TY - JOUR
T1 - Ethical considerations regarding oral preexposure prophylaxis in HIV prevention trials
AU - Sugarman, Jeremy
N1 - Publisher Copyright:
Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2016/1/1
Y1 - 2016/1/1
N2 - Purpose of review Although substantial evidence supports oral preexposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine (OPTF) for the primary prevention of HIV infection in certain settings, assessing whether other promising HIV prevention interventions are safe and effective as well as determining optimal prevention strategies necessitates research. However, given the established safety and efficacy of OPTF, it is necessary to determine when and how is it ethically acceptable to conduct this research, which is the focus of this review. Recent findings Although they are somewhat intertwined, questions regarding OPTF in research can be considered in two broad categories: use in a comparison arm and as a standard of prevention. Major statements addressing these issues are described and recent literature directed at the particular issue of OPTF in research is reviewed and critiqued. Summary There is now arguably a rebuttable presumption for the use of OPTF as a comparator or as part of the standard of prevention in much future HIV prevention research. However, making such determinations necessitates taking into account scientific considerations, the modality being evaluated, acceptability, adherence, and the local context. Doing so should be optimized by robust stakeholder engagement.
AB - Purpose of review Although substantial evidence supports oral preexposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine (OPTF) for the primary prevention of HIV infection in certain settings, assessing whether other promising HIV prevention interventions are safe and effective as well as determining optimal prevention strategies necessitates research. However, given the established safety and efficacy of OPTF, it is necessary to determine when and how is it ethically acceptable to conduct this research, which is the focus of this review. Recent findings Although they are somewhat intertwined, questions regarding OPTF in research can be considered in two broad categories: use in a comparison arm and as a standard of prevention. Major statements addressing these issues are described and recent literature directed at the particular issue of OPTF in research is reviewed and critiqued. Summary There is now arguably a rebuttable presumption for the use of OPTF as a comparator or as part of the standard of prevention in much future HIV prevention research. However, making such determinations necessitates taking into account scientific considerations, the modality being evaluated, acceptability, adherence, and the local context. Doing so should be optimized by robust stakeholder engagement.
KW - HIV infection
KW - comparator arm
KW - ethics
KW - preexposure prophylaxis
KW - research ethics
KW - standard of prevention
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U2 - 10.1097/COH.0000000000000214
DO - 10.1097/COH.0000000000000214
M3 - Review article
C2 - 26633642
AN - SCOPUS:84950290079
VL - 11
SP - 109
EP - 115
JO - Current Opinion in HIV and AIDS
JF - Current Opinion in HIV and AIDS
SN - 1746-630X
IS - 1
ER -