Share
 
Title
Incidence of HIV-infection in the ANRS Prevenir study in Paris region with daily or on-demand PrEP with TDF/FTC
Presenter
Jean-Michel Molina
Authors
J.-M. Molina1, J. Ghosn2, L. Béniguel3, D. Rojas-Castro4, M. Algarte-Genin3, G. Pialoux5, C. Delaugerre1, Y. Yazdanpanah6, C. Katlama7, C. Ségouin8, S. Morel9, C. Pintado10, B. Loze10, S. Le Mestre11, S. Gibowski11, V. Doré11, L. Assoumou3, B. Spire12, D. Costagliola3, Prevenir ANRS study group
Institutions
1University of Paris Diderot, Sorbonne Paris Cité, Saint-Louis Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 2Paris Descartes University, Sorbonne-Paris-Cité, Hotel-Dieu Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 3INSERM, Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP), Paris, France, 4Coalition PLUS, Pantin, France, 5Sorbonne Université, Tenon Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 6INSERM, University of Paris Diderot, Sorbonne Paris Cité, IAME (Infection, Antimicrobials, Modelling, Evolution), Bichat Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 7INSERM, Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP), Pitié-Salpétrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 8Lariboisière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 9AIDES, Pantin, France, 10Saint-Louis Hospital, Assistance Publique Hôpitaux de Paris, Paris, France, 11ANRS, France Recherche Nord & Sud Sida-hiv Hépatites, Agence autonome de l'INSERM, Paris, France, 12Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques and Sociales de la Santé and Traitement de l'Information Médicale, ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France

Background: On-demand PrEP with TDF/FTC has been recommended as an alternative to Daily PrEP for MSM by the European AIDS Clinical Society following the results of clinical studies but data are limited on real-world experience.
Methods: The ANRS Prevenir study is an ongoing prospective cohort study in the Paris region enrolling high risk individuals willing to/or using PrEP. Both daily and On-demand PrEP were offered to eligible individuals. At baseline, month 1 and every 3 months thereafter subjects were tested for HIV using a 4th generation combined ELISA test and other STIs and creatinine plasma levels were monitored. At each visit participants provided information regarding sexual behaviour and adherence using computer assisted self-interviews. Analysis of HIV incidence was assessed to provide additional data on the efficacy and safety of the two PrEP dosing regimens.
Results: From May 3rd 2017 to May 1st 2018, 1435 subjects were enrolled across 22 sites, 59% being PrEP experienced for a median of 10 months. Median age was 37 years (IQR: 30-44), 98.7% were MSM. At enrolment, PrEP was used Daily in 44% and On-demand in 53% of participants. Median number of partners in the 3 months before enrolment was 15 (IQR: 7-25) in the Daily group and 10 (5-15) in the On-demand group (P< 0.001). Median number of condomless sex in the prior 4 weeks was 3 (1-8) and 2 (0-4), respectively, P< 0.001. The current follow-up lasted 302 and 361 person-years (PY) in the Daily and On-demand groups, respectively. The incidence of HIV-1 infection was 0 (95% CI: 0-1.2) per 100 PY and 0 (95% CI: 0-1.0) in the Daily and On-demand groups respectively (P=1.00) and the incidence of study discontinuation was 3.0 and 3.6 per 100 PY (P=0.674) respectively, including 1.3 and 1.1 per 100 PY drop out of PrEP because participants no longer feel at risk. No participant discontinued PrEP for drug-related adverse events.
Conclusions: In this ongoing PrEP cohort in Paris region, enrolling mainly MSM at high risk of HIV-acquisition, no breakthrough HIV-infection was reported so far with either daily or on-demand PrEP, supporting continuing use of both dosing regimens in this population.