TUAC0103 - Oral Abstract Session
High adherence rate to intermittent oral PrEP with TDF/FTC among high risk MSM (ANRS Ipergay)
Presented by Jean-Michel Molina (France).
J. Fonsart1, C. Capitant2, B. Spire3,4, L. Cotte5,6, G. Pialoux7, N. Lorente3,4, G. Peytavin8,9, I. Charreau2, J.-P. Aboulker2, J.-M. Molina10, ANRS Ipergay Study Group
1Saint-Louis Hospital, Biochimie, Paris, France, 2INSERM, SC10-US019, Villejuif, France, 3INSERM, UMR912 (SE4S), Marseille, France, 4Aix Marseille University, IRD, UMR-S912, Marseille, France, 5Hospices Civils de Lyon, Infectious Diseases, Lyon, France, 6INSERM, U1052, Lyon, France, 7Tenon Hospital, Infectious Diseases, Paris, France, 8Bichat Hospital, Laboratoire de Pharmaco-Toxicologie, Paris, France, 9INSERM, UMR 1137, Paris, France, 10Saint-Louis Hospital, Infectious Diseases, Paris, France
Background: Adherence is a critical factor associated with PrEP efficacy. Long-term adherence to daily oral PrEP remains challenging. Intermittent oral PrEP might improve adherence. We assessed adherence to intermittent PrEP among participants (pts) enrolled in the ANRS Ipergay trial.
Methods: High risk MSM are enrolled in an ongoing, randomized, double-blind, placebo-controlled trial of on demand PrEP with oral TDF/FTC. Pts were instructed to take 2 pills of TDF/FTC or placebo before sex (2 to 24 hours before), and 2 pills after sex (1 pill every 24 hours). The trial is currently in its pilot phase to assess adherence and feasibility. Adherence was assessed by computer-assisted self-interviews (CASIs) performed before visits, pill count, and assessment of TFV and FTC concentrations in plasma and hair samples. TFV and FTC concentrations were measured centrally, blinded to the randomization arm, using a sensitive LC-MS/MS assay (LLOD in plasma: 0.1 and 0.4 ng/ml for TFV and FTC respectively).
Results: From February 2012 to May 2013, 153 pts were randomized. Median age: 35 years (IQR: 20-61), follow-up: 98.6 pt-years, median number of sexual intercourses/week: 2 (range: 0-31), and number of sexual partners/2 months: 10 (range: 0-84). During their last sexual intercourse (n=543), according to CASIs: 53% (44-66% according to study visits) of pts used PrEP as scheduled, 28% (15-38%) used PrEP but did not follow the treatment schedule, and 19% (15-23%) did not use PrEP. Only 3% were using daily PrEP. The median number of pills used was 15 per month (IQR: 8-23). Only 59 hair samples from 38 pts were available for analysis. TFV and FTC were detected in 51% and 49% of pts in the TDF/FTC arm, and 14% and 0% in the placebo arm, respectively. 548 plasma samples from the first 113 randomized pts were analyzed. TFV and FTC were detected in 86% (82-100% according to study visits) and 82% (75-100%) of pts in the TDF/FTC arm, and 4% (0-6%) and 3% (0-6%) in the placebo arm, respectively.
Conclusions: Preliminary assessment of adherence among high risk MSM enrolled in this on demand PrEP trial, revealed a high adherence rate.
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