Slicing through silos: Development and evaluation of a hospital-based telehealth hepatitis C virus treatment program

Abstract

Background:

There exist many barriers to hepatitis C virus (HCV) treatment for those with substance use disorder (SUD) or who lack access to routine medical care. A hospital-based telehealth program was developed to provide treatment opportunities for hospitalized patients living with HCV.

Methods:

This single site prospective cohort study conducted from July 2022 to March 2023 aimed to measure linkage to care with an HCV clinician and initiation of HCV treatment in hospitalized patients. Patients were assessed in-person by a social worker then seen via telehealth by a clinician who prescribed either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir. Treatment was initiated with pharmacist assistance. The team conducted in-person and/or telephonic outreach during and after hospitalization. Cure was confirmed by sustained virologic response at 12 weeks (SVR12) post-treatment.

Results:

A total of 25 patients were enrolled and completed telehealth visits. All patients had a history of SUD and 18 (72 %) were unstably housed. Nineteen patients (76 %) initiated treatment, and 14 (56 %) successfully completed treatment. Twelve patients (48 %) completed post-treatment labs, including two who prematurely discontinued treatment. Eleven patients (44 %) achieved confirmed cure with SVR12.

Conclusion:

A hospital-based, multidisciplinary telehealth program can be an innovative care model to successfully treat HCV in a difficult-to-treat patient populations.

Introduction

In 2019 it was estimated that 58 million people globally were living with chronic hepatitis C virus (HCV) infection. (World Health Organization, 2022) The World Health Organization’s Global Hepatitis Elimination Strategy seeks to reduce the number of new HCV infections by 90 % by 2030. (World Health Organization, 2022) In the United States the incidence of HCV has been increasing annually since 2013 with 40.7 chronic HCV cases per 100,000. (US Department of Health & Human Services, 2020) Injection drug use is the most commonly reported risk factor for HCV acquisition in the US, and the cure rates among people who use drugs (PWUD) are comparable to those who do not (Grebely et al., 2018, Hajarizadeh et al., 2018). Interventions to increase retention in HCV care among PWUD have been proposed, with increasing interest in engaging hospitalized patients (Levander et al., 2021, Le, Chee, Kwan & Cheung, 2022, Raja, Edwards, Stewart & Huynh, 2022). A hospital-based program which encouraged completion of pre-treatment laboratory tests and/or imaging studies during hospitalization and referrals placed to hepatology clinic did not increase the rate of outpatient HCV clinic visits (Chun, Lau, Lee & Ham, 2023). This outcome suggests more intensive interventions are needed to increase linkage to care and treatment uptake in high-risk and high-need patients. A recent stepped-wedge cluster randomized multicenter trial in Norway comparing HCV treatment initiation in hospitalized patients to referral-based standard of care reported superior rates of treatment uptake and completion among patients who initiated treatment prior to hospital discharge, particularly among those with unstable housing (Midgard et al., 2023). We incorporated these study findings, along with qualitative analyses of interviews with hospitalized patients, to design a co-localized model of care that uses telehealth to link hospitalized PWUD to an HCV clinician and supports retention in treatment after discharge (Levander et al., 2021).

Methods

Program design

This prospective cohort study conducted from July 2022 to March 2023 included a multidisciplinary team from internal medicine, infectious diseases, addiction medicine, pharmacy, and care management. Hospitalized patients at an academic medical center eligible for HCV treatment were identified using an electronic clinical surveillance program (see Participant Selection. A licensed clinical social worker met the candidates in-person to evaluate social determinants of health, readiness for and barriers to treatment, and to survey the patient’s perceived self-sufficiency levels in various domains (Supplementary Appendix. Table 2). With the assistance of an inpatient addiction medicine team, referrals to substance use treatment programs were provided (Englander et al., 2019). Pretreatment laboratory and imaging studies were recommended to the primary teams. Using telehealth video technology, an internal medicine physician met remotely with the patient to discuss treatment options and patients were prescribed the following direct acting antivirals (DAAs): glecaprevir/pibrentasvir for 8 weeks or sofosbuvir/velpatasvir for 12 weeks. Regimen selection was based on several factors, including drug interactions, food insecurity, and patient preference. DAAs were dispensed by the hospital’s outpatient pharmacy using patient’s prescription insurance and were made available for initiation. Patients started treatment while hospitalized or shortly after discharge.

Throughout treatment, the social worker and pharmacist followed patients with telephonic and/or in-person outreach to maintain engagement in care. The pharmacist assessed adherence and tolerance via telephone at 2 weeks into treatment and 2 weeks before completion. Social worker outreach (in-person/telephonic) was completed as needed, ranging from several times a week to once a month. Patients were provided with prepaid phones for follow-up and short-term medical motel stays as needed. Participants were provided with incentive rewards of escalating amounts for completing the initial eligibility assessment ($25), completing the telehealth visit ($50), and upon completion of post-treatment labs ($100). This study was deemed IRB exempt as a quality improvement project by the institutional review board (STUDY00026122).

Participant selection

Candidates for HCV treatment were identified twice weekly using TheraDoc, an electronic clinical surveillance program, that generates reports of hospitalized patients based on user-specified criteria. Selection criteria included: 1) positive HCV antibody and HCV quantitative PCR tests within the prior four years and 2) boarding in the emergency room or current inpatient admission status. Patients with decompensated cirrhosis, end stage renal disease (ESRD) on dialysis, current pregnancy, chronic hepatitis B infection, inability to make an informed decision, receiving care through the Veterans Affairs, uninsured status, already engaged in an outpatient HCV program, and living outside of Oregon or Washington were excluded.

Study outcomes

Primary study outcomes were 1) successful completion of telehealth visit and 2) HCV treatment initiation. Secondary clinical outcomes included treatment adherence, treatment completion, and cure confirmed by SVR12 (undetectable HCV RNA 12 weeks post-treatment).

Data collection

Baseline patient demographics were collected (Supplementary Appendix, Table 1). Time from social worker initial assessment to the telehealth visit and time from the telehealth visit to treatment initiation were measured. Treatment data including treatment prescribed, dispense history, confirmed first and last dose dates, and treatment completion status were collected. Outcomes related to social determinants of health (SDOH), such as change in housing status, linkage to a substance use disorder (SUD) treatment program and/or primary care provider (PCP) were also collected. All data were recorded and managed using institution-based OneDrive Microsoft Excel, which is a secure, web-based application.

Statistical analysis

Descriptive statistics were used to report all data. Categorical variables were reported using percentages and continuous variables were reported using medians with interquartile ranges (IQR). No statistical comparison was performed. Data were analyzed using R software (version 3.6.3).

Results

From July 2022 to March 2023, 78 patients with untreated HCV were screened. Forty-eight patients were excluded due to: decompensated cirrhosis (n = 3), hepatocellular carcinoma (n = 1), ESRD on dialysis (n = 5), pregnancy (n = 1), inability to make an informed decision (n = 3), patient declined participation (n = 4), resident outside of Oregon/Washington (n =1), unable to meet and assess prior to discharge (n =2), or preference to seek treatment elsewhere (n = 28). Thirty eligible patients completed social worker’s initial assessment and 25 out of 30 patients completed HCV telehealth visit and were officially enrolled (Supplementary Appendix. Fig. 1). Eleven patients were provided with prepaid phones. One patient was given 2 additional phones, and 4 patients 1 replacement phone each due to original phones being broken, lost, or stolen.

Enrolled patients were 60 % male with a median age of 43 years. All were treatment-naive. Fifty-two percent reported living with HCV for at least 5 years. More than two-thirds (68 %) of enrolled patients reported a mental health condition (i.e., bipolar disorder, major depressive disorder). All reported previous or current substance use, with 80 % reporting active use. Nearly three-quarters (72 %) of participants were without stable housing. Most patients (84 %) had joint federal and state health insurance as their primary insurance while the rest were insured through federal health insurance.

Treatment outcomes are summarized in Table 1. The median time from initial social worker assessment to the HCV telehealth visit was 3 days (IQR, 1–6 days). In patients who successfully started treatment, the median time from telehealth visit to treatment initiation was 16 days (IQR, 8–19 days). About half (56 %) of patients were prescribed glecaprevir/pibrentasvir for 8 weeks while the rest (44 %) were prescribed sofosbuvir/velpatasvir for 12 weeks. Of the 19 patients who started treatment, 8 patients started while hospitalized. Seventeen patients (68 %) completed at least 4 weeks of treatment, while 14 (56 %) completed the full course. SVR12 was obtained for a total of 12 patients: 10 patients had completed full treatment and 2 had prematurely discontinued. A total of 11 patients (44 %) achieved cure, including 1 patient who was cured despite incomplete treatment with only 8 weeks of sofosbuvir/velpatasvir. There were 7 patients (28 %) who did not complete the post-treatment labs, of which 4 patients had completed full treatment course. Given the high efficacy of DAA’s in curing HCV, a total of 15 patients likely achieved cure (11 confirmed and 4 presumed). Among the 14 patients who completed full treatment, 8 (57 %) had 90 % or higher adherence to their DAA treatment, while 4 patients (28.6 %) adhered to <75 % of treatment. The median time to treatment completion was 66 days (range 56–93 days) for 8 weeks of glecaprevir/pibrentasvir and 92 days (range 84–114 days) for 12 weeks of sofosbuvir/velpatasvir.

Table 1.

Clinical treatment outcomes.

Outcome
Time from SW assessment to telehealth visit, d, median (IQR)	3 (1, 6)
Time from telehealth visit to DAA start date, d, median (IQR)	16 (8, 19)
DAA prescribed
glecaprevir/pibrentasvir for 8 weeks	14 (56)
sofosbuvir/velpatasvir for 12 weeks	11 (44)
DAA dispensed	20 (80)
DAA initiateda	19 (76)
≥ 4 weeks of DAA completed	17 (68)
Full course completed	14 (56)
SVR-12 status
Cured following full treatment completion	10 (40)
Cured despite incomplete treatment	1 (4)
Failed to achieve cureb	1 (4)
Unknown treatment outcomec	7 (28)

Data are presented as No. (%) unless otherwise indicated.

Abbreviations: SW, social worker; IQR, interquartile range; DAA, direct acting antiviral; SVR-12, sustained virologic response at 12 weeks post-treatment

^a1 patient was lost-to-follow up following prescription delivery and we were unable to confirm if patient had started DAA.

^b1 patient who prematurely discontinued treatment at Week 5 of glecaprevir/pibrentasvir due to food and housing insecurity failed to achieve cure at 12 weeks after last dose.

^cOf the 7 patients with unknown cure status, 4 completed their full treatment. 1 patient who completed treatment died from non-HCV related cause before obtaining SVR-12.

Average patient self-sufficiency scores in the domain of engagement with and trust in medical care increased by 72 % from 1.8 prior to treatment to 3.1 (scale 1–5) at treatment completion. Eight patients established care with a PCP after previously being out of medical care. Seven patients (28 %) were connected to an outpatient or residential SUD treatment (Supplementary Appendix. Table 3).

Discussion

Our study achieved treatment completion in 14 of 25 (56 %) enrolled hospitalized patients with HCV and addressed numerous barriers to HCV treatment initiation. HCV care cascade barriers are well-described and include structural (lack of shelter, transportation and telecommunication difficulties), individual (financial barriers), stigma-related (poverty, incarceration, substance use, mental health), and distrust of the patient-provider relationship (Sherbuk, Tabackman & McManus, 2020). Specific strategies proposed to improve care retention include decentralizing HCV treatment away from the limited number of specialists (e.g., hepatology, infectious disease) and co-localizing screening, evaluation, and treatment with other medical specialties to reduce navigation of the healthcare system (Sherbuk, Tabackman & McManus, 2020). Our program incorporated several strategies and knowledge of patient-centered barriers to reduce the most common disruption points in the care cascade: linkage of patients to treatment while hospitalized, incorporation of social determinants of health resource assistance, and use of telehealth for care delivery.

Programmatic success as evidenced by 76 % treatment initiation rate was contingent on three key program components 1) co-localization of pre-treatment assessment and DAA initiation during hospitalization or soon after discharge, 2) reduction in time from identification of treatment eligibility and evaluation by a clinician, and 3) consistent outreach throughout treatment by social worker and pharmacist for continued engagement. Based on review of published data on inpatient-initiated HCV treatment studies, our outcomes demonstrated comparable treatment initiation and cure rates (Midgard et al., 2023, McCrary et al., 2023). Linking patients to social resources and provide financial incentives to reach critical points in the care cascade increased trust in the healthcare system and patient’s self-perceived capacity to manage their health.

An editorial responding to the OPPORTUNI-C trial lamented the lack of reproducibility of such a program design in the US due to fragmentation of the US healthcare system (Rowan & Wyles, 2023). Though our study was performed in a state without prior authorization requirements for DAA’s, it suggests hospital-based HCV treatment in the US is possible and highlights the importance of removing policy-level barriers to HCV treatment in order to eliminate HCV.

Limitations of our study include a small sample size and single-arm design at one academic hospital. Racial and ethnic diversity of enrolled patients was limited. The study’s short duration of follow-up precludes comment on how treating HCV in PWUD impacts long-term substance use disorder outcomes and healthcare engagement. Several future directions exist. One includes increasing HCV testing in patients with risk factors, or universal screening, at the time of hospital admission to rapidly identify patients with untreated HCV who may not routinely seek community-based care. Expanding treatment opportunities to partners of hospitalized patients with untreated HCV infection can also reduce the risk of reinfection. HCV telehealth visit expansion to affiliated hospitals and SUD treatment programs (i.e., residential, withdrawal management) could provide randomization opportunities to compare interventions while increasing access to HCV treatment within the region. Future studies could also explore implementation approaches and cost effectiveness of similar hospital-based HCV treatment interventions.

Conclusions

Multidisciplinary teams with psychosocial resources are needed to reduce barriers in the traditional model of referral-based HCV treatment. Our program innovatively initiated HCV treatment in the hospital setting using telehealth to provide rapid care and critical social resources to difficult-to-treat patients.