefeasibility World HealthAssemblyrequested theWorld the ongoingtransmissionofviralhepatitis,2014 In recognition oftheglobalburden ofdiseaseand reduction servicesforpeoplewhoinjectdrugs. a growth ininjectingdruguseandalackofharm infection control, lackofhealthsystemcapacity, the historicallegacyofinadequatescreening and control. T unscreened bloodproducts orinadequateinfection settings where infectionisattributabletoreceipt of • • T e HS,JensenDM.EpidemiologyofhepatitisBandC viruses:aglobaloverview. ClinLiverDis.2010Feb;14(1):1,21, vii. T T 2030. of 20perpersonyeartodayto200 peryearin2020and300person Increasing thecoverageofneedlesandsyringessuppliedtopeoplewhoinject drugsfrom anaverage 90% in2030. Increasing theproportion ofinjectionscarriedoutsafelyworldwidefrom 5%today to50%in2020and hepatitis B)from 38%today to50%in2020and90%2030. of birth-dosehepatitisBvaccine(orotherinterventionstoprevent mothertochildtransmissionof Increasing childhoodhepatitis Bvaccinecoveragefrom 81%to90%by2020,andincrease coverage A 10%reduction indeaths duetohepatitisBandCby2020,a65%reduction by2030. A 30%reduction innewinfections ofhepatitisBandCby2020,a90%reduction by2030 reating 3millionwithhepatitisCby2020andprovide treatment for80%by2030. reating 5millionpeoplewithhepatitisBby2020andprovide treatment for80%by2030 oday’s hepatitisCepidemicrepresents

4 Prevalence risessharplywithagein

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2015 port e r g tin ee m 13 2015 meeting report 14 6 5 year follow-upstudy. JNatlCancerInst.2009Oct7;101(19):1348-55. diseases: a20-yearcohortstudyof3.8millionvaccinees.Hepatology. 2014;60(1):125-32. revention (case finding). (case revention P and Control ilan (treatment); Dr John Ward, Director, Division of Viral Hepatitis, Centers for Disease Disease for Centers Hepatitis, Viral of Division Director, Ward, John Dr (treatment); ilan M of University aggiore, M T rgan O and edicine M of assimo Colombo, Chairman, Department Department Chairman, Colombo, assimo M rofessor P prevention); C (hepatitis University Caledonian Glasgow Health, opulation opulation P and Epidemiology of rofessor P Hutchinson, Sharon rofessor P prevention); B (hepatitis edicine M of College summarised thecurrent evidencesupportingarangeofhighlyeffective interventions. of prevention, screening, diagnosisandtreatment willneedtobedeveloped.Severalpresentations In order toachieveeliminationofviralhepatitistransmission,comprehensive nationalprogrammes T ational N aediatrics, P of rofessor P i, N Yen-Husan rofessor P by: presentations from messages Key evidence T people withmultiplesexpartners. partners ofpeoplewithchronic HBVinfection,haemodialysisandfrequent transfusionrecipients, and is alsorecommended for groups athighriskofHBVinfection:peoplewhoinjectdrugs,sexual vaccine. By201160%ofcountrieshadachievedimmunizationcoverage90%orgreater. Vaccination vaccinate infantsagainsthepatitisBaspartoftheirEPI,and81%children received thehepatitisB complete thecourse.In2013,93MemberStateshadintroduced thebirthdose,183MemberStates preferably within24hours. Thebirthdoseshouldbefollowedby2or3dosesofHBVvaccineto WHO recommends that allinfantsreceive HBVvaccineassoonpossibleafterbirth, from 9.8%in1984to0.6% in2014. prevalence surveyshaveshown adeclineinHBsAgprevalence inchildren and youngadultsunder30, launch auniversalinfantvaccinationprogramme in1984,achieving97%coverageby2014.Subsequent hepatitis Bhasproved highly successfulintheprevention ofhepatitisB.T transmission,andtreatmentbloodborne ofchronically infectedpeople.Universalinfantvaccinationagainst of perinataltransmission,universalinfantvaccination,adoptionpreventive measures toprevent Hepatitis Btransmissioncanbeeliminatedthrough screening ofpregnant womenandprevention B carcinoma inchildren havedeclinedbyapproximately 70%inT a widerangeofcountriesaftertheimplementationuniversalinfantvaccination.Rateshepatocellular ChangMH,You SL,ChenCJ, LiuCJ,LeeCM,LinSetal.Decreased incidenceofhepatocellularcarcinoma inhepatitisBvaccinees:a20- ChienYC,JanCF, ChiangCJ,KuoHS,You carrierstatus,andincreased SL,ChenCJ.IncompletehepatitisBimmunization,maternal riskofliver est he

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5 Similarmagnitudesofdeclineinprevalence havebeenobservedin prevention

aiwanese childrenafter1984. born hepatitis

programming aiwan wasthefirstcountryto B aiwan University University aiwan 6 : 13 12 11 10 9 8 7 2010. PLoSOne.2014;9(6):e99677.. drugs: areview ofreviews toassessevidenceofeffectiveness. IntJDrugPolicy. 2014;25(1):34-52. 2010;105(5):844-59. provision inpreventing hepatitisCandhumanimmunodeficiencyvirustransmissionamonginjectingdrugusers:a review of reviews. Addiction. inject drugs:Modelingtreatment scale-upintheageofdirect-acting antivirals.Hepatology. 2013 Nov;58(5):1598-609. drugs: asystematic review ofglobal,regional, andnationalcoverage. Lancet.2010;375(9719):1014-28 therapy ontheincidenceofhepatitis Cvirusininjectingdrugusers:poolingofUKevidence.Addiction. 2011;106(11):1978-88. inject drugs.JInfectDis.2011;204(1):74-83. acting antiviraltreatment are simultaneouslyincreased. achieved where coverageofneedleandsyringeprogrammes, opioidsubstitutiontreatment anddirect- of treatment coveragewouldbeneededtoachieveasimilareffect, andthegreatest impactislikelytobe people whoinjectdrugswithinadecade.AthigherlevelsofHCVprevalence, correspondingly higherlevels coverage of40treatments per1000PWIDShasthepotentialtoeliminateHCVtransmissionamong Modelling ofthree HCVepidemic settingssuggeststhatwhere prevalence islower (30%),achieving transmission amongpeoplewhoinjectdrugssubstantially, evenatrelatively modestlevelsofcoverage. Increasing theuptakeoftreatment usingdirect-acting antiviralshasthepotential toreduce HCV World HealthOrganizationrecommendation toprovide needleandsyringesprogrammes inprisons. Prisons represent ahigh-risksettingforHCVtransmissionbutfewcountrieshaveyetimplemented associated withreductions ininjectingriskbehaviours. safeinjectionroomsof injectingparaphernalia, andeducation,informationcounsellinghavebeen therapy haveeachbeenassociatedwithareduced riskofHCVtransmission,whileprovision Brazil, NorthAmericaandWesternEurope. Needleandsyringeprovision andopioidsubstitution high prevalence (>60%)in Pakistan, China,Thailand,Indonesia,RussianFederation,Ukraine,Vietnam, Worldwide approximately 60%ofpeoplewhoinjectdrugsare infectedwithHCV,especially safety-engineered injectiondeviceswithre-use prevention andsharps(needle)injuryprevention. safe cleaningofallequipment,disposalsharpsandwaste,atransitiontotheusenew quality-assured testingofalldonatedblood,togetherwithinfectioncontrol measures thatinclude recommended thatcountriesshouldimplemententirely voluntaryblooddonationsystemsand these keyinterventionsremains extremely lowoutsideWestern Europe andAustralasia. new HCVinfectionsin2010,compared to1.9millionin2000. achieved 100%voluntaryblooddonation.Unsafeinjectionswere estimatedtoaccountfor315,000 In 201225countrieswere stillunabletoscreen alldonated blood,andonly60%ofcountrieshad procedures inhealthcare settingsaccountforthevastmajorityofhepatitisCtransmissionworldwide. Along withthere-use ofinjectingequipmenttoinjectdrugs,infectedbloodproducts orinvasivemedical B when compared tolowcoverage ofneedleandsyringeprovision alone. and opioidsubstitutiontherapyhasbeenassociatedwithan80%reduction intheoddsofHCVacquisition PepinJ,AbouChakraCN,E,aultV, Valiquette L.Evolutionoftheglobalburden ofviralinfectionsfrom unsafemedicalinjections,2000- MacArthur GJ,vanVelzen E,PalmateerN,KimberJ,harrisA,HopeV, etal.Interventionstoprevent HIVandHepatitisCinpeoplewhoinject Palmateer N,KimberJ,HickmanMHutchinsonS,RhodesT K, Vickerman P MartinNK,Vickerman L,HickmanM,attickRP MathersB,Degenhardt L,AliH,Wiessing T HaganH,PougetER,DesJarlaisDC.Asystematicreview andmeta-analysisofinterventions toprevent hepatitis Cvirusinfectioninpeoplewho P KM , HutchinsonS,Vickerman urner est

pra ctie , Grebely J, Hellard M,HutchinsonSJ, Lima VD,etal.HepatitisCvirustreatment forprevention amongpeoplewho

, HopeV, Craine N,Palmateeretal.Theimpactofneedleandsyringeprovision andopiatesubstitution the

prevention , GoldbergD.Evidencefortheeffectiveness ofsterileinjectingequipment , etal.HIVprevention, treatment, andcare servicesfor peoplewhoinject 8 910 13

of Highcoverageofneedleandsyringeprovision 7

TheWorld HealthOrganizationhas hepatitis 11 Neverthelesscoverageof C

2015 port e r g tin ee m 15 2015 meeting report 16 16 15 14 carcinoma inpatientswithchronic hepatitisB:anationwidecohortstudy. Gastroenterology. 2014;147(1):143,151.e5. Gastroenterol Hepatol. 2007Aug;5(8):921-31. in thosewithhighlevelsofreplicating virus. provides therationaleforsuppressive antiviraltreatment toreduce theriskofprogression ofliverdisease hepatitis Bastrong correlation betweenhigherlevels ofHBVDNAandincreased liver-related mortality Highly effective treatment isnowavailableforboth hepatitisBandC.Inthecaseof B liver cancerby69%. 43190 patientsinT viral suppression in>95%oftreatment-naïve andnucleoside-experienced patients,andalargestudyin and treatment-experienced patientswithgenotype3infection. including thosewithprevious experienceofdirect-acting antivirals,thosewithdecompensatedcirrhosis will beacontinuingneedforregimens suitableforpatientswithspecialneeds inallepidemicsettings, predominance ofgenotype1(asinWesternEurope, NorthAmericaandAustralasia).However, there in settingswhere nationalepidemicsencompassawidedistributionofgenotypes ratherthana to treatment. Pan-genotypicregimens wouldalsobeadvantageousfrom apublichealthperspective lower- andmiddle-income countries,duetotheirsuitabilityforusewithouttheneedgenotypingprior Pan-genotypic regimens for hepatitisChavebeenadvocatedasameansofscalinguptreatment in EASL recommendations for HCVtherapy2015 patients andpost-transplantwithrecurrent HCV. improving inharder-to-treat patientgroups, includingthosewithdecompensatedcirrhosis,pre-transplant and treatment-experienced patients,includingthosewithcompensatedcirrhosis.Outcomesare also Direct-acting antiviraltreatment forhepatitisCisnow curativeinthevastmajorityofpreviously untreated results inAL Caucasian patientswhoare HBeAgpositiveatbaseline,and<1%ofotherpatientgroups, treatment European AssociationforStudyofLiver. EASLRecommendations onT Wu CY, LinJT IloejeUH,Yang HI,JenCL,SuJ,Wang LY, You SL,etal.Riskandpredictors ofmortalityassociatedwithchronic hepatitisBinfection.Clin PegIFNa +RBVsimeprevir PegIFNa +RBVsofosbuvir Interferon-based regimens Ombitasvir/Paritaprevir/Ritonavir (± RBV) Sofosbuvir +Daclatasvir(±RBV) Sofosbuvir +Simeprevir (± RBV) Ombitasvir/Paritaprevir/Ritonavir +Dasabuvir(± RBV) Sofosbuvir /ledipasvir+/-ribavirin Sofosbuvir /ribavirin Regimen Interferon-free regimens est

pra , HoHJ,SuCW, LeeTY, Wang SY, et al.Associationofnucleos(t)ideanaloguetherapywithreduced riskofhepatocellular T normalisationinapproximately 85%ofpatients. ctie aiwan hasshownthatnucleosidetreatment reduced thefive-yearriskofdeveloping 15 Althoughsuppressive antiviraltreatment results inHBsAgclearance<20%of

treatment 14 Antiviraltreatment withtenofovirorentecavirresults in 16

of reatment of HepatitisC2015.JHepatol.2015;63(1):199-236.

hepatitis B and 1, 4 All 4 All 1, 4 1 1, 4,5,6 2, 3 Genotypes C All OralTherapyofPost Pre T ransplant AllOralTherapyforHCV

ransplant Recurrent HCV-1

2015 port e r g tin ee m 17 2015 meeting report 18 17 1–5 antibodyinU.S.primarycareMed.2012;21;156(4):263-70. settings.AnnIntern B virus replication orcure hepatitisC.Timelydiagnosisandtreatment ofhepatitisBhasbeenshown and through linkagetocare andtreatment, permittingstagingofliverdiseaseandtherapytosuppress Case findingsupportssecondaryprevention ofdiseasethrough counsellingonhazards suchasalcohol, settings. change interventionsinpeoplewhoinjectdrugs,andenhancedinfectioncontrol measures inhaemodialyis contacts. Casefindingcanalsoenhancetheimpactofharm reduction bypermittingfocusedbehaviour be provided inadditiontoinfantvaccination.Casefindingalsopermitsthevaccinationofhousehold Case findingsupportsprimaryprevention ofHBVinfectionbyallowingantiviralprophylaxis orHBIGto monitoring. transmission. Casefindingisalsoanessentialelementinpublichealthsurveillanceandprogramme infected personspermitstreatment fortheprevention ofdiseaseandmortality, aswellpreventing Case findingplaysmultiple roles inacomprehensive response toviralhepatitis.Identificationofchronically Wedemeyer, H.,Dore, G.J.andWard, J.W.Viral Hepatitis,22: (2015),EstimatesonHCVdiseaseburden of worldwide–fillingthegaps.Journal est

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17 finding 20 from USplasma donorsandinjectingdrug users. JClinVirol. 2015;66:15-8. Mixson-Hayden T improvement inhealthsystemsandprioritiesforfuture investments. receipt oftestresults through referral toattendancefor care, willbecriticalforidentifying opportunitiesfor Monitoring bothchangesintestingvolumefollowingpolicy, andtrackinglinkagetocare from Monitoring ofcasefindingandlinkagetocare willalsoformanessentialelementofnationalprogrammes. for hepatitisC. 551 blooddonorsandpeoplewhoinjectdrugs,implyingthatitmaybesuitableasasinglediagnostic test shows thathepatitisCcore antigentestingdemonstratedasensitivityof100%andspecificity94.3%in efficiency andcostasingle testtodiagnosechronic hepatitisCwouldbepreferable. Preliminary evidence test positiveforHCVantibodydonotreceive aconfirmatoryPCRtestintheUnitedStates.Ongrounds of PCR testingare usuallyrecommended forconfirmationofchronic infection,butup to50%ofpeoplewho identification ofchronic hepatitis Binfection.Inhigher-income settingsHCVantibodyandconfirmatory Quality oftestingwillbecriticaltoensure thatscreening achievesitsgoals.HBsAgisrecommended for with menandpeoplewhoinjectdrugs. inAfricanorAsiancountrieswithHBVprevalencepersons born of2%orover, menwhohavesex effectiveness. IntheUnitedStates,forexample,nationalpoliciesrecommend hepatitisBtestingfor National casefindingpolicieswillvaryaccording tolocalepidemiologyandpopulationcost- 25 24 23 22 21 20 19 18 nucleoside ornucleotideanalogues. with viralloads>20,000IU/ml,andthegreatest benefitobservedinthosewho received treatment with to significantly reduce theriskofdevelopinglivercancer,withgreatest reduction inriskthose 1992. recommending testingfor people whoinjectdrugsandreceived bloodtransfusionspriorto adopted aone-timebirthcohortscreening1945-1965),aswell policyforhepatitisC(thoseborn prevalence of2%andabove intheUnitedStates. in all-causemortalityof50%-74%,a75%reduction inlivercanceranda93%reduction inliverfailure. recommendation Med.2013;159(5):349-57. statement.AnnIntern 2011;52(11):1294-306. during1945-1965.MMWRecommep.2012;61( RR-4):1-32. infection amongpersonsborn European countries.Gastroenterology. 2012;143(4):974,85.e14. carcinoma: Med.2013;158(5 Pt 1):329-37. ameta-analysisofobservationalstudies.AnnIntern cause mortalityamongpatientswithchronic hepatitisCandadvancedhepaticfibrosis. JAMA.2012;26;308(24):2584-93. development ofhepatocellularcarcinoma inaUSpopulation.ClinGastroenterol Hepatol.2014;12(5):885-93. and 246%intheUnitedKingdom. and ribavirinalonehadthepotentialtoincrease theuptakeoftreatment by50%inFrance,150%Italy enhanced casefindinginadditiontoprovision ofdirect-acting antiviralscompared topegylatedinterferon enhanced casefindinganddirect-acting antiviraltreatmentEuropean insixwestern stateshasshownthat viral hepatitis.Ratesofdiagnosisremain lowinmostcountries.Modellingofthepotentialimpact ein DB, Smith BD, Wittenborn JS,LesesneSB,Wagner LD,RoblinDW,Rein DB,SmithBD, Wittenborn etThecost-effectiveness al. ofbirth-cohortscreening forhepatitisC Moyer VA, U.S.Preventive ServicesT Eckman MH,KaiserTE,ShermanKE. The cost-effectiveness ofscreening forchronic hepatitisBinfectionintheUnitedStates.ClinInfectDis. Smith BD,MorganRL,BeckettGA,Falck-YtterY, HoltzmanD,T Deuffic-Burban S,Deltenre P Morgan RL,BaackB,SmithBD,Yartel A,PitasiM,Falck-YtterY. EradicationofhepatitisCvirusinfectionandthedevelopment ofhepatocellular van derMeerAJ,Veldt BJ,FeldJJ,Wedemeyer H,DufourJF, LammertF, etal.Associationbetweensustainedvirological response andall- Gordon SC,LameratoLE,RuppLB,LiJ,HolmbergSD,MoormanAC,etal.Antiviraltherapyforchronic hepatitisBvirusinfectionand LackofknowledgeHCVstatusisahugebarriertosuccessfulpublicheathresponse to 24 Birthcohortscreening has beenshowntobecost-effective intheUnitedStates. , DawsonGJ,T 26 , ButiMStroffolini T eshale E,LeT ask Force. Screening forhepatitisCvirusinfectioninadults:U.S.Preventive ServicesT , ChengK,Drobeniuc J,etal.PerformanceofA RCHITECT HCVcore antigentestwithspecimens 21 18 , ParkesJ,MuhlbergerNetal.redicted effects oftreatment forHCVinfectionvaryamong T 22 imely diagnosisandtreatment ofhepatitisCresults in reductions HBVtestinghasbeenshowntobecost-effective atanHBV eo CG,etal.Recommendationsfortheidentification ofchronic hepatitisC virus 23 TheUnitedStatesCentersforDiseaseControl has 25 ask Force 19

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2015 port e r g tin ee m 21 2015 meeting report 22 inistry of Health, Uganda. Health, of inistry M Services, Clinical Commissioner Jacinto, Amandua Dr Gambia; he he T Welfare, Social and Health of inister M Sey, mar O Hon. Egypt; nstitute, I Liver ational N Waked, mam I rofessor P Liver Institute,Cairo. have beencured, reported Professor ImamWakedNational ofthe cure ratesare veryhigh:approximately 85%ofthosewithcirrhosis years. Despitetheadvanceddiseasestageofpeople treated sofar, most advancedliverdisease–350,000peopleover thenextthree by July2015,butEgyptwillprioritisefortreatment thosewiththe websiteearlier thisyear,government and1.1millionhadregistered evaluation forfree treatment withinthree daysofthelauncha interferon. T negotiated pricereductions inthecostsofsofosbuvirandpegylated world, hastreated 100,000 peopleinthepastyearasaresult of Egypt, thecountrywithhighestprevalence ofhepatitisCinthe cured by2020. people. Thiswouldresult in81%of all peoplewithhepatitisCbeing treat 95%ofthoselinkedto care andachievecure in95%oftreated people withHCVby2020,link95%ofdiagnosedtocare, C EliminationStrategyandActionPlanaimstodiagnose95%of and SocialAffairs toldthe summit. Georgia’s 2016-2020Hepatitis years, DrDavidSergeenko,GeorgianMinisterofLabour, Health hepatitis Cin2015alone,withanincrease involumesubsequent people withadvancedliverdamageandtoscreen 70,000peoplefor on programme designand monitoring,Georgiaaimstotreat 5000 of treatment from GileadSciences,andwithadvicetraining systems. Bynegotiatingasubstantialpricereduction inthecost proposition evenformiddle-incomecountrieswithlimitedhealth in thedisappearanceofdiseaseoverseveraldecades–isafeasible demonstrate thatelimination–theendingoftransmissionresulting ledipasvir (Harvoni).Georgia’s programme isintended,inpart,to Sciences, themanufacturer ofsofosbuvir(Sovaldi)andsofosbuvir/ US CentersforDiseaseControl andPrevention (CDC)andGilead Georgia; Affairs, programme designedtoeliminatehepatitisC,inpartnershipwiththe Social and Health prevalence ofhepatitisC(6.7%),hasembarkedonanambitious Labour, of inister EuropeM Georgia, oneofseveralstatesinEastern withahigh Sergeenko, David Dr by: presentations from messages Key early C ountries

wo hundred thousandpeopleregistered onlinefor examples

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towards

national

programmes : first-line treatment. advantage ofthelowpricegenerictenofovir($7 permonth)as will beoffered through twohospitals to350eligiblepatients,taking risk populationsbefore thegeneralpopulation.Antiviraltreatment will prioritisehealthworkers,students,thearmed forces andhigh- includes integratedtestingforHBV, HIV, syphilisandmalaria, Uganda.Thevaccinationprogramme2015, beginninginnorthern was launchedbyPresident MusevenionWorld HepatitisDay treatment in2015/16.Afour-year nationalvaccinationprogramme Parliament hasallocated$2.8millionforhepatitisBprevention and vaccination ofhealthcare workers againstHBV. Uganda’s B asaFormidableEpidemicDisease)Order, 2014,andmandatory Hepatitis, supportedbyThePublicHealth(DeclarationofHepatitis 2007. UgandahasdevelopedaNationalPlanfortheControl of have resulted inadecline prevalence amongdonorssince although nationalefforts to improve selectionofblooddonors districts(4.2%-5.7%), among blooddonorsinseveralnorthern regions ofthecountry. T 10%) withanespeciallyhighconcentrationofinfectionsinnorthern Uganda hasahighprevalence ofchronic hepatitisB(approximately vaccination. prevalence of10%inunder-15 yearoldspriortotheintroduction of 1990 HBsAgprevalence was0.41%,compared toan estimated Three Riversegionin2007-2008foundthatchildrensince born programme in1990.Across-sectional studyconducted inthe intervals from 2monthsofage.TheGambiabeganitsvaccination the birthdoseandthree dosesofpentavalentvaccineatmonthly The Gambiafollowsafour-dose hepatitisBschedulecomprising is supportedbyGAVI inthe73poorest countriesoftheworld. B vaccination,and96%coverageofthepentavalentvaccinethat live birthsperyear, achieved98%coverageofbirth-dosehepatitis The Gambia,aWest Africancountrywithapproximately 80,000

esting showsahighprevalence ofHBV

2015 port e r g tin ee m 23

2015 meeting report 24

2015 port e r g tin ee m 25 2015 meeting report 26 community organisationsandpeoplelivingwithviral hepatitis. moreworkshop sessions,andfordecisionmakerstolearn abouttheperspectivesandexperiencesof with viralhepatitistoengageindialoguenationaldecisionmakersthrough thesimulationexercise and their development.TheSummitprovided opportunities forcommunityorganisationsrepresenting people Delegates identifiedcommunityinvolvementaskeybothtocatalysingnationalplansand to national T viral S sessions thatfocusedonkeynationalplanningthemes. indevelopingsuchplansanddelegateshadtheopportunitytoattendaselectionofparallel governments made towards decreasing theburden ofviralhepatitis.TheWHO’s NationalPlanningT Having acomprehensive nationalviralhepatitistreatment andprevention planiscriticalifprogress istobe global movement.” and professionally reassuring tobepartofthis advocates from around theworld,personalhealing “Most amazinggatheringofhepatitispatients, intended: and thecurrent levelofresponse, peoplewoulduse this manualindifferent ways.Thismanualis a response toviralhepatitis.Aseverycountry’s needsare different withrespect toitsepidemiology The purposeofthismanualistoprovide guidancetopublichealthprofessionals taskedwithmanaging viral hepatitisplans:aprovisional document World HealthOrganization:Manualforthedevelopment andassessmentofnational Download themanualathttp://who.int/hepatitis/publications/manual-hep-plan/en/ he teps • • • •

role to propose theoutlineofa nationalhepatitisplan. to proposestructure agovernance thatcanbeadaptedaccording toneeds;and to provide astep-by-stepapproach tosettingupanationalhepatitisplanand/orprogramme; to helpthinkmore comprehensively aboutthehepatitisresponse inacountry;

hepatitis plans

of towards

the

community

plans

development

catalysing be apartofglobalmovement.” together toachievegoalofelimination.Iwant I cannowseetheimportanceofallworking players. Ithasopenedmyeyestoglobalissues, “First opportunitytonetworkwithallthemajor

and

developing

national oolkit cansupport

S expertise andofconsensusbuildingwere repeatedly emphasized. all partiesaround thetable toagree onacommonmodeofaction.Theimportancedifferent typesof fromMany peopleemphasizedthatthemainlessonlearnt exercise wastheimportanceofbringing Delegates commented: diagnosis ofviralhepatitisC. were alsotaskedwithidentifyingpriorityactionstoachieveaspecifictargetforprevention, treatment or pressure from aMinisterofHealthconfronted bysuddenmediainterest inviralhepatitis.Delegateteams clinicians, healthofficials andadvocatescalledtodevelopanational response toviralhepatitisundertime The Summitincludedasimulationexercise inwhichdelegatesplayedtheroles ofpublichealthexperts, steps that we are developing for hepatitis strategy.” my country. Theworkhelpedinaggregating the “[The] simulationtomelookedlikeascenarioof imulation

exercise

to holdhandsandhandlethingstogether.” situation regarding viralhepatitis;itisalwaysbest “[I am]abletorelate ittomy country’s health

2015 port e r g tin ee m 27

2015 meeting report 28

2015 port e r g tin ee m 29 2015 meeting report 30 • • • • • from planning P T reatment is aneedforregular circulation ofinformation of lowerpricestoscaleup treatment. There national programmes from takingadvantage voluntary licensingagreements isconstraining Lack ofknowledgeregarding thescopeof confidentiality clausesinagreements. transparency istoooftenrestricted by leverage innegotiationsregarding price; regions inorder togivenationalprogrammes pricetransparencyInternational isneededinall drugs. transparency impedesconsideration ofgeneric applications havebeenfiled.Thelackof the lackoftransparency over where patent wereConcerns alsoexpressed regarding and NationalRegulatoryAgencies. WHO Prequalification ofM edicines Programme manufacturer inspectiondata betweenthe enables thesharingofproduct evaluationand Collaborative RegistrationProcedure, which of prequalified products byjoiningtheWHO an opportunitytospeeduptheregistration proactive infilingfor registration. Countrieshave registration where companieshavenotbeen shouldtaketheinitiativeregardingGovernments level andtheneedforacceleratedreview. slowness ofregistration procedures atcountry There iswidespreadregarding concern the quality. patients areaboutgenericdrug concerned products thathavenotbeenprequalified, but are donorsunwillingtosupporttreatment with importance ofWHOprequalification. Notonly to good-qualityhepatitisCdrugsandthe Delegates stressed theimportanceofaccess arallel

presentations

and

themes sessions

a ccess

to :

drugs main

and • • • • •

fall tolessthan$250per treatment course. treatment packageevenwhengenericprices might compriseuptohalfthetotalcostof the costofmonitoringandgenotyping,which The costoftreatment isalsoinfluencedby ranging from $267-$444pertreatment course. regimens couldbemadeavailableatprices that currently available12and24-week costs, research publishedin2015estimates pharmaceutical ingredient andmanufacturing estimation ofthechemicalprocesses, active programmes byGilead.Based onan current agreements negotiatedwithnational reduce drugcostsconsiderably below Generic competitionhasthepotentialto payments etc. be excludedfrom benefit by highprices,co- affordable, peopleonlowincomesmaystill mean thatevenifproducts are judgedtobe Differences ofincomewithincountries as inthecaseofBrazil. gives countriesleverageinpricingnegotiations, Consideration oftheuseTRIPSflexibilities circumstances. choice ofinstrumentwilldependoncountry licenses, direct negotiation withpharma).The production ofgenericdrugs,compulsory to attainaffordable drugs(i.e.TRIPSflexibilities, on therangeofinstrumentsthatcanbeused would welcomegreater adviceandinformation that profits are comingbefore lives.Countries DAAs are unaffordable atcurrent pricesand There wasaconsensusamongdelegatesthat prequalification ofnewproducts. on thescopeoftheseagreements andon key points

discussions

national

arising

2015 port e r g tin ee m 31 2015 meeting report 32 • • • • • • S trategic for viralhepatitis. `Consolidated StrategicInformationGuidance` develop `StrategicInformationFramework`and Low- andMiddle-IncomeCountries`,to HepatitisSurveillance for `Guidance onViral HepatitsB,C,D`and Indicators forViral WHO isworkingtofinalise`Guidanceon for donorinvestmentinsurveillancesystems. member states.Delegateshighlightedtheneed diagnosis andtreatment, in consultationwith on theprogress inviralhepatitisprevention, a systemforregular monitoring andreporting policy. TheWHArequested thatWH O develop support decision-makingonevidence-based surveillance systemsforviralhepatitisto member statestodevelopepidemiological The 2014World HealthAssembly urged outcomes. incidence, diseaseburden andtreatment control bydeprivingusofdata onprevalence, data weakensthepolicycaseforhepatitis B and51forhepatitisC.Lackofsurveillance countries hadsurveillancesystemsforhepatitis WHO GlobalHepatitisProgramme found55 countries. Apreliminary 2012surveyforthe surveillancesystemsremainViral weakinmany meet localneeds. and burden ofdisease,andtotailorpolicies identify modesoftransmission,riskpopulations, Surveillance dataenablepolicy-makersto identify bottlenecksandopportunities. return onresources investedandhelpsto improvement, assures qualityandmaximal Strategic informationinformsprogramme changes asaresult ofinterventions. understand theepidemicandmonitorhowit hepatitis. Strategicinformationhelpsusto Lack ofdataunderpinslackactiononviral

information

for

planning • •

will beresponsible fordefining eligibility. the proposed globaltreatment target,andwho treatment eligibilitywillbedeterminedaspartof Delegates askedforclarificationonhow important elementofimproved surveillance. inexpensive andquickdiagnostictestsasan the needfornational-levelaccesstoreliable, or highlystigmatised).Delegatesstressed settings where injectingdruguseiscriminalised the impactofneedleandsyringeprograms in of OSTorantiretroviral therapytomeasure captured through HIVprogrammes (e.g.receipt as welluseofindirect measures already of laboratoryserology andcancerregistries, of capturingperformancedata,suchasuse Delegates discussedpotentialinnovativeways

2015 port e r g tin ee m 33 2015 meeting report 34 • • • • • • P revention many countries risk factorfortransmissionofviralhepatitisin Healthcare related injectionsare animportant governments can beunderthreat asaresult ofchanging with well-establishedprogrammes, HR programmes; nevertheless, evenincountries implementation ofharmreduction (HR) Countries are atdifferent stagesinthe evidence base PWID are nowunderpinnedby astrong interventions toprevent these infectionsamong people whoinjectdrugs(PWID);harmreduction (HCV) infectionare asignificant issueamong Hepatitis Bvirus(HBV)andhepatitisC may beconsidered interventions –suchasscreening allmothers– vaccine intheWesternPacific region, other Given thehighcoverageofbirth-dose empt anynegativeimpactonvaccineuptake. and timelyresponse iscrucialinorder topre- not causedbythevaccineitself).Anappropriate adverse eventshaveoccurred (whichare often persist insomecountries,particularlywhere withregardSafety concerns tothevaccine reduced levelsofHBVinfectionamongchildren (particularly inChina),andhasbeenreflected by implementation oftargetsandpolicies Pacific region through thesuccessful vaccine hasbeenachievedintheWestern High coverageofthebirth-doseHBV • • •

provide keyevidence and evaluatedtoremove shakyestimatesand Impact ofinterventionsmustbemeasured transmission interventions isnecessarytoinhibitforward of comprehensive structuralandbehavioural Multi-stakeholder engagementandformation unregulated privatehealthcare sector behaviours, thisisnotablydifficult inthe barriers tochangingriskyhealthcare injection There are manyeconomicandpsychosocial

2015 port e r g tin ee m 35 2015 meeting report 36 • • • • • S ervice high riskgroups. health educationandharm reduction among HIV andSTIclinics,offers theopportunityfor tuberculosis). Integrationofservices,suchas HIV, sexuallytransmittedinfections(STI)or into thosewhichare already established(e.g. hepatitis programmes canbeincorporated and toensure apatient-centred approach, T found tobeinfected. be given,andtreatment to beoffered tothose found tobenegative,harmreduction adviceto This approach enablesvaccination ofthose travellers) washighlightedbyseveralpresenters. sex workers,menwhohavewithmen, armed forces, prisoners,S TI clinicattendees, groups (e.g.healthcare workers,students, The deliveryoftargetedscreening ofhighrisk services. are already offering integratedHIVandhepatitis HIV andhepatitis:of58focuscountries,41% retention incare. Thisisalready happeningwith at onesitehascontributedtoaccessibilityand decentralisation ofcare. Integrationoftreatment has enabledtheexpansionoftreatment and physicians toothercadres inthehealthsector Simplification oftreatment andtaskshiftingfrom resource-limited settings. is feasibletoimplementonalargescalein the best-proven standard ofcare andwhat has struckabalancebetweenimplementing approach toprevention, treatment andcare A simplifiedandstandardised publichealth from averylowbaselinein2000. important inachievingextraordinary progress research andcareful monitoringhavebeen donor mobilisation,targetsetting,operational A combinationofreductions indrugcosts, million peopleare nowreceiving antiretrovirals. fromWhat canwelearn HIVscaleup?15 o maximisethecost-effectiveness ofservices

delivery • • • • • • week, withstaff workinginthree shiftseachday. treatment from 26to36clinics, opensixdaysa worldwide andexpandingclinicsproviding 2014, bynegotiatingthelowestdrugcosts treatment for130,000peoplesinceSeptember is possible.Egypthasbeenabletoprovide Very rapidscale upofhepatitisCtreatment treatment forhepatitisC. monitoring requirements wouldgreatly simplify interactions andminimalassessment A pangenotypicregimen with noseriousdrug disease. function testscouldbeusedtostageliver hepatitis Cmanagement.Similarlyroutine liver simplifying thelaboratoryrequirements for the potentialtoreplace molecular diagnostics, of cure. HepatitisCcore antigentestinghas C, bothforentryintocare and forconfirmation simplifying thediagnosticpathwayforhepatitis Delegates agreed ontheimportance of surveillance system. of astandardised patientmonitoring and has beensupportedbytheimplementation (the GlobalAIDSResponseProgress Report) A strong monitoringandevaluation framework agenda. these challengesandtoprogress thehepatitis Resources mustbeputinplacetomeet systems toquantifytheburden ofdisease. the necessarysurveillanceanddatacollection commitment.Manycountrieslack government national epidemiologicaldatatoattract of impactandprioritisationinterventions. Programme planninghasrequired modelling secondary andtertiarycare). multiple levels(e.g.community, healthcentres, follow-up. InKenya,servicesare delivered at and treatment adherence andavoidinglossto provided atlocallevelthereby improving uptake T

o improve servicedelivery, care shouldbe

2015 port e r g tin ee m 37 2015 meeting report 38 • • • • • U niversal treatment. which mightbedisplacedbyprioritisationof and ascost-effective asother interventions become ascost-effective as existingalternatives it isusefultoaskatwhatpricetheywould When consideringthecostofnewmedicines of nationalplans. national plansonpopulationhealthandthecost strategic planningtoquantifytheimpactoftheir Decision makerscanusetheOneHealthtoolfor medicines. capacity, inorder todeliver new interventionsor investments neededtoimprove skillsand health system,availableresources andthe will considertheexistingstrength ofthe seeking todoeverythingatonce.Planning implementation withcleargoals,ratherthan Strategic planningwilldevelopatimescalefor services? payments bereduced forpeopleusingexisting be increased, andhowcanoutofpocket where shouldcoverageofexistingservices population groups shouldbecovered first, universal healthcoveragewillask:which Priority settingaspartofadrivetoachieve local ratesoftransmission. depend ontheburden oflatestageillnessand National prioritisationofHCVinterventionswill

health

coverage , costing • • access totreatment. years toeliminateHCVatthecurrent paceof example Brazilestimatesthatitwouldtake100 unachievable inthemid-tolong-term–for elimination ofHCVfrom thepopulationis where priceandfundingare constraints, At thecurrent paceofaccesstotreatment, advanced liverdisease. expand accesstotreatment, prioritising health care. Brazilhassoughttogradually witihin thecontextofaconstitutionalrightto In BrazilaccesstoHCVtreatment hasemerged

and

prioritisation

2015 port e r g tin ee m 39 2015 meeting report 40 • • • • • • • • • G overnance especially inthefaceoflimitedresources. and dialoguebetweenallstakeholders emphasized, particularlytheneedforsynergies The importanceofpartnershipswas prices negotiating theloweringofdruganddiagnostic to continueensure efficiency, suchas increase inthebudget,however, workneeds hasledtoan Dialogue withgovernment the developmentofahepatitisstrategy Hepatitis Control Program in Indonesia ledto In ndonesiaaMinisterialRegulationon critical forinformingnationalresponses Serosurveys inPakistanand Indonesia were a decentralizedsituation andhepatitisprogrammegovernment leadingto population andthedevolutionof Challenges inPakistanincludethelarge the beginningofplanningwascritical. beginning. PrimeMinisterialinvolvementfrom In Pakistanpoliticswere importantinthe actors –thisiscriticaltogoodgovernance. T implementation isshared betweenallpartners. partners ensures activitiesare delivered, thatis, and research organizations.Coordination ofall groups andcommunity-basedorganizations; non-stateactorsincludingpatient governments; territory included theAustraliangovernment; viruswastakeninAustralia.Partners borne A partnershipapproach toSTIsandblood- development ofstrategies. In Australiaministerial“buy-in”waskeytothe argets provided goalsforallstakeholdersand , O wnership

and P • • • • • artnership

important forongoingsuccess a SurveillanceandMonitoringPlanwillbe An ImplementationandEvaluationPlan investment nowwillbecostsavinginthefuture. communicating todecisionmakersthatthe is A majorchallengeforgovernance responsibility betweenallstakeholders There needstobeacleardivisionofroles and implementation ofstrategies and partnershipare keyenablersforthe Policy dialogue,stakeholderinvolvement targets Strategy tobedevelopedwithclearlydefined responses. requires Governance aNational the importanceofcivilsocietyinjump-starting success storyofcivilsocietyinvolvementand In MongoliatheOnomFoundationpresents a

2015 port e r g tin ee m 41 2015 meeting report 42 people, andtheimmunisation programme forhepatitis Bvaccination.Asimplifiedtreatment packagethat programmes withinthehealthsystem,suchasH IV forharmreduction andfortreatment ofcoinfected be importantforhealth systemstoidentifywaysinwhichcostscan beshared withexisting Prevention andtreatment ofviral hepatitiswillbecomeaffordable iftreatment costsdecline,butitwill costs begintodecline. Thereafter totalcostswoulddecline,to$9billionin2030asharmreduction andhepatitisBtreatment countries wouldrisefrom $2billionin2016and$82020,to just over$11billionin2025. According tothepreliminary model,thecostofviralhepatitiscontrol inlower- andmiddle-income coverage ofneedleandsyringeprogrammes inorder torapidlyreduce transmissionofhepatitisC. therapy willbethebiggestbudgetiteminperiod leadingupto2020,asWHOseeksexpand Funding ofharmreduction interventionssuchasneedleandsyringeexchangeopioidsubstitution speed atwhichthesepricesdeclineasaresult ofcompetitionandgrowth inmarketvolume. versions ofdirect-acting antiviralsforhepatitisCandantiviraldrugsB,the thattheestimateswouldbecriticallydependentonpricingofgeneric warned Stefan Wiktor reduced by2020. grow from 2018andreach aninterimWHOtargetof3milliontreated by 2020,withdrugpricessharply after itspatentexpires). Thefinancingprojections assume thathepatitisCtreatment scaleupwillbeginto cost $80ayear(tenofovirwillbecomeavailableingenericformforhigher-income countriesfrom 2017 middle-income countriesand$10,000percourseinhigher-income countries.HepatitisBtreatment will treatment forhepatitisCat $200percourseoftreatment inlower-income countries,$500percoursein proposed WHOtargetsforviralhepatitiscontrol. Themodelassumesthatitwillbepossibletoprovide The modelwasdesignedtoproduce estimatesofhowmuchfundingwouldbeneededtoachievethe WHO withincollaborationmodellersatImperialCollege,London. oftheWHOHepatitisProgramme presentedStefan Wiktor preliminary results ofmodellingcarriedoutby • • • meeting discussedcriticalelementsthatwillcontributetothedevelopmentofaninvestmentcase: national programmes bymobilisingfundingforcomprehensive programmes. Severalpresentations atthe The developmentofaglobalinvestmentcaseforviralhepatitiscontrol willsupportthedevelopmentof case S prevention C ost permitting greater affordability oftreatment Potential mechanismsforreducing drugcoststhrough voluntarylicensingandgenericproduction, Potential mechanismsforfundingviralhepatitisprogramming from donoranddomesticresources elimination targets,2016-2030 Projected costingsforviralhepatitiscontrol activitiesthat willcontributetotheproposed WHO teps - modelling

towards

and

treatment

comprehensive

global a ctivities

global

investment

viral

hepatitis

systems. to placeagrowing burden onhealth diseases thatotherwisewillcontinue way foreliminationoftwoinfectious prevention andtreatment willpavethe liver cancer. Investinginviralhepatitis hospitalisation, livertransplantationand management ofchronic liver disease, viral hepatitis,arisingintheformsof avert thefuture costsof untreated prevention andtreatment will run, hetolddelegates,because cheaper thaninactioninthelong was notdiscretionary. Actionwillbe makers thatspendingonviralhepatitis Health Organizationreminded policy HIV/ADS andHepatitisattheWorld headofthedepartment Hirnschall, Opening theconference, DrGottfried ineffective formsoftreatment. and mightalsoeliminatespendingon by preventing progression ofliverdisease, China forbothhepatitisBandC to treatment wouldprove costsavingin for China,thispublichealthapproach investment-case analysisconducted would alsoreduce costs.Basedonan and astandardised treatment regimen can bedelivered withlessmonitoring

2015 port e r g tin ee m 43 2015 meeting report 44 • • • • new fundinginseveralareas: mechanisms forfundinghepatitistreatment. Themeetingidentifiedpotentialopportunitiesformobilising HepatitisPreventionof theViral Board reported onarecent stakeholdermeetingwhichreviewed potential income countries-wasoneofthebigquestionsWorld HepatitisSummit.DanielLavanchy How hepatitistreatment canbemadeaffordable -especiallyforlower-income andmiddle- P mechanisms Develop newfunding Hepatitis-specific newfund existing frameworks Create newfundingpools within Redirect existingfundingpools Potential fundingmechanism otential and insurers. impact bonds,commodityoractivity-specifictaxes,developmentofnationalhealthinsurancesystems Develop newfinancingmechanismssuchasdiscountingforlargescalepurchasers ofdrugs,social Create aspecificfundingbodyforviralhepatitis developing andmanaginglarge-scalepublichealthprogrammes inpartnershipwithgovernments. and Malariaspecificallydedicatedtohepatitis,leveragingtheexperienceoftheseexistingfundsin Create newfundingpoolswithinexistingfundssuchasGlobalFundtoFightAIDS,T Fund toFightAIDS,T Directing existingpoolsofdonorfundingtosupportviralhepatitisprogramming, suchastheGlobal

funding uberculosis andMalaria,GAV I AllianceandUNIT

mechaniss • • • • • • • • • Pros other proposals Potentially compatiblewith new streams offinance such aspensionfunds,or mobilise newtypesoffunders May havethepotentialto case Requires astrong investment hepatitis Dedicated fundingfor case Requires astrong investment Avoids re-inventing thewheel and structures Profits from existingexpertise case Requires astrong investment Extends existingprogrammes

for

national • • • • • • Cons AID Largely unproven from existingpriorities avoid drawingmoneyaway generate newfundingto Investment casemust may betime-consuming structure andgovernance Finding theappropriate from existingpriorities avoid drawingmoneyaway generate newfundingto Investment casemust heavily committed Existing institutionsalready existing programmes Has thepotentialtoharm

programmes uberculosis • • • • • • • • • depend on: HepatitisPreventionThe Viral Board stakeholdermeetingconcludedthatmobilisationoffundingwill investors asareward forputtingupthemoneytopay foratreatment programme. impact bonds,inwhichaportionofthehealthcare costssavedbypreventing diseaseare returnedto as longthepoliticalwillexists.Innovativemethodsoffinanceare alsobeingexamined,suchassocial voluntary licensing,discountsforlarge-scalepayersmightenablesomecountriestoscaleuptreatment – will playacriticalpartinmakingtreatment affordable andinsurancefunds.Besides forgovernments Regardless ofhowtreatment isfinanced,mechanisms to reduce drugpricesinmiddle–incomecountries health coverageandinsurancesystems. treatment willneedtobemetfrom domesticresources, emphasisingtheimportanceofimproving universal that nolongerqualifyfordevelopmentassistance,suchasChina,India,BrazilandRussia.Thecostsof malaria indevelopingcountriesisthatalargeproportion oftheburden ofviralhepatitisisincountries problems ofreproducing amodelthathassucceededinexpandingtreatment ofHIV, tuberculosis and Although someare attractedbytheideaofaspecificdonorfundingpoolforhepatitis,onebig

Identification ofbestpracticesanddemonstration projects forfurtherdevelopment Research intoidentifyingthe successfactorsofprojects, programmes andfinancing mechanisms partners’ interests Creation ofnewpartnerships andcommitments,withbuildingabusinesscasebasedonpriorities Identification andestablishmentofabasefortheworkdescribed. activities onprevention and controllevel ofviralhepatitisataninternational Identification ofabroad base ofpotentialpartnersinanallianceorcoalitiontoadvanceandcoordinate Definition ofobjectivesandprioritysetting leadership Generation ofcommitmentandpoliticalwillthrough continuedadvocacy, andidentificationofstrong none exist Formulation ofpoliciesandstrategiesforprevention andcontrol ofviralhepatitisatnationallevelwhere trends; improved qualityofdata Better definitionoftheburden ofdiseaseandsocio-economiccosts,togetherwithanalysisdata

2015 port e r g tin ee m 45 2015 meeting report 46 countries, and43to49% inlowermiddle-incomecountries. for DiseaseAnalysissuggests that23to29%ofpeoplewithhepatitisClive inuppermiddle-income China, BrazilandRussiawhichmaynotbecovered byvoluntarylicensing deals.Areview bythe Center price ofhepatitisCtreatment liesinthefactthatalarge numberofthesepeopleliveincountriessuch as Hazawi oftheCenterforDiseaseAnalysissaid,but amajorchallengefacingallefforts toreduce the Approximately 85%ofpeoplewithhepatitisCliveinlower-income ormiddle-incomecountries,Homi treat different genotypes. variations inthegenotypemix,andwouldovercome delaysinregistration ofmultipleproducts neededto would vastlysimplifytreatment byremoving theneedforamosaicofnationalguidelinestocaterlocal 1, someare muchlesspotentwhenusedtotreat genotype3.Havingoneregimen thatsuitsallpatients more variedinAsiaandAfrica.Whereas alldirect-acting antiviralcombinationsare activeagainstgenotype predominates inthehigh-value marketsofEurope andNorthAmerica,themixture of genotypesisfar of thepopulationwithhepatitisCinfectiontobenefitfrom lower-cost treatment. Whereas genotype1 against allthegenotypespresent inlower- andmiddle-incomecountries,allowingalarger proportion the needforgenotypetesting,agreater advantagetoapan-genotypiccombinationwouldbeefficacy argue thatpan-genotypiccombinationsare neededinorder tosimplifytreatment bydispensingwith combinations shouldbeequallyactiveagainstallgenotypesofhepatitisC.Althoughmanyadvocates allow thedevelopmentofpan-genotypiccombinationsdirect-acting antivirals.Pan-genotypicdrug The MedicinesPatentool’s firstpriorityistonegotiatevoluntarylicensingagreements thatwould hepatitis, where accessto newantiviraldrugsisverylimitedoutsidehigher-income countries. Now theMedicinesPatentoolisweighingwhetheritcanmakeasimilardifference inthefieldofviral agreements, althoughthe geographical scopeoftheagreements variesbetweenproducts. Some ofthemostimportantdrugsusedinHIVtreatment are nowcovered by Medicines Patentool generic manufacturers for sale atgreatly reduced pricesinlower- andmiddle-incomecountries. the majorpharmaceuticalcompaniesthatallowsomeoralloftheirantiretroviral products tobecopiedby Since itslaunchin2010,theMedicinesPatentoolhasnegotiatedvoluntarylicensingagreements withall delivery oftreatment inlower- andmiddle-incomecountries. development offixed-dosedrugcombinationsproducts from more thanonemanufacturer, forefficient HIV treatment. TheMedicinesPatentoolwasalsodesignedasamechanismtoovercome barrierstothe with pharmaceuticalcompaniesthatwouldallowwidespread accesstolow-costantiretroviral drugsfor diagnostics purchase fundforHIV, tuberculosis andmalaria,tonegotiatevoluntarylicensingagreements The MedicinesPatentoolwasestablishedwiththesupportofUNIT around 85%ofpeoplewithhepatitisCare estimated tolive. speed upandexpandaccesstodirect-acting antiviralsforlower- andmiddle-incomecountries,where meeting duringtheWorld HepatitisSummitthattheorganisationwasconsideringhowitcouldactto Greg Perry, ExecutiveDirector oftheMedicinesPatentool,tolddelegatesataconsultationsatellite P otential

mechaniss

for

reducing

drug D, the international drugand AID, theinternational

costs

income countriesinfuture licenses. terms andgreater coverage ofmiddle- Advocates wouldliketoseelessonerous patient confidentialityandautonomy. sans Frontières fortheirpotentialtoharm have beenstrongly criticised byMédecins have alsobeenagreed, buttheseterms in marketsnotcovered bythelicence designed toprevent thedrugsbeingsold Gilead. Strictanti-diversionmeasures with otherproducts notownedby countries, andtocombinetheagents in 101lower- andlowermiddle-income to marketversionsoftheGileadproducts manufacturers allowsthosecompanies Voluntary licensingto11Indiangeneric and Harvoni(sofosbuvir/ledipasvir). Gilead’s products Sovaldi(sofosbuvir) arrangements forhepatitisCcover The onlyexistingvoluntarylicensing

2015 port e r g tin ee m 47 2015 meeting report 48 • • 6. • • 5. 4. 3. 2. 1. immediate actions: The undersignedonbehalfofthe400millionpeoplelivingwithhepatitisBandCcallforfollowing C. Thisisascandal.Itunacceptable. important reason forthisisthattheydonothaveaccesstolife-savingdrugshepatitisBand More peopledieeachyearfrom hepatitisBandCthan from HIV/ADS,TBormalaria.hesinglemost Organization representatives. andWorldorganisations, activistsandpublichealthspecialists,aswellevensomegovernment Health signed byover175organisationsandindividualsfrom 55countries,representing WHAmembers,patient makers andpatientsfrom across theglobeare brought together. DuringtheSummitletterwas andpharmaceuticalcompaniesasitisonlyforumwheregovernment pharmarepresentatives, policy- believed thattheSummitwasperfectopportunitytolaunchacallformore vigorous efforts from The World HepatitisAlliancehasbeenexaminingtheissueofaccesstotreatment forsometimeand saving T he affordable prices Use adominant marketpositiontoprevent peoplegettingaccess tothebestcombination ofdrugsat hepatitis BorC Put inplaceanti-diversion policies thatinfringetheconfidentialityorhuman rights ofpeoplelivingwith Pharmaceutical companies shouldnot: countries aspossible Making theIntellectualProperty ofthebestdrugsavailabletoMedicines Patent oolinasmany cost-effectiveness duration are alwayscost-effective ineverymarketbasedonacceptedpercapitaGDPdeterminantsof Pricing thedrugssothat,asabare minimum,thebestcombinationsforoptimum treatment countries, whetherhigh,middleorlowincome.Thesestepsshouldinclude: Pharmaceutical companiesshouldtakeallnecessary stepstoensure theirdrugs are affordable inall negotiation withpharmaceuticalcompanies. to thoseinneed,whetherthatistheuseofTRIPSflexibilities,patentopposition,generics or These measures shouldbe decided according towhateverdeliversthequickestaffordable access programmes butequallyso thatthoseforced topayforthedrugsthemselvescanalsoafford them. for hepatitisBandCtotheextentthattheycanafford tomassivelyscaleupnationaltreatment shouldtakeallnecessarystepstoreduceNational governments thepriceofbestanti-viraldrugs requirements forspecificnationaldrugtrialswhere goodevidenceofefficacy andsafetyalready exists. process of,nationalregistration ofanti-viralhepatitisBandCdrugs,includingtherelaxation of shouldtakeallnecessarystepstoremoveNational governments barriersto,andspeedupthe and ensure thatthosetesting positivecanprogress from diagnosistotreatment. reduce thepriceofdiagnostics sufficiently sothattheycanafford toscreen theirat-riskpopulations shouldtakeallnecessarystepstoputinplaceadequateinfrastructureNational governments andto remain undiagnosed. prevents peoplecomingforward fortesting,sincethevastmajorityofthosewithhepatitisBandC shouldtakeallnecessarystepstoremoveNational governments thestigmaanddiscriminationthat

global

hepatitis

drugs

community

calls

for

a ccess

life - and largescaleupprojects. significant proportion especiallyinthecaseofNIH,andthere islittlefundingofimplementationresearch time, andthatfundingforHCVisaround twotothree timesthatofHBV. Basicscienceaccountsfora observations were thatfundingavailableisafractionofHIV, hasnotincreased significantlyover Centers forDiseaseControl, UKMedicalResearch Council,French A NRS, Wellcome T Selected keyresearch fundingagencieswere surveyed,includingUSNationalInstitutesofHealth, • • • Professor PhilippaEasterbrook outlinedpriorityareas foroperational research: Operational andpublichealthresearch formsanessential elementofthescaleupviralhepatitiscontrol. O Evaluate treatment strategies Develop andevaluatemodelsofservicedeliveryforhepatitistesting,care andtreatment Improve qualityoftestingtechnologies,algorithms,andservicesevaluatetheirimpact perational T o accesspresentations, videos andphotosfrom theWorld HepatitisSummit,visit:

www.worldhepatitissummit.com research M ore

information .

rust. Themain

2015 port e r g tin ee m 49

2015 meeting report 50

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