Tertiary care clinics led by gastroenterologists, hepatologists or infectious diseases physicians have traditionally been the main sites for HCV clinical referral, assessment and treatment. Tertiary treatment centres should continue to be the main treatment sites for people with chronic HCV infection who have cirrhosis, complex comorbidities or other types of liver disease, or in whom first-line DAA therapy has failed. Tertiary treatment centres will continue to provide treatment for people with all stages of liver disease. Tertiary centres will also be required to support, up-skill and facilitate treatment by non-specialists in non-hospital settings. A useful tool has been developed for GPs and nurses to facilitate remote consultations with tertiary care specialists and initiation of HCV therapy (available at: www.gesa.org.au/education/clinical-information).
The PBS listing of DAA medicines enables GPs to initiate HCV therapy in primary care, with the goal of substantially increasing the HCV treatment workforce. As noted above, GPs who are experienced in the treatment of chronic HCV infection may prescribe independently. GPs who are not experienced in the treatment of HCV are eligible to prescribe the new HCV medicines provided this is done in consultation with an experienced gastroenterologist, hepatologist or infectious diseases physician. The consultation process promotes GP prescribing and experience without the need for formal accreditation. The PBAC has not defined “experienced”. It should include all practitioners who have previously been accredited as prescribers for HCV medicines. For interested practitioners who do not have experience in treating HCV, we recommend participation in a formal education session. Links to useful and complementary online resources are given in Box 1..
Clinical experience should be gained by providing treatment in consultation with a doctor who is experienced in the treatment of hepatitis C. Ideally, the treatments prescribed in consultation should occur with one specialist, to develop an ongoing working relationship. The PBS does not require formal accreditation. The important role of GPs in prescribing DAA therapy is supported by local data showing superior cost-effectiveness and net monetary benefit associated with a GP model of care. [13]
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Box 1. Resources containing useful information about assessment, treatment, monitoring and adherence |
For people living with HCV, receiving treatment in familiar environments with their trusted, accessible, long-term doctors removes an important barrier to treatment and will improve the cascade of care. Evidence from the IFN era supports the efficacy of GP-led treatment with remote specialist supervision. [14,15] Primary care-based treatment is suitable for most people living with HCV, particularly those with mild–moderate liver fibrosis. To support this, the availability and interpretation of simple tools for liver fibrosis assessment in the community is very important. People with cirrhosis, complex comorbidities or other types of liver disease, or in whom first-line DAA therapy has failed, should still be referred for specialist care.
Prescribing by GPs is increasing. The proportion of HCV treatments prescribed by GPs increased from 14.6% in 2016 to 36.8% in 2017, and GP prescribers were the main providers of DAA treatment in all states except NSW and Victoria.16,17 [16,17] Continued promotion of GP prescribing, particularly in areas of low specialist concentration, will be a key model of care required to achieve HCV elimination targets.
In collaboration with a medical specialist, appropriately qualified and experienced hepatology nurses are involved in educating, supporting and clinically managing people with liver disease during their treatment journey. Shared care between specialists and nurses has shown cost-effectiveness and net monetary benefits relative to traditional specialist-alone models of care. [13] Several Australian state governments have already committed significant investment to deliver nurse-led models of care for clinical assessment and management of HCV infection, with clinics staffed by advanced practice nurses or nurse practitioners. [18,19] Such models involve supervised practice within well-defined clinical protocols, including education, patient support, clinical assessment, performance of diagnostic tests such as transient elastography, and monitoring of treatment. Nurse-led HCV outreach clinics appear to be a cost-effective way of decentralising care and increasing HCV treatment capacity. They have been used to expand HCV education and treatment into a variety of HCV high-prevalence community settings, including prison populations, opioid substitution treatment centres, primary health services for PWID, and remote regions described below. [19,20]
Nurse practitioners can prescribe DAAs independently. The PBAC has expanded the criteria for prescribing DAA treatments through the S100 HSD Program to include authorised nurse practitioners experienced in the treatment of chronic HCV infection. Medicines for the treatment of HCV were previously only listed for prescribing by authorised nurse practitioners under the General Schedule.
Prison populations in Australia have a high prevalence of HCV infection, estimated at 30%, [21] which reflects the close relationship between injecting drug use, HCV infection and incarceration. Although treatment uptake in custodial settings across Australia was extremely low before March 2016, incarceration presents a unique opportunity for HCV therapy due to improved direct access to health care and stable accommodation. Both Australian and international studies have shown the safety, feasibility and acceptability of nurse-led models of IFN-based HCV treatment in prison populations,[14,22-25] supported by specialist teleconferencing. With newer DAA regimens, the ease of treatment has been considerably enhanced in this setting. Treatment of prisoners is a priority to reduce the incidence of HCV transmission. [26] As noted, recent evidence from the SToP-C study showed a halving of incidence after rapid upscaling of DAA therapy in NSW prisons. [7]
Prison hepatitis programs are increasingly important to the national goal of eliminating hepatitis C as a public health threat. Prisons are now estimated to be responsible for more than a third of all hepatitis C treatment prescriptions in Australia. [27] Detailed discussion can be found in the recent Consensus statement on the management of hepatitis C in Australia’s prisons. [28]
About 80% of people infected with HCV in Australia have acquired the infection through sharing unsterile injecting equipment, and new infections almost exclusively occur in PWID. Although some practitioners previously excluded current PWID from treatment, there is clear evidence of equivalent treatment outcomes, albeit with a low risk of reinfection. [29] Holistic care therefore includes harm reduction strategies, such as opioid substitution therapy, together with access to needle and syringe programs and education on safer injecting practices. In addition, treating PWID may reduce HCV transmission (treatment as prevention), making this group a high priority for HCV treatment. [30] Engagement with PWID and their injecting networks is recommended. The integration of HCV therapy with addiction therapy in opioid substitution treatment centres represents an opportunity to enhance HCV treatment uptake. Successful Australian models have been described, demonstrating feasibility and cost-effectiveness. [31-33] Education and training of clinical staff at opioid substitution treatment centres to integrate HCV therapy with addiction therapy is therefore an important priority. Nurses can play a major and increasing role in this integration, through championing and facilitating HCV treatment in opioid substitution treatment centres and acting as an educational resource for medical practitioners prescribing HCV treatment in this setting.
The Australian Therapeutic Goods Administration (TGA) approved the Xpert® HCV viral load point-of-care assay (Cepheid) in May 2020. It measures HCV RNA from a finger-prick blood sample (100 mL) and provides a real-time result in less than 60 minutes. This assay will promote the development of hepatitis C “test-and-treat” models of care, which may simplify the treatment cascade, particularly for marginalised people.
Uneven distribution of health care resources is a contributing factor to poor treatment uptake in rural and remote regions of Australia. A recent HCV mapping study has highlighted that rural and remote settings are frequently areas of high HCV prevalence but low treatment uptake. [16,17] Providing adequate resources and training for GPs and clinicians in these settings is therefore an important priority. Successful models of care using a nurse practitioner and telehealth clinics supported by tertiary care specialists have been described in Australia and overseas. [14,34] Real-time videoconferencing involving both patients and local clinical staff is designed to increase treatment uptake and build local capacity. Results from this and other similar models appear equivalent to traditional face-to-face clinics in tertiary care centres [14,34] and have been associated with high levels of patient satisfaction.
Aboriginal and Torres Strait Islander people are another currently under-served population with a higher prevalence rate of HCV. Models of care that are centred in facilities close to home, involve local trusted providers and provide culturally competent care using best-practice protocols are likely to increase HCV treatment uptake in this population. Education and training of local clinicians with linkage to expert providers is an important priority..
Migrants from high-prevalence regions (Egypt, Pakistan, the Mediterranean and Eastern Europe, Africa and Southern Asia) also represent a population that is currently under-served. Again, models of care that are centred in facilities close to home, involve local trusted providers and provide culturally appropriate care using best-practice protocols are likely to increase HCV treatment uptake. Such care should include access to interpreting and translating services. Education and training of local clinicians with linkage to expert providers is an important priority.
People diagnosed with mental illness are more likely to have risk factors for HCV transmission, and the prevalence of HCV is higher in this population than in the general community. A recent multicentre Australian study described an HCV seroprevalence of 11% among patients admitted urgently to psychiatric inpatient facilities.35 When treatment was commenced, it was completed in all patients, with sustained virological response (SVR) able to be documented in 88% of treated patients. DAA treatment is not associated with the mental health side effects associated with IFN-based therapy. It is important to raise awareness of HCV testing and treatment among professionals and patients in the mental health community. HCV testing and treatment should be incorporated into models of care for people with mental illness. [36,37]