Alison J Rodger1, Valentina Cambiano1, Tina Bruun2, Pietro Vernazza3, Simon Collins4, Jan van Lunzen5, Giulio Maria Corbelli6, Vicente Estrada7, Anna Maria Geretti8, Apostolos Beloukas8, David Asboe9, Pompeyo Viciana10, Félix Gutiérrez11, Bonaventura Clotet12, Christian Pradier13, Jan Gerstoft14, Rainer Weber15, Katarina Westling16, Gilles Wandeler17, Jan M Prins18, Armin Rieger19, Marcel Stoeckle20, Tim Kümmerle21, Teresa Bini22, Adriana Ammassari23, Richard Gilson1, Ivanka Krznaric24, Matti Ristola25, Robert Zangerle26, Pia Handberg27, Antonio Antela28, Sris Allan29, Andrew N Phillips1, Jens Lundgren2. 1. Research Department of Infection and Population Health, University College London, London, United Kingdom. 2. Department of Infectious Diseases/CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 3. Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital, St Gallen, Switzerland. 4. HIV i-Base, London, United Kingdom. 5. University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany. 6. European AIDS Treatment Group, Bruxelles, Belgium. 7. Hospital Clinico San Carlos and Universidad Complutense, Madrid, Spain. 8. Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom. 9. Chelsea and Westminster NHS Foundation Trust, London, United Kingdom. 10. Hospital Virgen del Rocío, Sevilla, Spain. 11. Hospital General de Elche & Universidad Miguel Hernández, Alicante, Spain. 12. IrsiCaixa Foundation, UAB, UVIC-UCC, Hospital Universitari "Germans Trias i Pujol," Badalona, Catalonia, Spain. 13. Department of Public Health, Nice University Hospital and EA 6312, University Nice Sophia-Antipolis, France. 14. Rigshospitalet, Copenhagen, Denmark. 15. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. 16. Unit of Infectious Diseases and Dermatology, Department of Medicine, Karolinska Institutet, and Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden. 17. Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland. 18. Academic Medical Center, Amsterdam, the Netherlands. 19. Medical University of Vienna, Vienna, Austria. 20. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland. 21. Department of Internal Medicine 1, University Hospital of Cologne, Cologne, Germany. 22. Ospedal San Paolo, Milan, Italy. 23. Ospedale L. Spallanzani, Roma, Italy. 24. Praxis Driesener Straße, Berlin, Germany. 25. Helsinki University Central Hospital, Helsinki, Finland. 26. Medical University Innsbruck, Innsbruck, Austria. 27. Hvidovre Universitets Hospital, Hvidovre, Denamrk. 28. Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain. 29. Coventry and Warwickshire Hospital, Coventry, United Kingdom.
Abstract
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: 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. 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: 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.
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: 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. 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: 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.
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