A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial.

BACKGROUND: There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder. METHODS: This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles. DISCUSSION: This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.

Factors associated with experiencing stigma, discrimination, and negative health care treatment among people who inject drugs.

INTRODUCTION: Stigma has negative consequences for the health of people who inject drugs and people living with hepatitis C virus (HCV). This study evaluated factors associated with stigma related to injecting drug use (IDU) or HCV and those associated with being treated negatively by health workers. METHODS: ETHOS Engage is an observational cohort study of people who inject drugs attending drug treatment clinics and needle and syringe programs in Australia. Participants completed a questionnaire including IDU- and HCV-related stigma, and negative treatment by health workers. Logistic regression was used to identify factors associated with experiencing stigma and negative treatment in a cross-sectional sample. RESULTS: Of 1,211 participants, 31% were women, 64% had injected drugs in the previous month, and 65% had been diagnosed with HCV. IDU-related stigma was reported by 57% of participants and was associated with being a woman, higher than Year 10 education, homelessness, opioid agonist treatment, recent injecting, overdose history, hospitalisation for drug use, and unknown HCV status. HCV-related stigma was reported by 34% of participants diagnosed with HCV and was associated with being a woman, homelessness, receptive needle/syringe sharing, arrest for drug use/possession, and recent HCV testing. Negative treatment from health workers was reported by 45% of participants and was associated with being a woman, receptive needle/syringe sharing, hospitalisation for drug use, and arrest for drug use/possession. DISCUSSION AND CONCLUSIONS: Results highlight important intersections and disparities in stigmatising experiences among people who inject drugs. Considering these intersections can assist health services provide more inclusive care.

An Australian retrospective observational cohort comparison of the use of long-acting injectable buprenorphine products.

INTRODUCTION: In early 2019, Australia became the first jurisdiction to have two brands of long-acting injectable buprenorphine (LAI-B) products available. Previously published studies have mostly followed pre-planned dosing schedules and seldom compared use of both products. This study presents a retrospective analysis of the "real-world" dosing requirements of patients on LAI-B. METHOD: Five clinics provided data for patients commenced on LAI-B between 1 February 2019 and 30 June 2021 for buprenorphine doses and intervals between dosing. The study recorded basic demographic data including age, gender, and previous dose of transmucosal buprenorphine. The Local Institutional Ethics Committee provided approval. RESULTS: Over 3600 individual doses (59 % Buvidal® & 41 % Sublocade®) were administered to 340 individual patients (median age 40 years, 63 % male), with the longest duration in treatment of 856 days. Median estimated duration of a treatment episode was 16.5 months (95%CI: 14.3-19.1). Approximately 94 % transferred from transmucosal buprenorphine (median daily dose 16 mg, range 2-32 mg). Most common LAI-B doses were Sublocade® 100 mg (22.4 %) and Buvidal® Monthly 128 mg (21.5 %); Buvidal® Weekly 24 mg (0.8 %) was least used. 13 % transitioned between LAI-B products. Weekly dose intervals were a median 7 days and monthly doses were given a median of 28 days apart. Overall, 36 % discontinued LAI-B before the census date. DISCUSSIONS AND CONCLUSIONS: Most patients who started LAI-B remained in treatment, with similar rates in both products. A small, but appreciable number of people switched brands, suggesting that it remains important to have treatment options available.

Cytochrome P450-2D6 activity in people with codeine use disorder.

Compound-analgesics containing codeine (CACC) have been a common source of codeine for people seeking opioid replacement therapy (ORT) for codeine use disorder (CUD). Our previous work demonstrated no relationship between pre-treatment CACC and ORT buprenorphine doses; we hypothesised that CYP2D6 activity would partially account for this disconnection. One hundred six participants with CUD were compared to a published population sample of 5408 Australian patients. Mean age of participants with CUD at treatment entry was 35 years, with mean 6.1 years duration of CUD. Mean codeine dose was 660 mg/day (range 40-2700 mg). Mean calculated CYP2D6 activity scores were significantly higher in the codeine group (CUD 1.65 + 0.63 vs. Gen pop 1.39 + 0.65, Wilcoxon W = 347,001, p < 0.001). Pre-treatment CACC dose weakly predicted sublingual buprenorphine doses overall; there was a stronger relationship within ultrarapid metabolisers. While normal and ultrarapid metabolisers of codeine were more likely to have a diagnosis of CUD, poor or intermediate CYP2D6 metaboliser status may protect against CUD.

Deimplementation in the provision of opioid agonist treatment to achieve equity of care for people engaged in treatment: a qualitative study.

BACKGROUND: Deimplementation, the removal or reduction of potentially hazardous approaches to care, is key to progressing social equity in health. While the benefits of opioid agonist treatment (OAT) are well-evidenced, wide variability in the provision of treatment attenuates positive outcomes. During the COVID-19 pandemic, OAT services deimplemented aspects of provision which had long been central to treatment in Australia; supervised dosing, urine drug screening, and frequent in-person attendance for review. This analysis explored how providers considered social inequity in health of patients in the deimplementation of restrictive OAT provision during the COVID-19 pandemic. METHODS: Between August and December 2020, semi-structured interviews were conducted with 29 OAT providers in Australia. Codes relating to the social determinants of client retention in OAT were clustered according to how providers considered deimplementation in relation to social inequities. Normalisation Process Theory was then used to analyse the clusters in relation to how providers understood their work during the COVID-19 pandemic as responding to systemic issues that condition OAT access. RESULTS: We explored four overarching themes based on constructs from Normalisation Process Theory: adaptive execution, cognitive participation, normative restructuring, and sustainment. Accounts of adaptive execution demonstrated tensions between providers' conceptions of equity and patient autonomy. Cognitive participation and normative restructuring were integral to the workability of rapid and drastic changes within the OAT services. Key transformative actors included communities of practice and "thought leaders" who had long supported deimplementation for more humane care. At this early stage of the pandemic, providers had already begun to consider how this period could inform sustainment of deimplementation. When considering a future, post-pandemic period, several providers expressed discomfort at operating with "evidence-enough" and called for narrowly defined types of data on adverse events (e.g. overdose) and expert consensus on takeaway doses. CONCLUSIONS: The possibilities for achieving social equity in health are limited by the divergent treatment goals of providers and people receiving OAT. Sustained and equitable deimplementation of obtrusive aspects of OAT provision require co-created treatment goals, patient-centred monitoring and evaluation, and access to a supportive community of practice for providers.

'I just thought that was the best thing for me to do at this point': Exploring patient experiences with depot buprenorphine and their motivations to discontinue.

INTRODUCTION: Long-acting injectable depot buprenorphine is a recent addition to the suite of opioid agonist therapies (OAT) used to treat opioid use disorder (OUD). However, there has been little research that focuses on the lived experience of people receiving depot buprenorphine treatment and reasons for why people decide to discontinue. The aim of this study was to explore what it is like to receive depot buprenorphine and to understand the motivations behind why people discontinue. METHODS: Open-ended, semi-structured interviews were conducted between November 2021 and January 2022 with individuals who were either currently receiving depot buprenorphine or had discontinued or were in the process of discontinuing depot buprenorphine. Liberati, et al.'s (2022) adaptation of Dixon-Woods's (2006) candidacy framework was used to analyse the participant experiences. RESULTS: 40 participants (26 male, 13 female, 1 undisclosed; mean age 42 years) were interviewed about their experience with depot buprenorphine. At the time of the interview, 21 were currently receiving depot buprenorphine and 19 had discontinued this treatment or were in the process of discontinuing. Participants cited 4 key reasons why they decided to discontinue depot buprenorphine:1) feeling forced into the program, 2) experiencing negative side-effects, 3) finding the treatment ineffective, and 4) wanting to stop depot buprenorphine/OAT to use opioids again or feeling 'cured' and no longer in need of OAT. Participants were ultimately discussing issues related to clinician-patient power relations, agency and bodily autonomy, and the pursuit of well-being. CONCLUSION: Depot buprenorphine remains a promising treatment for OUD and offers potential to improve treatment adherence. Instances of restricted OAT choice and consumer concerns regarding a lack of agency must be addressed in order to enhance therapeutic relationships. Clinicians and other healthcare workers in this field also need greater access to information about depot buprenorphine to better address issues patients face during treatment. More research is required to understand patient and treatment choice given the options of these new treatment formulations.

"You'll come in and dose even in a global pandemic": A qualitative study of adaptive opioid agonist treatment provision during the COVID-19 pandemic.

BACKGROUND: Opioid agonist treatment (OAT) improves multiple health and social outcomes, yet requirements to attend for supervised dosing can be burdensome and stigmatising. The COVID-19 pandemic and associated restrictions threatened continuity of care and the wellbeing of people receiving OAT, risking a parallel health crisis. This study sought to understand how adaptations in the complex system of OAT provision impacted and responded to risk environments of people receiving OAT during the COVID-19 pandemic. METHODS: The analysis draws on semi-structured interviews with 40 people receiving and 29 people providing OAT located across Australia. The study considered the risk environments that produce COVID-19 transmission, treatment (non-)adherence, and adverse events for people receiving OAT. Drawing on theories of risk environments and complex adaptive systems, data were coded and analysed to understand how adaptations to the typically rigid system of OAT provision impacted and responded to risk environments during the COVID-19 pandemic. RESULTS: During COVID-19, the complex system of OAT provision demonstrated possibilities for responsive adaptation to the entangled features of risk environments of people receiving OAT. Structural stigma was evident in the services which stayed rigid during the pandemic, requiring people to attend for daily supervised dosing and risking fracturing therapeutic relationships. In parallel, there were several examples of services developing enabling environments by offering flexible care through increased takeaways, treatment subsidies, and home delivery. CONCLUSIONS: Rigidity in the delivery of OAT has been an impediment to achieving health and wellbeing over past decades. To sustain health-promoting environments for people receiving OAT, the wider impacts of the complex system should be acknowledged beyond narrowly defined outcomes relating solely to the medication. Centring people receiving OAT in their own care plans will ensure adaptations in the complex system of OAT provision are responsive to the individual's risk environment.

A Testing Campaign Intervention Consisting of Peer-Facilitated Engagement, Point-of-Care HCV RNA Testing, and Linkage to Nursing Support to Enhance Hepatitis C Treatment Uptake among People Who Inject Drugs: The ETHOS Engage Study.

This study evaluated HCV treatment initiation among people who inject drugs (PWID) following an intervention of campaign days involving peer connection, point-of-care HCV RNA testing, and linkage to nursing support. ETHOS Engage is an observational cohort study of PWID attending 25 drug treatment clinics and needle and syringe programs in Australia (May 2018-September 2019). Point-of-care results were provided to the nurse, facilitating confirmatory testing and treatment. The study aimed to evaluate treatment uptake and factors associated with treatment at 24 months post-enrolment. There were 317 people with current HCV infection and eligible for treatment (median age 43, 65% male, 15% homeless, 69% receiving opioid agonist treatment, 70% injected in last month). Overall, 15% (47/317), 27% (85/317), 38% (120/317), and 49% (155/317) of people with current HCV infection had initiated treatment at 3-, 6-, 12-, and 24-months following testing, respectively. Homelessness (adjusted hazard ratio (aHR): 0.40; 95% confidence interval: 0.23, 0.71) and incarceration in the past 12 months (vs. never, aHR:0.46; 0.28, 0.76) were associated with decreased treatment initiation in the 24 months post-enrolment. This testing campaign intervention facilitated HCV treatment uptake among PWID. Further interventions are needed to achieve HCV elimination among people experiencing homelessness or incarceration.

Prevalence and factors associated with hospitalisation for bacterial skin infections among people who inject drugs: The ETHOS Engage Study.

BACKGROUND: Injecting-related skin and soft tissue infections (SSTIs) are a preventable cause of inpatient hospitalisation among people who inject drugs (PWID). This study aimed to determine the prevalence of hospitalisation for SSTIs among PWID, and identify similarities and differences in factors associated with hospitalisation for SSTIs versus non-bacterial harms related to injecting drug use. METHODS: We performed cross-sectional analyses of baseline data from an observational cohort study of PWID attending drug treatment clinics and needle and syringe programs in Australia. Logistic regression models were used to identify factors associated with self-reported hospitalisation for (1) SSTIs (abscess and/or cellulitis), and (2) non-bacterial harms related to injecting drug use (e.g., non-fatal overdose; hereafter referred to as non-bacterial harms), both together and separately. RESULTS: 1851 participants who injected drugs in the previous six months were enrolled (67% male; 85% injected in the past month; 42% receiving opioid agonist treatment [OAT]). In the previous year, 40% (n = 737) had been hospitalised for drug-related causes: 20% (n = 377) and 29% (n = 528) of participants were admitted to hospital for an SSTI and non-bacterial harm, respectively. Participants who were female (adjusted odds ratio [aOR]: 1.53, 95% CI: 1.19-1.97) or homeless (aOR: 1.59, 95% CI: 1.16-2.19) were more likely to be hospitalised for an SSTI, but not a non-bacterial harm. Both types of hospitalisation were more likely among people recently released from prison. CONCLUSIONS: Hospitalisation for SSTIs is common among PWID. Community-based interventions to prevent SSTIs and subsequent hospitalisation among PWID will require targeting of at-risk groups, including women, people experiencing homelessness, and incarcerated people upon prison release.

Kamini, a little recognised source of illicit opioid: A case series of 12 patients.

INTRODUCTION: This case series describes 12 patients who developed opioid use disorder after ingesting a prohibited, imported herbal product, Kamini, which contains Papaver somniferum. They appeared unaware of the risk of dependence from Kamini and most had struggled to manage their use for many months before presenting for treatment. METHODS: After two cases were presented at a clinical meeting, a chart review was conducted of cases across four public opioid treatment clinics in south-east Queensland with about 1500 patients registered, identifying 10 further cases. RESULTS: Twelve patients presented with features of opioid withdrawal, seeking treatment after use of Kamini for periods between 6 months and 8 years. Eleven patients were born in India. Nine patients stabilised on buprenorphine maintenance treatment, three of whom commenced long-acting injectable buprenorphine. One patient left after 1 day and subsequently began methadone treatment with a private prescriber. Two patients on smaller doses and shorter-term use undertook withdrawal with prescribed (off-label) trans-dermal buprenorphine. One patient, initially lost to follow-up, later stabilised on long-acting injectable buprenorphine. Reasons for presenting included supply shortages and financial distress during the COVID-19 pandemic. DISCUSSION AND CONCLUSION: Kamini represents an illicit source of non-prescription opioid in Australia. Although classified as an illegal import by the Therapeutic Goods Administration, patients confirm that it is readily available in Brisbane. Targeted efforts are needed to prevent further patients developing opioid dependence from use of Kamini and also to highlight treatment options for those seeking to stop Kamini use.

Declining prevalence of current HCV infection and increased treatment uptake among people who inject drugs: The ETHOS Engage study.

BACKGROUND: Evaluating trends in HCV treatment and prevalence is crucial for monitoring elimination. We evaluated the change in current infection and treatment among people who inject drugs (PWID) between 2018-2019 and 2019-2021. METHODS: ETHOS Engage is an observational cohort study of PWID attending drug treatment clinics and needle and syringe programs in Australia. Participant enrolment occurred over two periods, Wave 1 (May 2018-September 2019, 25 sites) and Wave 2 (November 2019-June 2021, 21 sites), with baseline questionnaire completion and point-of-care HCV RNA testing (Xpert® HCV Viral Load Fingerstick). Logistic regression was used to identify factors associated with current HCV infection and historic HCV treatment. RESULTS: 2,395 individuals were enrolled across the two recruitment waves (66% male, median age 43, 72% current opioid agonist therapy, and 65% injecting in the previous month). HCV prevalence decreased from 24% to 17% between 2018-2019 and 2019-2021, respectively (p=0.003). HCV treatment increased from 66% to 74% between 2018-2019 and 2019-2021, respectively (p<0.001). After adjusting, there was a reduction in current HCV infection in 2019-2021 (adjusted odds ratio [aOR] 0.62; 95% CI, 0.50, 0.77) compared to 2018-2019. Other factors associated with current infection included homelessness (aOR, 1.70; 1.26, 2.30), incarceration (vs. never; historic: aOR 1.69; 95%CI 1.31, 2.19; recent: aOR 1.85; 95%CI, 1.35, 2.54), and recently injecting drugs (vs. >12 months ago; previous month

Progress Towards Elimination of Hepatitis C Infection Among People Who Inject Drugs in Australia: The ETHOS Engage Study.

BACKGROUND: Evaluating progress towards hepatitis C virus (HCV) elimination is critical. This study estimated prevalence of current HCV infection and HCV treatment uptake among people who inject drugs (PWID) in Australia. METHODS: The Enhancing Treatment of Hepatitis C in Opioid Substitution Settings Engage is an observational study of PWID attending drug treatment clinics and needle and syringe programs (NSPs). Participants completed a questionnaire including self-reported treatment history and underwent point-of-care HCV RNA testing (Xpert HCV Viral Load Fingerstick; Cepheid). RESULTS: Between May 2018 and September 2019, 1443 participants were enrolled (64% injected drugs in the last month, 74% receiving opioid agonist therapy [OAT]). HCV infection status was uninfected (28%), spontaneous clearance (16%), treatment-induced clearance (32%), and current infection (24%). Current HCV was more likely among people who were homeless (adjusted odds ratio, 1.47; 95% confidence interval, 1.00-2.16), incarcerated in the previous year (2.04; 1.38-3.02), and those injecting drugs daily or more (2.26; 1.43-2.42). Among those with previous chronic or current HCV, 66% (n = 520/788) reported HCV treatment. In adjusted analysis, HCV treatment was lower among females (.68; .48-.95), participants who were homeless (.59; .38-.96), and those injecting daily or more (.51; .31-.89). People aged ≥45 years (1.46; 1.06-2.01) and people receiving OAT (2.62; 1.52-4.51) were more likely to report HCV treatment. CONCLUSIONS: Unrestricted direct-acting antiviral therapy access in Australia has yielded high treatment uptake among PWID attending drug treatment and NSPs, with a marked decline in HCV prevalence. To achieve elimination, PWID with greater marginalization may require additional support and tailored strategies to enhance treatment.

Hepatitis C virus testing, liver disease assessment and treatment uptake among people who inject drugs pre- and post-universal access to direct-acting antiviral treatment in Australia: The LiveRLife study.

Gaps in hepatitis C virus (HCV) testing, diagnosis, liver disease assessment and treatment uptake among people who inject drugs (PWID) persist. We aimed to describe the cascade of HCV care among PWID in Australia, prior to and following unrestricted access to direct-acting antiviral (DAA) treatment. Participants enrolled in an observational cohort study between 2014 and 2018 provided fingerstick whole-blood samples for dried blood spot, Xpert HCV Viral Load and venepuncture samples. Participants underwent transient elastography and clinical assessment by a nurse or general practitioner. Among 839 participants (mean age 43 years), 66% were male (n = 550), 64% (n = 537) injected drugs in the previous month, and 67% (n = 560) reported currently receiving opioid substitution therapy. Overall, 45% (n = 380) had detectable HCV RNA, of whom 23% (n = 86) received HCV treatment within 12 months of enrolment. HCV treatment uptake increased from 2% in the pre-DAA era to 38% in the DAA era. Significant liver fibrosis (F2-F4) was more common in participants with HCV infection (38%) than those without (19%). Age 50 years or older (aOR, 2.88; 95% CI, 1.18-7.04) and attending a clinical follow-up with nurse (aOR, 3.19; 95% CI, 1.61-6.32) or physician (aOR, 11.83; 95% CI, 4.89-28.59) were associated with HCV treatment uptake. Recent injection drug use and unstable housing were not associated with HCV treatment uptake. HCV treatment uptake among PWID has increased markedly in the DAA era. Evaluation of innovative and simplified models of care is required to further enhance treatment uptake.

Acceptability and preferences of point-of-care finger-stick whole-blood and venepuncture hepatitis C virus testing among people who inject drugs in Australia.

BACKGROUND: Uptake of hepatitis C virus (HCV) testing remains inadequate globally. Simplified point-of-care tests should enhance HCV diagnosis and elimination. We aimed to assess the acceptability of finger-stick and venepuncture HCV RNA testing among people who inject drugs (PWID). METHODS: Participants were enrolled in an observational cohort study with recruitment at 13 sites between June 2016 and February 2018. Capillary whole-blood collected by finger-stick and plasma collected by venepuncture were performed for Xpert® HCV viral load testing. Participants completed a questionnaire on acceptability of, and preferences for, blood collection methods. RESULTS: Among 565 participants (mean age, 44 years; 69% male), 64% reported injecting drugs in the last month, and 63% were receiving opioid substitution treatment. Eighty three percent reported that finger-stick testing was very acceptable. Overall, 65% of participants preferred finger-stick over venepuncture testing, with 61% of these preferring to receive results in 60 min. The most common reason for preferring finger-stick over venepuncture testing was it was quick (62%) followed by venous access difficulties (21%). The main reasons for preferring venepuncture over finger-stick testing were that it was quick (61%) and accurate (29%). Females were more likely to prefer finger-stick testing than males (adjusted OR 1.96; 95% CI 1.30, 2.99; p = 0.002). Among people with recent (previous month) injecting drug use, Aboriginal and/or Torres Strait Islander people were less likely than non-Aboriginal people to prefer finger-stick testing (adjusted OR 0.57; 95% CI 0.34, 0.9; p = 0.033). CONCLUSIONS: Finger-stick whole-blood collection is acceptable to people who inject drugs, with males and Aboriginal and/or Torres Strait Islander people with recent injecting drug use less likely to prefer finger-stick testing. Further research is needed to evaluate interventions integrating simplified point-of-care HCV testing to engage people in care in a single-visit, thereby facilitating HCV treatment scale-up.

An overview of take-home naloxone programs in Australia.

INTRODUCTION AND AIMS: Take-home naloxone (THN) programs commenced in Australia in 2012 in the Australian Capital Territory and programs now operate in five Australian jurisdictions. The purpose of this paper is to record the progress of THN programs in Australia, to provide a resource for others wanting to start THN projects, and provide a tool for policy makers and others considering expansion of THN programs in this country and elsewhere. DESIGN AND METHODS: Key stakeholders with principal responsibility for identified THN programs operating in Australia provided descriptions of program development, implementation and characteristics. Short summaries of known THN programs from each jurisdiction are provided along with a table detailing program characteristics and outcomes. RESULTS: Data collected across current Australian THN programs suggest that to date over 2500 Australians at risk of overdose have been trained and provided naloxone. Evaluation data from four programs recorded 146 overdose reversals involving naloxone that was given by THN participants. DISCUSSION AND CONCLUSIONS: Peer drug user groups currently play a central role in the development, delivery and scale-up of THN in Australia. Health professionals who work with people who use illicit opioids are increasingly taking part as alcohol and other drug-related health agencies have recognised the opportunity for THN provision through interactions with their clients. Australia has made rapid progress in removing regulatory barriers to naloxone since the initiation of the first THN program in 2012. However, logistical and economic barriers remain and further work is needed to expand access to this life-saving medication.

Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay.

Point-of-care hepatitis C virus (HCV) RNA testing is advantageous, enabling diagnosis of active infection in a single visit. This study evaluated the sensitivity and specificity of the Xpert HCV Viral Load Finger-Stick assay (Xpert HCV VL FS) for HCV RNA detection (finger-stick) and the Xpert HCV Viral Load assay (plasma) compared with the Abbott RealTime HCV Viral Load assay by venepuncture. Plasma and finger-stick capillary whole-blood samples were collected from participants in an observational cohort in Australia. Of 223 participants enrolled, HCV RNA was detected in 40% of participants (85 of 210) with available Xpert HCV Viral Load testing. Participants receiving HCV therapy were excluded from subsequent analyses (n = 16). Sensitivity of the Xpert HCV Viral Load assay for HCV RNA quantification in plasma collected by venepuncture was 100.0% (95% confidence interval [CI] 96.9%-100.0%) and specificity was 100.0% (95% CI, 94.4%-100.0%). Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in samples collected by finger-stick was 100.0% (95% CI, 93.9%-100.0%) and specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis.

General practitioner attitudes to prescribing hepatitis C antiviral therapy in a community setting.

There is a growing debate about the prescription of hepatitis C virus (HCV) antiviral therapies within a community setting in Australia. This study aimed to identify interest and confidence among general practitioners (GPs) in prescribing HCV antiviral therapy in a community setting. Data from 580 GPs who responded to a cross-sectional population-based survey were analysed to measure: self-reported interest and confidence in initiating HCV antiviral therapy; and/or prescribing maintenance antiviral therapy; and self-perceived education needs about HCV antiviral therapy. Forty-two percent of respondents indicated they would be interested in prescribing HCV antiviral therapy. Most were not confident to initiate therapy (80%). Higher proportions indicated that they would be more confident in prescribing maintenance therapy (35%) rather than initiating (7%) therapy (z=10.5, P<0.001). Confidence in prescribing was related to a higher caseload of patients with HCV (P=0.001) and being a HIV community-based prescriber (P=0.002). Fifty-three percent of respondents expressed an interest in education about HCV antiviral therapy. The initial step to recruit potential primary care prescribers of HCV antiviral therapies should be to develop an integrated education program. Recruitment to this program might be most efficient from GPs with a high caseload of patients with HCV.