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.