S U P P L E M E N T A R T I C L E

Bioethical Challenges With HIV Treatment as

Prevention
Jeremy Sugarman
1,2,3
1
Berman Institute of Bioethics, Johns Hopkins University,
2
School of Medicine, and
3
Bloomberg School of Public Health, Johns Hopkins University,
Baltimore, Maryland
To best realize the opportunities afforded by treatment as prevention, important ethical challenges must be
addressed, including those related to acceptability, safety, and effectiveness, as well as alternatives. Absent uni-
versal access to quality antiretroviral treatment, safety, fairness, and allocation must also be considered.
Keywords. ethics; HIV prevention; HIV treatment; policy.
With mounting scientic evidence, substantial enthusi-
asm appropriately accompanies the use of human im-
munodeciency virus (HIV) treatment as prevention
(TasP) as a means of helping to curtail the HIV pan-
demic. As demonstrated by epidemiological and clinical
research, the early treatment of HIV infection can have
salutary effects not only for those treated but also in di-
minishing the chance of HIV transmission. In addition,
TasP promises to diminish morbidity and mortality re-
lated to tuberculosis [1]. Accordingly, major efforts are
being directed at implementing TasP. To best realize the
opportunities afforded by TaSP, several important eth-
ical challenges must be addressed. Some of these chal-
lenges relate to TaSP in general, while others are
especially relevant due to the current lack of universal
access to antiretroviral treatment (ART).
ETHICS AND TASP
TasP involves ethical issues related to acceptability, safe-
ty and effectiveness, as well as alternatives.
Acceptability
Acceptability of initiating ART among both those who
are infected with HIV and those who are not infected
and rely on TasP as a means of prevention is obviously
critical in order for TasP to meet its dual goals of treat-
ment and prevention. For those who are HIV infected,
early treatment with ART may involve medicalization
of infection prior to when they perceive themselves to
be sick, which may be accompanied by reluctance to ini-
tiate treatment [2]. Since lifelong adherence is generally
understood to be important in the treatment of HIV in-
fection, it is essential that upon starting ART there is a
genuine commitment to adhere as well as an ability to
do so. As with all medical treatments, ART can have
side effects that may be especially relevant in weighing
the risks and benets for particular individuals in decid-
ing to initiate treatment. In addition to possible physical
reactions to ART, in some settings social risks and stigma
associated with treatment need to be considered. This
range of concerns underscores the importance of in-
formed and voluntary uptake of ART for TasP [3].
Since TasP aims to benet not only the individuals
being treated but also their sexual partners, it is neces-
sary to consider the acceptability of TasP as a means of
prevention for these partners. Considered as such, TasP
is different from other forms of prevention in which at-
risk individuals take some type of measure that is in-
tended to afford a prevention benet, such as ensuring
condom use or using antiretroviral agents as preexpo-
sure prophylaxis (PrEP). In contrast, TasP is predicated
on the actions of others. Therefore, uninfected individ-
uals must trust that their HIV-infected sexual partners
are adherent to ART and that the ART is sufciently ef-
fective to mitigate transmission risk. While in some
mutually monogamous dyadic relationships such trust
Correspondence: Jeremy Sugarman, MD, MPH, MA, Johns Hopkins Berman Insti-
tute of Bioethics, 1809 Ashland Ave, Baltimore, MD 21205 ( jsugarman@jhu.edu).
Clinical Infectious Diseases 2014;59(S1):S324
The Author 2014. 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.
DOI: 10.1093/cid/ciu246
S32 CID 2014:59 (Suppl 1) Sugarman

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may be justied, in particular at-risk populations it may not,
raising concerns about the safety and well-being of those at risk.
Safety and Effectiveness
The safety and effectiveness of TasP is dependent upon having
sound and reliable ART delivery systems. This includes the abil-
ity to provide appropriate care and monitoring at a reasonable
cost. In addition, safety and effectiveness in preventing new in-
fections will be inuenced somewhat by risk behaviors; and per-
haps to the certainty ascribed to the ability of TasP to prevent
transmission of HIV [4]. Finally, while efcacy data regarding
TaSP are convincing in dyadic heterosexual couples, effective-
ness information in this setting is arguably lacking as are data
in other at-risk populations.
Alternatives
In considering the use of TasP for the prevention of new infec-
tions, it is important to keep in mind that there are other evi-
dence-based means of prevention, including other ART-based
means, such as PrEP, and that no single approach to HIV preven-
tion is likely to be sufcient [5]. Indeed, a combination of preven-
tive measures is likely to be needed [6]. In addition, data are
emerging regarding the possible safety and efcacy of alternative
means of prevention, such as vaginal microbicides, that are within
the control of at-risk individuals. Also, there are the aspirations of
identifying an effective HIV vaccine that could afford durable pre-
vention benets that would not require assiduous adherence to
ART [7]. Similarly, another aspirational approach relates to
achieving an HIV cure [8] that, if realized in a way that could
be practically implemented, would obviously provide profound
benets for treatment and in turn prevention.
CONSIDERATIONS DUE TO A LACK OF
UNIVERSAL ACCESS TO ART
Without universal access to quality ART, especially in resource-
limited settings, there are special ethical considerations related
to safety, fairness, and allocation. While these considerations are
largely emblematic of global disparities in wealth and power
that will unfortunately not be easily resolved, they necessarily
shape the contours of health-related programs such as TasP.
Safety
Safety must be the initial consideration in initiating TasP. Al-
though maintaining safety while on ART can be difcult in
any setting, doing so in resource-poor settings where HIV prev-
alence is high can be expected to be especially challenging due to
the need to ensure consistent access to suitable ART [9]. Similar-
ly, it will be critical to establish context-appropriate systems
of maintaining adherence and conducting monitoring. More-
over, these programs and processes need to be sustainable and
insulated to the extent possible from political whim and inevita-
ble changes in economic conditions.
Fairness
While many communities would stand to derive substantial
benet from the implementation of TasP when universal access
to ART is lacking, questions of fairness arise in determining
where TasP should be initiated rst. As TasP is implemented,
further questions of fairness will arise in relation to which indi-
viduals will be selected for treatment. Although what precisely
constitutes fairness at both of these levels is unclear and com-
plex, it is essential that mechanisms of selection be procedurally
fair and transparent [10].
Allocation
Across the globe, there are clear and unmet needs for access to
HIV treatment and prevention services, not to mention other
non-HIVrelated global health priorities. At one level are concerns
about the allocation of resources to ART- and non-ARTbased
means of HIV prevention. At another level are concerns
about allocating ART for a variety of uses, such as treatment
of those who are ill, early treatment of those who are infected
for TasP, and prevention (including prevention of maternal-
to-child transmission [PMTCT], PrEP, and postexposure
prophylaxis [PEP]). As long as there is true scarcity of ART,
allocation decisions will be particularly difcult and it will be
difcult to nd easy answers. While some have advocated that
when ART is scarce, priority should be given to treatment, then
TasP, and then PrEP [11], others have illustrated the aws of
this intuitive conclusion [1214]. It is beyond the scope of
this article to examine the related arguments and counterargu-
ments in detail, yet it is clear that additional attention needs to
focus on the ethics of allocation. Recent scholarship in social
justice theory [15, 16] may provide the necessary tools to help
navigate appropriate paths forward.
CONCLUDING COMMENTS
TasP is an extremely promising means of helping to end the HIV
pandemic. Nevertheless, like most, if not all, biomedical interven-
tions, TasP involves ethical challenges that are exacerbated by
global disparities in health, wealth, and the particular vulnerabil-
ities of those infected with HIV and at heightened risk of becom-
ing infected. Transparent and explicit deliberation about these
issues along with meaningful engagement of the relevant stake-
holders should help to address them in order to mitigate unin-
tended actions and consequences as TasP is implemented.
Notes
Financial support. Work on this article was supported in part by the
Johns Hopkins Center for AIDS Research, funded by the US National Insti-
tutes of Health (1P30AI094189).
Ethics and TasP CID 2014:59 (Suppl 1) S33

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Supplement sponsorship. This article is published as part of a supple-
ment entitled Controlling the HIV Epidemic With Antiretrovirals, spon-
sored by the International Association of Providers of AIDS Care.
Potential conict of interest. Author certies no potential conicts of
interest.
The author has submitted the ICMJE Form for Disclosure of Potential
Conicts of Interest. Conicts that the editors consider relevant to the con-
tent of the manuscript have been disclosed.
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