Progression towards microelimination of hepatitis B virus infection among people living with HIV in Spain

ARTICLE IN PRESS
G Model
EIMC-2963;
No.
o
Pages
8
En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
www.else ie .es/eimc
O iginal
a icle
P og ession
owa ds
mic oelimina ion
o
hepa i is
B
i us
in ec ion
among
people
li ing
wi h
HIV
in
Spain
Ma a
San osa,b,c,
Jesica
Ma ín
Ca monaa,b,c,
Anais
Co ma-Gómeza,b,c,
Ma ga i a
Pé ez-Ga cíaa,b,c,
Ca men
Ma ín-Sie aa,b,c,
Pila
Rincón-Mayoa,b,c,
Juan
An onio
Pinedad,
Luis
Miguel
Realb,c,e,1,
Juan
Macíasa,b,c,d,∗,1
aHospi al
Uni e si a io
Vi gen
de
Valme,
Se illa,
Spain
bIns i u o
de
Biomedicina
de
Se illa
(IBiS),
Spain
cCen o
de
In es igación
Biomédica
en
Red
de
En e medades
In ecciosas
(CIBERINFEC),
Spain
dDepa men
o
Medicine,
Uni e si y
o
Se illa,
Se illa,
Spain
eDepa men
o
Medical
Biochemis y,
Molecula
Biology
and
Immunology,
Uni e si y
o
Se illa,
Se illa,
Spain
a
i
c
l
e
i
n
o
A icle
his o y:
Recei ed
8
No embe
2024
Accep ed
4
Feb ua y
2025
A ailable
online
xxx
Keywo ds:
HIV
Hepa i is
B
i us
An i e o i al
he apy
Mic oelimina ion
Vaccine
a
b
s
a
c
In oduc ion:
The
WHO
p oposed
o
achie e
hepa i is
B
i us
(HBV)
elimina ion
by
2030,
bu
his
goal
is
e y
di ficul
o
a ain.
People
li ing
wi h
HIV
(PLWH)
may
ep esen
a
subse
whe e
mic oelimina ion
can
be
eached
soone .
This
s udy
aimed
o
assess
he
incidence
o
HBV
in ec ions
and
changes
in
he
p e alence
o
ac i e
HBV
in ec ion
among
PLWH
in
Spain.
Me hods:
A
p ospec i e
coho
s udy,
including
all
PLWH
a ending
a
uni e si y
hospi al
in
Sou he n
Spain
om
Janua y
2011
o
Decembe
2022,
was
conduc ed.
Se um
HBV
ma ke s
(HBsAg,
an i-HBs,
an i-
HBc)
we e
es ed
a
baseline
and
a
leas
yea ly
a e wa ds.
Inciden
cases
we e
iden ified
by
an i-HBc
se ocon e sion.
Resul s:
Nine
hund ed
and
eigh y
PLWH
we e
included.
A
he
beginning
o
he
s udy,
26
(2.7%
[95%
CI:
1.7–3.8%])
es ed
posi i e
o
HBsAg,
428
(43.7%
[95%
CI:
42.8–49.4%])
o
an i-HBc
and
386
(39.4%
[95%
CI:
39.8–46.3%])
o
an i-HBs.
A e
a
median
(Q1–Q3)
ollow-up
o
115
(35–143)
mon hs,
wo
new
in ec ions
we e
documen ed,
yielding
an
incidence
a e
o
2.24
(95%
CI:
0.27–8.1)/100,000
pe son-
yea s.
The
p e alence
o
ac i e
HBV
in ec ion
declined
om
3.4%
[95%
CI:
2.0–5.0%]
in
2011
o
2%
[95%
CI:
1.0–3.0%]
in
2022
(p
o
linea
end
=
0.027).
A
he
end
o
he
s udy,
167
(24%)
PLWH
s ill
we e
suscep ible
o
HBV.
Conclusions:
The
incidence
o
HBV
in ec ion
among
PLWH
in
Spain
is
close
o
he
WHO
a ge .
The
p e a-
lence
o
ac i e
HBV
in ec ion
has
dec eased
subs an ially
du ing
he
las
12
yea s.
These
da a
sugges
ha
mic o-elimina ion
o
HBV/HIV
in ec ion
is
on
he
ack
in
Spain.
©
2025
The
Au ho s.
Published
by
Else ie
Espa˜
na,
S.L.U.
on
behal
o
Sociedad
Espa˜
nola
de
En e medades
In ecciosas
y
Mic obiolog´
ıa
Cl´
ınica.
This
is
an
open
access
a icle
unde
he
CC
BY-NC-ND
license
(h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/).
P og esión
hacia
la
mic oeliminación
de
la
in ección
po
el
i us
de
la
hepa i is
B
en
pe sonas
que
i en
con
VIH
en
Espa˜
na
Palab as
cla e:
VIH
Vi us
de
la
hepa i is
B
T a amien o
an i e o i al
Mic oeliminación
Vacuna
e
s
u
m
e
n
In oducción:
La
OMS
p opuso
la
eliminación
del
i us
de
la
hepa i is
B
(VHB)
en
2030.
Las
pe sonas
que
i en
con
VIH
(PVVIH)
pueden
ep esen a
un
subg upo
en
el
que
la
mic oeliminación
pod ía
alcanza se
an es.
Nues o
obje i o
ue
e alua
la
incidencia
de
in ecciones
po
VHB
y
los
cambios
de
p e alencia
de
la
in ección
ac i a
po
VHB
en e
las
PVVIH
en
Espa˜
na.
Abb e ia ions:
WHO,
Wo ld
Heal h
O ganiza ion;
HBV,
hepa i is
B
i us;
PLWH,
people
li ing
wi h
HIV;
TFV,
eno o i ;
FTC,
em ici abine;
3TC,
lami udine;
ART,
an i e o i al
he apy;
MSM,
men
who
ha e
sex
wi h
men;
PWID,
people
who
injec ed
d ugs.
∗Co esponding
au ho .
E-mail
add ess:
[email p o ec ed]
(J.
Macías).
1These
au ho s
make
equal
con ibu ions.
h ps://doi.o g/10.1016/j.eimc.2025.02.003
0213-005X/©
2025
The
Au ho s.
Published
by
Else ie
Espa˜
na,
S.L.U.
on
behal
o
Sociedad
Espa˜
nola
de
En e medades
In ecciosas
y
Mic obiolog´
ıa
Cl´
ınica.
This
is
an
open
access
a icle
unde
he
CC
BY-NC-ND
license
(h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/).
Please
ci e
his
a icle
as:
M.
San os,
J.
Ma ín
Ca mona,
A.
Co ma-Gómez
e
al.,
P og ession
owa ds
mic oelimina ion
o
hepa i is
B
i us
in ec ion
among
people
li ing
wi h
HIV
in
Spain,
En e m
In ecc
Mic obiol
Clin.,
h ps://doi.o g/10.1016/j.eimc.2025.02.003
ARTICLE IN PRESS
G Model
EIMC-2963;
No.
o
Pages
8
M.
San os,
J.
Ma ín
Ca mona,
A.
Co ma-Gómez
e
al.
En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
Mé odos:
Es udio
de
coho e
p ospec i o,
incluyendo
a
odas
las
PVVIH
a endidas
en
un
hospi al
uni e -
si a io
en
el
su
de
Espa˜
na
desde
ene o
de
2011
has a
diciemb e
de
2022.
Se
analiza on
los
ma cado es
sé icos
de
VHB
(HBsAg,
an i-HBs,
an i-HBc)
al
inicio
y
al
menos
anualmen e.
Resul ados:
Se
incluye on
980
PVVIH.
A
la
en ada
en
el
es udio,
26
(2,7%
[IC
95%:
1,7-3,8%])
die on
posi i o
pa a
HBsAg,
428
(43,7%
[IC
95%:
42,8-49,4%])
pa a
an i-HBc
y
386
(39,4%
[IC
95%:
39,8-46,3%])
pa a
an i-
HBs.
T as
un
seguimien o
mediano
(Q1-Q3)
de
115
(35-143)
meses,
documen amos
dos
nue as
in ecciones
( asa
de
incidencia
de
2,24
[IC
95%:
0,27-8,1]/100.000
pe sonas-a˜
no).
La
p e alencia
de
la
in ección
ac i a
po
VHB
disminuyó
del
3,4%
[IC
95%:
2,0-5,0%]
en
2011
al
2%
[IC
95%:
1,0-3,0%]
en
2022
(p
pa a
endencia
lineal
=
0,027).
Al
finaliza
el
es udio,
167
(24%)
PVVIH
seguían
siendo
suscep ibles
al
VHB.
Conclusiones:
La
incidencia
de
in ección
po
VHB
en e
las
PVVIH
en
Espa˜
na
se
ap oxima
al
obje i o
de
la
OMS.
La
p e alencia
de
la
in ección
ac i a
po
VHB
ha
disminuido
sus ancialmen e
en
los
úl imos
12
a˜
nos.
Es os
da os
sugie en
que
la
mic oeliminación
de
la
coin ección
VHB/VIH
es á
p óxima
en
Espa˜
na.
©
2025
Los
Au o es.
Publicado
po
Else ie
Espa˜
na,
S.L.U.
en
nomb e
de
Sociedad
Espa˜
nola
de
En e medades
In ecciosas
y
Mic obiolog´
ıa
Cl´
ınica.
Es e
es
un
a ´
ıculo
Open
Access
bajo
la
licencia
CC
BY-NC-ND
(h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/).
In oduc ion
Ch onic
hepa i is
B
i us
(HBV)
in ec ion
emains
a
majo
public
heal h
conce n,
causing
820,000
dea hs
wo ldwide
due
o
ci hosis
and
hepa oca cinoma.1The
es ima ed
global
p e alence
o
ch onic
HBV
in ec ion
is
3.61%.2In
2016,
he
WHO
p oposed
o
achie e
elimina ion
o
i al
hepa i is
by
2030.3Elimina ion
indica o s
o
HBV
in ec ion
include
eaching
a
yea ly
incidence
o
new
cases
o
11
pe
100,000
by
2025
and,
finally,
a
goal
o
2
pe
100,000
by
2030.4HBV
elimina ion
would
equi e
diagnosis
o
mos
ac i e
in ec ions,
ea men
o
diagnosed
cases
and,
mainly,
widesp ead
accina ion
o
suscep ible
people.
Howe e ,
un o una ely,
la ge-
scale
accina ion
p og ams
a e
no
cu en ly
being
implemen ed
wo ldwide.4Ba ie s
o
uni e sal
accina ion
include
accine
a ail-
abili y,
cos s,
lack
o
awa eness
o
he
benefi s
o
he
accine
and
accine
hesi ancy.5,6 The
WHO
a ge
will
likely
be
he e o e
di -
ficul
o
a ain.
P esen ly,
da a
on
he
p og ess
o
HBV
elimina ion
a e
limi ed,
p ima ily
elying
on
modeling
s udies.7
The
wo ldwide
p e alence
o
HBV
in ec ion
among
people
li -
ing
wi h
HIV
(PLWH)
is
es ima ed
o
be
7.6%.8Howe e ,
se e al
ea u es
o
PLWH
sugges
ha
HBV
mic o-elimina ion
could
be
eas-
ie
o
ob ain
in
such
a
popula ion9:
(i)
PLWH
unde go
close
clinical
moni o ing
han
he
gene al
popula ion,
so
ha
a
highe
p opo ion
o
PLWH
has
a
diagnosis
o
HBV
se os a us;
(ii)
he e
a e
ecommen-
da ions
om
many
heal h
se ices
o
accina ion
o
PLWH
agains
HBV10;
(iii)
ce ain
an i e o i al
d ugs,
such
as
eno o i
(TFV),11
em ici abine
(FTC)12 and
lami udine
(3TC),13 possess
an i-HBV
ac i i y
and
may
con e
p o ec ion
agains
inciden
HBV
in ec ions
in
PLWH.14 Fo
he
abo e-s a ed
easons,
PLWH
may
ep esen
a
unique
oppo uni y
o
explo ing
HBV
mic oelimina ion
e olu ion.
Howe e ,
again,
da a
on
how
he
incidence
o
HBV
in ec ion
among
PLWH
is
e ol ing
along
he
wo ld
a e
e y
sca ce.
Ou
aim
was
o
assess
he
incidence
o
new
cases
o
HBV
in ec-
ion
among
PLWH
in
Spain,
as
well
as
o
app aise
changes
in
he
se ial
p e alence
o
ac i e
in ec ion
in
his
popula ion.
Me hods
Pa ien s
and
design
All
PLWH
a ending
he
In ec ious
Diseases
Uni
o
a
e ia y-
ca e
uni e si y
hospi al
in
Sou he n
Spain
om
Janua y
2011
o
Decembe
2022
we e
included
in
his
p ospec i e
coho
s udy.
PLWH
a e
seen
a
leas
e e y
six
mon hs.
An i e o i al
he -
apy
(ART)
was
gi en
acco ding
o
he
ecommenda ions
om
he
GeSIDA
Spanish
G oup.15 Acco ding
o
hese
ecommenda ions,
all
HIV/HBV-coin ec ed
pa ien s
should
be
ea ed
wi h
ART
com-
bina ions
including
TFV
plus
FTC
o
3TC.
In
addi ion,
all
PLWH
a e
ecommended
o
unde go
HBV
sc eening.
Se um
HBV
ma k-
e s
(HBsAg,
an i-HBs,
an i-HBc)
we e
es ed
a
baseline
and
a
leas
yea ly
a e wa ds.
HBV
accina ion
was
o e ed
o
suscep-
ible
pa ien s
acco ding
o
he
c i e ia
o
he
a ending
physician
un il
2019.
Since
Janua y
2020,
HBV
accina ion
was
ou inely
ecommended
o
all
suscep ible
pa ien s
a
each
isi .
Fo
HBV
ac-
cina ion,
pa ien s
we e
e e ed
o
specific
accine
deli e y
uni s.
Da a
we e
collec ed
om
May
o
Oc obe
2023.
Defini ion
c i e ia
Ac i e
HBV
in ec ion
was
diagnosed
when
se um
HBsAg
u ned
ou
o
be
posi i e.
A
new
HBV
in ec ion
was
diagnosed
when
an i-HBc
se ocon e sion
was
documen ed.
PLWH
who
es ed
pos-
i i e
o
an i-HBc
we e
classified
as
exposed,
while
hose
who
we e
nega i e
o
bo h
an i-HBs
and
an i-HBc
we e
ca ego ized
as
suscep ible.
Subjec s
bea ing
an i-HBs
wi hou
an i-HBc
we e
conside ed
o
show
a
p io
accina ion
p ofile.
De e mina ion
o
HBV
in ec ion
se um
ma ke s
HBsAg,
an i-HBs
and
an i-HBc
we e
es ed
by
elec ochemilu-
minescence
immunoassay
Elecsys®,
using
comme cially
a ailable
equipmen s
(Roche
Diagnos ics,
Mannheim,
Ge many).
Da a
analysis
The
p ima y
a iable
o
he
s udy
was
he
de elopmen
o
a
new
HBV
in ec ion.
The
seconda y
a iable
was
ac i e
HBV
in ec ion.
The
incidence
o
new
HBV
in ec ions
was
calcula ed
as
he
numbe
o
pa ien s
showing
an i-HBc
se ocon e sion
di ided
by
he
numbe
o
pa ien -yea s
a
isk,
i.e.
he
ime
in
ollow-up
o
hose
who
we e
se onega i e
o
an i-HBc.
Likewise,
he
se ial
p e alence
o
ac i e
HBV
a
each
yea
o
he
s udy
was
es ima ed.
Ca ego ical
a iables
a e
exp essed
as
numbe s
(pe cen -
age)
and
con inuous
a iables
as
median
(qua ile
1–qua ile
3
[Q1–Q3]).
95%
confidence
in e als
(CI)
a e
p o ided
o
he
main
a es.
F equencies
we e
compa ed
by
he
Chi-squa e
es
o
lin-
ea
end
and
con inuous
a iables
by
he
F iedman
es .
Fac o s
associa ed
wi h
HBV
exposu e
in
he
uni a ia e
analysis
wi h
a
p- alue
≤0.1,
along
wi h
age
and
sex,
we e
en e ed
in o
a
bina y
logis ic
eg ession
model.
These
analyses
we e
ca ied
ou
using
he
IBM
SPSS
26.0
(IBM
Co po a ion,
Chicago,
IL,
USA)
and
he
S a a
16.1
S a is ics/Da a
Analysis
(S a aCo p
College
S a ion,
TX,
USA)
packages.
E hics
The
s udy
was
app o ed
by
he
E hics
Commi ee
o
he
Hos-
pi al
Uni e si a io
Vi gen
de
Valme.
All
PLWH
ga e
hei
w i en
2
ARTICLE IN PRESS
G Model
EIMC-2963;
No.
o
Pages
8
M.
San os,
J.
Ma ín
Ca mona,
A.
Co ma-Gómez
e
al.
En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
Table
1
Cha ac e is ics
o
he
popula ion
(n
=
980).
Cha ac e is ics
Values
Male
sex,
n
(%)
784
(80.0)
Baseline
age,
yea s*44
(38–50)
Coun y
o
bi h
Spain,
n
(%)
919
(94.2)
Rou e
o
HIV
in ec ion,
n
(%)
-
PWID
433
(44.2)
-
MSM
313
(31.9)
-
O he s
234
(23.9)
HBV
ma ke s
a
joining
he
s udy,
n
(%)
-
Posi i e
HBsAg
26
(2.7)
-
Posi i e
an i-HBs
386
(39.4)
-
Posi i e
an i-HBc
428
(43.7)
-
Posi i e
an i-HBc/nega i e
an i-HBs
187
(19.1)
-
Posi i e
an i-HBs/nega i e
an i-HBc
186
(19.0)
-
Nega i e
an i-HBs/nega i e
an i-HBc
300
(30.6)
Exposu e
o
ART
du ing
he
ollow-up,
n
(%)
-
TFV
750
(77.0)
-
3TC/FTC 910
(93.0)
PWID:
people
who
injec ed
d ugs;
MSM:
men
who
ha e
sex
wi h
men;
ART:
an i e o i al
ea men ;
TFV:
eno o i ;
3TC:
lami udine;
FTC:
em ici abine.
*Median
(Q1–Q3).
in o med
consen
be o e
en ollmen .
This
s udy
was
conduc ed
in
acco dance
wi h
he
Decla a ion
o
Helsinki.
Resul s
Cha ac e is ics
o
he
popula ion
Nine
hund ed
and
eigh y
PLWH
we e
included
in
he
s udy.
Among
pa ien s
included
in
2011,
483
(92.4%)
we e
ecei ing
ART,
as
we e
524
(91.8%)
pa icipan s
in
2012
and
574
(94.4%)
o
hose
analyzed
in
2013.
F om
2014
onwa ds,
acco ding
o
he
Spanish
na ional
guidelines,16 all
pa ien s
we e
p esc ibed
ART.
The
cha -
ac e is ics
o
he
popula ion
a e
desc ibed
in
Table
1.
The
age
and
he
ou e
o
HIV
in ec ion
o
he
pa ien s
analyzed
each
yea
du -
ing
he
s udy
a e
depic ed
in
Fig.
1.
The
median
ollow-up
was
115
(35–143)
mon hs.
Fi y-nine
(6%)
PLWH
died
and
189
(19.3%)
we e
los
o
ollow-up
du ing
he
s udy
pe iod.
Baseline
ma ke s
o
HBV
in ec ion
When
pa ien s
joined
he
s udy,
26
(2.7%
[95%
CI:
1.7–3.8%])
pa ien s
es ed
posi i e
o
HBsAg,
428
(43.7%
[95%
CI:
42.8–49.4%])
o
an i-HBc
and
386
(39.4%
[95%
CI:
39.8–46.3%])
o
an i-HBs.
The
p esence
o
an i-HBc,
i.e.,
ha
o
p e ious
HBV
exposu e,
was
associa ed
wi h
olde
age
and
wi h
ha ing
acqui ed
HIV
h ough
in a enous
d ug
use
(Table
2).
Incidence
o
new
HBV
in ec ions
An i-HBc
se ocon e sion
was
documen ed
in
wo
PLWH
du ing
he
ollow-up.
This
figu e
yields
an
incidence
a e
o
HBV
in ec ions
o
2.24
(95%
CI:
0.27–8.1)/100,000
pe son-yea s.
Bo h
we e
men.
One
o
hem
was
a
man
who
has
sex
wi h
men
(MSM)
and
he
o he
was
an
injec ing
d ug
use .
The
fi s
se ocon e sion
case
occu ed
in
2011
and
he
second
one
in
2014.
None
o
hese
pa ien s
had
p e-
iously
been
accina ed.
One
o
hem
was
on
da una i / i ona i
plus
e a i ine
he apy.
The
o he
was
on
TFV
plus
FTC
plus
ne i-
apine,
bu
his
adhe ence
was
no
op imal,
because
he
missed
doses
wi h
some
equency.
Changes
in
HBV
ma ke s
by
yea s
The
p e alence
o
ac i e
HBV
in ec ion
ell
om
3.4%
(95%
CI:
2.0–5.0%]
in
2011
o
2%
(95%
CI:
1.0–3.0%]
in
2022
(p
o
linea
end
=
0.027)
(Fig.
2).
Figu es
obse ed
each
yea
du ing
he
s udy
pe iod
a e
shown
in
Fig.
2.
Two
hund ed
and
fi y- wo
(52%)
indi iduals
showed
p io
HBV
exposu e
in
2011,
e sus
298
(43.1%)
in
2022.
The
co esponding
figu es
o
subjec s
wi h
p io
accina ion
p ofile
and
suscep ible
indi iduals
we e,
espec i ely,
75
(15%)
and
158
(33%)
in
2011
and
227
(33%)
and
167
(24%)
(p
<
0.001)
(Fig.
3).
O
205
PLHIV
suscep-
ible
a
he
ime
o
da a
closu e,
119
(58.0%)
ecei ed
a
leas
one
accine
dose,
bu
we
do
no
ha e
da a
on
how
many
ecei ed
he
ull
accina ion
egimen.
Among
he
pa icipan s
in
2011,
36
(38%)
MSM
had
been
p e-
iously
exposed
o
HBV,
30
(31%)
showed
a
se ological
p ofile
o
p io
accina ion
and
29
(31%)
we e
suscep ible
o
HBV
in ec ion.
In
2022,
hese
figu es
we e
73
(27%),
136
(50%)
and
62
(23%),
espec i ely
(p
<
0.001)
(Fig.
4a).
Among
people
who
injec ed
d ugs
(PWID)
analyzed
in
2011,
193
(73%)
had
been
o me ly
exposed
o
HBV,
13
(5%)
showed
a
accina ion
p ofile
and
59
(22%)
we e
sus-
cep ible.
In
2022,
he
numbe
o
exposed
PWID
was
189
(74%),
ha
o
wi h
accina ion
p ofile
had
inc eased
o
27
(11%)
and
38
(15%)
emained
suscep ible
o
HBV
in ec ion
(p
=
0.029)
(Fig.
4b).
Discussion
This
s udy
shows
ha
he
cu en
incidence
o
HBV
in ec ion
among
PLWH
in
Spain
is
low,
alling
below
he
WHO-p oposed
miles one
o
2025
and
nea ing
he
a ge
o
2030.
Acco dingly,
he
p e alence
o
ac i e
HBV
in ec ion
has
no ably
dec eased
du ing
he
las
12
yea s,
and
no
new
HBV
in ec ion
case
was
obse ed
du ing
he
final
eigh
yea s
o
he
s udy.
These
da a
poin
ou
ha
mic oe-
limina ion
o
HBV
in ec ion
in
PLWH
is
p og essing
e ec i ely
in
ou
coun y.
The
low
incidence
o
new
cases
and
he
declining
p e alence
o
ac i e
HBV
in ec ion
obse ed
in
PLWH
he ein
can
be
a ibu ed
o,
a
leas ,
h ee
ac s:
(i)
he
widesp ead
use
o
ART
ac i e
agains
HBV
in
his
popula ion.
P e ious
s udies
ha e
demons a ed
ha
his
he apy
p o ec s
agains
he
occu ence
o
deno o
HBV
in ec ion17;
(ii)
an
inc easing
p opo ion
o
pa ien s
a e
p o ec ed
by
he
HBV
accine.
This
ac
has
been
associa ed
wi h
a
decline
in
bo h
he
incidence
and
p e alence
o
HBV
coin ec ion
among
PLWH
in
o he
coun ies18;
(iii)
a
dec easing
p opo ion
o
PWID,
who
a e
a
a
highe
isk
o
exposu e
o
HBV
han
o he
PLWH,
obse ed
h ough-
ou
he
s udy
pe iod.
These
esul s
align
wi h
findings
om
o he
PLWH
popula-
ions
in
Spain.
Fo
ins ance,
a
se ial
p e alence
s udy
conduc ed
in
ano he
coho
o
PLWH
in
Spain
epo ed
a
dec ease
in
he
p o-
po ion
o
HIV/HBV-coin ec ed
pa ien s
om
4.9%
in
2002
o
3.2%
in
2018.19 Likewise,
ano he
Spanish
s udy
epo ed
ha
he
inci-
dence
o
acu e
hepa i is
B
was
low
and
had
p og essi ely
declined
om
2000
o
2018.20 Simila
esul s
o
hose
obse ed
in
his
s udy
ha e
also
been
ound
in
Ge many.18
Despi e
a
p oac i e
e e al
campaign
o
HBV
accina ion
in
all
eligible
pa ien s,
pa icula ly
du ing
he
la e
yea s
o
he
s udy,
a
qua e
o
he
PLWH
in
his
coho
emained
suscep i-
ble
o
his
in ec ion
a
he
end
o
he
ollow-up
pe iod.
This
ac
is
a
consequence
o ,
a
leas ,
wo
easons:
(i)
PLWH
exhibi
a
poo e
esponse
o
he
hepa i is
B
accine
compa ed
o
he
gene al
popula ion,21 pa icula ly
hose
wi h
less
han
350
CD4/mm3.22
Schedules
specifically
ecommended
o
PLWH,23 such
as
double-
dose
o
ou -dose
accina ion
schemes,
yield
a
be e
esponse
han
s anda d
schedules,24 bu
s ill
wo se
han
ha
obse ed
in
he
gen-
e al
popula ion.
Wi h
ega ds
o
his
issue,
Heplisa -B® accine,
a
3
ARTICLE IN PRESS
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No.
o
Pages
8
M.
San os,
J.
Ma ín
Ca mona,
A.
Co ma-Gómez
e
al.
En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
Fig.
1.
(A)
Median
(Q1–Q3)
age
and
(B)
ou e
o
HIV
in ec ion
o
he
pa ien s
analyzed
each
yea
in
he
s udy.
ecombinan
accine,
has
been
shown
o
con e
p o ec ion
o
non-
immunized
PLWH25 and
PLWH
who
did
no
espond
o
s anda d
accina ion
egimens.26 Fu he
and
wide
s udies
wi h
his
ac-
cine
a e
equi ed,
bu
i
hese
esul s
a e
confi med,
his
accine
could
significan ly
educe
he
a e
o
PLWH
wi hou
immuniza ion.
Fu he mo e,
PLWH
expe ience
a
mo e
apid
waning
immuni y
han
hose
wi hou
HIV21;
(ii)
p og ams
based
on
e e al
o
ac-
cine
deli e y
uni s
o he
han
hose
p o iding
ca e
o
PLWH,
as
he
one
used
in
his
coho ,
yield
subop imal
esul s.27 Despi e
he
low
incidence
o
HBV
in ec ion
and
he
declining
p e alence
o
ac i e
in ec ion
obse ed
in
ou
a ea,
achie ing
he
final
goal
o
mic oelimina ion
will
likely
equi e
a
much
lowe
p opo ion
o
suscep ible
indi iduals.
To
his
end,
new
accina ion
s a egies
and
p og ams
aimed
a
achie ing
be e
linkage
o
accina ion
sched-
ules
mus
be
de eloped
while
also
ad ancing
he
esea ch
o
no el
accines
wi h
imp o ed
e ficacy.
In
PLWH
in
de eloped
coun ies,
se e al
ci cums ances
may
lead
o
ea lie
mic oelimina ion
o
HBV
in ec ion
han
in
o he
subse s.
Thus,
HBV
sc eening
is
usually
ecommended28 and
con-
duc ed
in
all
pa ien s.
In
addi ion,
ac i e
d ugs
agains
HBV
a e
e y
commonly
gi en
as
a
pa
o
many
ecommended
ART
combina ions.28 Mo eo e ,
accina ion
o
suscep ible
PLWH
is
also
gene ally
ad ised.28 Howe e ,
all
hese
ac ions
could
no
be
su -
ficien
o
achie e
he
WHO
mic oelimina ion
goals.
In
ac ,
in
a
s udy
ca ied
ou
in
Taiwan
in
PLWH
who
had
unde gone
neona al
HBV
accina ion
and
we e
on
ART
con aining
d ugs
wi h
an i-
HBV
ac i i y,
an
incidence
o
new
in ec ions
much
highe
han
he
WHO
a ge
was
obse ed.29 This
ac
could
be
explained
by
a
significan
a e
o
waning
immuni y,29 which
could
ha e
been
lowe
in
ou
pa ien s.
Indeed,
neona al
HBV
accina ion
s a ed
in
Spain
a
he
beginning
o
he
1990s,
and
mos
o
ou
pa ien s
we e
bo n
be o e.
Because
o
his,
hey
ecei ed
he
ac-
4
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No.
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8
M.
San os,
J.
Ma ín
Ca mona,
A.
Co ma-Gómez
e
al.
En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
Fig.
2.
P opo ion
o
pa ien s
wi h
ac i e
HBV
in ec ion
pe
yea .
Fig.
3.
Changes
in
se ological
p ofile
o
he
s udy
popula ion
pe
yea .
Table
2
Basal
ac o s
associa ed
wi h
HBV
exposu e
(n
=
980).
Cha ac e is ic
An i-HBc
posi i e,
n
(%)
OR
uni a ia e
(95%
CI)
p
uni a ia e
Adjus ed
OR
(95%
CI)
p
mul i a ia e
Sex,
n
(%)
1.8
(1.3–2.6)
<0.001
1.4
(0.9–2.1)
0.168
-
Male
364
(49.1)
-
Female
64
(34.6)
Age,
n
(%)
4.3
(3.2–5.7)
<0.001
3.1
(2.2–4.5)
<0.001
-
<44
yea s
117
(27.5)
-
≥44
yea s
311
(62.1)
Coun y
o
bi h,
n
(%)
1
(0.6–1.7)
0.994
-
Spain 402
(46.2)
-
Elsewhe e
24
(46.2)
Rou e
o
in ec ion,
n
(%)
-
PWID
295
(73.6)
Re e ence
Re e ence
-
MSM
86
(28.1)
0.1
(0.1–0.2)
<0.001
0.2
(0.1–0.3)
<0.001
-
O he s
47
(21.5)
0.1
(0.1–0.1)
0.1
(0.1–0.2)
PWID:
people
who
injec ed
d ugs;
MSM:
men
who
ha e
sex
wi h
men.
5

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No.
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M.
San os,
J.
Ma ín
Ca mona,
A.
Co ma-Gómez
e
al.
En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
Fig.
4.
Changes
in
se ological
p ofile
pe
yea
acco ding
o
he
ou e
o
HIV
in ec ion.
(A)
Men
who
ha e
sex
wi h
men
and
(B)
people
who
injec ed
d ugs.
cine
la e
in
hei
li es,
and
he
likelihood
o
loss
o
immune
p o ec ion
could
ha e
been
lowe
han
in
he
s udy
men ioned
abo e.
In
any
case,
achie ing
HBV
mic oelimina ion
will
equi e
no
only
he
ex ension
o
immune
p o ec ion
h ough
accina-
ion
bu
also
he
pe iodic
moni o ing
o
se um
an i-HBs
le els
wi h
boos ing
doses
o
hose
who
lose
his
ma ke .
Mo eo e ,
in
pa ien s
wi hou
immune
p o ec ion,
ART
including
d ugs
ac i e
agains
HBV
should
be
p io i ized
o e
nucleoside- ee
egimens.
The
cu en ly
a ailable
HIV
d ug
a mamen a ium
and
he
d ug
pipeline
include
egimens
ha
lack
ac i i y
agains
HBV.
These
include
o al
d ugs
o
combina ions,
as
dolu eg a i / ilpi i ine
o
isla a i ,
as
well
as
long-ac ing
injec able
an i e o i al
d ugs
such,
such
as
cabo eg a i / al eg a i
o
lenacapa i .
In es iga ional
he apies,
including
immuno he apies
and
b oadly
neu alizing
monoclonal
an ibodies,
also
show
no
ac i i y
agains
HBV.
The e-
o e,
i
is
essen ial
o
pe sonalize
an i e o i al
ea men
aking
in o
accoun
he
ac i i y
o
HBV- a ge ed
he apies.
In
ac ,
he
epo
o
acu e
HBV
hepa i is
cases
in
PLWH
who
we e
swi ched
o
non-HBV
p o ec i e
ARV
egimens30 suppo s
his
s a emen .
Ou
s udy
has
some
limi a ions,
no ably
being
a
single-cen e
analysis,
which
could
a oid
he
gene alizabili y
o
he
esul s
o
o he
a eas.
Howe e ,
he
managemen
o
PLWH
does
no
subs an-
ially
di e
ac oss
Spain
and
Wes e n
Eu ope,
gene ally
ollowings
common
na ional
and
Eu opean
guidelines.15,28 Acco dingly,
as
s a ed
abo e,
esul s
consis en
wi h
hose
epo ed
he e
ha e
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En e medades
In ecciosas
y
Mic obiología
Clínica
xxx
(xxxx)
xxx–xxx
been
ound
in
o he
s udies
in
ou
coun y,20 as
happened
in
o he
Eu opean
na ions.18 Because
o
his,
da a
like
hese
a e
expec ed
o
be
ound
in
he
Wes e n
Eu opean
a ea.
Howe e ,
he
landscape
o
HIV/HBV
is
likely
o
be
e y
di e en
in
o he
a eas,
pa icula ly
in
de eloping
coun ies.
Thus,
su eys
like
his
a e
wa an ed
in
o he
a eas.
A
second
limi a ion
is
he
una ailabili y
o
an
accu a e
his o y
o
HBV
accina ion
om
all
included
pa ien s.
Consequen ly,
we
had
o
define
he
p io
accina ion
p ofile
based
on
he
p esence
o
isola ed
an i-HBs.
In
any
case,
o
ou
knowledge,
his
is
he
fi s
analysis
o
he
incidence
o
HIV/HBV
coin ec ion
pe o med
in
a
la ge
coho
wi h
a
ollow-up
exceed-
ing
10
yea s.
This
cons i u es
he
main
s eng h
o
he
p esen
s udy.
In
summa y,
he
incidence
o
HBV
in ec ion
among
PLWH
on
ART
is
e y
low
in
Spain
and
he
p e alence
o
ac i e
in ec ions
is
significan ly
dec easing,
which
sugges
ha
mic oelimina ion
can
be
eached
by
he
WHO-p oposed
imeline.
Howe e ,
a
subs an ial
p opo ion
o
pa ien s
emain
suscep ible
o
HBV
in ec ion.
The e-
o e,
e o s
o
expand
HBV
immuniza ion
among
PLWH,
as
well
as
o
keep
he
immune
s a us
in
he
long
e m,
mus
be
ca ied
ou
o
defini i ely
elimina e
HIV/HBV
coin ec ion.
CRediT
au ho ship
con ibu ion
s a emen
MS
and
JAP
pe o med
he
s udy
p o ocol.
MS,
JMC,
ACG,
CMS,
MPG,
PRM
pe o med
da a
collec ion.
MS
w o e
he
manusc ip
and
p oduced
he
ables
and
figu es.
CMS
conduc ed
a
comp ehensi e
e iew
o
he
English
language.
LMR,
JAP
and
JM
we e
esponsible
o
e ision
o
he
manusc ip .
JAP
supe ised
he
en i e
p ocess.
Funding
This
s udy
has
been
unded
by
Ins i u o
de
Salud
Ca los
III
h ough
he
p ojec
“PI018/00606”
(co- unded
by
Eu opean
Regional
De elopmen
Fund/Eu opean
Social
Fund
“A
way
o
make
Eu ope”/“In es ing
in
you
u u e”).
CMS
is
suppo ed
by
CIBER
“Conso cio
de
In es igación
Biomédica
en
Red”
( e e ence
CB21/13/00118),
Ins i u o
de
Salud
Ca los
III,
Minis e io
de
Cien-
cia
e
Inno a ión
y
Unión
Eu opea
–
Nex gene a ionEU.
ACG
has
ecei ed
a
esea ch
ex ension
g an
om
Acciones
pa a
el
e ue zo
con
ecu sos
humanos
de
la
ac i idad
in es igado a
en
las
Unidades
Clínicas
del
Se icio
Andaluz
de
Salud
2021,
acción
B
(Clínico-
In es igado es)
(g an
numbe
B-0061-2021).
She
has
also
ecei ed
a
Juan
Rodés
g an
om
he
Ins i u o
de
Salud
Ca los
III
(g an
numbe
JR23/00066).
MS
has
ecei ed
a
Río
Ho ega
g an
om
he
Ins i u o
de
Salud
Ca los
III
(g an
numbe
CM21/00263).
JMC
has
ecei ed
a
Rio
Ho ega
g an
om
he
Ins i u o
de
Salud
Ca los
III
(g an
numbe
CM23/00255).
Conflic
o
in e es s
None
o
he
au ho s
ha e
a
conflic
o
in e es
o
his
s udy.
Da a
a ailabili y
We
would
like
o
hank
all
pa ien s
who
a e
always
eady
o
pa icipa e
in
s udies
so
ha
we
can
con inue
o
con ibu e
o
scien ific
knowledge.
We
hank
all
hose
who
pa icipa ed
in
he
p epa a ion
o
his
manusc ip .
Lea ning
om
he
expe-
ience
o
senio
esea che s
and
eamwo k
a e
he
key
o
success.
The
quali a i e
da a
on
which
he
analysis
p esen ed
he e
is
based
is
a ailable
om
he
co esponding
au ho
upon
easonable
eques ,
only
i
i
has
unde gone
e hical
e iew.
Re e ences
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RT,
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G,
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JJ.
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o
wo ldwide
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o
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hepa i is
B
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men
o
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2016–2021;
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