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TasP et prévention combinée

TasP et prévention combinée. Gilles PIALOUX Tenon APHP COREVIH Idf Centre Vice Président SFLS www.vih.org. ASSISES de la SFLS 2011.

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TasP et prévention combinée

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  1. TasP et prévention combinée Gilles PIALOUX Tenon APHP COREVIH Idf Centre Vice Président SFLS www.vih.org ASSISES de la SFLS 2011

  2. Déclaration de conflits d’intérêts , Gilles Pialoux :Membre de board, d’un conseil scientifique, ouintervenant dans un symposium d’un laboratoirepharmaceutique :Abbott, Boehringer-Ingelheim, BMS, GSK, Gilead, MSD, Pfizer, Roche, Schering-Plough, Nephrotec, Tibotec, ViiVHealthcareParts sociales ou actions dans un laboratoirepharmaceutique : Aucune

  3. TasP2000-2011* * elle fut longue la route …

  4. 2000RAKAI

  5. L’étude « Rakai »Quinn et al. N Engl J Med 2000;342:921-9 Rakai

  6. Tous Homme-Femme Femme-Homme Pas de transmission si CV « indétectable » Etude « Rakai »: Risque de transmission en fonction de la charge virale 415 couples séro-discordants héterosexuels VIH-1 – 30 mois (fin des années 90); 21.7% transmission VIH ! Quinn et al. N Engl J Med 2000;342:921-9

  7. 2011HPTN 052

  8. HPTN 052 Study Design The scaling up in TasP Stable, healthy, serodiscordant couples, sexually active CD4 count: 350 to 550 cells/mm3 HPTN 052 Randomization Immediate ART CD4 350-550 Delayed ART CD4 <250 Primary Transmission Endpoint Virally linked transmission events Primary Clinical Endpoint WHO stage 4 clinical events, pulmonary tuberculosis, severe bacterial infection and/or death Cohen, M et al. 6th IAS Conf. MOAX0102.

  9. CONFIDENTIAL – NOT FOR EXTERNAL USE 9 HPTN 052 Enrollment 10,838 Individuals Screened Major reasons for exclusion: 3058 HIV+ but CD4 count out of range 2565 HIV- but HIV+ partner ineligible 308 Seroconcordant couples 155 Ineligible due to sexual history 1763 Couples (3526 Individuals) Randomized Immediate Arm 886 Couples Delayed Arm 877 Couples Cohen, M et al. 6th IAS Conf. MOAX0102.

  10. HPTN 052 Enrollment (Total Enrollment: 1763 couples) U.S. Thailand India Americas 278 Kenya Malawi Asia 531 Brazil Zimbabwe Botswana South Africa Africa 954 Cohen, M et al. 6th IAS Conf. MOAX0102.

  11. HPTN 052 Enrollment Cohen, M et al. 6th IAS Conf. MOAX0102.

  12. HPTN 052: Baseline Characteristics Cohen, M et al. 6th IAS Conf. MOAX0102.

  13. HPTN 052: Baseline Characteristics Cohen, M et al. 6th IAS Conf. MOAX0102.

  14. “The Board recommends that the results of the trial be announced as soon as possible” HPTN 052 continues to follow couples, but all HIV-infected participants are being offered ART CONFIDENTIAL – NOT FOR EXTERNAL USE 14 DSMB Recommendation April 28, 2011 Cohen, M et al. 6th IAS Conf. MOAX0102.

  15. HPTN 052: HIV-1 Transmission Total HIV-1 Transmission Events: 39 Linked Transmissions: 28 Unlinked or TBD Transmissions: 11 • 18/28 (64%) transmissions from infected participants with CD4 >350 cells/mm3 • 23/28 (82%) transmissions in sub-Saharan Africa • 18/28 (64%) transmissions from female to male partners !? Immediate Arm: 1 Delayed Arm: 27 p < 0.001 Cohen, M et al. 6th IAS Conf. MOAX0102.

  16. Multivariate Analysis – Linked Transmission 96 % de réduction du risque de transmission hétérosexuelle si traitement anti-VIH du partenaire VIH+ Cohen, M et al. 6th IAS Conf. MOAX0102.

  17. All Primary Clinical Events (N = 129) CONFIDENTIAL – NOT FOR EXTERNAL USE 17 17 subjects experienced >1 primary clinical event … et en plus le traitement précoce diminue la morbidité * Extrapulmonary crypto, HIV-related encephalopathy, lymphoma, PCP, septicemia (recurrent) Grinsztejn, B et al. 6th IAS Conf. MOAX0105.

  18. Prévention combinée « Sida: 12 millions d’infections évitables avec une prévention combinée» (AFP 6/8/2008)

  19. Efficacité des outils de Prevention vihEssais randomisés Study Effect Size, % (95% CI) préservatif ART for prevention; HPTN 052, Africa, Asia, Americas 96 (73-99) - 80 % [35,4 - 94,2%] PrEP for discordant couples;Partners PrEP, Uganda, Kenya 73 (49-85) PrEP for heterosexual men and women; TDF2, Botswana 63 (21-84) Medical male circumcision; Orange Farm, Rakai, Kisumu 54 (38-66) PrEP for MSMs; iPrEX, Americas, Thailand, South Africa 44 (15-63) Sexually transmitted diseases treatment; Mwanza, Tanzania 42 (21-58) Microbicide;CAPRISA 004, South Africa 39 (6-60) HIV vaccine;RV144, Thailand 31 (1-51) 0 20 40 60 80 100 Efficacy (%) Abdool Karim SS, et al. Lancet. 2011

  20. Qu’est ce que la prévention combinée ? 2 1 4 3 Coates et al., Lancet 2008

  21. Pathway to reversing the epidemic Seeing prevention research/funding as a continuum Circumcision Treatment as prevention ARV PrEP (oral, microbicide) Partially effective vaccine HIV incidence highly effective vaccine Behavioral and structural interventions Robin Shattock IAS Roma 2011 et Science. 2011;333:42-3

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