%0 Journal Article %A Rodger, Alison J %A Cambiano, Valentina %A Bruun, Tina %A Vernazza, Pietro %A Collins, Simon %A van Lunzen, Jan %A Corbelli, Giulio Maria %A Estrada, Vicente %A Geretti, Anna Maria %A Beloukas, Apostolos %A Asboe, David %A Viciana, Pompeyo %A Gutiérrez, Félix %A Clotet, Bonaventura %A Pradier, Christian %A Gerstoft, Jan %A Weber, Rainer %A Westling, Katarina %A Wandeler, Gilles %A Prins, Jan M %A Rieger, Armin %A Stoeckle, Marcel %A Kümmerle, Tim %A Bini, Teresa %A Ammassari, Adriana %A Gilson, Richard %A Krznaric, Ivanka %A Ristola, Matti %A Zangerle, Robert %A Handberg, Pia %A Antela, Antonio %A Allan, Sris %A Phillips, Andrew N %A Lundgren, Jens %A PARTNER Study Group %T Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy. %D 2016 %U http://hdl.handle.net/10668/10259 %X A key factor in assessing the effectiveness and cost-effectiveness of antiretroviral therapy (ART) as a prevention strategy is the absolute risk of HIV transmission through condomless sex with suppressed HIV-1 RNA viral load for both anal and vaginal sex. To evaluate the rate of within-couple HIV transmission (heterosexual and men who have sex with men [MSM]) during periods of sex without condoms and when the HIV-positive partner had HIV-1 RNA load less than 200 copies/mL. The prospective, observational PARTNER (Partners of People on ART-A New Evaluation of the Risks) study was conducted at 75 clinical sites in 14 European countries and enrolled 1166 HIV serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex (September 2010 to May 2014). Eligibility criteria for inclusion of couple-years of follow-up were condomless sex and HIV-1 RNA load less than 200 copies/mL. Anonymized phylogenetic analysis compared couples' HIV-1 polymerase and envelope sequences if an HIV-negative partner became infected to determine phylogenetically linked transmissions. Condomless sexual activity with an HIV-positive partner taking virally suppressive ART. Risk of within-couple HIV transmission to the HIV-negative partner. Among 1166 enrolled couples, 888 (mean age, 42 years [IQR, 35-48]; 548 heterosexual [61.7%] and 340 MSM [38.3%]) provided 1238 eligible couple-years of follow-up (median follow-up, 1.3 years [IQR, 0.8-2.0]). At baseline, couples reported condomless sex for a median of 2 years (IQR, 0.5-6.3). Condomless sex with other partners was reported by 108 HIV-negative MSM (33%) and 21 heterosexuals (4%). During follow-up, couples reported condomless sex a median of 37 times per year (IQR, 15-71), with MSM couples reporting approximately 22,000 condomless sex acts and heterosexuals approximately 36,000. Although 11 HIV-negative partners became HIV-positive (10 MSM; 1 heterosexual; 8 reported condomless sex with other partners), no phylogenetically linked transmissions occurred over eligible couple-years of follow-up, giving a rate of within-couple HIV transmission of zero, with an upper 95% confidence limit of 0.30/100 couple-years of follow-up. The upper 95% confidence limit for condomless anal sex was 0.71 per 100 couple-years of follow-up. Among serodifferent heterosexual and MSM couples in which the HIV-positive partner was using suppressive ART and who reported condomless sex, during median follow-up of 1.3 years per couple, there were no documented cases of within-couple HIV transmission (upper 95% confidence limit, 0.30/100 couple-years of follow-up). Additional longer-term follow-up is necessary to provide more precise estimates of risk. %~