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Beatriz Grinsztejn, MD Site Investigator Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz 6th IAS Conference, Rome,

. B Grinsztejn, H Ribaudo, M Cohen, S Swindells, S Badel-Faesen, D Burns, S Chariyalertsak, Y Chen, G De Bruyn, J Eron, S Eshleman, T Fleming, J Gallant, T Gamble, S Godbole, J Hakim, M Hosseinipour, K Klingman, N Kumarasamy, J Kumwenda, J Makhema, K Mayer, M McCauley, L Mills, J Pilotto, E Piwowar-Manning, B Santos, L Wang, D Havlir, and the HPTN 052 Protocol Team .

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Beatriz Grinsztejn, MD Site Investigator Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz 6th IAS Conference, Rome,

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    1. Beatriz Grinsztejn, MD Site Investigator Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz 6th IAS Conference, Rome, Italy July 18, 2011

    2. B Grinsztejn, H Ribaudo, M Cohen, S Swindells, S Badel-Faesen, D Burns, S Chariyalertsak, Y Chen, G De Bruyn, J Eron, S Eshleman, T Fleming, J Gallant, T Gamble, S Godbole, J Hakim, M Hosseinipour, K Klingman, N Kumarasamy, J Kumwenda, J Makhema, K Mayer, M McCauley, L Mills, J Pilotto, E Piwowar-Manning, B Santos, L Wang, D Havlir, and the HPTN 052 Protocol Team I would like to acknowledge the contributions of the abstract authors, and other investigators who contributed to the presentation.I would like to acknowledge the contributions of the abstract authors, and other investigators who contributed to the presentation.

    3. Controversy around best time to initiate antiretroviral therapy (ART) CIPRA Haiti showed delayed disease progression and increased survival at CD4 cell counts 250-350 compared to <200 CD4 cell count At higher CD4, observational studies from developed countries suggested a benefit from earlier initiation of ART Benefit relative to toxicity complications and risk viral resistance is less clear ART associated costs present a challenge in the resource limited settings HPTN 052 provides an opportunity to address “when to start” ART in a randomized population with CD4 cell counts 350-550

    4. Death, WHO stage 4 clinical event, pulmonary TB or severe bacterial infection All events underwent blinded independent review using standardized criteria ACTG Diagnoses Appendix (Appendix 60) Classified as confirmed or probable The primary clinical endpoint Time to first primary clinical event, including death

    6. Median follow-up: 1.7 years 105 individuals experienced at least one primary clinical endpoint event 40 immediate arm 65 delayed arm

    8. 17 subjects experience >1 clinical event - 8 immediate arm (5 had 2 events, 1 had 3 events, and 2 had 4 events) of which 2 had a clinical event followed by death - 9 delayed arm (7 had 2 events, 2 had 3 events) of which 4 had a clinical event followed by death 17 subjects experience >1 clinical event - 8 immediate arm (5 had 2 events, 1 had 3 events, and 2 had 4 events) of which 2 had a clinical event followed by death - 9 delayed arm (7 had 2 events, 2 had 3 events) of which 4 had a clinical event followed by death

    10. Of the abdominal cases, one also had lymph node involvement – one is still under review. Of the abdominal cases, one also had lymph node involvement – one is still under review.

    11. 3 subjects experienced >1 infection All in the immediate arm All subjects with repeat infections were in the immediate group - 1 subject had 3 infections, and 2 had 2.All subjects with repeat infections were in the immediate group - 1 subject had 3 infections, and 2 had 2.

    12. 23 deaths during the course of the study 10 in the immediate arm 13 in the delayed arm

    14. 403 participants had a severe or life-threatening laboratory abnormality 27% immediate arm 18% delayed arm Grade 3 and 4 was per DAIDS 2004 grading criteria (http://rsc.tech-res.com/Document/safetyandpharmacovigilance/Table_for_Grading_Severity_of_Adult_Pediatric_Adverse_Events.pdf).Grade 3 and 4 was per DAIDS 2004 grading criteria (http://rsc.tech-res.com/Document/safetyandpharmacovigilance/Table_for_Grading_Severity_of_Adult_Pediatric_Adverse_Events.pdf).

    15. Events coded using the MedDRA System 246 participants had one or more severe or life-threatening adverse events 14% immediate arm 14% delayed arm

    16. Immediate ART was associated with 41% reduction in HIV-related clinical events ART therapy was well tolerated in this wide range of high CD4 population Rates of serious lab abnormalities and adverse events were low More extensive analyses of WHO stage 1-3 and non-AIDS events will follow

    17. This study required a great effort from many people that I want to recognize BEFORE our presentations. First, there were thirteen sites in 9 countries.This study required a great effort from many people that I want to recognize BEFORE our presentations. First, there were thirteen sites in 9 countries.

    18. Myron S. Cohen, MD Protocol Chair 6th IAS Conference, Rome, Italy July 18, 2011

    19. ART prevented linked transmission of HIV Unlinked transmissions were noted despite intensive couples counseling HIV infected participants had reduced numbers of clinical events Regional differences in HIV transmission associated with ART were noted Because of the strong biological plausibility we decided to undertake an RCT to understand-prospectively-the magnitude and durability of protection afforded by ART. The study design would also allow evaluation of early vs. delayed ART.Because of the strong biological plausibility we decided to undertake an RCT to understand-prospectively-the magnitude and durability of protection afforded by ART. The study design would also allow evaluation of early vs. delayed ART.

    20. Because of the strong biological plausibility we decided to undertake an RCT to understand-prospectively-the magnitude and durability of protection afforded by ART. The study design would also allow evaluation of early vs. delayed ART.Because of the strong biological plausibility we decided to undertake an RCT to understand-prospectively-the magnitude and durability of protection afforded by ART. The study design would also allow evaluation of early vs. delayed ART.

    21. The HIV prevention effect demonstrated in HPTN 052 is the proof of a concept These results could inform The “Test and Treat” strategies Management of HIV discordant couples Because of the strong biological plausibility we decided to undertake an RCT to understand-prospectively-the magnitude and durability of protection afforded by ART. The study design would also allow evaluation of early vs. delayed ART.Because of the strong biological plausibility we decided to undertake an RCT to understand-prospectively-the magnitude and durability of protection afforded by ART. The study design would also allow evaluation of early vs. delayed ART.

    22. This study required a great effort from many people that I want to recognize BEFORE our presentations. First, there were thirteen sites in 9 countries.This study required a great effort from many people that I want to recognize BEFORE our presentations. First, there were thirteen sites in 9 countries.

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