Original Investigation | July 12, 2016

Alison J. Rodger, MD1; Valentina Cambiano, PhD1; Tina Bruun, RN2; Pietro Vernazza, MD3; Simon Collins4; Jan van Lunzen, PhD5; Giulio Maria Corbelli6; Vicente Estrada, MD7; Anna Maria Geretti, MD8; Apostolos Beloukas, PhD8; David Asboe, FRCP9; Pompeyo Viciana, MD10; Félix Gutiérrez, MD11; Bonaventura Clotet, PhD12; Christian Pradier, MD13; Jan Gerstoft, MD14; Rainer Weber, MD15; Katarina Westling, MD16; Gilles Wandeler, MD17; Jan M. Prins, PhD18; Armin Rieger, MD19; Marcel Stoeckle, MD20; Tim Kümmerle, PhD21; Teresa Bini, MD22; Adriana Ammassari, MD23; Richard Gilson, MD1; Ivanka Krznaric, PhD24; Matti Ristola, PhD25; Robert Zangerle, MD26; Pia Handberg, RN27; Antonio Antela, PhD28; Sris Allan, FRCP29; Andrew N. Phillips, PhD1; Jens Lundgren, MD2 ; for the PARTNER Study Group

[+] Author Affiliations

JAMA. 2016;316(2):171-181. doi:10.1001/jama.2016.5148.

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ABSTRACT

ABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONS |ARTICLE INFORMATIONREFERENCES

Importance 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.

Objective Evaluar la tasa de transmisión VIH dentro de la pareja (heterosexual y de hombres que hacen sexo con hombres [MSM]) durante períodos de sexo sin condones cuando el miembro seropositivo de la pareja tenga menos de 200 copias por mL de HIV-1 RNA .

Design, Setting, and Participants 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.

Exposures Condomless sexual activity with an HIV-positive partner taking virally suppressive ART.

Main Outcomes and Measures Risk of within-couple HIV transmission to the HIV-negative partner

Results 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.

Conclusions and Relevance Entre los heterosexuales serodiferentes y las parejas HSH en las que el miembro de pareja seropositivo estaba usando TAR supresiva y que informaban sexo sin condón, durante una mediana de seguimiento de 1.3 años por pareja no hubo casos de transmisión documentada dentro de la pareja  (por encima del 95% de límite de confianza, 0.30/100 años-pareja de seguimiento). Se necesita seguimiento de largo plazo adicional para proveer estimaciones de riesgo más precisas.