Daily or on demand oral TDF/FTC for HIV pre-exposure prophylaxis: experience from an hospital-based clinic in France.

BACKGROUND On Demand oral TDF/FTC has been approved for pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) in France following the results of clinical studies but data are limited on real-world experience. DESIGN A single center, open-label, prospective cohort study that recruited people at high risk of HIV infection in Paris. METHODS Subjects were enrolled in a single hospital-based outpatient clinic and were proposed to start PrEP with daily or on demand TDF/FTC. At baseline and every 3 months thereafter subjects were tested for HIV and creatinine plasma levels and data on sexual behavior, other sexually transmitted infections (STIs), and tolerability were collected. RESULTS From November 10, 2015 to April 30, 2017, 1069 subjects were screened and 1049 (98.1%) started PrEP. Median age was 36 years, 99.4% were MSM with a median number of partners of 10, and 793 (75.6%) opted for on demand PrEP. Over 486 person-years (PY) of follow-up, 4 HIV-infection were diagnosed in poorly or non-adherent subjects (incidence: 0.82/100 PY). Rate of condomless sex at last intercourse increased from 53.3% at baseline to 79% at month 12 (p < 10) but increase in bacterial STI rates was modest (14.6% at baseline vs 19.2% at month 12, (p < 10). Most adverse events were gastrointestinal and did not lead to PrEP discontinuation. CONCLUSIONS Most PrEP users were high risk MSM and opted for on demand PrEP. PrEP use was associated with a low HIV incidence and a high rate of condomless sex with a modest increase in bacterial STIs.