Integrating Hepatitis C Virus Treatment Programs Within Community Mental Health

The advent of highly efficacious direct-acting antiviral (DAA) therapies has heralded the prospect of global eradication of the hepatitis C virus (HCV). For HCV eradication to be achieved, treatment prioritization of high-risk transmission groups, especially people who inject drugs, is required (1). However, many high-risk populations face unique barriers to traditional specialist outpatient management. Adaptive models of care, including colocated HCV screening and treatment programs, have therefore been trialed, particularly in addiction medicine and with prison populations. These models have shown high efficacy and patient acceptability (2). However, HCV health care prioritization has lagged among people with serious mental health issues, and a paucity of data addresses colocated blood-borne virus (BBV) screening and treatment programs (3) despite high HCV prevalence (4), high rates of injection drug use, and complex barriers to conventional health care.

An audit of mental health inpatients diagnosed as having HCV at our center showed that 43% (N=90 of 208) of treatment-eligible people were not referred to follow-up care and that 65% (N=57 of 88) of people who were referred to specialist services did not attend. Through an intensified community access program, untreated HCV-positive individuals were offered HCV workup and treatment by a hepatologist who coordinated care via community case managers. This program resulted in 10 additional individuals achieving a sustained virological response (i.e., undetectable HCV RNA [ribonucleic acid]) at week 12 (SVR12), although two-thirds of people remained untreated because of patient- and system-related factors (5). Ramachandran et al. (6) similarly showed enhanced SVR12 outcomes through intensified community engagement among people with complex mental health issues. Specifically, nurse-led coordination of viral hepatitis health care via hospital liver clinics; rural, doctor-led clinics; and community clinics resulted in SVR12 among seven out of 16 people who had previously not attended specialist outpatient appointments (6). In another study, Harney et al. (7) demonstrated enhanced HCV access and treatment outcomes through colocation of a nurse-led HCV program in a dual mental health and addiction medicine setting. These data collectively support a contention that decentralized HCV treatment pathways can mitigate fundamental barriers to care for people with mental illness.

To our knowledge, colocated HCV treatment access programs have not been implemented specifically in a general community mental health setting. We therefore assessed the feasibility of colocated HCV health care among adults (≥18 years) receiving case management within community mental health treatment centers. Ethics approval was provided by the Monash Health Human Research and Ethics Committee, and the study was conducted in accordance with the National Statement on Ethical Conduct in Human Research, updated in 2018.

Context and Setting

Monash Health is a multicampus tertiary care center in Victoria, Australia, that encompasses a catchment area of 1.5 million people. The mental health service provides case management support to 1,157 individuals across five geographically separated centers. General medical health screening is routinely performed, but BBV screening, including HCV, is not. After diagnosis, HCV treatment is provided via outpatient specialist or general practitioner services. These services are universally funded by the Australian federal government. DAA therapies attract a copayment of $US92 for a treatment course or $US15 for people with health care concession. In contrast, DAA therapies prescribed via inpatient services are subject to the maximum dispensed pharmaceutical cost because of differential state and territory funding agreements.

Interventions

Three community mental health services, hereafter referred to as sites A, B, and C, were approached with a view toward providing colocated hepatologist support for HCV workup and management. Community-based mental health settings were chosen because of the support scaffold offered by case management, favorable funding structure, and stability from a patient follow-up and mental health perspective. The model implemented in this study relied on individuals receiving case management being referred by mental health clinicians for specialist input. The rationale for colocated specialist support was borne from an empiric hypothesis that integrated care would bridge gaps in health care access. The decision to use a hepatologist was made primarily because the intervention was part of an investigator-initiated proof-of-principle study, but this approach also allowed expedited workup, including point-of-care liver assessment, risk versus benefit discussions, and DAA prescribing, within a single visit.

At site A, which provided case-managed support for 162 individuals, logistical barriers prevented establishment of a colocated service. Remote support was instead provided, whereby mental health clinicians could refer patients for investigation and workup. Support materials were provided, including study protocol, HCV screening algorithms, pathology requisitions, and study coordinator contact details. At site B, which supported 298 individuals receiving case management, a colocated hepatologist-driven clinic was established. This clinic was attended on a weekly basis. At site C, which provided case-managed support to 223 individuals, a hepatology clinic was established and was attended every two weeks. A part-time nurse practitioner offering general medical health care at site C had previously identified seven individuals with untreated HCV as part of a quality assurance audit.

Assessment and Follow-up

Care coordination, including arrangement of clinical reviews and liver-related investigations, were facilitated by the hepatologist in consultation with individual case managers at sites A and B. At site C, clinic bookings and HCV workup were initially coordinated by the nurse practitioner. The nurse practitioner went on extended leave shortly after the study commenced, and subsequent care coordination was driven by the hepatologist. Outreach assessments and follow-up were provided to individuals within supported residential services who had difficulty attending community centers. DAA therapies were prescribed predicated upon drug-drug interactions and liver disease stage. Follow-up included end-of-treatment and 12-week posttreatment liver function tests and HCV viral load. HCV cure was predicated upon SVR12 being achieved. Recruitment at each site was terminated after 6 months, ending March 2020, because of statewide restrictions in the context of the COVID-19 pandemic.

Costs and Resourcing

In terms of human resources and resourcing, there was ostensibly no disruption to the workflow of mental health clinicians during the program. The hepatologist was funded through a research training program stipend. All pathology costs were covered by bulked billed services via universal government subsidization.

Analysis

The primary goal of this study was to describe SVR12 across the three sites. Categorical variables were expressed as frequencies and proportions. Parametric continuous variables were expressed as means with standard deviations, and nonparametric continuous variables were expressed as median values with interquartile ranges (IQRs). Pairwise analysis was performed between the sites to describe baseline cohort heterogeneity by using the standard t test for parametric continuous variables and the Mann-Whitney U test for pairwise testing of nonparametric continuous variables. Statistical significance was indicated at p<0.05. All analyses were conducted by using Stata/IC, version 14.

Demographic Characteristics

The median age across the three combined case-managed cohorts (N=683) was 42 (IQR 34–51) years. Most participants were men (N=396, 58%), and there were high rates of social disadvantage, including unemployment (N=583, 85%) and history of incarceration (N=63, 9%). Schizophrenia and schizoaffective disorders (N=388, 57%) were the most common psychiatric disorders, followed by bipolar affective disorder (N=64, 9%). A compulsory (nonvoluntary) treatment order was in place for 27% (N=185) of the cohort.

Preintervention Outcomes

By March 2020, 30% (N=202) of the pooled cohort had been screened for HCV within the preceding 5 years. HCV prevalence, on the basis of a composite of seropositivity and/or viraemia, was 8% (N=53). Among the 53 individuals with HCV seropositive cases, 11 had either been previously treated or had spontaneously seroconverted without need for treatment. An additional 13 had achieved SVR12 through treatment in specialist clinics. We calculated that there were a minimum of 29 untreated HCV-positive individuals in case management across the three sites (three at site A, 16 at site B, and 10 at site C). The actual number of HCV-positive individuals was expected to be higher given that not all people with documented HCV or risk factors thereof had been screened serologically.

Postintervention Outcomes

By March 2020, 18 referrals for HCV treatment had been received. We received 11 referrals from site B in addition to the seven individuals from site C who had originally been identified by the nurse practitioner. The referred cohort had complex and chronic mental health issues, with a median of nine (IQR 5–13.5) inpatient admissions, 138 (IQR 55.5–412.0) inpatient days, and 3.5 (IQR 2.2–5.8) years of cumulative case management since 2011. DAA therapy was commenced for each of the referred individuals at site C, and 100% (N=7) achieved SVR12. At site B, 36% (N=4 of 11) of referred individuals achieved SVR12. In the group who did not achieve SVR12, 43% (N=3 of 7) declined DAA therapy, whereas 57% (N=4 of 7) began DAA therapy but either did not tolerate therapy or were lost to follow-up. Notably, one individual reported compliance with therapy but was discharged from community-based care before SVR12 was assessed and could not be contacted thereafter. Another individual was lost to follow-up within the study period, but subsequently achieved SVR12 after being reintegrated with a hepatology clinic via a refugee health service. People at site B had greater psychosocial instability than people at site C, including lower employment rates (6% [N=18] versus 14% [N=32], p<0.001), higher supported accommodation residence (15% [N=45] versus 4% [N=8], p<0.001), and higher rates of nonvoluntary treatment orders (37% [N=109] versus 20% [N=44], p<0.001).

Discussion

People with serious mental illness have heightened risk of HCV infection but frequently experience barriers across the entire HCV health care continuum, ranging from screening (8) to traditional outpatient access and health care retention. Barriers to screening notwithstanding, a multitude of issues may impact service access among people with serious mental illness, even after HCV has been diagnosed. These include housing instability and lack of transport as well as mental health symptoms, such as suspicion or cognitive issues. This may be compounded by barriers specific to HCV treatment access, such as perceived or actual stigma, DAA funding issues, and legacy clinician concerns regarding adverse treatment-related effects. Historically, many barriers to HCV health care stemmed from poor tolerability and perceived mental health ramifications of interferon-based therapies (9). However, HCV treatment disparity appears to have perpetuated despite the advent of highly effective, well-tolerated DAA therapies (10).

Colocated management strategies have been trialed in order to circumvent traditional outpatient barriers for people with psychiatric illness (11). The outcomes from these programs have been mixed. However, few programs have focused on HCV. It is conceivable that the short duration, high tolerability, and excellent efficacy of DAA therapies would lend to bolstered treatment outcomes if delivered through integrated health care delivery programs. In this regard, community mental health services may provide an important avenue to augment HCV treatment access, particularly for people who either experience barriers to conventional outpatient health care services or for those who do not fit into existing opioid substitution or prison elimination strategies.

Our study was neither designed to show superiority over existing models of care nor powered to elucidate optimal models of care. However, given the barriers to health care experienced by people with mental health issues, it is conceivable that colocated, intensified HCV health care will bolster DAA treatment access. Colocation of specialist clinicians, in isolation, is unlikely to be scalable because of cost and human resourcing factors. Longitudinal data have, however, shown that decentralized, mixed models of nursing-based and specialist care are cost effective when compared with specialist care in tertiary settings for treatment of noncirrhotic HCV (12). Furthermore, implementation of specially trained nurses into mental health settings may be favorable relative to visiting specialists who, as a function of fractional clinical allocations, would likely have attenuated patient and clinician rapport.

An opportunity exists to empower general medical nurses working within community mental health settings to provide opt-in HCV screening as part of routine care. Seropositive individuals could be referred to nurse practitioners who have been trained to drive a local HCV elimination agenda. These practitioners could perform basic workup and would be supported by hepatologists in guiding liver disease management and DAA treatment. In doing so, treatment outcomes could be enhanced without a substantial financial impost (2). Future models of care will invariably require individualization predicated on heterogenous global DAA and clinician funding strategies. These nuances notwithstanding, a focus on providing streamlined, coordinated access to HCV health care in marginalized populations is required.

Conclusion

Adaptive strategies that prioritize HCV treatment access among people with serious mental illness are important in driving a cohesive global HCV elimination agenda, as well as in striving for health care parity. Community mental health settings provide a particularly important avenue for HCV health care access and for implementation of integrated care coordination networks that may ultimately augment treatment acceptability and adherence and minimize harm. Capacity enhancement of mental health community services to drive an HCV micro-elimination agenda should therefore be explored.