@article{fdi:010070974,
  title = {{E}fficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for {HIV} in men who have sex with men : an observational cohort study},
  author = {{M}olina, {J}. {M}. and {C}harreau, {I}. and {S}pire, {B}. and {C}otte, {L}. and {C}has, {J}. and {C}apitant, {C}. and {T}remblay, {C}. and {R}ojas-{C}astro, {D}. and {C}ua, {E}. and {P}asquet, {A}. and {B}ernaud, {C}. and {P}intado, {C}. and {D}elaugerre, {C}. and {S}agaon {T}eyssier, {L}uis and {L}e {M}estre, {S}. and {C}hidiac, {C}. and {P}ialoux, {G}. and {P}onscarme, {D}. and {F}onsart, {J}. and {T}hompson, {D}. and {W}ainberg, {M}. {A}. and {D}ore, {V}. and {M}eyer, {L}. and {ANRS} {IPERGAY} {S}tudy {G}roup},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {D}ata for on-demand pre-exposure prophylaxis ({P}r{EP}) are scarce. {W}e implemented a cohort study to assess its efficacy, safety, and effect on sexual behaviour. {M}ethods {W}e invited men and transgender women who have sex with men, previously enrolled in the randomised placebo-controlled {ANRS} {IPERGAY} trial at seven sites (six in {F}rance and one in {C}anada), to participate in an openlabel extension with on-demand tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) to be taken before and after sexual intercourse. {W}e assessed the incidence of {HIV} and other sexually transmitted infections ({STI}s), {P}r{EP} adherence, safety, and sexual behaviour. {S}tatistical analyses included comparisons of proportions and incidence between the randomised phase of the {ANRS} {IPERGAY} trial and the open-label phase, and all participants were included in safety analyses. {ANRS} {IPERGAY} is registered with {C}linical{T}rials. gov, number {NCT}01473472. {F}indings {B}etween {N}ov 4, 2014, and {J}an 27, 2015, we enrolled 361 participants. {M}edian follow-up was 18.4 months ({IQR} 17.7-19.1). {O}ne participant who discontinued {P}r{EP} acquired {HIV} infection. {HIV} incidence was 0.19 per 100 person-years (95% {CI} 0.01-1.08), compared with 6.60 per 100 person-years (3.60-11.05) in the placebo group of the randomised study, indicating a relative reduction of 97% (95% {CI} 81-100) in the incidence of {HIV} with ondemand {P}r{EP}. {P}articipants used a median of 18 pills of study drugs per month ({IQR} 11-25), and at the 6 month visit 240 (71%) of 336 participants had tenofovir detected in plasma. {D}rug-related gastrointestinal events were reported in 49 participants (14%) but were self-limited. {O}nly four participants (1%) discontinued {P}r{EP}, three because of an increase in plasma creatinine. {T}he proportion of participants reporting condomless sex at their last receptive anal intercourse significantly increased from 77% (136 of 176 participants) at baseline to 86% (66 of 77 participants) at 18 months' follow-up (p for trend= 0.0004). {T}he incidence of a first bacterial {STI} during this open-label phase did not change significantly compared with the randomised phase (59.0 vs 49.1 per 100 person-years, respectively; p= 0.11). {I}nterpretation {O}n-demand oral {P}r{EP} is highly effective at preventing {HIV} infection among high-risk men who have sex with men and therefore represents an alternative to daily {P}r{EP}, expanding choices for {HIV} prevention. {H}igh rates of {STI}s resulting from low condom use did not undermine {P}r{EP} efficacy, but warrant frequent testing.},
  keywords = {{FRANCE} ; {CANADA}},
  booktitle = {},
  journal = {{L}ancet {HIV}},
  volume = {4},
  numero = {9},
  pages = {{E}402--{E}410},
  ISSN = {2352-3018},
  year = {2017},
  DOI = {10.1016/s2352-3018(17)30089-9},
  URL = {https://www.documentation.ird.fr/hor/fdi:010070974},
}