BACKGROUND PATIENTS WITH HCV RNA PCR POSITIVE RESULTS€¦ · • Retrospective audit of electronic...

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HEPATITIS C VIRUS INFECTION: BARRIERS TO TREATMENT Lakhan P 1 , Pokino L 1 , Sendall C 1 , Clark P 1 2 3 4 , Askew D 1 2 , Chong D 1 , Hayman N 1 2 1 Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, 2 The University of Queensland School of Medicine, 3 The Princess Alexandra Hospital, 4 QIMR Berghofer Medical Research Institute BACKGROUND The Southern Queensland Centre of Excellence (CoE) in Aboriginal and Torres Strait Islander Primary Health Care aims to provide quality and culturally safe primary health care to the Aboriginal and Torres Strait Islander community. Despite facilitating access to treatments for Hepatitis C Virus (HCV), few patients attending the CoE Liver Clinic had received treatment in 2014. STUDY AIM To identify factors, including personal and social aspects that were inhibitive in treating patients with HCV infection attending the CoE Primary Health Care clinic. METHODS Steps of data collection: Electronic GP Clinic medical records software package, Practix, was searched to identify all patients with a diagnosis of Hepatitis C in November 2014. Retrospective audit of electronic medical records of patients who were HCV RNA PCR positive. Data extracted and simultaneously recorded electronically on a form developed in Microsoft Access software program for the following: o Details of most recent HCV RNA PCR pathology test o Socio-demographic characteristics o Treatment details o Presence of co-morbidities, lifestyle risk factors, liver disease. Study was approved by the Inala Community Jury for Aboriginal and Torres Strait Islander Health Research. Metro South Human Research Ethics Committee deemed this a quality assurance project. Data analysis STATA © version 14.1 was used for data analysis for all patients, then separately for Aboriginal and Torres Strait Islander patients. RESULTS 219 patients had a diagnosis of Hepatitis C listed in their medical records, 186 patients had HCV PCR testing, Fig 1. Poster produced by Media & Communications, Princess Alexandra Hospital, 2016 The rate of newly-diagnosed HCV is increasing in Australia’s Indigenous population (130 per 100000 Indigenous population in 2008 to 166 in 2012), while the rate is decreasing in the non-Indigenous population (51 per 100000 in 2008 to 40 in 2012) 12 . REFERENCES 1. Commonwealth of Australia, Department of the Prime Minister and Cabinet, Closing the Gap Prime Minister’s Report 2016, http://closingthegap.dpmc.gov.au/assets/pdfs/closing_the_gap_report_2016.pdf. Accessed 17/8/2016. 2. Australian Government Department of Health. Fourth National Aboriginal & Torres Strait Islander blood-borne viruses and sexually transmissible infections strategy 2014-2017. Available at www.health.gov.au/internet/main/publishing.nsf/content/ohp-bbvs-atsi. Accessed 15/8/2016. 3. Treloar C, Jackson C, Gray, R et al. (2016). Care and treatment of hepatitis c among Aboriginal people in New South Wales, Australia: implications for implementation of new treatments. Ethnicity & Health. 21 (1): 39-57. CONCLUSIONS Management of HCV in this community–based clinic is made amidst complex personal and social environments. A high proportion of patients in this study experienced mental health conditions, conflict and domestic violence, and lifestyle risk factors. Many of these factors may pose barriers to treatment, even with newer HCV therapies. The study highlights the need to address the broader problems of addiction, for example trauma, to address substance abuse and associated risky behaviours, such as sharing of needles. A holistic approach is essential for adequate treatment of HCV infection. Figure 1: HCV infection status; treatment (pre-2016) details for patients with diagnosis of Hepatitis C in patients’ medical records - November 2014. PATIENTS WITH HCV RNA PCR POSITIVE RESULTS Sample 113 patients had HCV RNA PCR positive results (50% were genotype 3). 95/113 (84%) patients self-identified as having an Aboriginal and/or Torres Strait Islander background. Table 1 describes the socio-demographic characteristics of all patients. A separate analysis for patients from Aboriginal and Torres Strait Islander background showed either none, or a 1-2% percentage difference for most variables, except for the 50% (versus 46% for ‘All’ patients) living with other family members. Fig 1. describes details of referrals/treatment for patients in HCV negative and positive groups. Table 1: Socio-demographic characteristics of patients with HCV RNA PCR positive results* Characteristic HCV RNA PCR positive Age median (mean, ±SD, min-max), years 38 (39; 9.7, 7-63) Gender n % Male 75/113 66 Ethnicity Aboriginal 90/113 79 Torres Strait Islander 2/113 2 Aboriginal & Torres Strait Islander 3/113 3 Non-Aboriginal/Torres Strait Islander 18/113 16 Regular Attendance at Clinic (3 visits in last two years) 69/113 61 Living Condition Homelessness or Overcrowding present 6/81 7 Living Arrangement Living alone 4/54 7 Living with spouse, or spouse & children 15/54 28 Living with other family members including own children 25/54 46 Living with friends/shared accommodation, hostel, under care of Department of Children’s Services 10/54 19 Table 2: Patient-associated and other factors present among patients with HCV RNA PCR positive * HCV RNA PCR positive n % Patient-associated factors 1. Comorbidities Depression 71/99 72 Anxiety 56/92 61 Other current mental illness 28/92 30 History of previous suicide/self harm attempt 15/65 23 Fatty liver 18/32 56 Cirrhosis of liver 7/33 21 Primary carcinoma of liver 1/32 3 Hypertension 10/90 11 Diabetes 9/90 10 Ischaemic Heart Disease 4/91 4 2. Lifestyle-associated factors Current smoker 94/108 87 Alcohol abuse 39/97 40 Alcoholic Liver Disease 4/26 15 Using an opiate 22/77 29 On replacement opiate 19/82 23 Current Intravenous Drug User 36/77 47 Past Intravenous Drug User 89/93 96 Body Mass Index (kg/m 2 ) <18.5 1/89 1.0 18.5 - 25 (normal healthy weight) 45/89 51 >25 43/89 48 Other factors History of incarceration 72/105 69 Conflict and domestic violence 33/81 41 *Data not available for all patients, analysis conducted with available data. 219 patients with diagnosis of Hepatitis C (Data missing n=10) HCV RNA PCR negative n=71/209; 34% Treatment details Out of 67 patients with available data: 13/67 (19%) had cleared through treatment. 54/67 (81%) did not require treatment (self-cleared or antibody positive only) HCV RNA PCR positive n= 113/209; 54% Treatment details, n=107 45/107 (42%) referred for treatment 2/45 commenced treatment 1/2 treatment incomplete due to intolerance to treatment side-effects (data missing n=1) Reasons for non-treatment of referred patients (n=43/45) 2/43 refused treatment 16/43 did not attend treatment appointment 16/43 doctor decision not to treat 9/43 data missing No confirmed PCR n =25/209; 12% * Some data was missing for all variables for the 113 patients; analysis is conducted with available data. DISCUSSION This study has identified the vulnerability of this group of patients with HCV infection. Majority of patients experienced mental illnesses and incarceration. High proportions of patients experienced conflict and domestic violence, and lifestyle risk factors such as addiction to cigarettes, alcohol and intravenous drugs use. At least one-fifth of patients had a cirrhotic liver, highlighting the urgency of treatment to avoid long-term liver damage and its consequences on health status and quality of life. The high incarceration rate increases risk of HCV transmission, with unsafe injecting and tattooing practices in prisons occurring in a highly prevalent reservoir of infection. While newer medications have overcome many of the barriers associated with the previous drugs, successful treatment and avoidance of re-infection relies on many complex social and behavioural factors. Successful treatment of HCV requires a holistic patient-centered approach, utilizing other strengths such as connections to community, culture, and family dynamics in preventing intravenous drug use, and simultaneous treatment /prevention of broader issues of drug and alcohol addiction, mental illness, conflict and domestic violence, and incarceration 3 . Information on social determinants of health was not obtained in this study. The association between education, employment, mental illness, incarceration, exposure to trauma and abuse, domestic violence, and HCV needs to be explored to prevent HCV infections among this group of vulnerable Indigenous patients. Possible barriers to accessing treatments Patients with HCV infection suffered from other comorbidities; lifestyle-associated and domestic factors that could influence treatment decisions, Table 2. Separate analysis of patients from Aboriginal and Torres Strait Islander background showed either none, or a 1-2% percentage difference for most variables, except for presence of: depression (60%), fatty liver (48% ), conflict and domestic violence (35%).

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Page 1: BACKGROUND PATIENTS WITH HCV RNA PCR POSITIVE RESULTS€¦ · • Retrospective audit of electronic medical records of patients who were HCV RNA PCR positive. Data extracted and simultaneously

HEPATITIS C VIRUS INFECTION: BARRIERS TO TREATMENT

Lakhan P1, Pokino L1, Sendall C1, Clark P1 2 3 4, Askew D1 2, Chong D1, Hayman N1 2 1 Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care,

2 The University of Queensland School of Medicine, 3 The Princess Alexandra Hospital,4 QIMR Berghofer Medical Research Institute

BACKGROUND• TheSouthernQueenslandCentreofExcellence(CoE)inAboriginalandTorresStraitIslanderPrimary HealthCareaimstoprovidequalityandculturallysafeprimaryhealthcaretotheAboriginalandTorres StraitIslandercommunity.DespitefacilitatingaccesstotreatmentsforHepatitisCVirus(HCV),few patientsattendingtheCoELiverClinichadreceivedtreatmentin2014.

STUDY AIMToidentifyfactors,includingpersonalandsocialaspectsthatwereinhibitiveintreatingpatientswithHCVinfectionattendingtheCoEPrimaryHealthCareclinic.

METHODSSteps of data collection:• ElectronicGPClinicmedicalrecordssoftwarepackage,Practix,wassearchedtoidentifyallpatientswith adiagnosisofHepatitisCinNovember2014.

• RetrospectiveauditofelectronicmedicalrecordsofpatientswhowereHCVRNAPCRpositive.Data extractedandsimultaneouslyrecordedelectronicallyonaformdevelopedinMicrosoftAccess softwareprogramforthefollowing: o DetailsofmostrecentHCVRNAPCRpathologytest o Socio-demographiccharacteristics o Treatmentdetails o Presenceofco-morbidities,lifestyleriskfactors,liverdisease.

• StudywasapprovedbytheInalaCommunityJuryforAboriginalandTorresStraitIslanderHealth Research.MetroSouthHumanResearchEthicsCommitteedeemedthisaqualityassuranceproject.

Data analysisSTATA©version14.1wasusedfordataanalysisforallpatients,thenseparatelyforAboriginalandTorresStraitIslanderpatients.

RESULTS219patientshadadiagnosisofHepatitisClistedintheirmedicalrecords,186patientshadHCVPCRtesting,Fig1.

Poster produced by Media & Communications, Princess Alexandra Hospital, 2016

• Therateofnewly-diagnosedHCVisincreasinginAustralia’sIndigenouspopulation(130per100000 Indigenouspopulationin2008to166in2012),whiletherateisdecreasinginthenon-Indigenous population(51per100000in2008to40in2012)12.

REFERENCES1. Commonwealth of Australia, Department of the Prime Minister and Cabinet, Closing the Gap Prime Minister’s Report 2016, http://closingthegap.dpmc.gov.au/assets/pdfs/closing_the_gap_report_2016.pdf. Accessed 17/8/2016.2. Australian Government Department of Health. Fourth National Aboriginal & Torres Strait Islander blood-borne viruses and sexually transmissible infections strategy 2014-2017. Available at www.health.gov.au/internet/main/publishing.nsf/content/ohp-bbvs-atsi. Accessed 15/8/2016.3. Treloar C, Jackson C, Gray, R et al. (2016). Care and treatment of hepatitis c among Aboriginal people in New South Wales, Australia: implications for implementation of new treatments. Ethnicity & Health. 21 (1): 39-57.

CONCLUSIONS• ManagementofHCVinthiscommunity–basedclinicismadeamidstcomplexpersonalandsocial environments.• Ahighproportionofpatientsinthisstudyexperiencedmentalhealthconditions,conflictand domesticviolence,andlifestyleriskfactors.Manyofthesefactorsmayposebarrierstotreatment, evenwithnewerHCVtherapies.• Thestudyhighlightstheneedtoaddressthebroaderproblemsofaddiction,forexampletrauma,to addresssubstanceabuseandassociatedriskybehaviours,suchassharingofneedles.• AholisticapproachisessentialforadequatetreatmentofHCVinfection.

Figure 1:HCVinfectionstatus;treatment(pre-2016)detailsforpatientswithdiagnosisofHepatitisCinpatients’medicalrecords-November2014.

PATIENTS WITH HCV RNA PCR POSITIVE RESULTSSample• 113patientshadHCVRNAPCRpositiveresults(50%weregenotype3).• 95/113(84%)patientsself-identifiedashavinganAboriginaland/orTorresStraitIslanderbackground.• Table1describesthesocio-demographiccharacteristicsofallpatients.• AseparateanalysisforpatientsfromAboriginalandTorresStraitIslanderbackgroundshowedeither none,ora1-2%percentagedifferenceformostvariables,exceptforthe50%(versus46%for‘All’ patients)livingwithotherfamilymembers.• Fig1.describesdetailsofreferrals/treatmentforpatientsinHCVnegativeandpositivegroups.

Table 1: Socio-demographic characteristics of patients with HCV RNA PCR positive results*

Characteristic HCV RNA PCR positiveAgemedian(mean,±SD,min-max),years 38(39;9.7,7-63)Gender n %Male 75/113 66EthnicityAboriginal 90/113 79TorresStraitIslander 2/113 2Aboriginal&TorresStraitIslander 3/113 3Non-Aboriginal/TorresStraitIslander 18/113 16Regular Attendance at Clinic(≥3visitsinlasttwoyears) 69/113 61Living ConditionHomelessnessorOvercrowdingpresent 6/81 7Living ArrangementLivingalone 4/54 7Livingwithspouse,orspouse&children 15/54 28Livingwithotherfamilymembersincludingownchildren 25/54 46Livingwithfriends/sharedaccommodation,hostel,undercareofDepartmentofChildren’sServices

10/54 19

Table 2: Patient-associated and other factors present among patients with HCV RNA PCR positive *

HCV RNA PCR positiven %

Patient-associated factors1. ComorbiditiesDepression 71/99 72Anxiety 56/92 61Othercurrentmentalillness 28/92 30Historyofprevioussuicide/selfharmattempt 15/65 23Fattyliver 18/32 56Cirrhosisofliver 7/33 21Primarycarcinomaofliver 1/32 3Hypertension 10/90 11Diabetes 9/90 10IschaemicHeartDisease 4/91 42. Lifestyle-associated factorsCurrentsmoker 94/108 87Alcoholabuse 39/97 40AlcoholicLiverDisease 4/26 15Usinganopiate 22/77 29Onreplacementopiate 19/82 23CurrentIntravenousDrugUser 36/77 47PastIntravenousDrugUser 89/93 96BodyMassIndex(kg/m2) <18.5 1/89 1.018.5-25(normalhealthyweight) 45/89 51 >25 43/89 48Other factorsHistoryofincarceration 72/105 69Conflictanddomesticviolence 33/81 41*Datanotavailableforallpatients,analysisconductedwithavailabledata.

219 patients with diagnosis of Hepatitis C (Data missing n=10)

HCV RNA PCR negative n=71/209; 34%

Treatment details

Outof67patientswithavailabledata:13/67(19%)hadclearedthroughtreatment.

54/67(81%)didnotrequiretreatment(self-clearedorantibodypositiveonly)

HCV RNA PCR positive n= 113/209; 54%

Treatment details, n=107

45/107(42%)referredfortreatment2/45commencedtreatment 1/2treatmentincompletedue tointolerancetotreatmentside-effects(datamissingn=1)

Reasons for non-treatment of referred patients (n=43/45)

2/43refusedtreatment 16/43didnotattendtreatmentappointment 16/43doctordecisionnottotreat 9/43datamissing

No confirmed PCRn =25/209; 12%

*Somedatawasmissingforallvariablesforthe113patients;analysisisconductedwithavailabledata.

DISCUSSION• ThisstudyhasidentifiedthevulnerabilityofthisgroupofpatientswithHCVinfection.Majorityof patientsexperiencedmentalillnessesandincarceration.Highproportionsofpatientsexperienced conflictanddomesticviolence,andlifestyleriskfactorssuchasaddictiontocigarettes,alcoholand intravenousdrugsuse.

• Atleastone-fifthofpatientshadacirrhoticliver,highlightingtheurgencyoftreatmenttoavoid long-termliverdamageanditsconsequencesonhealthstatusandqualityoflife.

• ThehighincarcerationrateincreasesriskofHCVtransmission,withunsafeinjectingandtattooing practicesinprisonsoccurringinahighlyprevalentreservoirofinfection.

• Whilenewermedicationshaveovercomemanyofthebarriersassociatedwiththepreviousdrugs, successfultreatmentandavoidanceofre-infectionreliesonmanycomplexsocialandbehaviouralfactors.

• SuccessfultreatmentofHCVrequiresaholisticpatient-centeredapproach,utilizingotherstrengths suchasconnectionstocommunity,culture,andfamilydynamicsinpreventingintravenousdruguse, andsimultaneoustreatment/preventionofbroaderissuesofdrugandalcoholaddiction,mentalillness, conflictanddomesticviolence,andincarceration3.

• Informationonsocialdeterminantsofhealthwasnotobtainedinthisstudy.Theassociationbetween education,employment,mentalillness,incarceration,exposuretotraumaandabuse,domestic violence,andHCVneedstobeexploredtopreventHCVinfectionsamongthisgroupofvulnerable Indigenouspatients.

Possible barriers to accessing treatments• PatientswithHCVinfectionsufferedfromothercomorbidities;lifestyle-associatedanddomesticfactors thatcouldinfluencetreatmentdecisions,Table2.• SeparateanalysisofpatientsfromAboriginalandTorresStraitIslanderbackgroundshowedeithernone, ora1-2%percentagedifferenceformostvariables,exceptforpresenceof:depression(60%),fattyliver (48%),conflictanddomesticviolence(35%).