BRIEF REPORT
Open Fo um In ec ious Diseases
BRIEF REPORT • o id • 1
Recei ed 28 Ap il 2021; edi o ial decision 14 June 2021; accep ed 16 June 2021.
Co espondence: Benjamin Maasoumy, MD, Hanno e Medical School, Ca l-Neube g-S . 1,
30625 Hanno e , Ge many (maasoumy.benjamin@mh-hanno e .de).
Open Fo um In ec ious Diseases®2021
© The Au ho (s) 2021. Published by Ox o d Uni e si y P ess on behal o In ec ious Diseases
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h ps://doi.o g/10.1093/o id/o ab325
Reaching he Un eachable: S a egies
o HCV E adica ion in Pa ien s Wi h
Re ac o y Opioid Addic ion—A Real-
wo ld Expe ience
LisaSandmann,1, JulianDeppe,2,3 Ch is ophBeie ,1 Vale ieOhlendo ,1
JuliaSchneide ,1 Heine Wedemeye ,1,4 FelixWedegä ne ,2 Ma kusCo nbe g,1,4,5
and BenjaminMaasoumy1,4,5
1Depa men o Gas oen e ology, Hepa ology and Endoc inology, Hanno e Medical School,
Hanno e , Ge many, 2Depa men o Psychia y, Social Psychia y and Psycho he apy,
Hanno e Medical School, Hanno e , Ge many, 3Pa ida Medizinisches Ve so gungszen um,
Hanno e , Ge many, 4Ge man Cen e o In ec ion Resea ch (DZIF), Pa ne Si e Hanno e -
B aunschweig, Hanno e , Ge many, and 5Cen e o Indi idualised In ec ion Medicine (CiiM),
Helmhol z Cen e o In ec ion Resea ch, Hanno e , Ge many
To achie e global hepa i is C i us (HCV) e adica ion, ba -
ie s p ohibi ing ea men access need o be o e come.
We es ablished a s a egy o ini ia e an i i al he apy in pa-
ien s wi h se e e, e ac o y he oin addic ion. All pa ien s
achie ed sus ained i ological esponse. Ou each p og ams
o hepa ologis s migh be a easonable way o o e come ba -
ie s o HCV ea men .
Keywo ds. ac i e d ug use; DAA; diamo phine; HCV;
he oin.
Since he in oduc ion o di ec -ac ing an i i als (DAAs),
ea men o ch onic hepa i is C i us (HCV) in ec ion has
been well ole a ed and highly e ec i e. The e o e, he Wo ld
Heal h O ganiza ion (WHO) has se he goal o e adica ing
HCV in ec ion by 2030 [1]. To achie e his aim, ea ing
ch onic HCV in ec ion in popula ions wi h a high p e a-
lence o HCV is essen ial. People who injec d ugs (PWID)
a e highly a ec ed by ch onic HCV in ec ion. In his popula-
ion, an i-HCV p e alence is es ima ed o be 52.3% globally
[2]. In Ge many, an i-HCV p e alence in he PWID popula-
ion anges om 63% o 68% [3]. I has been shown ha an i-
i al ea men is sa e and e ec i e o PWID wi h mode a e
addic ion diso de who can be managed wi h opioid agonis
main enance he apy (OAT) [4–6]. Howe e , pa ien s wi h
documen ed ac i e d ug use ha e a ely been included in such
ials [5, 7, 8]. Mo eo e , da a on hose wi h se e e, e ac o y
addic ion a e sca ce. People wi h ongoing in a enous d ug
use su e om mul iple como bidi ies and di icul ies wi h
ega d o in eg a ion in o he egula heal h ca e sys em. A
he same ime, a es o ch onic HCV in ec ion a e high and
an i i al ea men is u gen ly needed, o bo h indi idual [9]
and public heal h bene i [10]. Howe e , ini ia ion o an i i al
ea men has been shown o be hinde ed a mul iple le els.
Implemen a ion o HCV es ing, linkage o hepa ologis ca e,
lack o on-si e deli e y o HCV ea men , and comple ion o
he apy a e examples o gaps ha ha e been iden i ied by se -
e al s udies [11, 12]. To o e come hese ba ie s, no el ea -
men app oaches a e needed. The e o e, we de eloped a local
ea men s a egy in coope a ion wi h he ou pa ien clinic
o he oin-assis ed ea men (HAT) o deli e HCV ea men
o pa ien s wi h se e e opioid dependency.
METHODS
The ou pa ien clinic o HAT in Hanno e o e s ea men
wi h in a enous diamo phine o pa ien s wi h se e e, e-
ac o y he oin addic ion who ha e p e iously ailed con-
en ional subs i u ion ea men . Pa ien s isi he ou pa ien
clinic on a daily basis o ecei e diamo phine ea men man-
aged by psychia is s who specialize in addic ion medicine. In
coope a ion wi h he psychia is s, we es ablished a s a egy
o ini ia e an i i al he apy in hese pa ien s: An i-HCV and
HCV-RNA-posi i e pa ien s we e iden i ied by he psychia -
is s du ing ou ine assessmen . The hepa ologis eam isi ed
he ou pa ien clinic o baseline isi . Decompensa ed li e
ci hosis was excluded based on clinical and basic labo a-
o y alues. Due o he use o pangeno ypic DAA ea men
wi h so osbu i / elpa as i , HCV geno yping was abdicable.
Labo a o y es s we e educed o a minimum o minimize
blood wi hd awal p ocedu es and we e only pe o med be o e
baseline o e i y ongoing i al in ec ion and 12 and 96 weeks
a e he end o ea men o assess SVR and e-in ec ion (all
on-si e). An i i al ea men was ca ied ou on-si e by he
psychia is s, and he hepa ologis eam p o ided consul a-
ion i needed. No addi ional medical appoin men s we e nec-
essa y o he pa ien s. I was he pa ien ’s choice whe he o
manage hei DAA ea men independen ly o wi h he sup-
po o he HAT eam. Heal h- ela ed quali y o li e (HRQOL)
was assessed by he SF-36 ques ionnai e be o e and a e he
end o DAA ea men (Figu e 1A).
S a is ical analyses we e pe o med using Excel ( e sion
16.37 o Windows, Mic oso , Redmond, WA, USA), G aphPad
P ism ( e sion 7.05 o Windows, G aphPad So wa e, La Jolla,
CA, USA), and SPSS ( e sion 26, SPSS Inc, Chicago, IL, USA).
applypa as yle “ ig//cap ion/p[1]” pa as yle “FigCap ”
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2 • o id • BRIEF REPORT
RESULTS
Fo y- i e pa ien s wi h e ac o y he oin addic ion we e ea ed
in he HAT clinic. An i-HCV an ibody was de ec ed in mo e
han one- hi d o he pa ien s (n = 17/45), and he as majo i y
had ch onic HCV in ec ion (82%, 14/17). An i i al ea men
was o e ed o all i emic pa ien s. Howe e , 5 pa ien s did
no s a DAA he apy o a ious nonhepa ic easons: 2 ex-
pe ienced imp isonmen , 2 discon inued HAT, and 1 decided
agains DAA ea men (Figu e 1B). Pa ien s we e p edomi-
nan ly male (89%). Six pa ien s (70%) we e an i-HBc posi i e,
bu HBsAg was nega i e in all pa ien s. Fou pa ien s (44%)
we e a isk o li e ci hosis based on aspa a e ansaminase o
pla ele a io index (APRI) sco e, bu li e disease was compen-
sa ed in all pa ien s (Table 1).
In pa ien s s a ing an i i al ea men , in ec ion had been
known o a median o 11yea s (min 4, max 30). All pa ien s
we e awa e o hei in ec ion, bu only 1 pa ien had p e i-
ously been ea ed wi h an in e e on-based egimen. “Fea o
in e e on side e ec s” was he mos p e alen eason o no
commencing an i i al ea men be o e (n = 5/9, 56%). The
a ailabili y o DAA he apy was al eady known by 78% (n = 7/9)
o he pa ien s. All pa ien s epo ed pa allel consump ion o
addi ional d ugs including alcohol (44% wi h ha m ul use),
and all bu 2 pa ien s named he HAT ou pa ien clinic as hei
p ima y medical con ac (no addi ional p ima y ca e physi-
cian). The a e o psychia ic como bidi ies was 100% (n = 9/9).
All bu 1 pa ien decided o ake he daily DAA dose du ing
hei isi o he ou pa ien clinic. Du ing DAA he apy, no
side e ec s we e epo ed. All pa ien s who s a ed ea men
Psychia is s:
Pa ien s:
On-si e ea men managemen
On-si e ea men
No addi ional appoin men s
(Di ec ly obse ed he apy)
Blood wi hd awal (minimum)
HAT ou pa ien clinic
On-si e isi
A
C
B
Clinical exclusion o
decompensa ed ci hosis
Pangeno ypic, p o ease- ee
ea men egimen
Consul a ion i needed
Hepa ologis : 7 pa ien s did no s a ea men :
1 pa ien decided agains
s a ing he apy
To al
n = 45
an i-HCV posi i e
n = 17
Baseline isi
n = 10
S a o ea men
n = 9
HCV RNA neg. EOT
n = 9/9 (100%)
SVR 12
n = 9/9 (100%)
1 pa ien swi ched o OAT
Rein ec ion a e (FU96)
n = 0/8 (0%)
lack o ch onici y (<6
mon hs), n = 1
HCV RNA neg., n = 2
P ison, n = 2
Los o FU, n = 2
HAT (baseline)
100 **
80
60
40
Physical Func io
n
Role Physical
Bodily Pain
Gene al Heal h
Vi ali y
Social Func ion
Role Emo ional
Men al Heal h
Physical Componen Summa y
Men al Componen Summa y
HAT (FU 24)
Ge man popula ion (1994)
Addic ion diso de (Ge many, 1998)
-
-
-
-
Figu e 1. T ea men app oach (A), s udy o e iew (B), and esul s om he SF-36 ques ionnai e be o e an i i al ea men (HAT baseline) and 24 weeks a e he end o
ea men (HAT FU24) (C). Values a e compa ed wi h he Ge man no m popula ion (Ge man popula ion 1994)and he Ge man e e ence popula ion wi h addic ion diso de
(Addic ion diso de Ge many 1998). *P < .05, calcula ed by pai ed es . Abb e ia ions: EOT, end o ea men ; FU, ollow-up; FU24, ollow-up 24 weeks; HAT, he oin-assis ed
ea men ; SVR, sus ained i ological esponse.
Table 1. Baseline Cha ac e is ics
To al (n = 9)
Gende , male 8/9 (89)
Age, y 47± 8.6
HCV RNA, log IU/mL 6.16± 0.9
An i-HBc pos. 6/9 (66.7)
HBsAg pos. 0/9 (0)
An i-HBs pos. 5/9 (55.6)a
ALT, U/L 60.4± 25.3
Bili ubin, µmol/L 10.8± 6.1
C ea inine, µmol/L 75± 20.5
Th ombocy es, sd/µL183± 95.6
INR 0.94± 0.08
APRI sco e 0.95± 0.47
APRI >1 4/9 (44.4)
Ca ego ical da a a e exp essed as No. (%). Con inuous da a a e exp essed as mean ±SD.
Abb e ia ions: ALT, alanine ansaminase; APRI, AST o pla ele a io index; AST, aspa a e
ansaminase; HBV, hepa i is B i us; HCV, hepa i is C i us; INR, in e na ional no malized
a io.
aHBV eac i a ion o he 2 an i-HBc-posi i e, an i-HBs-nega i e pa ien s was excluded by
no mal ALT le els and nega i e HBV DNA a he end o ea men .
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BRIEF REPORT • o id • 3
comple ed he apy and achie ed SVR (mITT: 9/9, 100%; ITT:
9/14, 64%) (Figu e 1B). No e-in ec ion occu ed du ing 96
weeks o ollow-up.
HRQOL was assessed by he SF-36 ques ionnai e. Pa ien s’
sco es on he physical and men al subscales we e o e all
lowe compa ed wi h he popula ion no m i espec i e o
ea men s a us. When compa ed wi h he Ge man no m
popula ion wi h addic ion diso de , sco es in all subscales
excep “Bodily Pain” we e lowe in ou coho be o e an i-
i al ea men . Howe e , 24 weeks a e he end o ea men ,
all subscale sco es excep o “Role Emo ional” we e highe
han o simila o his no m popula ion. O e all, subscales
measu ing physical and men al cha ac e is ics imp o ed 24
weeks a e he end o ea men (Figu e 1C). The inc eases
exceeded 5% (which is conside ed o be a meaning ul clin-
ical change) [13] in 7 o he 8 domains and included a 33%
imp o emen on he Vi ali y scale, which has been iden i ied
as he HRQOL domain o he SF-36 ha is mos ele an o
ch onic HCV in ec ion [14].
DISCUSSION
In ou s udy, we es ablished a eal-li e ea men concep o de-
li e an i i al ea men o ch onic HCV in ec ion o pa ien s
wi h se e e, e ac o y opioid dependency. We showed ha
an i i al ea men is easible, well ole a ed, and success ul in
pa ien s on HAT. This is in line wi h indings om he in e -
e on e a ha showed compa able i al esponse a es be ween
se e ely opioid-dependen pa ien s on HAT and non–d ug
use s [15]. Mo eo e , he e icacy o DAA in PWID wi h less
se e e addic ion diso de , ha is hose s able on OAT, has been
demons a ed by mul iple s udies [5, 16, 17]. Vi al e adica ion
causes se e al posi i e e ec s: Fi s , he isk o hepa ic de e i-
o a ion due o HCV in ec ion is emo ed [9]. Second, pa ien s
expe ience imp o emen in HRQOL [18, 19]. Fu he mo e,
indi idual i al e adica ion leads o a educ ion o he gene al
bu den o HCV in ec ion and educes u he i al sp eading
[20, 21]. Despi e i s posi i e e ec s, implemen a ion o an i i al
ea men in he PWID popula ion emains insu icien . The
easons o his a e mul ilaye ed and include sys em-, p o ide -,
and pa ien - ela ed ac o s. In ou coho , pa ien s epo ed
ea o ea men - ela ed side e ec s and lack o mo i a ion
as he main easons o no ha ing s a ed ea men be o e.
Addi ionally, pe cei ed lack o capabili y o ini ia e ea men
au onomously, he bu den o addic ion diso de i sel , and s ig-
ma iza ion we e named as gene al easons o no s a ing ea -
men . Simila aspec s eme ged in he s udy by Skee e al., who
addi ionally iden i ied “pe cei ed lack o e e al o ea men ”,
“lack o ca e con inui y”, and he pe cei ed need o ea men
including “lack o dese ingness o ea men ” as ba ie s
o ca e [22]. Despi e being awa e o hei in ec ion, mos pa-
ien s do no pe cei e li e disease as he medical p oblem mos
u gen ly in need o add essing [22]. This is mainly due o hei
immense psychia ic como bidi y and concomi an social di -
icul ies, which mo e di ec ly a ec he pa ien s’ e e yday li e.
Due o he compounding men al symp om load in pa ien s wi h
se e e addic ion diso de , a mul idisciplina y ea men ap-
p oach is needed o success ully o e an i i al ea men . The
se ing o HAT and OAT allows con ac wi h his di icul - o-
each popula ion on a egula basis. S ill, physicians in ol ed in
addic ion uni s a e no usually ained in HCV ca e, and suc-
cess ul e e al o specialized ou pa ien clinics is no easible
in mos cases. The e o e, on-si e an i i al ea men eme ges
as he bes op ion o hese pa ien s. In ou coho , he HAT
ou pa ien clinic se ed as he main medical con ac o he
pa ien s, and on-si e ea men was acili a ed in se e al ways.
Appoin men s we e lexible, and pa ien s bene i ed om a-
milia clinical s a . An i i al ea men was explained and ini-
ia ed by he hepa ologis eam bu conduc ed by he on-si e
psychia ic eam. No addi ional appoin men s we e necessa y
o he pa ien s. This mul idisciplina y ea men app oach and
he con inui y o ca e a e impo an ac o s acili a ing an i i al
ea men in his popula ion [7]. Fo ou eal-wo ld s udy, i
can be assumed ha wi hou he on-si e ea men app oach,
pa ien s would p obably no ha e s a ed an i i al ea men in
he medium e m.
Despi e he single-cen e expe ience and he o e all low
numbe o ea ed pa ien s, ou s udy o e s se e al insigh s:
I shows ha by es ablishing a mul ip o essional on-si e ea -
men app oach, compa ably high a es o ea men up ake and
i al clea ance a e achie ed. Impo an ly, pa ien s a high isk
o u he delaying o ne e s a ing an i i al ea men we e
linked o ca e. The s udy migh se e as an example no only
o mo i a e o he pa ien s o s a an i i al he apy bu also o
encou age medical p o essionals o de elop mul idisciplina y
s a egies o o e come ea men ba ie s.
Acknowledgmen s
Financial suppo . No unding was ecei ed o hes udy.
Po en ial con lic s o in e es . B.M.has ecei ed consul ing and/o lec-
u e ees om AbbVie, B is ol-Mye s Squibb, Me ck/MSD, Roche, Janssen,
and Abbo , as well as g an / esea ch suppo om Abbo , Roche, and
Fuji ebio. M.C.has ecei ed pe sonal ees om AbbVie, Gilead Sciences,
GSK, Janssen-Cilag, MSD Sha p & Dohme, No a is, Roche, Sp ing Bank
Pha maceu icals, and Swedish O phan Bio i um AB (SOBI). H.W. has
ecei ed g an / esea ch suppo and consul ing and/o lec u e ees om
Abbo , AbbVie, Al immune, Bio es , BMS, BTG, Dice na, Gilead, Janssen,
Me ck/MSD, MYR GmbH, No a is, Roche, and Siemens. L.S.has ecei ed
hono a ia om D Falk Pha ma. J.D., C.B., V.O., F.W., and J.S.ha e no con-
lic s o in e es o decla e. All au ho s ha e submi ed he ICMJE Fo m o
Disclosu e o Po en ial Con lic s o In e es . Con lic s ha he edi o s con-
side ele an o he con en o he manusc ip ha e been disclosed.
Pa ien consen . All pa ien s ag eed o he usage o hei da a a e
anonymiza ion. Da a analysis o HCV ea men has been app o ed by he
e hics commi ee o Hanno e Medical School (No.9227).
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