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Context - TasP

Early ART, sexual behaviors and HIV-1 transmission risk : Estimates from the Temprano -ANRS 12136 Randomized Controlled Trial (Abidjan, Côte d’Ivoire) .

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Context - TasP

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  1. Early ART, sexualbehaviors and HIV-1 transmission risk:Estimatesfrom the Temprano-ANRS 12136 RandomizedControlled Trial (Abidjan, Côte d’Ivoire) K. Jean, D. Gabillard, R. Moh, C. Danel, R. Fassassi, A. Desgrées-du-Loû, S. Eholié, F. Lert, X. Anglaret, R. Dray-Spira InsermUMR-S 1018, Centre for Research in Epidemiology and Population Health, Villejuif, FRANCE PAC-CI Program, CHU de Treichville, Abidjan, CÔTE D’IVOIRE

  2. Context - TasP 2 HPTN-052: among serodiscordant couples, early ART (350<CD4<550) decreases HIV transmission by 96%, as compared to initiation <250 CD4(Cohen et al, NEJM 2011)

  3. Context - TasP 2 HPTN-052: among serodiscordant couples, early ART (350<CD4<550) decreases HIV transmission by 96%, as compared to initiation <250 CD4(Cohen et al, NEJM 2011) Extrapolation to the population-level impact?

  4. Context - TasP 2 HPTN-052: among serodiscordant couples, early ART (350<CD4<550) decreases HIV transmission by 96%, as compared to initiation <250 CD4(Cohen et al, NEJM 2011) Extrapolation to the population-level impact? • Less than 1/3 of HIV transmission in sub-Saharan Af. occur among serodiscordant couples (Chemaitellyet al, AIDS 2013) • Which preventive impact of early ART among a population with diverse sexual partnerships (stable/non-stable partners, serodiscordant/ concordant)?

  5. Context - TasP 2 HPTN-052: among serodiscordant couples, early ART (350<CD4<550) decreases HIV transmission by 96%, as compared to initiation <250 CD4(Cohen et al, NEJM 2011) Extrapolation to the population-level impact? • Less than 1/3 of HIV transmission in sub-Saharan Af. occur among serodiscordant couples (Chemaitellyet al, AIDS 2013) • Which preventive impact of early ART among a population with diverse sexual partnerships (stable/non-stable partners, serodiscordant/ concordant)? • Impact of early ART on sexual behaviors? • Observational studies documented decreased risky sexual behaviors after ART initiated according to WHO guidelines (Venkatesh et al, AIDS 2011) • What effect among patients treated earlier, thus potentially healthier?

  6. Objectives 3 • To measure the impact of early antiretroviral therapy (ART) on sexual behaviors, • To estimate its protective effect against HIV transmission among adults engaged in diverse heterosexual partnerships in Abidjan, Côte d’Ivoire.

  7. Temprano-ANRS12136 4 • Multicenter randomized open-label superiority trial conducted in Côte d’Ivoire • To assess the clinical benefits and risks of early ART +/- INH prophylaxis • Main outcomes: mortality and morbidity • Resultsexpected in 2015 • Inclusion criteria: >18y; HIV-1 or HIV 1+2; 350<CD4<800mm3 and no current WHO criteria for starting ART Randomization « Standard ART » WHO recommendations (CD4<350mm3) « Early ART » ART initiation immediatlyafter inclusion

  8. Methods 5

  9. Baseline characteristics 6

  10. Viral Load 7 Wilcoxonrank-sum test • p=0.51

  11. Viral Load 7 Standart ART: 70 (15%) initiated ART (Median time until ART: 9.5 months) Wilcoxonrank-sum test • p=0.51 • p<0.001

  12. Last sexualpartnershipat M12 8

  13. Last sexual partnership at M12 8

  14. Last sexualpartnershipat M12 8

  15. Estimated HIV transmission rates at last sexual intercourse in the pastmonth 9

  16. Estimated HIV transmission rates at last sexual intercourse in the pastmonth 9 90% [81%-95%]

  17. Discussion 10 • Sexualbehaviors M12 afterearly ART initiation • No difference as compared to standard ART (large sample size) • Levels of sexual behaviors consistent with previous studies conducted in Côte d’Ivoire (Moatti et al, 2003; Diabate et al, 2008; Protopopescu et al, 2010) • Protective effect of early ART: 90% • Estimatedamong a population closer to the general HIV+ population (as compared to previousstudies) • Throughbiologicaleffect of ART on HIV replication • Estimated… not measured • Consistent withpreviousresults(Cohen et al, NEJM2011; Baggaley et al, Epidemiology 2013)

  18. Perspectives on TasP 11 Our results, obtainedamong a population withdiverse sexualpartnershipssuggest a strong protective effect of early ART on HIV transmission withoutanyeffect on sexualbehaviors • For now: early ART isrecommendedonly for patients in serodiscordant couples • Acceptability /equity of prioritizingaccess to early ART to this population? (Delva et al, Plos Med 2012) • Targetingsolelythese couples may have a limited impact (Chemaitelly et al, AIDS 2013, Bellan et al, Lancet 2013) Resultsprovidingevidence for the public healthsignificance of early ART amongawider segment of the HIV-infected population

  19. Thankyou for your attention! Any question? contact: kevin.jean@inserm.fr

  20. Tempranotrial: design ART according to WHO criteria « standard ART » group 6-months IPT ART according to WHO criteria Randomization Immediate ART « early ART » group ImmediateART + 6-months IPT IPT: IsoniazidProphylaxisagainstTuberculosis 2009 WHO criteria for ART initiation: <350 CD4 or WHO clinical stage 3 or 4

  21. Methods: Estimate of preventiveeffect Viral Load(measuredat the time of last intercourse) r : HIV transmission riskat last intercourse Characteristics of the last intercourse (condom use, serodiscordant/concordant partner) Ref: Hughes et al, JID 2012 • Then: • If VL<300 copies/mL: r=0 (sensitivityanalysis) • Ifpartneris HIV+: r=0 • If partneris HIV?: considered as HIV- (sensitivityanalysis) • If condom reported: r=0.22*p • If patient iswomen, thenpartnerconsidered as circumcised man:r=0.53*p • (Additionalsensitivityanalysis)

  22. Methods: Estimate of preventiveeffect Viral Load(measuredat the time of last intercourse) r : HIV transmission riskat last intercourse Characteristics of the last intercourse (condom use, serodiscordant/concordant partner) Ref: Hughes et al, JID 2012 For both ART group: Estimatedtransmission rate at last intercourse mean (r) = Î Estimated protective effect: • First: amongthosesexually active in the pastmonth • Then: in the whole population (r = 0 if sexualy inactive)

  23. Sensitivityanalysis

  24. Preventiveeffectamongsub-sample

  25. Representativity of the population? • Results obtained in a selected pop. (long-term trial) • Virological failure rate (≈ 20%): comparable to what is routinely observed(Barth et al, Lancet Inf Dis 2010) • 80% of women: mayreflectsex-specificprevalence + testinglandscape in Côte d’Ivoire (Jean et al, Plos One 2012)

  26. Probability of ART initiation in the standard group • Median time until ART initiation: ≈24 months • (1st quartile: ≈ 13 months) • % under ART at the end of follow-up (30-months): ≈ 60%

  27. Characteristicsat M12

  28. SexualbehaviorsatM12, by gender

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