Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study

Summary Background The level of evidence for HIV transmission risk through condomless sex in serodifferent gay couples with the HIV-positive partner taking virally suppressive antiretroviral therapy (ART) is limited compared with the evidence available for transmission risk in heterosexual couples. The aim of the second phase of the PARTNER study (PARTNER2) was to provide precise estimates of transmission risk in gay serodifferent partnerships. Methods The PARTNER study was a prospective observational study done at 75 sites in 14 European countries. The first phase of the study (PARTNER1; Sept 15, 2010, to May 31, 2014) recruited and followed up both heterosexual and gay serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex, whereas the PARTNER2 extension (to April 30, 2018) recruited and followed up gay couples only. At study visits, data collection included sexual behaviour questionnaires, HIV testing (HIV-negative partner), and HIV-1 viral load testing (HIV-positive partner). If a seroconversion occurred in the HIV-negative partner, anonymised phylogenetic analysis was done to compare HIV-1 pol and env sequences in both partners to identify linked transmissions. Couple-years of follow-up were eligible for inclusion if condomless sex was reported, use of pre-exposure prophylaxis or post-exposure prophylaxis was not reported by the HIV-negative partner, and the HIV-positive partner was virally suppressed (plasma HIV-1 RNA <200 copies per mL) at the most recent visit (within the past year). Incidence rate of HIV transmission was calculated as the number of phylogenetically linked HIV infections that occurred during eligible couple-years of follow-up divided by eligible couple-years of follow-up. Two-sided 95% CIs for the incidence rate of transmission were calculated using exact Poisson methods. Findings Between Sept 15, 2010, and July 31, 2017, 972 gay couples were enrolled, of which 782 provided 1593 eligible couple-years of follow-up with a median follow-up of 2·0 years (IQR 1·1–3·5). At baseline, median age for HIV-positive partners was 40 years (IQR 33–46) and couples reported condomless sex for a median of 1·0 years (IQR 0·4–2·9). During eligible couple-years of follow-up, couples reported condomless anal sex a total of 76 088 times. 288 (37%) of 777 HIV-negative men reported condomless sex with other partners. 15 new HIV infections occurred during eligible couple-years of follow-up, but none were phylogenetically linked within-couple transmissions, resulting in an HIV transmission rate of zero (upper 95% CI 0·23 per 100 couple-years of follow-up). Interpretation Our results provide a similar level of evidence on viral suppression and HIV transmission risk for gay men to that previously generated for heterosexual couples and suggest that the risk of HIV transmission in gay couples through condomless sex when HIV viral load is suppressed is effectively zero. Our findings support the message of the U=U (undetectable equals untransmittable) campaign, and the benefits of early testing and treatment for HIV. Funding National Institute for Health Research.

Hansjakob Furrer | Manuel Battegay | Pietro Vernazza | Enos Bernasconi | Simon Collins | Linos Vandekerckhove | Patrick Schmid | Gilles Wandeler | Stephane De Wit | Clara Lehmann | Rainer Weber | Anders Blaxhult | Christian Pradier | Andri Rauch | Valentina Cambiano | Michel Ohayon | Mark Gompels | Jan Prins | David Asboe | Slobodan Ruzicic | Dorthe Raben | Clifford Leen | Sarah Fidler | H. Jessen | C. Leen | A. Blaxhult | H. Günthard | D. Podzamczer | R. Weber | H. Stellbrink | M. Battegay | H. Furrer | P. Vernazza | E. Bernasconi | J. Lundgren | D. Raben | A. Rieger | J. Rockstroh | P. Schmid | A. Antinori | A. León | A. Clarke | M. Meschiari | C. Mussini | J. Prins | F. Raffi | M. Gompels | J. Fox | C. Boesecke | T. Kümmerle | I. Krznaric | S. Collins | G. Wandeler | D. Braun | A. Rauch | A. Hüfner | A. Rodger | D. Verhagen | J. Sutinen | L. Vandekerckhove | S. De Wit | D. Clutterbuck | C. Pradier | R. Sandoval | C. Lehmann | M. Brady | G. Kronborg | G. Pialoux | A. Geretti | Slobodan Ruzicic | M. Ristola | L. Taramasso | A. di Biagio | M. Stoeckle | Daniel Podzamczer | Jean-Christophe Goffard | Andrea Antinori | P. Tarr | S. Fidler | Andrew N Phillips | Jens Lundgren | Anna Maria Geretti | Huldrych Günthard | Norbert Brockmeyer | N. Brockmeyer | Cristina Mussini | Kees Brinkman | Jan Gerstoft | Gitte Kronborg | Norbert H Brockmeyer | A. Potthoff | Agathe Leon | Jürgen Rockstroh | Christoph Boesecke | Adriane Skaletz-Rorowski | Johannes Bogner | J. Gerstoft | S. Fedele | Apostolos Beloukas | Heiko Jessen | Hans-Jürgen Stellbrink | K. Westling | Olaf Degen | Richard Gilson | Gilles Pialoux | T. Bini | V. Cambiano | A. Antela | P. Viciana | L. López-Cortés | O. Degen | Martin Gisinger | P. Ingiliz | U. Seybold | Francois Raffi | Alison J Rodger | Tina Bruun | Giulio Maria Corbelli | Vicente Estrada | Pep Coll | Nneka Nwokolo | Armin Rieger | Jan M Prins | Arne Van Eeden | Amanda Clarke | Jorge del Romero Guerrero | Johannes R Bogner | Felix Gutiérrez | Maria Kitchen | Lars Ostergaard | Matti Ristola | Pep Patricia Aroa Michael Antonia Jorge Jorge D.R. Mar Coll Cobarsi Nieto Meulbroek Carrillo Saz Gue | Patricia Cobarsi | Aroa Nieto | Michael Meulbroek | Antonia Carrillo | Jorge Saz | Jorge D.R. Guerrero | Mar Vera García | Mar Masiá | Catalina Robledano | Lorna Leal | Eva G. Redondo | Vicente P. Estrada | Rocio Marquez | Raquel Sandoval | Pompeyo Viciana | Nuria Espinosa | Luis Lopez-Cortes | Juan Tiraboschi | Sandra Morenilla | Antonio Antela | Elena Losada | Janey Sewell | Sarah Kirk | Alyson Knott | Thomas Fernandez | Louise Jennings | Lana Ward | Julie Fox | Julianne Lwanga | Ming Lee | Sheila Morris | Dan Clutterbuck | Michael Brady | Serge Fedele | Anja Potthoff | Johannes Bogner | Ulrich Seybold | Julia Roider | Arne Jessen | Tim Kümmerle | Sindy Bartel | Anja Hüfner | Karina Mohrmann | Ivanka Krznaric | Patrick Ingiliz | Christina Grube | Dominique Braun | Manuela Rasi | Denise Borso | Markus Stratmann | Oliver Caviezel | Marcel Stoeckle | Philip Tarr | Vanessa Christinet | Florent Jouinot | Camille Isambert | Beatrice Bernasconi | Lene P. Jensen | Anne A. Bayer | Yordanos Yehdego | Ann Bach | Pia Handberg | Svend s. Pedersen | Nete Bülow | Bente Ramskover | Outi Debnam | Jussi Sutinen | Ronnie Ask | Bernt Hildingsson-Lundh | Katarina Westling | Eeva-Maija Frisen | Gráinne Cortney | Siobhan O'Dea | Coca Necsoi | Sophie Henrard | Hans-Henrik Nobel | Annouschka Weijsenfeld | Loek Elsenburg | Danielle Vos | Imke Hoijenga | Elisabeth Gisolf | Petra Van Bentum | Dominique Verhagen | Eric Billaud | Daniel Gosset | Alexandre Fior | Pelagie Thibaut | Julie Chas | Vincent Leclercq | Vincent Pechenot | Vincent Coquelin | Sophie Breaud | Veronique Touzeau-Romer | Maria Kitchen - Maria Geit | Mario Sarcletti | Angela Oellinger | Samanta Menichetti | Teresa Bini | Marianna Meschiari | Antonio Di Biagio | Lucia Taramasso | Benedetto M. Celesia | Maria Gussio | Nuno Janeiro | F. Gutiérrez | K. Brinkman | R. Gilson | M. Masiá | A. Carrillo | M. Meulbroek | L. Leal | J. Sewell | D. Asboe | N. Nwokolo | B. Celesia | M. Gussio | V. Estrada | A. Phillips | G. Corbelli | J. Tiraboschi | J. Goffard | S. Pedersen | A. Skaletz‐Rorowski | C. Robledano | E. Losada | N. Espinosa | E. Gisolf | L. Elsenburg | J. Prins | A. Beloukas | J. Roider | L. Ostergaard | M. Sarcletti | C. Necsoi | L. Jennings | E. Billaud | B. Bernasconi | S. O’Dea | A. Weijsenfeld | J. Lwanga | M. Kitchen | T. Fernandez | S. Morris | J. Chas | V. Christinet | A. van Eeden | Alyson Knott | F. Gutiérrez | J. Saz | M. Rasi | Florent Jouinot | P. Cobarsí | M. Gisinger | Christina Grube | M. Ohayon | D. Gosset | Sandra Morenilla | P. Coll | S. Henrard | A. Jessen | A. Bayer | T. Bruun | A. Nieto | P. Thibaut | M. Lee | Sarah Kirk | Lana Ward | P. van Bentum | J. del Romero Guerrero | M. Stratmann | Y. Yehdego | L. P. Jensen | D. Boršo | Pep Patricia Aroa Michael Antonia Jorge Jorge D.R. Mar Coll Cobarsi Nieto Meulbroek Carrillo Saz Gue | Jorge D.R. Guerrero | Margarida García | Eva G. Redondo | Rocio Marquez | Sindy Bartel | Karina Mohrmann | Oliver Caviezel | Camille Isambert | Ann L E Bach | Pia Handberg | Nete Bülow | Bente Ramskover | Outi Debnam | R. Ask | Bernt Hildingsson-Lundh | Eeva-Maija Frisen | G. Cortney | Hans-Henrik Nobel | D. Vos | Imke Hoijenga | Alexandre Fior | V. Leclercq | V. Péchenot | V. Coquelin | S. Breaud | Veronique Touzeau-Romer | Maria Kitchen - Maria Geit | Angela Oellinger | S. Menichetti | N. Janeiro | Andrea Antinori | Jan M Prins | J. Bogner | Anders Blaxhult | Alison J Rodger | Pietro Vernazza | Olaf Degen | Pep Coll | Nneka Nwokolo | Armin Rieger | Arne Van Eeden | Norbert H Brockmeyer | Francois Raffi | Johannes R Bogner | Jan Gerstoft | Lars Ostergaard | Matti Ristola | Heiko Jessen | Hans-Jürgen Stellbrink | J. D. Guerrero | Norbert Brockmeyer | Johannes Bogner | S. Ruzicic | Jan Prins | E. Redondo | Marianna Meschiari | Anders Blaxhult | Pietro Vernazza | Olaf Degen | Vicente Estrada | Andrea Antinori | Armin Rieger | Jan M Prins | Anders Blaxhult | Rainer Weber | Norbert H. Brockmeyer | Francois Raffi | Felix Gutiérrez | Lars Ostergaard | Agathe Leon | Heiko Jessen | Matti Ristola | J. Gerstoft | Amanda Clarke | F. Raffi | P. Vernazza | Jussi Sutinen | Jan Gerstoft | Alison Rodger | François Raffi | O. Degen | Vicente P. Estrada | Andrea Antinori | Armin Rieger | Jan M Prins | Rainer Weber | Norbert H Brockmeyer | J. Bogner | Gilles Wandeler | F. Gutiérrez | K. Brinkman | Lars Ostergaard | Agathe Leon | Catalina Robledano | Patricia Cobarsí | Johannes R. Bogner | J. Gerstoft | Vicente Estrada | Jan M Prins | Rainer Weber | Amanda Clarke | Francois Raffi | Lars Ostergaard | Agathe Leon | Jan M Prins | Rainer Weber | Amanda Clarke | Lars Ostergaard | Agathe Leon | H. Nobel

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