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ACHI E V2 E , COHERE & EuroCoord Added value of collaborative studies

ACHI E V2 E , COHERE & EuroCoord Added value of collaborative studies. Geneviève Chêne Inserm U897, Bordeaux Segalen University. Main features of HIV2. Occur mainly in West Africa , though growing numbers in Europe, India and the US Low transmissibility

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ACHI E V2 E , COHERE & EuroCoord Added value of collaborative studies

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  1. ACHIEV2E, COHERE & EuroCoord Added value of collaborative studies Geneviève ChêneInserm U897, Bordeaux Segalen University

  2. Main features of HIV2 • Occurmainly in West Africa, thoughgrowingnumbers in Europe, India and the US • Lowtransmissibility • HIV2 RNA undetectableevenatlatestages, slow CD4 decline, slow immuno-clinical progression • Intrinsicallyresistant to somecommonlyused classes for antiretroviraltreatment • Poor CD4 recovery once treatmentisstarted

  3. Main challenges for HIV2 • Are naturalhistory of HIV1 & HIV2 sodifferent? • How best to quantify the virus? • How best to monitor treatmentresponse? • Whatendpointshouldbeused in clinical trials? • When to starttreatment? What to startwith? • Use of collaborative studies • Power, representativeness • Potential for standardisation • Comparisonswith HIV1

  4. Rationale of collaborative studieson HIV2: examples • Needfor standardisation • Establish a standard to quantify HIV2 RNA • What to startwith? • Compare different first-line regimens • Comparisonswith HIV1 • Are HIV1 and HIV2 characterised by different CD4 cell decline at any HIV RNA levels?

  5. HIV2 RNA quantification, quality control: lessonslearned • Feasible: 12 labsparticipating in 3 continents (Europe, Africa, NorthAmerica) • Different situations for subtypes • Use of a standard improved quantification of subtype A • Remainingheterogeneity in the quantification of subtype B virus, evenwith the use of a standard, collaborations neededacross countries wheresubtype B iscirculating • Comparisonsdifficultwhensubtype B involved • Commercial kit warranted, control qualityneeded Damond et al. J Clin Microbiol 2008, 2011 (revised)

  6. 170 naive HIV2 patients startedon either PI/r or 3 nucs, 7 Europeancohorts Benard et al. Clin Infect Dis 2011 Standardisation of data collection through the HICDEP system commonlyused for collaborations on HIV1Potential of 1,000 HIV2 patients/250 treatment-naive Informthe design of clinical trials

  7. Gottlieb et al. J Infect Dis 2002 Individualsseen on at least 3 occasions, during ≥ 1 year, baseline CD4+ T cell > 200/µl Meanfollow-up ~3 years Plasma HIV RNA higher in HIV1 than HIV2 despitesimilar rates of DNA Similar rate of CD4 declineafteradjustment for baseline HIV2 RNA

  8. Drylewicz et al. AIDS 2008 ANRS CO3 Aquitaine and CO5 HIV-2 *Differenceremainingafteradjustment for baseline HIV RNA or CD4

  9. Collaboration with COHERE in EuroCoord EU-funded NoE established by several of the biggest HIV-1 cohorts and collaborations within Europe 35 cohorts, 30 countries ~250,000adults, mothers, children

  10. Investigating the lower pathogenicity of HIV-2,COHERE in EuroCoord/ACHIEVE • Project lead: S Matheron, Statistician: R Thiébaut • Objective: to compare immunological outcome in HIV-1 and HIV-2 infected patients while controlling for plasma HIV RNA in three different populations • Natural history (absence of antiretroviral therapy) • seroincident patients (known/estimated date infection) • seroprevalent patients • Response to first line cART • Largest possible sample size, longitudinal design, comparison to matched HIV1 individuals, most recent and potent ARV • Outcomes: CD4 slopes adjusted for plasma HIV RNA in HIV-1 and HIV-2 infected patients presenting similar characteristics at inclusion or cARTinitiation • Timelines: data merger end July 2011, preliminary results March 2012

  11. Perspectives • Results inform the design of clinical trials (standardised quantitative viral load, composite outcome, rate of progression) and ongoing collaborations • Exploit the infrastructures of international consortium of longitudinal studies • Census of available biobank (Achieve, EuroCoord) • Drug resistance: comparison of preferred pathways between HIV1 & HIV2 (CHAIN) • Models of clinical progression, when to start (ART-CC, IeDEA) • Need to identify specific funding for this research

  12. Acknowledgments To the patients, to the funder of ACHIEVE: AgenceNationale de Recherchessur le Sida et les hépatitesvirales (ANRS) To the ACHIEV2E collaboration Clinical centres France: Sophie MATHERON Germany: Jürgen ROCKSTROH, Carolynne SCHWARZE-ZANDER Netherlands: Frank DE WOLF Ard van SIGHEM ,PeterREISS Maarten SCHIM VAN DER LOEFF Portugal: Francisco ANTUNES* Emilia VALADAS Kamal MANSINHO Spain: Vicente SORIANO* Ana TREVINO Carlos TORO Berta RODES Switzerland: Jürg BÖNI Martin RICKENBACH Alexandra CALMY UK: JaneANDERSON JenniferTOSSWILL Laboratories Belgium: Patrick GOUBAU , Jean RUELLE Canada: Marc WAINBERG France: BrigitteAUTRAN Françoise BRUN-VEZINET Florence DAMOND*, Diane DESCAMPS François SIMON Gambia: AkumAVEIKA, MatthewCOTTEN Sarah ROWLAND-JONES Germany: BerndKUPFER Italy: ClaudiaBALOTTA CarloTORTI Netherlands: Martin SCHUTTEN Portugal: Vitor DUQUE, Joao VAZ RicardoCAMACHO ,Perpetua GOMES Sweden: JanALBERT USA: GeoffreyGOTTLIEB UK: Deenan PILLAY, Bridget FERNS, Jeremy GARSON Coordinating centre, INSERM U897 France: Antoine BENARD Geneviève CHENE Audrey TAIEB COHERE (www.cohere.org) and EuroCoord (www.EuroCoord.net)

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