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Summary: Background: Global targets to eliminate hepatitis C (HCV) might be met by sustained treatment uptake. Aim: To describe factors facilitating HCV treatment uptake and potential challenges to sustaining treatment levels after universal access to direct‐acting anti‐virals (DAA) across Australia. Methods: We analysed national Pharmaceutical Benefits Scheme data to determine the number of DAA prescriptions commenced before and after universal access from March 2016 to June 2017. We inferred facilitators and barriers to treatment uptake, and challenges that will prevent local and global jurisdictions reaching elimination targets. Results: In 2016, 32 877 individuals (14% of people living with HCV in Australia) commenced HCV DAA treatment, and 34 952 (15%) individuals commenced treatment in the first year of universal access. Treatment uptake peaked at 13 109 DAA commencements per quarter immediately after universal access, but more than halved (to 5320 in 2017 Q2) within 12 months. General practitioners have written 24% of all prescriptions but with a significantly increased proportion over time (9% in 2016 Q1 to 37% in 2017 Q2). In contrast, hepatology or infectious diseases specialists have written a declining share from 74% to 38% during the same period. General practitioners provided a greater proportion (47%) of care in regional/remote areas than major cities. Conclusions: Broad treatment access led to rapid initial increases in treatment uptake, but this uptake has not been sustained. Our results suggest achieving global elimination targets requires more than treatment availability: people with HCV need easy access to testing and linkage to care in community settings employing a diverse prescriber base. [ABSTRACT FROM AUTHOR]

Direct-acting antivirals (DAAs) have dramatically changed the landscape of hepatitis C treatment and prevention. The World Health Organization has called for the elimination of hepatitis C as a public health threat by 2030. However, the discrepancy in DAA prices across low-, middle- and high-income countries is considerable, ranging from less than US$ 100 to approximately US$ 40,000 per course, thus representing a major barrier for the scale-up of treatment and elimination. This article describes DAA pricing and pathways to accessing affordable treatment, providing case studies from Australia, Egypt and Portugal. Pathways to accessing DAAs include developing comprehensive viral hepatitis plans to facilitate price negotiations, voluntary and compulsory licenses, patent opposition, joint procurement, and personal importation schemes. While multiple factors influence the price of DAAs, a key driver is a country's capacity and willingness to negotiate with pharmaceutical companies. If negotiations do not lead to a reasonable price, governments have the option to utilise flexibilities outlined in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Affordable access to DAAs is underpinned by collaboration between government, civil society, global organisations and pharmaceutical companies to ensure that all patients can access treatment. Promoting these pathways is critical for influencing policy, improving access to affordable DAAs and achieving hepatitis C elimination. [ABSTRACT FROM AUTHOR]

Background: Achieving hepatitis C elimination requires novel approaches to engage people at highest risk of infection into care pathways. Point-of-care-tests may help to overcome some of the barriers preventing people who inject drugs (PWID) accessing testing and progressing to treatment for hepatitis C virus (HCV). We assessed the feasibility and acceptability of HCV point-of-care testing at needle and syringe exchange programs (NSPs) co-located in three community health clinics in Melbourne, Australia.Methods: NSP clients were offered an oral fluid point-of-care test for HCV antibody by NSP staff. Positive HCV antibody tests were followed by a point-of-care test for HCV RNA alongside standard-of-care laboratory testing for hepatitis C treatment work-up. Participants were offered same-day point-of-care results on site, via phone or text message, or upon return to the service. Participants were scheduled for follow-up review with the study nurse for assessment and linkage to treatment.Results: A total of 174 participants completed HCV antibody point-of-care test; 150 (86%) had a reactive result. Of these, 140 (93%) underwent a HCV RNA point-of-care test and 76 (54%) tested positive; few participants (5%) waited on site for results delivery, but the majority of RNA positive (63%) attended a follow-up visit for treatment work-up (median time to follow-up visit = 11 days; IQR = 7-20 days). The majority of participants reported a preference for point-of-care tests (66%) and supported NSP staff involvement in testing (90%).Conclusion: Provision of HCV point-of-care tests, follow-up and linkage to treatment services through NSPs was feasible and acceptable to PWID. Despite few participants waiting to receive same-day results, there was effective linkage to care, suggesting value in further evaluation of this approach. [ABSTRACT FROM AUTHOR]

Graphical abstract Highlights • Nurse-led care was associated with SVR12 rates of >95% in large numbers of prisoners. • <20% of prisoners required specialist input. • >80% of prisoner had never pursued specialist hepatitis C care in the community. Background & Aims Treatment programs for people who inject drugs (PWID), including prisoners, are important for achieving hepatitis C elimination targets. There are multiple barriers to treatment of hepatitis C in prisons, including access to specialist physicians, testing and antiviral therapy, short prison sentences, and frequent inter-prison transfer. We aimed to assess the effectiveness of a nurse-led model of care for the treatment of prisoners with hepatitis C. Methods A statewide program for assessment and management of hepatitis C was developed in Victoria, Australia to improve access to care for prisoners. This nurse-led model of care is supported by telemedicine to provide decentralized care within all prisons in the state. We prospectively evaluated the feasibility and efficacy of this nurse-led model of care for hepatitis C within the 14 adult prisons over a 13-month period. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12) using per protocol analysis. Results There were 416 prisoners included in the analysis. The median age was 41 years, 90% were male, 50% had genotype 3 and 44% genotype 1 hepatitis C and 21% had cirrhosis. Injecting drug use was reported by 68% in the month prior to prison entry, 54% were receiving opioid substitution therapy, and 86% reported never previously engaging with specialist HCV care. Treatment duration was 8 weeks in 24%, 12 weeks in 59%, and 24 weeks in 17% of treatment courses. The SVR12 rate was 96% (301/313) per protocol. Inter-prison transfer occurred during 26% of treatment courses but was not associated with lower SVR12 rates. No treatment-related serious adverse events occurred. Conclusion Hepatitis C treatment using a decentralized, nurse-led model of care is highly effective and can reach large numbers of prisoners. Large scale prison treatment programs should be considered to support hepatitis C elimination efforts. Lay summary There is a high burden of hepatitis C infection among prisoners worldwide. Prisoners who continue to inject drugs are also at risk of developing new infections. For this reason, the prison setting provides an opportunity to treat those people at greatest risk of infection and to stop transmission to others. We developed a new method of providing hepatitis C treatment to prisoners, in which nurses rather than doctors assessed prisoners locally at each prison site. Treatment was safe and most prisoners were cured. Such programs will contribute greatly to achieving the World Health Organization's hepatitis C elimination goals. [ABSTRACT FROM AUTHOR]

Background: Modelling suggests that achieving the World Health Organization's elimination targets for hepatitis C virus (HCV) is possible by scaling up use of direct-acting antiviral (DAA) therapy. However, poor linkage to health services and retention in care presents a major barrier, in particular among people who inject drugs (PWID). We identify and assess the cost-effectiveness of additional health system interventions required to achieve HCV elimination targets in Australia, a setting where all people living with HCV have access to DAA therapy.Methods: We used a dynamic HCV transmission and liver-disease progression mathematical model among current and former PWID, capturing testing, treatment and other features of the care cascade. Interventions tested were: availability of point-of-care RNA testing; increased testing of PWID; using biomarkers in place of liver stiffness measurement; and scaling up primary care treatment delivery.Results: The projected treatment uptake in Australia reduced the number of people living with HCV from approximately 230,000 in 2015 to approximately 24,000 by 2030 and reduced incidence by 45%. However, the majority (74%) of remaining infections were undiagnosed and among PWID. Scaling up primary care treatment delivery and using biomarkers in place of liver stiffness measurement only reduced incidence by a further 1% but saved AU$32 million by 2030, with no change to health outcomes. Additionally replacing HCV antibody testing with point-of-care RNA testing increased healthcare cost savings to AU$62 million, increased incidence reduction to 64% and gained 11,000 quality-adjusted life years, but critically, additional screening of PWID was required to achieve HCV elimination targets.Conclusion: Even with unlimited and unrestricted access to HCV DAA treatment, interventions to improve the HCV cascade of care and target PWID will be required to achieve elimination targets. [ABSTRACT FROM AUTHOR]

Background: Monitoring trends in hepatitis C virus (HCV) incidence is critical for evaluating strategies aimed at eliminating HCV as a public health threat. We estimate HCV incidence and assess trends in incidence over time among primary care patients.Methods: Data were routinely extracted, linked electronic medical records from 12 primary care health services. Patients included were aged ≥16 years, tested HCV antibody negative on their first test recorded and had at least one subsequent HCV antibody or RNA test (January 2009-December 2020). HCV incident infections were defined as a positive HCV antibody or RNA test. A generalised linear model assessed the association between HCV incidence and calendar year.Results: In total, 6711 patients contributed 17,098 HCV test records, 210 incident HCV infections and 19,566 person-years; incidence was 1.1 per 100 person-years (95% confidence interval (CI): 0.9 to 1.2). Among 559 (8.2%) patients ever prescribed opioid-related pharmacotherapy (ORP) during the observation period, 135 infections occurred during 2,082 person-years (incidence rate of 6.5 per 100 person-years (95% CI: 5.4 to 7.7)). HCV incidence declined 2009-2020 overall (incidence rate ratio per calendar year 0.8 (95% CI: 0.8 to 0.9) and among patients ever prescribed ORT (incidence rate ratio per calendar year 0.9, 95% CI: 0.75 to 1.0).Conclusion: HCV incidence declined among patients at primary care health services including among patients ever prescribed ORP and during the period following increased access to DAA therapy. [ABSTRACT FROM AUTHOR]

Background: At least 160,000 Australians are living with hepatitis C (HCV), many of whom are people who inject drugs and access needle and syringe programs (NSP). Secondary NSPs provide injecting equipment via health services that are not dedicated to the provision of services to people who inject drugs; these sites could be a suitable space to increase engagement of people who inject drugs in HCV treatment. Drawing on data from a pilot study exploring the potential of upscaling linkage to HCV care in secondary NSPs, the aim of this research was to explore barriers and enablers to HCV treatment for clients who use these services.Methods: We interviewed 34 people who inject drugs (who self-reported HCV positivity) from six secondary NSPs in urban and regional Victoria, Australia in 2018. Fifty per cent were male, with ages ranging from 33 to 58. Twenty-two (65%) had never received HCV treatment and none had experience with direct-acting antiviral (DAA) treatment. Interviews were transcribed and analysed thematically. Field notes from a program evaluation with feedback from secondary NSP staff was also used as a secondary data source.Results: Five themes encompassing a set of contrasting barriers and enablers to accessing HCV care through secondary NSPs were uncovered. Themes included 'misinformation' vs. 'multiple trusted information sources; 'lack of symptoms and motivation' vs. 'benefits of cure'; 'competing priorities' vs. 'willingness and readiness to be cured'; 'unsupportive relationships with staff' vs. 'supportive relationships with staff'; and 'inaccessibility and stigma in health services' vs. 'enhanced support'. Secondary program evaluation data also highlighted that secondary NSP staff were under-resourced and had limited capacity to implement HCV care linkage and information.Conclusion: We identified contrasting barriers and opportunities for accessing DAAs among a sample of secondary NSP clients and staff. Interventions that consider individual, provider and health system level factors are needed if secondary NSP services are to become a suitable setting to initiate conversations with clients around HCV treatment and provide linkages to care. [ABSTRACT FROM AUTHOR]