Patients receiving opioid maintenance treatment in primary care: successful chronic hepatitis C care in a real world setting.

0.18 MB·English

by  Seidenberg, Andre

Seidenbergetal.BMCInfectiousDiseases2013,13:9
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RESEARCH ARTICLE Open Access
Patients receiving opioid maintenance treatment
in primary care: successful chronic hepatitis C
care in a real world setting
André Seidenberg1,2, Thomas Rosemann1 and Oliver Senn1*
Abstract
Background: Injection drugusers (IDUs) represent a significant proportion of patients with chronic hepatitisC
(CHC). The low treatment uptake among these patients results ina low treatmenteffectiveness and a limited public
health impact. We hypothesised that a general practitioner (GP) providing anopioid maintenance treatment (OMT)
for addicted patients can achieve CHC treatment and sustained virological response rates (SVR) comparable to
patients without drug dependency.
Methods: Retrospective patient record analysis of85 CHC patientswho received OMT for more than3 months in a
single-handed general practice inZurichfrom January 1, 2002 through May 31, 2008. CHC treatment was based on
a combination with pegylated interferon and ribavirin. Treatment uptake and SVR(undetectable HCV RNA 6months
after end of treatment) were assessed.The associationbetweentreatment uptake and patient characteristics was
investigated bymultiple logistic regression.
Results: In35 out of 85 CHC patients (52 males) with a median (IQR) age of 38.8 (35.0-44.4) years, antiviral therapy
was started (41.2%). Median duration (IQR) of OMT inthe treatment group was 55.0 (35.0-110.1) months compared
to thegroup without therapy 24.0 (9.8-46.3) months (p<0.001). OMT duration remained a significant determinant
for treatment uptake when controlled for potentialconfounding. SVRwas achieved in 25 out of 35 patients (71%).
Conclusion: In addicted patients a high CHCtreatmentand viral eradication rate ina primary care setting in
Switzerland is feasible. Opioid substitution seems a beneficial framework for CHCcare inthis “difficult to treat”
population.
Keywords: Hepatitis C, Methadone substitution, Primary care
Background confirmed CHC go untreated [6-8] therefore reducing
Chronic hepatitis C infection (CHC) is a major cause of therapeutic effectivenessofananti-HCVtherapy.
end-stage liver disease (ESLD). Injection drug users Increasing evidence suggests similar treatment efficacy
(IDUs)areamajorriskgroupforHCVinfection[1]thus of a pegylated interferon-based (pegIFN) combination
they significantly contribute to the patient group with therapywith ribavirinonHCVclearancein patientswith
ESLDinthefuture[2]. Inrecentyearstreatmentefficacy substance abuse compared to patients without drug de-
of CHC has been steadily increased and a successful pendency [9-13]. Despite the revised NIH consensus on
virus eradication can be achieved in up to 80% of medical management of HCV infection that recom-
patients with genotype 2 and 3 and in about 50% of mended a treatment decision on an individual basis [14]
patients chronically infected with genotype 1 [3-5]. current clinical practice suggests that CHC patients with
However data suggest that about 70% of patients with a history of IDU have a lower chance of getting antiviral
therapy compared to other patient groups [7,15]. This
further emphasize that the true therapeutic impact of an
*Correspondence:[email protected]
anti-CHC therapy is rather an issue of access to treat-
1InstituteofGeneralPracticeandHealthServicesResearch,Universityof
Zurich,Zurich,Switzerland mentthanofdrugefficacy.
Fulllistofauthorinformationisavailableattheendofthearticle
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In IDUs concomitant illicit drug use, problem drink- Treatmentprotocol
ing, comorbid medical (e.g. HIV) and psychiatric condi- In all 85 CHC patients risks and opportunities of a spe-
tions are prevalent representing common barriers to cific antiviral therapy have been discussed. Patients
antiviral treatment. On the other hand opioid mainten- infected with HCVgenotypes 1 and 4 were treated with
ance treatment (OMT) is established in the therapy of once-weekly injections of peginterferon alfa-2a (180 μg),
substance abuse [16] and has been shown to be an ef- plus ribavirin (1000 mg or 1200 mg/day by weight in
fective framework for adherence and virological success divided dose) for 48 weeks. Atreatment regimen ofriba-
in HIV treatment [17,18]. In addition we previously virin 800 mg/day (divided in two doses) and peginter-
demonstrated the beneficial role of a substitution treat- feron alfa-2a 180 μg/week subcutaneously for 24 weeks
ment as a therapeutic framework for a successful CHC was used for patients with HCV genotype 3 (no patient
case finding [19]. We hypothesized that a general practi- of the current study population was infected with geno-
tioner (GP) providing an integrated chronic care ap- type 2). Peginterferoninjectionswereappliedbythemed-
proach including an OMT can achieve similar CHC ical staff of the general practice mostly while patients
treatment rates and viral eradication rates compared to received their substitution treatment. Direct dose adjust-
patients without drug dependency. In addition we aimed mentsaccordingtocurrenttreatmentguidelineswerepos-
to assess patient characteristics including duration of sible as laboratory point-of care testing (differential blood
OMT which were associated with CHC treatment initi- count) was available at the general practice. Ribavirin has
ationinaprimarycaresetting. been distributed on a weekly basis in patients with good
compliance and a daytime structure (e.g. certificate of
Methods employment) or on a daily observed treatment regimen.
Patientsandsetting Viremiawasmeasuredatweek12,attheendoftreatment,
Retrospective records review of patients receiving opioid and6monthsaftertheendoftreatment.
maintenance treatment (OMT) in the study period be- Prior to antiviral treatment start patients with poorly
tween January 1, 2002 through May 31, 2008. A detailed controlledpsychiatricdisorderswerestabilizedbypharma-
description of the study population and the setting has cologicaltherapies.Aprophylactictreatmentwasstartedin
been previously reported elsewhere [19]. Briefly, all patientswithahistoryofdepressivedisorderbeforebegin-
patients ≥ 18 years old and participating for at least ning an antiviral therapy. Patients were systematically
3monthsinanofficialoffice-basedOMTprogrammerun counselled for a reliable contraception and in women a
™
by a single-handed general practice located in Zurich, hormone-releasing intrauterine device (Mirena ) was rou-
Switzerland were eligible for CHC assessment and evalu- tinely recommended. Substance abuse including injection
ation for antiviral therapy in the case of a CHC infection. drug use was not an exclusion criteria for an interferon-
In 327 out of 360 patients (90.8%) on OMTa successful basedtherapy,howeverabstinence(oratleastasubstantial
CHC assessment could be performed and 85 out of the reduction) of alcohol and concomitant substance abuse
327patients(26%)werechronicallyinfectedwithhepatitis wasstronglyrecommendedinallpatients.
C. The OMT regimen (methadone, buprenorphine or
morphine) was based on a computer-assisted drug pre- Outcomemeasuresandassessments
scription and delivery system (CDDD) that provides a pa- Treatment rate and treatment success were primary out-
tient tailored dosage regime within a safety framework comes and defined as follow: The proportion of evaluated
allowing the patients to choose dosage within an indivi- CHC patients who started an interferon-based therapy
dualisedmaximaldailydose[20].Thediagnosisofchronic andtheproportionoftreatedpatientswithasustainedvir-
hepatitis C wasbased ona detectable HCV RNAconcen- ologic response (SVR) (i.e. undetectable HCV RNA in the
tration and a reported HCV genotype performed by an serum 6 months after end oftreatment). Viral eradication
approvedlaboratoryusingaquantitativepolymerase-chain rate at the end of treatment (ETR) and SVR according to
reaction. All patients had not been treated previously for genotypes and in HIV-coinfected patients were secondary
CHC.Thepracticestaff haslongexperienceandisspecif- outcomes.
icallytrainedinOMTandHCVcare.AllHCVtreatments OMT-related data (i.e. duration, average dose) could
weregiven in the general practice coordinated and super- be accessed and further processed from CDDD (see
visedbytheGP.Aclosecollaborationwithinanetworkof above). Demographics, psychiatric co-morbidities (based
hepatologists, infectiologists and psychiatrists guaranteed on clinical grounds), self-declared addiction-specific
rapidaccesstospezializedcarewithinlessthanthreedays. variables (i.e. history of IDU and current IDU, concomi-
PriortotheOMTandHCVscreeningpatientswereasked tant problematic drug and alcohol abuse), and social-
fortheirinformedconsentinananonymousdataanalysis. and occupational characteristics (i.e. housing situation,
Under Swiss ethics guidelines the study did not require a employability expressed as a percentage of a full time
formalethicsapproval. aequivalent based on a certificate of employment) were
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assessed by systematic charts review. Problematic sub- CHCtreatmentrateandpatientdeterminantsfor
stancemisuseincludingalcoholwasdefinedonconsensus treatmentdecision
withinthepracticeteambasedonclinicalobservationand In 35 patients out of the 85 CHC patients an antiviral
patients’self-reports during routine daily or weekly OMT treatment with pegylated interferon and ribavirin was
provision. Substance users’ self-reports have been shown started, corresponding to a treatment rate of 41.2%.
to be reliable, especially in OMT programmes that assure Group comparisons between patients who started a ther-
confidentiality and absence of adverse consequences [21]. apy and patients who disagreed to a HCV treatment are
Patients suffering froma severeadverse eventrelated toa presented in Table 2. Duration of OMT was significantly
psychiatric co-morbidity (e.g. suicidal behaviour, psychi- longer in patients who started an antiviral therapy. This
atrichospitalisation)wereconsideredasunstable. association remained statistically significant and revealed
an odds ratio (95% CI) of 1.020 (1.006-1.04) (p=0.01)
when controlling for potential confounders in a multiple
Statisticalanalysis
logistic regression. Therewas no evidence of a non-linear
Descriptive statistics were calculated for all variables.
Patients were categorized according to their history of
Table1CharacteristicsofCHCpatients>3monthson
CHC treatment (i.e. “treatment start” vs. “no CHC treat- opioidmaintenancetreatment(OMT)
ment”). Non-parametric group comparisons were per-
Demographics %(n)*ormedian
formed to test for differences in distributions of patient [IQR](n)*
characteristics. A multiple logistic regression was used to Male 61.2(52)
further assess the independent associations between CHC
Age(years) 38.8(35.0-44.4)
treatment history and patient characteristics. All statistical
Opioidmaintenancetherapy(OMT):
analysis were performed using STATA for Windows
Agebeginningsubstanceabuse(years) 18.3(15.6-20.7)
(version10.1;StataCorp.,CollegeStation,Texas).
AgebeginningthecurrentOMT(years) 34.0(30.2-39.6)
MethadoneaslastOMTmedication 90.6(77)
Results
BuprenorphinaslastOMTmedication 4.7[4]
Baseline characteristics of the 85 patients receiving OMT
MorphinaslastOMTmedication 4.7[4]
with a concomitant diagnosis of chronic hepatitis C
Useof≥1differentopioidinthepast 12.9[11]
(CHC)aredescribedinTable1.Patientsstartedsubstance
DurationofOMT(months) 37.1(14.5-72)
abuseonaverageattheage(IQR)of18.6(15.6-20.7)years.
AveragemethadonedoseduringOMT(mg) 72.8(50.1-119.8)
Median (IQR) age and age entering the current OMT
programme was 38.8 (35.0-44.4) and 34.0 (30.2-39.6) Psychiatriccomorbidity:
years, respectively. Avast majority of the patients (90.6%) Nopsychiatricdisorder 28.2[24]
wasonmethadonemaintenancetreatmentand11patients Stabledisorderwithouttreatment 12.9[11]
(12.9%) experienced more than 1 opiate for long-term Stabledisorderundertreatment 15.3[13]
substitution. The median (IQR) duration on OMT was Unstabledisorder 43.5(37)
37.1 (14.5-72) months with a wide range between 4 to Injectiondruguse(IDU):
310.9 months. During the study period median prescrip-
Inthepast 92.9(79)
tion for methadone, buprenorphine and morphine was
Current 17.7[15]
72.8 (50.1-119.8), 6.2 (3.0-6.5), and 430.5 (312.1-514.8)
Otherdrugandexcessivealcoholuse:
milligram, respectively. Psychiatric comorbidity was high
Heroin 27.1[23]
with about 40% suffering from an unstable disorder and
Cocaine 25.9[22]
almostonethirdhavingastableconditionwithorwithout
treatment. The majority of the patients (70.3%) suffering Benzodiazepines 20.2[17]
from an unstable psychiatric disordercould havebeen re- Alcohol 31.8[27]
ferred for a psychiatric treatment. All of the referred Occupationalandhousingvariables:
patients have been diagnosed with a mood disorder and Employability(%) 60(30–100)
the majority (80.8%) of them suffered from a psychiatric Singlehousehold 54.1(46)
comorbidepersonalitydisorder.Formerinjectiondruguse
Sharedhousehold 36.5(31)
(IDU) was reported in the vast majority of the patients
Otherlodging# 9.4[8]
and almost 20% reported current IDU. Problematic drug
HIV-co-infection
abuseorexcessivealcoholconsumptionwaspresentinal-
HIVpositive 20[16]*
mostone thirdofthe patients. Mostofthe patients had a
*Totalnumberofpatients=85;HIVstatuswasmissingin5patients;#lodging
permanent residence with part- or fulltime employment.
ofpatientswithoutstablehousingwasasfollows:homeless[2],asylum[2],
HIV-co-infectionprevalencewas20%. socialinstitutions[2],accommodationbyfriends[2].
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Table2DeterminantsofCHCtreatmentdecisioninCHCpatients>3monthsonOMT
Determinants Treatmentstart(n=35) NoCHCtreatment(n=50) P-value*
%(n)ormedian[IQR] %(n)ormedian[IQR]
Demographics:
Male 65.7[23] 58[29]
Female 34.3[12] 42[21] 0.48
Age(years) 41.8(37.2-45.1) 37.5(34.8-43.8) 0.06
AgebeginningOMT(years) 35.0(31.9-39.9) 33.4(29.2-39.1) 0.45
Opiatemaintenancetherapy:
Methadone 88.5(31) 92(46)
Buprenorphin 8.6[3] 2[1]
Morphin 2.9[1] 6[3] 0.51
SingleOMTtherapy 88.6(31) 86(43)
Useof≥1differentopiateinthepast 11.4[4] 14[7] 1.0
DurationofOMT(months) 55.0(35.0-110.1) 24.0(9.8-46.3) <0.001#
AveragemethadonedoseduringOMT(mg) 73(50–120) 73(50–122) 0.83
Psychiatriccomorbidity:
Noneorstabledisorder 68.6[24] 52[24]
Unstabledisorder 31.4[11] 48[26] 0.060
Injectiondruguse(IDU):
Inthepast,yes 91(32) 94(47)
Inthepast,no 9[3] 6[3] 0.69
Current,yes 8.6[3] 24[12]
Current,no 91.4(32) 76(38) 0.086
Otherdrugandexcessivealcoholuse:
Currentheroinuse 20[7] 32[16]
Noheroinuse 80[28] 68(34) 0.22
Currentcocaineuse 25.7[9] 26[13]
Nococaineuse 74.3[26] 74(37) 0.98
Currentbenzodiazepineuse 14.7[5] 26[12]
Nobenzodiazepineuse 85.3[29] 74(38) 0.41
Excessivealcoholuse 28.6[10] 34[17]
Noalcoholexcess 71.4[25] 66(33) 0.60
Occupationalandhousingvariables:
Employability(%) 60(30–100) 60(30–100) 0.52
Singlehousehold 40[14] 34[17]
Sharedhousehold 51.4[18] 56[28]
Otherlodging 8.6[3] 10[5] 0.90
HIV-co-infection†
HIVpositive 14.7[5] 23.9[11]
HIVnegative 85.3[29] 76.1(35) 0.40
*GroupcomparisonsbyChi-squareorFisherexactasappropriateandMann–Whitneytest;
#remainedindependentlyassociatedwithtreatmentstartaftercontrollingforage,sex,psychiatriccomorbidity,IDU,drugandalcoholuse,employability,housing
andHIV-co-infectionwithanOR(95%CI)of1.02(1.006-1.04)(p=0.01);†HIV-statuswasmissingin5patients.
relationship between OMT duration and treatment CHCtreatmentsuccess
uptake. The most frequent reason against CHC treatment In 25 out of 35 patients who started a CHC treatment no
was patient refusal in 40 cases (80%). No treatment was HCV-RNA could be detected 6 months after the end of
performedduetovarioussomaticreasonsintheremaining treatment corresponding to a sustained virological re-
10patients(20%). sponse rate (SVR) of 71%. Three patients with successful
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HCV-clearance after initial treatment suffered from a re- treatment[16,18]andisinlinewiththefindingthatanon-
lapse, corresponding to a success rate at the end of treat- goingOMTsignificantlyincreasedthechanceofasuccess-
ment of 80% (28/35). When stratified according to HCV ful CHC case finding [19]. We are not aware of a study
genotypes SVR was 76.% in genotype 3 (10 out of 13 that has assessed the specific role of an OMT programme
patients),73.7%ingenotype1 (14 outof19patients),and inthecontextofCHCtreatmentinitiation.Ourresultsfur-
33.3%ingenotype4(1outof3patients).In3outofthe5 therstrengthenedOMTasafavourabletherapeuticsetting,
HIV-co-infectedpatientsaSVRcouldbeachieved. expandingitsroleforHCV-relatedcare.
Reasons for a failure of pegIFN+RBV in the 10 patients We achieved a viral eradication rate similar compared
startinganantiviraltherapywereasfollow:non-responder to randomized controlled efficacy trials reporting a sus-
(n=6), relapse (n=3), early treatment stop due to medical tained virological response up to 80% of patients with
reasons(n=1). genotype 2 and 3 and in about 50% of patients chronic-
ally infected with genotype 1 [3-5]. The selection criteria
Discussion for the aforementioned multicenter registration trials
This study examined CHC treatment and success rates however excluded IDUs thus although internal validity
in unselected patients appearing “difficult to treat” in a of these studies is high illicit drug users constitute the
single-handed general practice in Switzerland. Although largest proportion of CHC patients and the results do
a substantial proportion of the study population suffered not represent treatment effectiveness in a “real world
from psychiatric comorbidities, reported excessive alcohol setting”. Our response rate is in line with a recent meta-
consumption and current drug misuse including injection analysis suggesting similar treatment efficacy of an anti-
druguse,treatmentcouldbestartedin41.2%andresulted viral therapy on HCV clearance in patients receiving
in an overall sustained virological response rate of 71%. OMT compared to patients without drug dependency
The duration of OMT was associated independently and [9]. However in only 3 out of the 16 studies included in
positivelywiththestartofaCHCtreatment. the aforementioned meta-analysis active ongoing illicit
Theobserved treatment rate compares favourably with drug use was not an exclusion criteria thus our results
previous studies although comparisons have to be inter- provided further evidence that successful viral eradica-
preted with caution as patient populations differ greatly tion is feasible in a population normally excluded from
across studies. In a UK population of CHC patients, clinicaltrialsandjudged“difficulttotreat”.
Irving et al. [22] reported an overall treatment rate of We are aware that the analysis of our study does not
10.2% with a wide range varying according to the source address the CHC treatment effectiveness of a primary
of original HCV screening test with the highest rate of care setting in comparison to a specialized medical care
21.4%inpatientsreferredfrom GPsandatreatment rate setting due to the lack of a randomised controlled inter-
of only 1.6% in patients originally screened for HCV by vention. The current standard of care for the treatment
specialist units for drug and alcohol. Butt and colleagues of chronic HCV infection which is also recommended
[23] found a treatment rate of 11.8% in unselected veter- for patients with substance abuse was applied by the
ans who were older (median age 50 years) compared to attending GP with a high level of commitment and a
our study sample but comparable with regard to the special interest in addiction medicine. Providing chronic
prevalence of comorbidities such as psychiatric disorders care (i.e. substitution, psychiatric comorbidities) in com-
and drug and alcohol dependence. The cumulative binationwithacutesomaticcareisamainfeatureofapri-
chance of starting CHC treatment in a 5 year period has mary care setting. Our treatment rate is in line with a
been estimated to 33% in a representative Danish CHC recent randomized controlled study evaluatingthe impact
cohort study [24]. Among patients attending the special- of an integrated care approach among CHC patients ori-
ist consultations of the Swiss Hepatitis C Cohort Study ginally deferred from CHC therapy due to mental health
(SDDS) [25] a history of CHC related treatment has and substance abuse comorbidities [26]. In this study
been reported in 31% of the whole cohort and in 51% in patients receiving an integrated care intervention reached
the subgroup of cirrhotics. We found an independent a treatment eligibility of 42% compared to the standard
and positive association between treatment initiation care group with a significant lower eligibility rate of 18%.
and the duration of OMT. Thus a patient spending In our population the level of homelessness and un-
37 months (i.e. the median duration of OMT in our employment was relatively low but similar when com-
study population) on opioid substitution has doubled pared to GP patients in other OMT programmes in
the chance ( i.e. OR 1.0237 months =2.0) of getting started Switzerland, which probably reflects the low-threshold
CHC treatment compared to a patient simply fulfilling management of drugaddicts in Switzerland [27]. Further-
the inclusion criteria of minimum 3 months on substitu- more it is important to note that an OMT durationof
tion.ThisbeneficialeffectofOMThasalreadybeenshown fewer than 3 months was an exclusion criteria thus a se-
to increase adherence and virological success in HIV lection of our population probably related to a high level
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