www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 20 Early ART, sexual behaviors and HIV-1 transmission risk: Estimates from the Temprano-ANRS 12136 Randomized Controlled 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 Inserm UMR-S 1018, Centre for Research in Epidemiology and Population Health, Villejuif, FRANCE PAC-CI Program, CHU de Treichville, Abidjan, CÔTE D’IVOIRE
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www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Early ART, sexual behaviors and HIV-1 transmission risk:
Estimates from the Temprano-ANRS 12136 Randomized Controlled 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
Inserm UMR-S 1018, Centre for Research in Epidemiology and Population Health, Villejuif, FRANCE
PAC-CI Program, CHU de Treichville, Abidjan, CÔTE D’IVOIRE
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
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)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Context - TasP
Extrapolation to the population-level impact?
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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)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Context - TasP
Extrapolation to the population-level impact?
• Less than 1/3 of HIV transmission in sub-Saharan Af. occur among serodiscordant couples (Chemaitelly et al, AIDS 2013)
• Which preventive impact of early ART among a population with diverse sexual partnerships (stable/non-stable partners, serodiscordant/ concordant)?
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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)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Context - TasP
Extrapolation to the population-level impact?
• Less than 1/3 of HIV transmission in sub-Saharan Af. occur among serodiscordant couples (Chemaitelly et 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?
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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)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Objectives
1. To measure the impact of early antiretroviral therapy (ART) on sexual behaviors,
2. To estimate its protective effect against HIV transmission
among adults engaged in diverse heterosexual partnerships
in Abidjan, Côte d’Ivoire.
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conducted in Côte d’Ivoire– To assess the clinical benefits and risks of early ART +/- INH prophylaxis– Main outcomes: mortality and morbidity– Results expected in 2015
• Inclusion criteria: >18y; HIV-1 or HIV 1+2; 350<CD4<800mm3 and no current WHO criteria for starting ART
« Early ART »ART initiation immediatly
after inclusion
« Standard ART »WHO recommendations
(CD4<350mm3)
Randomization
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Methods• Characteristics of last sex reported at M12• VL measured at M12Measures
• Risky sex: unprotected last sex in the past month with a partner of HIV-/unknown status
• Partner’s exposure to HIV: risky sex + VL>300 copies/mL• HIV transmission risk at last intercourse: sex. behaviors + VL +
per-coital HIV transmisson proba (Hughes et al, JID 2012)
Outcomes
• Sexual behaviors comparison between early vs. standard ART: Chi2 test
• For each ART group: estimated transmission rate at last intercourse
• Preventive effect of early ART: ratio of estimated transmission rates
• (CI95%: bootstrap, 10,000 replications)
Analysis
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Baseline characteristics
Standard ART Early ART Chi2/ t-test p-val
N=467 N=490CD4 (/mm3) Median [IQR] 488 [401-586] 472 [388-580] 0.49Sex Men 93 (19.9%) 94 (19.2%) 0.78
>40 132 (28.2%) 161 (32.9%)Marital status Single 200 (42.8%) 203 (41.4%) 0.52
Living in couple 218 (46.7%) 224 (45.7%)
Widowed/Separated 49 (10.5%) 63 (12.9%)
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Viral Load
Wilcoxon rank-sum test
• p=0.51
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Viral Load
Wilcoxon rank-sum test
• p=0.51 • p<0.001
Standart ART: 70 (15%) initiated ART(Median time until ART: 9.5 months)
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Last sexual partnership at M12 8
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8Last sexual partnership at M12
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Last sexual partnership at M12 8
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Estimated HIV transmission rates at last sexual intercourse in the past month
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Among all participants
Exp
ecte
d H
IV-tr
ansm
issi
on ra
te /1
0,00
0
0.0
0.5
1.0
1.5
2.0
2.5
Standard armEarly arm
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Among all participants
Exp
ecte
d H
IV-tr
ansm
issi
on ra
te /1
0,00
0
0.0
0.5
1.0
1.5
2.0
2.5
Standard armEarly arm
Estimated HIV transmission rates at last sexual intercourse in the past month
90%[81%-95%]
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Discussion
• Sexual behaviors M12 after early ART initiationo No difference as compared to standard ART (large sample size)o 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%
o Estimated among a population closer to the general HIV+ population (as compared to previous studies)
o Through biological effect of ART on HIV replicationo Estimated… not measuredo Consistent with previous results (Cohen et al, NEJM 2011; Baggaley et al,
Epidemiology 2013)
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Perspectives on TasP
Our results, obtained among a population with diverse sexual partnerships suggest a strong protective effect of early ART on HIV transmission without
any effect on sexual behaviors
• For now: early ART is recommended only for patients in serodiscordant couples
• Acceptability /equity of prioritizing access to early ART to this population? (Delva et al, Plos Med 2012)
• Targeting solely these couples may have a limited impact (Chemaitelly et al, AIDS 2013, Bellan et al, Lancet 2013)
Results providing evidence for the public health significance of early ART among a wider segment of the HIV-infected population
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