PMID- 26123937
OWN - NLM
STAT- MEDLINE
DCOM- 20160711
LR  - 20150927
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 61
IP  - 8
DP  - 2015 Oct 15
TI  - Single-Tablet Emtricitabine-Rilpivirine-Tenofovir as HIV Postexposure Prophylaxis 
      in Men Who Have Sex With Men.
PG  - 1336-41
LID - 10.1093/cid/civ511 [doi]
AB  - 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. CLINICAL TRIALS REGISTRATION: NCT01715636.
CI  - (c) The Author 2015. Published by Oxford University Press on behalf of the 
      Infectious Diseases Society of America. All rights reserved. For Permissions, 
      please e-mail: journals.permissions@oup.com.
FAU - Foster, Rosalind
AU  - Foster R
AD  - Sydney Sexual Health Centre.
FAU - McAllister, John
AU  - McAllister J
AD  - HIV, Immunology and Infectious Diseases Unit, and Centre for Applied Medical 
      Research, St Vincent's Hospital, Sydney, New South Wales.
FAU - Read, Tim R
AU  - Read TR
AD  - Melbourne Sexual Health Centre Central Clinical School, Faculty of Medicine, 
      Nursing and Health Sciences, Monash University.
FAU - Pierce, Anna B
AU  - Pierce AB
AD  - Department of Infectious Diseases, The Alfred Hospital, Melbourne, Victoria.
FAU - Richardson, Robyn
AU  - Richardson R
AD  - HIV, Immunology and Infectious Diseases Unit, and Centre for Applied Medical 
      Research, St Vincent's Hospital, Sydney, New South Wales.
FAU - McNulty, Anna
AU  - McNulty A
AD  - Sydney Sexual Health Centre School of Public Health and Community Medicine, 
      University of New South Wales, Sydney, Australia.
FAU - Carr, Andrew
AU  - Carr A
AD  - HIV, Immunology and Infectious Diseases Unit, and Centre for Applied Medical 
      Research, St Vincent's Hospital, Sydney, New South Wales.
LA  - eng
SI  - ClinicalTrials.gov/NCT01715636
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150629
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Emtricitabine, Rilpivirine, Tenofovir Drug Combination)
RN  - 0 (Tablets)
SB  - IM
CIN - Nat Rev Urol. 2015 Aug;12(8):422. PMID: 26171802
MH  - Adult
MH  - Anti-HIV Agents/*administration & dosage/blood/therapeutic use
MH  - Australia
MH  - Drug Administration Schedule
MH  - Emtricitabine, Rilpivirine, Tenofovir Drug Combination/*administration & 
      dosage/blood/therapeutic use
MH  - HIV Infections/*prevention & control
MH  - *Homosexuality, Male
MH  - Humans
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - *Post-Exposure Prophylaxis
MH  - Tablets
MH  - Young Adult
OTO - NOTNLM
OT  - HIV
OT  - adherence
OT  - completion
OT  - postexposure prophylaxis
OT  - rilpivirine
EDAT- 2015/07/01 06:00
MHDA- 2016/07/12 06:00
CRDT- 2015/07/01 06:00
PHST- 2015/04/26 00:00 [received]
PHST- 2015/06/13 00:00 [accepted]
PHST- 2015/07/01 06:00 [entrez]
PHST- 2015/07/01 06:00 [pubmed]
PHST- 2016/07/12 06:00 [medline]
AID - civ511 [pii]
AID - 10.1093/cid/civ511 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2015 Oct 15;61(8):1336-41. doi: 10.1093/cid/civ511. Epub 2015 
      Jun 29.