Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy

Alison J Rodger; Valentina Cambiano; Tina Bruun; Pietro Vernazza; Simon Collins; Jan van Lunzen; Giulio Maria Corbelli; Vicente Estrada; Anna Maria Geretti; Apostolos Beloukas; David Asboe; Pompeyo Viciana; Félix Gutiérrez; Bonaventura Clotet; Christian Pradier; Jan Gerstoft; Rainer Weber; Katarina Westling; Gilles Wandeler; Jan M. Prins; Armin Rieger; Marcel Stoeckle; Tim Kümmerle; Teresa Bini; Adriana Ammassari; Richard Gilson; Ivanka Krznaric; Matti Ristola; Robert Zangerle; Pia Handberg; Antonio Antela; Sris Allan; Andrew N Phillips; Jens Lundgren

doi:10.1001/jama.2016.5148

Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy

Alison J Rodger, Valentina Cambiano, Tina Bruun, Pietro Vernazza, Simon Collins, Jan van Lunzen, Giulio Maria Corbelli, Vicente Estrada, Anna Maria Geretti, Apostolos Beloukas, David Asboe, Pompeyo Viciana, Félix Gutiérrez, Bonaventura Clotet, Christian Pradier, Jan Gerstoft, Rainer Weber, Katarina Westling, Gilles Wandeler, Jan M. PrinsArmin Rieger, Marcel Stoeckle, Tim Kümmerle, Teresa Bini, Adriana Ammassari, Richard Gilson, Ivanka Krznaric, Matti Ristola, Robert Zangerle, Pia Handberg, Antonio Antela, Sris Allan, Andrew N Phillips, Jens Lundgren

Department of Clinical Medicine

645 Citations (Scopus)

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 rateofwithin-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: Riskofwithin-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.

Original language	English
Journal	J A M A: The Journal of the American Medical Association
Volume	316
Issue number	2
Pages (from-to)	171-181
ISSN	0098-7484
DOIs	https://doi.org/10.1001/jama.2016.5148
Publication status	Published - 12 Jul 2016

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Rodger, A. J., Cambiano, V., Bruun, T., Vernazza, P., Collins, S., van Lunzen, J., Corbelli, G. M., Estrada, V., Geretti, A. M., Beloukas, A., Asboe, D., Viciana, P., Gutiérrez, F., Clotet, B., Pradier, C., Gerstoft, J., Weber, R., Westling, K., Wandeler, G., ... Lundgren, J. (2016). Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy. J A M A: The Journal of the American Medical Association, 316(2), 171-181. https://doi.org/10.1001/jama.2016.5148

Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy. / Rodger, Alison J; Cambiano, Valentina; Bruun, Tina et al.

In: J A M A: The Journal of the American Medical Association, Vol. 316, No. 2, 12.07.2016, p. 171-181.

Research output: Contribution to journal › Journal article › Research › peer-review

Rodger, AJ, Cambiano, V, Bruun, T, Vernazza, P, Collins, S, van Lunzen, J, Corbelli, GM, Estrada, V, Geretti, AM, Beloukas, A, Asboe, D, Viciana, P, Gutiérrez, F, Clotet, B, Pradier, C, Gerstoft, J, Weber, R, Westling, K, Wandeler, G, Prins, JM, Rieger, A, Stoeckle, M, Kümmerle, T, Bini, T, Ammassari, A, Gilson, R, Krznaric, I, Ristola, M, Zangerle, R, Handberg, P, Antela, A, Allan, S, Phillips, AN & Lundgren, J 2016, 'Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy', J A M A: The Journal of the American Medical Association, vol. 316, no. 2, pp. 171-181. https://doi.org/10.1001/jama.2016.5148

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title = "Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy",

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 rateofwithin-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: Riskofwithin-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.",

author = "Rodger, {Alison J} and Valentina Cambiano and Tina Bruun and Pietro Vernazza and Simon Collins and {van Lunzen}, Jan and Corbelli, {Giulio Maria} and Vicente Estrada and Geretti, {Anna Maria} and Apostolos Beloukas and David Asboe and Pompeyo Viciana and F{\'e}lix Guti{\'e}rrez and Bonaventura Clotet and Christian Pradier and Jan Gerstoft and Rainer Weber and Katarina Westling and Gilles Wandeler and Prins, {Jan M.} and Armin Rieger and Marcel Stoeckle and Tim K{\"u}mmerle and Teresa Bini and Adriana Ammassari and Richard Gilson and Ivanka Krznaric and Matti Ristola and Robert Zangerle and Pia Handberg and Antonio Antela and Sris Allan and Phillips, {Andrew N} and Jens Lundgren",

year = "2016",

month = jul,

day = "12",

doi = "10.1001/jama.2016.5148",

language = "English",

volume = "316",

pages = "171--181",

journal = "J A M A: The Journal of the American Medical Association",

issn = "0098-7484",

publisher = "American Medical Association",

number = "2",

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TY - JOUR

T1 - Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy

AU - Rodger, Alison J

AU - Cambiano, Valentina

AU - Bruun, Tina

AU - Vernazza, Pietro

AU - Collins, Simon

AU - van Lunzen, Jan

AU - Corbelli, Giulio Maria

AU - Estrada, Vicente

AU - Geretti, Anna Maria

AU - Beloukas, Apostolos

AU - Asboe, David

AU - Viciana, Pompeyo

AU - Gutiérrez, Félix

AU - Clotet, Bonaventura

AU - Pradier, Christian

AU - Gerstoft, Jan

AU - Weber, Rainer

AU - Westling, Katarina

AU - Wandeler, Gilles

AU - Prins, Jan M.

AU - Rieger, Armin

AU - Stoeckle, Marcel

AU - Kümmerle, Tim

AU - Bini, Teresa

AU - Ammassari, Adriana

AU - Gilson, Richard

AU - Krznaric, Ivanka

AU - Ristola, Matti

AU - Zangerle, Robert

AU - Handberg, Pia

AU - Antela, Antonio

AU - Allan, Sris

AU - Phillips, Andrew N

AU - Lundgren, Jens

PY - 2016/7/12

Y1 - 2016/7/12

N2 - 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 rateofwithin-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: Riskofwithin-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.

AB - 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 rateofwithin-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: Riskofwithin-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.

U2 - 10.1001/jama.2016.5148

DO - 10.1001/jama.2016.5148

M3 - Journal article

C2 - 27404185

SN - 0098-7484

VL - 316

SP - 171

EP - 181

JO - J A M A: The Journal of the American Medical Association

JF - J A M A: The Journal of the American Medical Association

IS - 2

ER -

Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy

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