title: Single-Tablet Emtricitabine-Rilpivirine-Tenofovir as HIV Postexposure Prophylaxis in Men Who Have Sex With Men.
abstract: BACKGROUND
  Completion rates for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP) are low. We investigated the adherence and safety of coformulated emtricitabine (FTC), rilpivirine (RPV), and tenofovir disoproxil fumarate (TDF) as a 3-drug, single-tablet regimen for PEP in men who have sex with men (MSM).
  
  
  METHODS
  In an open-label, single-arm study at 2 public sexual health clinics and 2 hospital emergency departments in urban Australia, 100 HIV-uninfected MSM requiring 3-drug PEP received single-tablet FTC-RPV-TDF once daily for 28 days. The primary endpoint was premature PEP cessation or primary HIV infection through week 12. Additional endpoints were adherence (by self-report of doses missed or not ingested with a meal, by pill count, and by plasma concentrations of tenofovir and FTC at week 4); and safety (clinical and laboratory adverse events [AEs]).
  
  
  RESULTS
  PEP completion was 92% (95% confidence interval, 85%-96%); premature cessation resulted from loss to follow-up (6%), AEs (1%), or study burden (1%). No participant was found to acquire HIV through week 12. Adherence was 98.6% (standard deviation [SD], 2.4) by pill count and 98.5% (SD, 2.7) by self-report; 86% reported taking all doses with food, and 88% of the subset tested had plasma tenofovir levels suggesting full adherence (>40 ng/mL). Eighty-eight participants experienced at least 1 clinical AE; 4 had grade 3 AEs or higher, possibly attributable to study drug. Fifty-six participants experienced at least 1 laboratory AE; 4 had AEs of grade 3 or higher, possibly attributable to study drug.
  
  
  CONCLUSIONS
  A single-tablet regimen of FTC-RPV-TDF was well tolerated as once-daily PEP, with high levels of adherence and completion.
  
  
  BACKGROUND
  NCT01715636.
authors.affiliation: Sydney Sexual Health Centre.
authors.forename: Rosalind
authors.initials: R
authors.lastname: Foster
authors.affiliation: HIV, Immunology and Infectious Diseases Unit, and Centre for Applied Medical Research, St Vincent's Hospital, Sydney, New South Wales.
authors.forename: John
authors.initials: J
authors.lastname: McAllister
authors.affiliation: Melbourne Sexual Health Centre Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University.
authors.forename: Tim R
authors.initials: TR
authors.lastname: Read
authors.affiliation: Department of Infectious Diseases, The Alfred Hospital, Melbourne, Victoria.
authors.forename: Anna B
authors.initials: AB
authors.lastname: Pierce
authors.affiliation: HIV, Immunology and Infectious Diseases Unit, and Centre for Applied Medical Research, St Vincent's Hospital, Sydney, New South Wales.
authors.forename: Robyn
authors.initials: R
authors.lastname: Richardson
authors.affiliation: Sydney Sexual Health Centre School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: McNulty
authors.affiliation: HIV, Immunology and Infectious Diseases Unit, and Centre for Applied Medical Research, St Vincent's Hospital, Sydney, New South Wales.
authors.forename: Andrew
authors.initials: A
authors.lastname: Carr
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D001315:Australia; D004334:Drug Administration Schedule; D000068678:Emtricitabine, Rilpivirine, Tenofovir Drug Combination / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D015658:HIV Infections / Q000517:prevention & control*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D056990:Post-Exposure Prophylaxis; D013607:Tablets; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D000068678:Emtricitabine, Rilpivirine, Tenofovir Drug Combination; D013607:Tablets
keywords: HIV; adherence; completion; postexposure prophylaxis; rilpivirine