Correspondence
tis virus are present in Angola, more studies of
this virus in this locality, including serosurveil-
lance, are needed. Increased levels of population
movement between Asia and Africa may provide
opportunities for pathogens to expand their geo-
graphic range. These data also highlight the
potential usefulness of high-throughput sequenc-
ing, particularly untargeted approaches, for patho-
gen surveillance.5
Etienne SimonLoriere, Ph.D.
Institut Pasteur
Paris, France
etienne.simon-loriere@pasteur.fr
AmadouA. Sall, Ph.D.
Institut Pasteur de Dakar
Dakar, Senegal
and Others
Changes in Frances Deferral of Blood Donation by Men
Who Have Sex with Men
To the Editor: Since the advent of AIDS, men
who have sex with men (MSM) have often been
permanently deferred from blood donation in
France and elsewhere.1 Such a ban, which is
more stringent than deferrals for other risk ex-
posures, can be considered to be discriminatory
and often is misunderstood.2
In France, the theoretical risk of transfusion-
transmitted human immunodeficiency virus (HIV)
infection is 1 in 3.0 million donations3 (i.e., one
infection per year). However, the last known
case of transfusion-transmitted HIV infection in
France occurred in 2002.
According to the French national surveillance
system for blood donors, between 2011 and
2015, a total of 108 of the 142 donors (76%) who
were found to be HIV-positive were men. Among
these 108 donors, 82 had data that could be
evaluated (see the Supplementary Appendix, avail-
able with the full text of this letter at NEJM.org),
and of these men, 49 (60%) reported having had
sex with men. Furthermore, among the 22 HIV
nucleic acidpositive, antibody-negative donors
identified between 2001 and 2015, a total of 20
were men (91%), and 65% of the men who had
data that could be evaluated were MSM. Therefore,
during a period in which a policy of permanent
deferral was in place, some MSM donated blood
very soon after they had been infected with HIV.
A more evidence-based deferral policy may result
n engl j med 376;15nejm.org April 13, 2017
The New England Journal of Medicine
Downloaded from nejm.org on April 24, 2017. For personal use only. No other uses without permission.
Copyright 2017 Massachusetts Medical Society. All rights reserved.
A complete list of authors is available with the full text of this
letter at NEJM.org.
Disclosure forms provided by the authors are available with
the full text of this letter at NEJM.org.
1. Monath TP, Vasconcelos PF. Yellow fever. J Clin Virol 2015;
64:160-73.
2. World Heath Organization. Japanese encephalitis vaccines:
WHO position paper February 2015. Wkly Epidemiol Rec 2015;
90:69-87.
3. Matranga CB, Andersen KG, Winnicki S, et al. Enhanced
methods for unbiased deep sequencing of Lassa and Ebola RNA
viruses from clinical and biological samples. Genome Biol 2014;
15:519.
4. Chen Z, Liu L, Lv Y, et al. A fatal yellow fever virus infection
in China: description and lessons. Emerg Microbes Infect 2016;
5(7):e69.
5. Gardy J, Loman NJ, Rambaut A. Real-time digital pathogen
surveillance the time is now. Genome Biol 2015;16:155.
DOI: 10.1056/NEJMc1701600
not only in an unchanged rate of donations from
persons with HIV infection4 but also in enhanced
donor adherence and ultimately in increased re-
cipient safety.
In 2015, the French Health Ministry held ex-
tensive meetings with stakeholders, including
health regulatory authorities, the French national
blood service (tablissement Franais du Sang),
patients, blood donors, and lesbian, gay, bisexual,
and transgender (LGBT) associations (see the
Supplementary Appendix). Almost all stakehold-
ers agreed that the permanent deferral could be
lifted. Although a 1-year deferral was recognized
as being substantially longer than the current
12-day window (i.e., the duration of time when
a person is infected with HIV before a test can
detect it), health authorities thought that data to
provide support for a shorter deferral were lack-
ing, particularly with respect to donor adherence
as well as to the incidence of HIV among MSM
with no more than one sexual partner. Neverthe-
less, several LGBT associations preferred that the
deferral policies be more aligned with individual
risk assessments.
To detect HIV in blood donated during the
window period, part of apheresis plasma in France
is quarantined until a new donation is made and
testing is repeated at least 2 months later. Thus,
several stakeholders reasoned that such a blood
donation could be made by MSM under the same
1485
 The n e w e ng l a n d j o u r na l of m e dic i n e

conditions as other donors (i.e., donors who Josiane Pillonel, M.Sc.

had no more than one partner over the previous Sant Publique France
4 months). Furthermore, such a donation offers Saint-Maurice, France
a unique opportunity to safely assess the epide- Franois Toujas, M.A.
miologic features of HIV among MSM donors Etablissement Franais du Sang
who are subjected to identical deferral rules as La Plaine Saint-Denis, France
other donors. However, with this policy, a large Benoit Vallet, M.D., Ph.D.
number of MSM donors would need to be screened
Ministre de la Sant
before sufficient data could be generated. Paris, France
Effective nationwide in France since July 2016, benoit.vallet@sante.gouv.fr
the deferral period with respect to donations by Disclosure forms provided by the authors are available with
MSM has been reduced to 1 year. The notable the full text of this letter at NEJM.org.
exception to this policy is apheresis-quarantined
1. Benjamin RJ, Bianco C, Goldman M, et al. Deferral of males
plasma, for which identical deferral rules now who had sex with other males. Vox Sang 2011;101:339-67.
apply to all donors. Results of ongoing studies 2. Sacks CA, Goldstein RH, Walensky RP. Rethinking the ban
of epidemiologic features of HIV and overall the U.S. blood supply and men who have sex with men. N Engl
donor adherence will be essential to verify the J Med 2017;376:174-7.
3. Sant publique France. Blood donor surveillance. (In French.)
safety of transfusions and pave the way to fur- (http://invs.santepubliquefrance.fr/%20fr/Dossiers-thematiques/
ther changes regarding deferral policies that apply Populations-et-sante/Donneurs-de-sang/).
4. Germain M. The risk of allowing blood donation from men
to MSM.
having sex with men after a temporary deferral: predictions ver-
Pierre Tiberghien, M.D., Ph.D. sus reality. Transfusion 2016;56:1603-7.
Etablissement Franais du Sang
La Plaine Saint-Denis, France DOI: 10.1056/NEJMc1700740

The Blood Supply and Men Who Have Sex with Men
To the Editor: A goal of the Food and Drug
Administration (FDA) is to gather the scientific
evidence needed to fairly and nonjudgmentally
assess the risk posed by the blood of a prospec-
tive donor while it maintains the safety of the
blood supply. This means developing and testing
questions that accurately assess individual risk for
potential donors whether the person is a man
who has sex with other men or someone with
other risk factors that currently still result in
indefinite deferral.
Work to generate the additional scientific data
needed was already in progress in December
2015, when the policy changed from an indefi-
nite deferral to a 12-month deferral for men who
have sex with men, and that work continues at
this time. The Medicine and Society article by
working together with all interested parties as it
proceeds to gather the scientific evidence neces-
sary to support implementation of individual risk
assessment for all blood donors.
PeterW. Marks, M.D., Ph.D.
U.S. Food and Drug Administration
Silver Spring, MD
Peter.Marks@fda.hhs.gov
No potential conflict of interest relevant to this letter was re-
ported.
1. Sacks CA, Goldstein RH, Walensky RP. Rethinking the ban
the U.S. blood supply and men who have sex with men. N Engl
J Med 2017;376:174-7.
2. Food and Drug Administration. Guidance for industry:re-
vised recommendations for reducing the risk of human immu-
nodeficiency virus transmission by blood and blood products.
December 2015 (http://www.fda.gov/downloads/BiologicsBlood
Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/
Blood/UCM446580.pdf).

Sacks et al. (Jan. 12 issue)1 regarding the current DOI: 10.1056/NEJMc1701828

blood donor deferral policy for men who have

sex with men oversimplifies this complex scien-
tific issue and mischaracterizes the FDAs posi-
tion. A summary of the available information
and the FDAs consideration of the relevant facts
is publicly available.2 The FDA looks forward to
The authors reply: We appreciate Dr. Markss
ongoing attention to this issue. We agree that the
blood-donation and deferral processes should seek
to fairly and nonjudgmentally assess a potential
donors risk. Our concerns arise because we be-

1486 n engl j med 376;15nejm.org April 13, 2017

The New England Journal of Medicine

Downloaded from nejm.org on April 24, 2017. For personal use only. No other uses without permission.
Copyright 2017 Massachusetts Medical Society. All rights reserved.