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FibroScan-AST Score vs Liver Stiffness for the Prediction of Liver Events After HCV Cure

Author: Corma-Gómez, A.; Corona-Mata, D; Martín-Carmona, Jésica; Galindo, MJ; Camacho, A; Martín-Sierra, C; Pineda Vergara, Juan Antonio; Real Navarrete, Luis Miguel; Macías Sánchez, Juan; GEHEP-011 Study Grp
Publisher: Oxford Univ Press
Year: 2025
DOI: 10.1093/ofid/ofae628
Source: https://idus.us.es/bitstreams/e563a606-19e3-4950-9ab3-729d84251fb0/download
Open Fo um In ec ious Diseases
MAJOR ARTICLE
Fib oScan-AST Sco e s Li e S i ness o he P edic ion
o Li e E en s A e HCV Cu e
Anaïs Co ma-Gómez,
1,2,3,
Diana Co ona-Ma a,
3,4,5,6
Jésica Ma ín-Ca mona,
1,2,3,7,
Ma ía José Galindo,
8
Angela Camacho,
3,4,5,6
Ca men Ma ín-Sie a,
1,2,
Ma ina Gallo-Ma ín,
3,4,5,6
Pila Rincón,
1
Ignacio Pe ez-Vale o,
3,4,5,6
Ma ga i a Pé ez-Ga cía,
1
Angela Ca asco-Do ado,
4,5,6,
Juan A. Pineda,
1,3,7
An onio Ri e o-Juá ez,
3,4,5,6,
An onio Ri e o,
3,4,5,6
Luis M. Real,
1,2,3,7,
and Juan Macías
1,2,3,7
; on behal o he GEHEP-011 S udy G oup
1
G upo de Vi ología Clínica e ITS Cinical Vi ology and STIs G oup, Uni o In ec ious Diseases and Mic obiology, de Hospi al Uni e si a io Vi gen de Valme, Se illa, Spain,
2
Ins i u o de Biomedicina de
Se illa (IBiS)/CSIC, Se illa, Spain,
3
Cen o de In es igación Biomédica en Red de En e medades In ecciosas (CIBERINFEC), Ins i u o de Salud Ca los III, Mad id, Spain,
4
Clinical Vi ology and Zoonoses
Resea ch G oup, Uni o In ec ious Diseases, Hospi al Uni e si a io Reina So ía, Có doba, Spain,
5
Ins i u o Maimónides de In es igación Biomédica de Có doba (IMIBIC), Có doba, Spain,
6
Uni e sidad
de Có doba (UCO), Có doba, Spain,
7
Uni e sidad de Se illa (US), Se illa, Spain, and
8
Uni o In ec ious Diseases, Hospi al Clínico Uni e si a io de Valencia, INCLIVA, Valencia, Spain
Backg ound. Li e s i ness (LS) p edic s li e complica ion occu ence in pa ien s wi h hepa i is C i us (HCV) in ec ion a e
sus ained i ological esponse (SVR). The Fib oScan-AST (FAST) sco e, which includes aspa a e amino ans e ase (AST) and
con olled a enua ion pa ame e (CAP; measu ed by Fib oScan), may imp o e he p edic ion abili y o isola ed LS. Ou aim
was o compa e he p edic i e capaci y o LS s FAST in his se ing.
Me hods. Mul icen e coho s udy including indi iduals wi h HIV/HCV coin ec ion o HCV monoin ec ion om Spain i
hey had (1) LS ≥9.5 kPa p e ea men , (2) SVR wi h a di ec -ac ing an i i al (DAA)–based egimen, and (3) LS and CAP
measu emen a SVR. Fa y li e disease (FLD) was de ined as CAP ≥248 dB/m. The p ima y ou come was he occu ence o a
li e complica ion (decompensa ion o hepa ocellula ca cinoma [HCC]) a e SVR.
Resul s. Th ee hund ed pa ien s we e included; 213 (71%) had HIV. A SVR, 131 (44%) had FLD. The FAST sco e was <0.35 in
182 (61%), 0.35–0.67 in 79 (27%), and >0.67 in 34 (12%) pa ien s. A e a median (Q1–Q3) ollow-up o 73 (53–83) mon hs, 36
(12%) li e complica ions (15 [5%] HCC) occu ed. LS was independen ly associa ed wi h an inc eased isk o de eloping li e
complica ions (sub–haza d a io [sHR], 1.06; 95% CI, 1.04–1.08; P < .001). In a sepa a e model, FAST ≥0.35 was also
independen ly associa ed wi h g ea e isk o li e complica ions (sHR, 8.12; 95% CI, 3.11–21.17; P < .001). The a ea unde he
ecei e ope a ing cha ac e is ics cu e o he model based on LS was 0.83 (95% CI, 0.76–0.91), and ha o he model based on
FAST was 0.80 (95% CI, 0.72–0.88; P = .158).
Conclusions. The FAST sco e p edic s he de elopmen o li e e en s a e SVR bu does no imp o e he p edic i e capaci y o
LS alone a his ime poin .
Keywo ds. FAST sco e; HCV in ec ion; li e complica ions; li e s i ness; sus ained i ological esponse.
Recei ed 15 July 2024; edi o ial decision 10 Oc obe 2024; accep ed 12 Oc obe 2024;
published online 8 Ap il 2025
Co espondence: Anaïs Co ma-Gómez, MD, PhD, Uni o In ec ious Diseases, Hospi al
Uni e si a io de Valme, A enida de Bella is a s/n, 41014 Se illa, Spain (anais.co go@gmail.
com); o Juan Macías, MD, PhD, Uni o In ec ious Diseases, Hospi al Uni e si a io de
Valme, A enida de Bella is a s/n, 41014 Se illa, Spain ([email p o ec ed]).
Open Fo um In ec ious Diseases
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h ps://doi.o g/10.1093/o id/o ae628
Wi h he a ailabili y o di ec -ac ing an i i al (DAA) agen s, hep-
a i is C i us (HCV) ch onic in ec ion has become a cu able in-
ec ion in nea ly all cases and a po en ially eliminable disease.
Howe e , li e - ela ed complica ions may occu in indi iduals
wi h HCV in ec ion e en a e achie ing sus ained i ological e-
sponse (SVR), pa icula ly among hose wi h ad anced li e
disease [1, 2]. The main challenge emains o ind ma ke s ha
accu a ely p edic clinical ou comes, allowing a mo e adequa e
su eillance a e SVR. In his se ing, li e s i ness (LS), mea-
su ed by ib a ion-con olled ansien elas og aphy (VCTE),
has p o en o be a s ong p edic o o li e e en s, bo h du ing
HCV ac i e in ec ion and a e HCV cu e [3]. Indeed, LS is he
e lec ion o li e ib osis and in lamma ion, as well as po al hy-
pe ension, so his p ocedu e has a high p edic i e alue o li e -
ela ed ou comes. Namely, a ale ≤14 kPa a he momen o SVR
iden i ies pa ien s wi h HCV in ec ion, ega dless o HIV coin ec-
ion, wi h low isk o de eloping li e complica ions, who may be
candida es o discon inue su eillance measu es [4]. Howe e ,
he mos impo an conce n is ha LS by i sel is insu icien o
de ec indi iduals a high isk o hese clinical ou comes, mainly
due o a limi ed posi i e p edic i e alue.
S ea o ic li e disease (SLD) is becoming a leading cause o
ch onic li e disease. SLD is es ima ed o in ol e nea ly one- hi d
o he global popula ion [5], and i is mainly ela ed o he obesi y
pandemic [6]. Among pa ien s wi h HCV in ec ion, he p e a-
lence o concomi an SLD could be highe , up o 50% [7, 8],
Fib oScan-AST Sco e s Li e S i ness o he P edic ion o Li e E en s A e HCV Cu e • OFID • 1
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due o a di ec lipogenic e ec o he i us o me abolic dys unc-
ion [9, 10] ha may pe sis a e HCV e adica ion [6, 11].
Concomi an SLD could play a ole in he eme gence o hese
li e - ela ed e en s, enhancing ib ogenesis and hepa oca cino-
genesis [12, 13]. The Fib oScan-AST (FAST) sco e, which in-
cludes aspa a e amino ans e ase (AST), con olled a enua ion
pa ame e (CAP; measu ed by VCTE), and LS, is an indica o
o s ea ohepa i is wi h g ea e isk o ib osis p og ession [14,
15]. The FAST sco e eliably p edic s clinical ou comes in pa ien s
wi h SLD [16, 17]. Consequen ly, i may also be a be e p edic o
o clinical ou comes han simple LS in pa ien s wi h HCV in ec-
ion who achie e SVR. Howe e , in o ma ion on his is lacking.
The e o e, he aim o his s udy was o compa e he p edic i e
alue o he FAST sco e s LS o li e complica ions in pa ien s
wi h HCV in ec ion and ad anced ib osis, wi h o wi hou HIV
coin ec ion, who achie e SVR.
METHODS
S udy Design and Pa ien s
This was a mul icen e p ospec i e s udy ha included
pa ien s wi h HCV ch onic in ec ion, wi h o wi hou HIV co-
in ec ion, om he GEHEP-011 Coho (clinical ials.go ID:
NCT04460157). Indi iduals we e ollowed a 17 in ec ious dis-
eases uni s h oughou Spain since Oc obe 2011. The inclusion
c i e ia o his s udy we e (1) an LS ≥9.5 kPa be o e s a ing
ea men , (2) ha ing achie ed SVR wi h egimens con aining
≥1 DAA, (3) ha ing an LS a ailable a he ime o SVR, and
(4) ha ing a CAP measu emen a he SVR ime poin .
Pa ien s wi h posi i e HBsAg we e excluded.
Follow-up
The da e o SVR was conside ed he baseline ime poin .
Following a common p o ocol, indi iduals we e clinically and
analy ically e alua ed e e y 6 mon hs. Pa icipan s we e ol-
lowed un il he da e o dea h, li e ansplan , HCV ein ec ion,
loss ollow-up, o censo ing da e (No embe 30, 2022). Pa ien s
wi h ci hosis we e managed acco ding o a speci ic p o ocol
epo ed elsewhe e [18]. In summa y, sc eening o hepa ocellu-
la ca cinoma (HCC) was pe o med biannually based on
alpha- e op o ein de e mina ion and li e ul asound examina-
ion. In addi ion, in pa ien s wi h LS ≥21 kPa, gas oesophageal
a ices su eillance was pe o med wi h se ial uppe gas oin-
es inal endoscopy.
Diagnosis C i e ia
Li e e en s included hepa ic decompensa ions (asci es, gas o-
in es inal bleeding due o po al hype ension, hepa ic enceph-
alopa hy, spon aneous bac e ial pe i oni is, and hepa o enal
synd ome) and HCC. Diagnosis o de no o HCC was es ab-
lished acco ding o he Ame ican Associa ion o he S udy
o Li e Diseases c i e ia [19]. Hepa ic decompensa ions we e
diagnosed as epo ed p e iously [20].
VCTE Examina ions
LS and CAP we e assessed by VCTE (Fib oScan, Echosens, Pa is,
F ance) acco ding o a s anda dized p ocedu e. An M p obe was
used. A each cen e , examina ions we e pe o med by a ained
ope a o . Fo de e mina ions o be conside ed eliable, e alua-
ions had o include a leas 10 measu emen s, wi h a success
a e ≥60% and an in e qua ile ange <30% o he median LS.
End Poin and O he De ini ions
The p ima y end poin o he s udy was he eme gence o a li e -
ela ed e en a e SVR. SVR was de ined as showing unde ec -
able HCV RNA 12 weeks a e he end o DAA-based he apy.
In line wi h p e ious s udies, a diagnosis o ci hosis was es ab-
lished in indi iduals wi h LS ≥14 kPa [4, 21, 22]. SLD was de ined
as CAP ≥248 dB/m [23]. The FAST sco e [14], which includes
AST, CAP, and LS, was calcula ed. A FAST sco e ≥0.67 was in-
e p e ed as likely nonalcoholic s ea ohepa i is (NASH) wi h i-
b osis s age ≥2, and a FAST sco e ≤0.35 was conside ed
unlikely NASH wi h ib osis ≥2.
S a is ical Analysis
The cumula i e incidence and incidence a e o li e - ela ed
complica ions we e es ima ed. The ime o he eme gence o
he main ou come was compu ed as he ime elapsed om SVR
o li e e en occu ence. Li e ables we e buil o calcula e he
su i al es ima es, exp essed as he cumula i e p opo ion o in-
di iduals who emained ee om de elopmen o he end poin .
Su i al cu es we e cons uc ed using he Kaplan-Meie me h-
od, and he log- ank es was pe o med o compa e he di e en
ca ego ies. Va iables associa ed wi h he main end poin in he bi-
a ia e analysis wi h P < .05, along wi h age and sex a bi h, we e
en e ed in a mul i a iable analysis, and Fine-G ay eg ession
models o compe ing isks we e c ea ed. Dea h by any cause
was conside ed he compe i i e e en . The pe o mance o he
models was assessed by compa ing ecei e ope a ing cha ac e -
is ics (ROC) cu es using he Hanley-McNeil es . The diagnos ic
accu acy o he FAST sco e and LS o he p edic ion o li e
e en s a e SVR was assessed by sensi i i y, speci ici y, posi i e
p edic i e alue (PPV), and nega i e p edic i e alue (NPV).
We calcula ed he pe cen age o missed e en s and he p opo ion
o indi iduals wi hou hepa ic complica ions iden i ied. All es i-
ma es a e p o ided, along wi h 95% CIs.
Fo he s a is ical analysis, he s a is ical package IBM SPSS
26 (SPSS Inc. IBM) and S a a, e sion 16.1 (S a aCo p), we e
used.
E hics
This s udy was conduc ed acco ding o he Helsinki Decla a ion
and was app o ed by he local e hics commi ee. All pa ien s
2 • OFID • Co ma-Gómez e al
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ga e w i en in o med consen be o e being ec ui ed in o he
coho .
RESULTS
Cha ac e is ics o he Pa ien s. Th ee hund ed pa ien s we e in-
cluded, 213 (71%) o whom we e people wi h HIV (PWH).
One hund ed i y- ou (51%) indi iduals showed compensa ed
ci hosis be o e s a ing DAA he apy. A he SVR ime poin ,
142 (47%) had an LS ≥14.0 kPa. Wi h espec o SLD, a he
SVR ime poin , 131 (44%) had CAP alues ≥248 dB/m. The
FAST sco e was <0.35 in 182 (61%), 0.35–0.66 in 79 (27%),
and ≥0.67 in 34 (12%) pa ien s. O he ele an cha ac e is ics
o he s udy popula ion a e lis ed in Table 1. All PWH we e
on an i e o i al he apy, and 161 (86%) o hem had a plasma
HIV-RNA <50 copies/mL. The median (Q1−Q3) CD4+ cell
coun was 489 (302–679) cells/mm
3
.
The median (Q1–Q3) ollow-up was 73 (57–83) mon hs.
Du ing his ime, 44 (15%) pa ien s died, 8 (3%) unde wen a
li e ansplan , and 10 (3%) we e los o ollow-up. The
main causes o dea h we e li e - ela ed e en s (16 [36.4%]),
non-HCC malignancies (12 [27.3%]), in ec ious diseases (5
[11%]), and o he causes (11 [25.3%]).
Li e -Rela ed E en s Pos -SVR
A e HCV cu e, 36 (12%) pa ien s de eloped a li e complica-
ion. The li e complica ion a e was 1.9 (1.4–2.6) pe 1000
pe son-yea s. The p obabili y o emaining ee om li e -
ela ed e en s a 1, 3, and 5 yea s a e he SVR ime poin
was 97% (94%–98%), 92% (88%–94%), and 89% (85%–92%),
espec i ely. Speci ically, 22 (7%) indi iduals had hepa ic de-
compensa ion, and 15 (5%) pa ien s de eloped HCC. Wi h e-
spec o li e decompensa ions, he mos equen one was
asci es (12 [4%]), ollowed by po al hype ensi e gas oin es i-
nal bleeding (7 [2%]) and hepa ic encephalopa hy (3 [1%]).
P edic ion o Clinical Ou come A e SVR
The p esence o SLD was no associa ed wi h he eme gence o
li e complica ions a e HCV cu e (Table 2). The p obabili y
o de eloping he main ou come was g ea e o pa ien s
wi h LS ≥14.0 kPa and o hose wi h highe FAST sco es
(Table 2, Figu e 1). A i s mul i a iable model was c ea ed, ad-
jus ed o sex a bi h, age, HIV coin ec ion, eme gence o li e
e en s be o e SVR, and LS a he SVR ime poin . In his anal-
ysis, LS a he SVR ime poin was independen ly associa ed
wi h an inc eased isk o de eloping li e complica ions
(Table 2). O he p edic o s a e shown in Table 2. In a second
model, adjus ed o sex a bi h, age, HIV coin ec ion, eme -
gence o li e e en s be o e SVR, FAST sco e a SVR, and
MELD sco e a he SVR ime poin , FAST ≥0.35 was indepen-
den ly associa ed wi h g ea e isk o li e complica ions
(Supplemen a y Table 1).
The diagnos ic pe o mance o he nonin asi e ools s udied
o he eme gence o li e complica ions a e HCV cu e is p e-
sen ed in Table 3. LS showed he highes NPV while missing he
lowes p opo ion o clinical e en s. In addi ion, LS <14 kPa
and FAST sco e ≤0.35 iden i ied a simila pe cen age o indi-
iduals who did no de elop li e complica ions a e SVR.
The PPV o he FAST cu o , 0.67, and he one o LS we e
all low (Table 3). The AUROC o he model based on LS was
0.83 (95% CI, 0.76–0.91), and ha o he model based on
FAST 0.80 (95% CI, 0.72–0.88; P = .158) (Figu e 2). The sensi-
i i y analysis, including pa ien s wi h SLD, yielded simila e-
sul s (Supplemen a y Da a). Sensi i i y analyses acco ding o
HIV coin ec ion a e shown in he Supplemen a y Da a.
DISCUSSION
This s udy sugges s ha , a e SVR, he FAST sco e is use ul o
iden i y indi iduals wi h HCV in ec ion and ad anced li e dis-
ease who a e a low isk o de eloping li e - ela ed ou comes.
Howe e , using he FAST sco e does no imp o e he p edic-
i e abili y o simple LS o he eme gence o hese clinical
e en s. Mo eo e , LS iden i ies a simila p opo ion o pa ien s
a low isk o li e complica ion occu ence while minimizing
he numbe o missed e en s.
Table 1. Baseline Cha ac e is ics o he S udy Popula ion (n = 300)
Pa ame e s Value
Be o e ea men
Sex a bi h, male, No. (%) 255 (85)
Age, y
a
52 (48–55)
IDUs, No. (%) 229 (76)
HCV GT3, No. (%) 58 (19)
Ci hosis (LS ≥14 kPa), No. (%) 191 (64)
CPT, class A, No. (%) 283 (94)
MELD sco e
a
7 (6–8)
Li e complica ion, No. (%) 37 (12)
A SVR ime poin
LS alue,
a
kPa 13.1 (8.8–22.6)
Diabe es melli us,
b
No. (%) 25 (8.4)
Alcohol consump ion, ≥50 g/d,
c
No. (%) 16 (7.2)
CPT class A, No. (%) 283 (94)
MELD sco e
a
6 (6–8)
Pla ele s coun , ×10
9
/µL
a
142 (107–187)
CAP alue, dB/m
a
241 (204–273)
FAST sco e
a
0.27 (0.12–0.49)
Da a a e No. (%) o pa ien s.
Abb e ia ions: CAP, con olled a enua ion pa ame e ; CPT, Child Pugh Tu co e sco e;
FAST, Fib oScan-AST; GT3, geno ype 3; HCV, hepa i is C i us; IDUs, injec ion d ug
use s; LS, li e s i ness; MELD, Model o End-S age Li e Disease sco e; SVR,
sus ained i ological esponse.
a
Median (Q1–Q3).
b
A ailable a 297 pa ien s.
c
A ailable a 220 pa ien s.
Fib oScan-AST Sco e s Li e S i ness o he P edic ion o Li e E en s A e HCV Cu e • OFID • 3
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Table 2. P edic o s o Li e Complica ions (n = 300)
Pa ame e Ca ego ies No. (%) P
bi a ia e
Adjus ed SHR (95% CI) P
mul i a iable
Sex a bi h Male
Female
32/255 (12.5)
4/45 (8.9)
.461 1.71 (0.53–5.54) .370
Age, y <52
≥52
15/150 (10.0)
21/150 (14.0)
.153 1.04 (0.99–1.08)
a
.051
IDU No
Yes
9/71 (12.7)
27/229 (11.8)
.886 — —
HCV geno ype O he s
GT3
26/242 (10.7)
10/58 (13.2)
.157 — —
HIV coin ec ion Nega i e
Posi i e
16/87 (12.4)
20/213 (9.4)
.014 0.37 (0.17–0.78) .009
Li e complica ion be o e DAA No
Yes
24/263 (9.0)
12/37 (32.4)
<.001 1.20 (0.44–3.28) .719
LS a SVR ime poin , kPa <14
≥14
3/158 (1.9)
33/142 (23.2)
<.001 1.06 (1.04–1.08) <.001
Alcohol in ake, g/d <50
≥50
28/204 (13.6)
2/16 (12.5)
.947 — —
Diabe es Melli us No
Yes
34/271 (12.5)
1/25 (4.0)
.261 — —
MELD a SVR ime poin <10
≥10
25/269 (9.3)
11/23 (47.8)
<.001 5.11 (2.19–11.92) <.001
CPT class a SVR ime poin A
B o C
31/283 (11.0)
5/10 (50.0)
<.001 — —
CAP alue a SVR ime poin , dB/m <248
≥248
20/169 (11.8)
16/131 (12.2)
.970 — —
Model including LS. The able shows pa ien cha ac e is ics associa ed wi h a g ea e p obabili y o de eloping li e complica ions a e HCV cu e. Fo he bi a ia e analysis, con inuous
a iables we e ca ego ized acco ding o he median alue o using clinically signi ican cu o poin s. Va iables associa ed wi h he main end poin in he bi a ia e analysis wi h P < .05,
along wi h age and sex a bi h, we e en e ed in a mul i a iable analysis, and a Fine-G ay eg ession model o compe ing was conduc ed. Dea h o any cause was conside ed he
compe i i e e en . Age and LS a he SVR ime poin we e en e ed as a con inuous a iable, and all o he pa ame e s we e en e ed as ca ego ical a iables.
Abb e ia ions: CAP, con olled a enua ion pa ame e ; CPT, Child Pugh Tu co e sco e; GT3, geno ype 3; HCV, hepa i is C i us; IDU, injec ion d ug use ; LS, li e s i ness; MELD, Model o
End-S age Li e Disease sco e; sHR, sub–haza d a io; SVR, sus ained i ological esponse.
a
Fo a 1-uni inc ease.
Figu e 1. P obabili y o emaining ee om li e - ela ed ou comes a e SVR, acco ding o FAST sco e. Abb e ia ions: FAST, Fib oScan-AST; SVR, sus ained i ological
esponse.
4 • OFID • Co ma-Gómez e al
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SLD is a g owing conce n because o i s high p e alence,
which is inc eased among indi iduals wi h HCV in ec ion [7,
8]. In he p esen s udy, he p opo ion o indi iduals wi h
SLD was g ea e han ha es ima ed among he gene al popu-
la ion [5, 24], which is no su p ising. In his se ing, he in e -
play be ween HCV in ec ion and SLD in ol es complex
in e ac ions ha can in luence he p og ession o li e disease.
Unde s anding he con ibu ion o ac o s such as ib osis and
SLD in his p edic i e model is c ucial o ailo ing ollow-up
ca e and in e en ions o indi iduals wi h HCV in ec ion
who achie e SVR. To da e, in o ma ion on his subjec is s ill
sca ce. While a aining SVR add esses he di ec e ec s o
HCV on he li e , indi iduals wi h pas HCV in ec ion may s ill
be a isk o me abolic issues, including SLD [6, 11, 25–27].
Indeed, insulin esis ance, which is commonly associa ed
wi h bo h HCV in ec ion and SLD, migh pe sis a e SVR,
con ibu ing o me abolic dis u bances [28]. In a ecen small
s udy, Chuaypen e al. demons a ed ha he imp o emen ob-
se ed in LS a e HCV e adica ion was no associa ed wi h a
dec ease o hepa ic s ea osis in a high p opo ion o he s udy
popula ion [11]. Thus, a e SVR, concomi an SLD migh
pu pa ien s wi h HCV ch onic in ec ion a a g ea e isk o
de eloping li e - ela ed complica ions, especially among hose
wi h ad anced li e disease. In ha ega d, s ea ohepa i is-
ela ed bioma ke s, speci ically he FAST sco e, ha e p o en
o be use ul o p edic ing he de elopmen o li e - ela ed ou -
comes in di e en se ings [15]. In he speci ic con ex o HCV
in ec ion, he p esence o s ea ohepa i is, as indica ed by a high
FAST sco e, may con ibu e o an inc eased isk o HCC a e
SVR [17]. The inclusion o AST, CAP, and LS in he FAST sco e
was in ended o p o ide a comp ehensi e assessmen o li e
disease, conside ing bo h ib osis and s ea ohepa i is. This
combina ion aims o cap u e a b oade spec um o li e con-
di ions ha may in luence he de elopmen o li e complica-
ions e en a e success ul HCV ea men .
The indings o his s udy e eal ha FAST sco e was inde-
penden ly associa ed wi h a highe isk o de eloping li e -
ela ed e en s, aligning wi h p e ious s udies demons a ing
he u ili y o he FAST sco e in p edic ing ou comes in indi id-
uals wi h SLD [17]. Howe e , he compa ison o he p edic i e
capaci ies o LS and he FAST sco e did no yield a s a is ically
signi ican di e ence. Mo eo e , LS showed a be e diagnos ic
pe o mance han FAST sco e wi h a g ea e NPV, maximizing
he p opo ion o pa ien s wi hou clinical e en s de ec ed
Table 3. Diagnos ic Th esholds o FAST Sco e and LS Assessed a he Time o SVR (n = 300)
Se (95% CI) Sp (95% CI)
PPV
(95% CI)
NPV
(95% CI)
Missed E en s,
n/N (%)
Pa ien s Wi hou E en s Iden i ied,
n/N (%)
FAST ≤0.35 83
(67–93)
67
(61–73)
26
(18–35)
97
(93–99)
6/183 (3.3) 177/300 (59)
FAST ≥0.67 33
(18–51)
91
(87–94)
35
(19–53)
91
(87–94)
24/264 (9.1) 240/300 (80)
LS ≥14 kPa 92
(77–98)
59
(52–65)
23
(16–31)
98
(94–100)
3/158 (1.9) 155/300 (52)
Abb e ia ions: FAST, Fib oScan-AST; LS, li e s i ness; NPV, nega i e p edic i e alue; PPV, posi i e p edic i e alue; Se, sensi i i y; Sp, speci ici y; SVR, sus ained i ological esponse.
Figu e 2. ROC cu es o FAST sco e and LS o he p edic ion o li e - ela ed e en s. Abb e ia ions: FAST, Fib oScan-AST; LS, li e s i ness; ROC, ecei e ope a ing
cha ac e is ics.
Fib oScan-AST Sco e s Li e S i ness o he P edic ion o Li e E en s A e HCV Cu e • OFID • 5
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while minimizing he numbe o missed complica ions. Finally,
he PPV o he FAST sco e was simila o ha o LS o occu -
ence o li e - ela ed e en s, sugges ing ha nei he LS no
FAST by i sel is use ul o accu a ely iden i y a - isk indi iduals.
The simila AUROC alues be ween he 2 models indica e ha
bo h a e simila ly e ec i e in iden i ying indi iduals a low isk
o de eloping li e complica ions. This implies ha he addi-
ional in o ma ion p o ided by CAP and AST in he FAST
sco e did no signi ican ly enhance he p ognos ic accu acy
o e LS alone. Tha sugges s ha ib osis, wha e e he o igin
is, ei he esidual o p io HCV in ec ion o o coexis ing
SLD, d i es he eme gence o complica ions a e HCV cu e.
This obse a ion aises impo an clinical implica ions, sug-
ges ing ha ocusing on ib osis assessmen by means o a
simple measu emen migh be su icien in his pa icula
pos -SVR se ing. Consequen ly, de ices measu ing SLD in ad-
di ion o LS a e no s ic ly equi ed o es ablish he p ognosis
in his se ing. Likewise, simple blood ma ke s o li e ib osis,
such as FIB-4 sco e, could be use ul in se ings whe e LS mea-
su emen de ices a e no a ailable [29]. De ini i ely, he e is a
need o ma ke s ha , while main aining he sensi i i y and
NPV o LS, inc ease speci ici y. Howe e , FAST sco e, e en
a i s uppe cu o alue, ails o mee his equi emen .
Resea ch in his a ea is impe a i e.
This s udy may ha e some limi a ions. Fi s , he absence o a
signi ican di e ence in p edic i e capaci y p omp s u he ex-
plo a ion in o he dynamic changes o LS and FAST o e longe
ollow-up pe iods. I is plausible ha he impac o SLD on ou -
comes may e ol e o e ime, in luencing he p ognos ic alue
o he FAST sco e in la e s ages pos -SVR. Second, concomi-
an como bidi ies and ac o s ela ed o li es yle ha e no
been analyzed in his s udy, pa icula ly alcohol in ake a e
SVR. None heless, his is he i s s udy compa ing he pe o -
mance o FAST sco e and LS o he p edic ion o li e e en s
a e SVR. Mo eo e , long- e m da a om a la ge sample o pa-
ien s wi h hepa i is C and ad anced li e disease in which in-
di iduals a e p ospec i ely ollowed in eal-li e clinical p ac ice
se ings a e p o ided. Those a e he s eng hs o his wo k.
In conclusion, he FAST sco e is independen ly associa ed
wi h a highe isk o li e - ela ed e en s a e HCV cu e.
Howe e , i does no su pass he p edic i e capaci y o LS
alone. Focusing on ib osis assessmen h ough LS o o he
bioma ke s may su ice in his pos -SVR se ing, ende ing ad-
di ional de ices measu ing SLD alongside LS no s ic ly
equi ed o p ognosis de e mina ion. This may be pa icula -
ly ele an o esou ce-limi ed cen e s ha ely on olde
de ices o o he ypes o elas og aphy. Fu u e s udies should
add ess SLD dynamic changes a e HCV ea men and
hei impac on ou comes o e ime, po en ially in luencing
he p ognos ic alue o he FAST sco e in la e s ages
pos -SVR.
Supplemen a y Da a
Supplemen a y ma e ials a e a ailable a Open Fo um In ec ious Diseases
online. Consis ing o da a p o ided by he au ho s o bene i he eade , he
pos ed ma e ials a e no copyedi ed and a e he sole esponsibili y o he
au ho s, so ques ions o commen s should be add essed o he co espond-
ing au ho .
Acknowledgmen s
Au ho con ibu ions. Concep ualiza ion: A.C.G., J.M., J.A.P., L.M.R.;
me hodology: A.C.G., J.M., J.A.P.; o mal analysis: A.C.G., J.M., J.A.P.; in-
es iga ion: all au ho s; esou ces: all au ho s; da a cu a ion: all au ho s;
w i ing—o iginal d a : A.C.G., J.M., J.A.P.; w i ing— e iew & edi ing:
all au ho s; isualiza ion: all au ho s; supe ision: L.M.R., J.M., A.C.G.,
J.A.P.; p ojec adminis a ion: A.C.G.; unding acquisi ion: A.C.G., J.A.P.
A.C.G. and J.M. had ull access o all he da a in he s udy and ake espon-
sibili y o he in eg i y o he da a and he accu acy o he da a analysis.
Da a a ailabili y. The da a ha suppo he indings o his s udy a e
a ailable om he co esponding au ho (A.C.G.) upon easonable eques .
Financial suppo . This s udy was pa ially unded by he Ins i u o de
Salud Ca los III (P ojec PI19/01443), in eg a ed in he Nacional I + D + i
2013–2016, and co unded by he Eu opean Union (ERDF/ESF,
“In es ing in you u u e”), Gilead Biomedical Resea ch Fellowship
P og am (GLD21_00096), and by GEHEP-SEIMC (GEHEP-011 p ojec ).
Anaïs Co ma-Gómez ecei ed a esea ch ex ension g an , Acción B,
Acción pa a el Re ue zo de la Ac i idad In es igado a en las Unidades
Clínicas del Se icio Andaluz de Salud 2021, Clínicos In es igado es (g an
numbe B-0061-2021). She has also ecei ed a Juan Rodès g an om he
Ins i u o de Salud Ca los III (g an numbe JR23/00066). Juan Macías
has ecei ed a esea ch ex ensión g an , Acción A, Acción pa a el
Re ue zo de la Ac i idad In es igado a en las Unidades Clínicas del
Se icio Andaluz de Salud 2021, In ensi icación anual (g an numbe
A1-0060-2021). Jésica Ma ín Ca mona is he ecipien o a Rio Ho ega
g an by Ins i u o de Salud Ca los III-ISCIII (CM23/00255). Diana
Co ona Ma a is he ecipien o a Rio Ho ega g an by Ins i u o de
Salud Ca los III-ISCIII (CM22/00176). Ángela Ca asco Do ado is he e-
cipien o an “INVESTIGO” esea ch p og am g an unded by he
Eu opean Union Nex Gene a ionEU Plan. An onio Ri e -Juá ez is sup-
po ed by a con ac om he Spanish Jun a de Andalucía (Nicolas
Mona des p og am: C1-0001-2023). The unde s did no play any ole in
he design, conclusions, o in e p e a ion o he s udy.
Po en ial con lic s o in e es . All au ho s: no epo ed con lic s.
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