SECONDEUROPEANHIVPREVENTIONSUMMITBrussels,January29—31,2016

MeeCngReport

Background

Following thepopularityof thefirstexpertmee6ngonpreven6onheld in January2015,a secondEuropean HIV Preven6on Summit was held on 29-31 January 2016. Organised jointly by theEuropeanAIDSTreatmentGroup(EATG)andAVAC,themee6ngbroughtpharmaceu6calcompanies,publichealthexperts,academicsand leadingscien6sts inthefieldofpreven6onresearchtogetherwith over 50 European community based advocates for three days of informa6on exchange anddebate in Brussels. Themee6ng agenda and slide presenta6ons delivered at themee6ng can befoundat:hWp://eatgavacpreven6on.tumblr.com/

Themee6ngexploredfourhottopicsinHIVpreven6onindepth:

HowdowegetPrePtothepeoplethatneeditinEurope?

ThissessionreviewedthestateofprogresstowardsPrEPauthorisa6onandaccess intheregiontodate.Updateswereprovided from fourongoingor concludedPrEP implementa6on studies in theUK,France,BelgiumandtheNetherlands,withpowerfulcontribu6onsfromcommunity-basedPrEPac6vistsinGermany,GreeceandtheUK.NoelGillofPublicHealthEnglandpresentedtheresultsofacost-effec6veness study designed to inform the upcoming decision of whether to make PrEPavailableontheNHS.

Considerablefrustra6onwasexpressedthatprogressonPrEPremainssoslowinEuropecomparedtotheUS.ThestrongdemandforPrEP has been shown by the ease withwhich demonstra6on studies have beenabletorecruit–within24hoursinthecaseof the Amsterdam study. Ac6vists havebegun to takemaWer into their ownhandsbyprovidinginforma6ontogaymenonhowtoimportgenericPrEPfromabroad.

PrEPstudieshavegivenrenewedimpetustoHIVpreven6oneffortsat thena6onal level.Researchersandac6vistsalikenoted thatPrEPshouldnot be regarded as a purely biomedical interven6on. It is ac6ng as a catalyst towards beWer HIVbehaviouralinterven6onsandreliesonstrongsocialpackaging:“TheadventofPrEPdoesnotmeanthatwearedroppingallthebehaviouralworkwedoinpreven6on.PrEPrequiresbehaviourchangeandcanactasacatalystforchangeinsomeone’slifeandriskbehaviour”.

Thediscussionfocusedonanumberofkeyques6onsthatthecommunityisgrapplingwith,includinghow to ensure access to popula6ons besides gaymen, in Eastern Europe, and especially how toreach the “naïve risk takers”. Concernswere also raised aboutpeoplebuyingPrEPonlinewithoutmedical supervision. Par6cipants also discussed whether the community should be demanding alower price for Truvada as preven6on. It was noted that the level of energy around PrEP isreminiscentofac6vismnotseenintheHIVsectorsincethelate1990s.Thereisunjus6fiedsuspicionofPrEPbutthecommunityhaslegi6mateques6onsthatwemustbeabletoanswer.

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What is the role of the PharmaceuCcalindustryinendingHIVandAIDS?

Three leading Pharmaceu6cal companiespresentedtheirpreven6onporgolios:

Gilead reported that 50,000 people are nowtakingTruvadaasPrEP in theUS.Mostof thisuptake is among gay men but the uptake islowestamongthegaymenandMSMthatneeditmost;amongwomen there isno increase innumbers. The publica6on of CDC guidelineswas the trigger for uptake among gay men.Gileadalsonotedthatadherenceinthesecondwave of PrEP studies [PROUD, Ipergay, Kaiser]

improved because of community advocacy and awareness raising. The company con6nues tosupport PrEP trials all over theworld by providing drug and technical assistance, andwill file forregulatoryapprovalonrequest.GileadislookingintootherdrugsforPrEPandwillcommenceatrialthisyearlookingattheefficacyofF/TAFasPrEP,whichwillincludeEuropeantrialsites.

Janssen/J&J presented their preventa6veHIV vaccine development plan. The company is keen tofindaglobalvaccinethatworksagainstallcladesofHIVaspartofitsbroaderHIVporgolio.Theyareexploring viral vectors,mosaic and prime boost approaches and they aremoving forward with anumberofPhase1/2atrials.Inthesecondquarterof2008,J&Jwillbeginanefficacytrialwithtwostudies.Aproofofconcept trial ismeanwhileplanned for2017, forwhichEuropeantrial sitesareneeded.

ViiV provided an update on their HIV Preven6on Programme, which is looking at a number ofcandidatesaslong-ac6nginjectable(LAI)PrEP.CabotegravirisanidealinjectablePrEPcandidateforanumberofreasonsandtheresultsofÉCLAIR,aPhaseIIastudyamongMSMintheUS,areexpectedat CROI. HPTN077 is a Phase IIa safety, tolerability and acceptability study of an injectable HIVintegraseinhibitorforPrEPinmenandwomen.APhase3study,HPTN083,co-designedwithGileadto compare Cabotegravir with oral Truvada in men and trans women is planned. ViiV is alsocon6nuing to study oral Maraviroc for PrEP as an alterna6ve to Truvada, and topical MaravirocthroughtheCHARMconsor6um.TheresultsofthedatainmenfromHPTN069willbepresentedatCROI,withdataonwomenataconferencelaterintheyear.

GenericmanufacturerMylanpresentedonthepoten6alforgenericARVsinEurope.Mylaniskeentobring generic TDF/FTC to market within weeks of it coming off patent. Since there are differentpatent6melinesindifferentcountriesandtherecanbemul6plepatentsonthesamedrug,itwillbecomplicated.Arolling introduc6on inEurope is likely.All theirproductsareregisteredthroughtheFDAortheWHOpre-qualifica6onprocedure.

Thediscussionperiod focusedonpursuing greater clarity fromGileadas to their intent tofile forregulatoryapprovalforTruvadaasPrEPfromtheEMA,theques6onofthedifficultyindesigningHIVpreven6on trials for new interven6ons in an era of PrEP, and how we can prepare for theintroduc6onofgenericop6ons,includingwhethercountriesintroduceTDF/3TCforPrEP.Advocateswill need to con6nue good rela6onshipswith both the generic andbranded sector as partners inendingAIDS.

GatewaystoprevenCon:ThecontribuConoftesCngandtreatmenttoendingHIV

ThissessionfocusedonkeypriorityareasforEuropeintermsofimprovingtes6ngratesandaccessto treatment,with detailed updates from IAPAC, the EuropeanCentre forDisease Preven6on andControl(ECDC)andongoingEATGprojectsinthisarea.

Tes6ngandtreatmentaremorethaneverinextricablylinkedtoHIVpreven6on.TheSTARTstudy,byconfirming that an6retroviral therapy (ART) is beneficial at all CD4 counts, removed any conflict

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betweenprovidingART for individualhealthandproviding it forpublichealth.ThismakesmaWerssimpler:theaimthenbecomestoimplementtherightofeachpersonwithHIVtoeffec6veART,andtoiden6fyandremovebarrierstogetngit.

The studyof theHIVCareCon6nuum– the so-called “treatment cascade”– indifferent countriesandregionsisausefulsurveillanceanddiagnos6ctoolinhighligh6ngspecificbarriersandhealthcaresystemweaknesses that prevent full access. Treatment cascades are evolving quickly as thenewguidelinesaretakenup,butnotquicklyenough;onepresenta6onhighlightedtheprofessionalandins6tu6onalbarriers,manyofthemgrounded inoutdatedattudestoHIVandART,that leavetoomanypeopleinmanycountriesuntestedandundiagnosed.

It is important not to take individual HIV Care Con6nua at face value, as many are based onmodelling or sketchy data, but look in depth at the detail in each context, including defini6on ofterms as these differ by country. Nonetheless they can be useful in iden6fyingwhich step in thecascade– tes6ng, linkagetocare, reten6on incare,ARTprovision,oradherencesupportandviralloadmonitoring–isweakest.Speakershighlightednumerousbarriers,includingthe6me-lagbeforenew guidelines are implemented, lack of funding, persistent s6gma, and legal and regulatoryobstaclestoincreasingtes6nguptake.Askingthecommunityfortheirspecificandlocalexperienceofthebarriersiscrucial.

To highlight the scale of the challenge, representa6ves of organisa6ons working in Russia andUkrainesharedtheirexperiencesofsuppor6ngwomen,childrenandpeoplewhousedrugstoaccessservices.ThewithdrawaloffundingbytheGlobalFundisamajorconcern.TheneedforEATGandotheractorstoengagemoreinRussiaandUkrainewashighlightedbypar6cipants,butthechannelsby which this is done will be important. Although there are tenta6ve signs that the RussiangovernmentisfinallyrealisingthegravityofitsHIVepidemic,itdoesnotfeellikethattoindividualworkers providing care in the field, and it is important that western ac6vists understand Russianpoli6cal sensi6vi6es. A strong plea was made for beWer horizontal communica6on betweengrassrootsHIVac6vistsandworkersprovidingcareinWesternEuropeandthenumerousindividualprojectsaWemp6ngtodothesameinRussia,UkraineandelsewhereinEasternEurope.

The future is geXng closer:M i c rob i c i de s , va c c i ne s andanCbodies

In the fourth session,par6cipantswereupdate on key areas of ongoing HIVpreven6on research. Two new vaccineconsor6a funded by the EuropeanCommission’s Horizon 2020 programwere presented. The European AIDSVaccine Ini6a6ve (EAVI) and theEuropean HIV Vaccine Alliance (EHVA)will focus on genera6ng preven6vevaccine candidates tobe taken forwardby the European and DevelopingCountries Clinical Trial Partnership(EDCTP). The laWer will also look attherapeu6capproachesforpeoplelivingwithHIV-researchcloselylinkedtothesearchforacure.The ques6on of the ethics of treatment interrup6ons sparked hot debate; to guide suchconversa6ons EHVA is currently seeking community representa6ves to take up advisory roles.Together,theseprogramsrepresent€45millioneurosoffunding,albeitafrac6onofthatinvestedbytheUS.

Another importantresearcharea is thatofmicrobicidesor topicalPrEP,which includesrings,filmsandgels, and is the focusof theMicrobicideTrialNetwork (MTN) in theUS. Trialsoforal PrEP in

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Note: PMTCT, Screening transfusions, Universal precautions, etc. have not been included

Behavioural Intervention

HIV Counselling and Testing Coates T, Lancet 2000 Sweat M, Lancet 2011

Male Condoms

Female Condoms

Treatment of STIs

Grosskurth H, Lancet 2000

Male circumcision

Auvert B, PloS Med 2005 Gray R, Lancet 2007 Bailey R, Lancet 2007

Treatment for prevention Cohen M, NEJM, 2011 Donnell D, Lancet 2010 Tanser, Science 2013

Needle Exchange

Drucker E, AIDS 1998

Oral pre-exposure prophylaxis

Opioid substitution therapy

Mathers BM, Lancet 2010

HIV PREVENTION

Grant R, NEJM 2010 (MSM) Baeten J , NEJM 2012 (Couples) Thigpen M, NEJM 2012 (Heterosexuals) Choopanya K, Lancet 2013 (IDU)

Microbicides for women

Abdool Karim Q, Science 2010

young women have had mixed results and it is clear that biological differences mean higherconcentra6ons in the rectum than the vagina.Adherence to gels and coitally dependentmethodshas been challenging. The efficacy results of the long-ac6ng dapivirine vaginal ring, a productspecificallydesignedtomeettheneedsofwomenhavingvaginalintercourse,arethereforeeagerlyawaited.Giventhebiasagainstwomen’sproducts,thecommunitywillneedtokeepupthepressureifresultsareshowntobenotthatgood.

Rectalmicrobicidesmeanwhile in the form of lubes, tablets, suppositories and enemas are beingstudiedintermsofsafetyandacceptability.Toaddressadherencechallenges,thereisconsiderableinterest in long-ac6ng PrEP injectables. These drugs remain in the body for many months, evenyears,whichcouldbeamajordisadvantage.

Whatdowewanttochange?

Themee6ng concluded with a special sessiondedicatedtoaddressingkeyareasforadvocacyand ac6on. Par6cipants were divided intogroups to produce recommenda6ons. Thefollowingac6onswereproposed:

1.EATGshouldwritetotheEMAtourgerapid/fast-trackapprovalofTruvadaasPrEP

2.Alladvocatesneedtocoordinatetheirac6onsaround PrEP – there is a need for a pan-European ini6a6ve that brings everythingtogether

3. MapaccesstoPrEPacrosstheregion,whatislegalintermsofimpor6nggenerics?

4. Ensurena6onalguidelinesarebasedonEACSandParismodels.

5. Communityconsulta6onsonPrEPshouldbeheldwithotherkeypopula6onnetworkssuchasIPPF,INPUD,NSWP

6. Amee6ngontrialdesignsneedstobeheldtoanswerkeyques6ons

7. Clarifica6onisneededastowhichPrEPcombina6onsshouldbeusede.g3TC

8. EATGshouldseekclarifica6ononGilead’sanswertothe leWersentbyEuroPrEP(Europeanresearchers)

9. Pushfordifferen6alpricingforTruvadaaspreven6on

10. AddressthelackoffundingforHIVpreven6oningeneral

11. StrengthentheEATGPreven6onPorgolio–addi6onalmembersof thePreven6onSteeringCommiWeearesought

Onbehalfoftheorganisers,GusCairnsandRebekahWebbclosedthemee6ngwiththankstoallthepresenters, chairs, par6cipants and thosewhoworked behind the scenes tomake themee6ng asuccess.Themee6ngwasclosedwiththeissueofajointpressrelease.

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