M Siguier1, R Mera2, G Pialoux3, M Ohayon4, L Cotte5, N Valin6, J Ghosn7, E Cua8, C Pintado1, J Chas3, G Barriere9, F Durand9, J M Molina1. 1. Hôpital Saint-Louis, Department of Infectious Diseases and University Paris Diderot, Paris, France. 2. Gilead Sciences, Epidemiology, Foster City, CA, USA. 3. Hôpital Tenon, Department of Infectious Diseases, Paris, France. 4. Le 190, Paris, France. 5. Hôpital Croix Rousse, Department of Infectious Diseases, Lyon, France. 6. Hôpital Saint-Antoine, Department of Infectious Diseases, Paris, France. 7. Hôtel Dieu, Department of Infectious Diseases, Paris, France. 8. Hôpital L'Archet, Department of Infectious Diseases, Nice, France. 9. Gilead Sciences S.A.S., Boulogne-Billancourt, France.
Abstract
BACKGROUND: In January 2016, the French Medicine Agency initiated a Temporary Recommendation for Use (TRU) to allow the use of oral intake of tenofovir disoproxil fumarate and emtricitabine for pre-exposure prophylaxis (PrEP) in adults at high risk of HIV. We report the results of the first year of PrEP implementation in France. METHODS: Data were collected by physicians using a secured web subject-monitoring interface, with two forms: an initiation form, with patients' baseline characteristics, and an HIV seroconversion form. Univariate and adjusted multivariate analysis using a logistic regression model were performed to identify baseline factors associated with on-demand PrEP regimen prescription. RESULTS: From 4 January 2016 to 28 February 2017, 3405 subjects were enrolled, with 2774 initiation forms completed; 98.1% were male and 96.9% were MSM. An on-demand regimen was prescribed to 57% of subjects. Older age (OR for participants older than 50 years = 1.76, 95% CI 1.35-2.3, P < 0.001) and site of prescription (OR of former IPERGAY sites = 2.28, 95% CI 1.84-2.83, P < 0.001) were associated with on-demand prescription. Those reporting sexually transmitted infection (STI) and condomless anal sex with at least two different partners were less likely to receive on-demand PrEP (OR = 0.68, 95% CI 0.57-0.82 and 0.75, 95% CI 0.57-0.98, respectively; P < 0.05 for all). Four breakthrough HIV infections were reported during the study, in the context of PrEP interruption or acute infection at the time of PrEP initiation. CONCLUSIONS: In a real-life setting in France, PrEP was used, either daily or on-demand, mostly by MSM, with breakthrough infections being rare.
BACKGROUND: In January 2016, the French Medicine Agency initiated a Temporary Recommendation for Use (TRU) to allow the use of oral intake of tenofovir disoproxil fumarate and emtricitabine for pre-exposure prophylaxis (PrEP) in adults at high risk of HIV. We report the results of the first year of PrEP implementation in France. METHODS: Data were collected by physicians using a secured web subject-monitoring interface, with two forms: an initiation form, with patients' baseline characteristics, and an HIV seroconversion form. Univariate and adjusted multivariate analysis using a logistic regression model were performed to identify baseline factors associated with on-demand PrEP regimen prescription. RESULTS: From 4 January 2016 to 28 February 2017, 3405 subjects were enrolled, with 2774 initiation forms completed; 98.1% were male and 96.9% were MSM. An on-demand regimen was prescribed to 57% of subjects. Older age (OR for participants older than 50 years = 1.76, 95% CI 1.35-2.3, P < 0.001) and site of prescription (OR of former IPERGAY sites = 2.28, 95% CI 1.84-2.83, P < 0.001) were associated with on-demand prescription. Those reporting sexually transmitted infection (STI) and condomless anal sex with at least two different partners were less likely to receive on-demand PrEP (OR = 0.68, 95% CI 0.57-0.82 and 0.75, 95% CI 0.57-0.98, respectively; P < 0.05 for all). Four breakthrough HIV infections were reported during the study, in the context of PrEP interruption or acute infection at the time of PrEP initiation. CONCLUSIONS: In a real-life setting in France, PrEP was used, either daily or on-demand, mostly by MSM, with breakthrough infections being rare.
Authors: Amy C Justice; Matthew B Goetz; Cameron N Stewart; Brenna C Hogan; Elizabeth Humes; Paula M Luz; Jessica L Castilho; Denis Nash; Ellen Brazier; Beverly Musick; Constantin Yiannoutsos; Karen Malateste; Antoine Jaquet; Morna Cornell; Tinei Shamu; Reena Rajasuriar; Awachana Jiamsakul; Keri N Althoff Journal: Lancet HIV Date: 2022-02-23 Impact factor: 16.070
Authors: Liza Coyer; Mark A M van den Elshout; Roel C A Achterbergh; Amy Matser; Maarten F Schim van der Loeff; Udi Davidovich; Henry J C de Vries; Maria Prins; Elske Hoornenborg; Anders Boyd Journal: EClinicalMedicine Date: 2020-12-01
Authors: Kathleen E Ryan; Jason Asselin; Chistopher K Fairley; Judy Armishaw; Luxi Lal; Long Nguyen; Dean Murphy; Michael Traeger; Margaret Hellard; Jennifer Hoy; Mark Stoové; Edwina Wright Journal: Sex Transm Dis Date: 2020-08 Impact factor: 3.868