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Treatment of Hepatitis C virus among people who inject drugs at a syringe service program during the COVID-19 response: The potential role of telehealth, medications for opioid use disorder and minimal demands on patients
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Highlights
• Low-contact HCV treatment can succeed in populations that are less easily reached.
• In this group of PWID, 93.5% of our patients successfully achieved SVR.
• 83.3% achieved SVR among the subset who were homeless.
• Reducing demands on patients treated with MOUD is feasible.
Abstract
Background
Healthcare delivery was disrupted during the COVID-19 pandemic, requiring minimized in-person contact between patients and clinicians. During the pandemic, people with opioid use disorder (OUD) were not only at elevated risk for COVID-19, but had markedly reduced access to treatment for OUD, Hepatitis C virus (HCV) and HIV due to recommended decreased in-person visits.
Methods
From March 15-June 15, 2020 at the syringe services program (SSP) in New Haven, Connecticut, USA, a differentiated care model evolved with reduced clinical demands on people who inject drugs (PWID) to ensure screening and treatment for HCV, HIV and OUD, with a focus on HCV treatment. This model involved a single, bundled screening, evaluation, testing (SET) and monitoring strategy for all three conditions, minimal in-person visits, followed by tele-health communication between patients, outreach workers and clinicians. In-person visits occurred only during induction onto methadone and phlebotomy at baseline and phlebotomy 12 weeks post-treatment for HCV to measure sustained virological response (SVR). Patients received supportive texts/calls from outreach workers and clinicians.
Results
Overall, 66 actively injecting PWID, all with OUD, underwent bundled laboratory screening; 35 had chronic HCV infection. Participants were 40 years (mean), mostly white (N = 18) men (N = 28) and 12 were unstably housed. Two were lost to-follow-up and 2 were incarcerated, leaving 31 who started pan-genotypic direct-acting antivirals (DAAs). The mean time from referral to initial phlebotomy and initiation of DAAs was 6.9 and 9.9 days, respectively. Fourteen additional patients were newly started on buprenorphine and 6 started on methadone; three and four, respectively, were on treatment at baseline. Overall, 29 (93.5%) PWID who initiated DAAs achieved SVR; among unstably housed persons the SVR was 83.3%.
Conclusions
In response to COVID-19, an innovative differentiated care model for PWID at an SSP evolved that included successful co-treatment for HCV, HIV and OUD using a client-centered approach that reduces treatment demands on patients yet supports ongoing access to evidence-based treatments.
Access to MOUD for PWID was also impacted by COVID-19 restrictions. Prior to the pandemic, MOUD induction required in-person visits, laboratory and urine drug testing (UDT) and required counseling visits. Emergency regulations for MOUD emerged in late March 2020 from the Substance Abuse and Mental Health Services Agency (SAMHSA) and the Drug Enforcement Agency (DEA) that reduced demands on patients and clinicians for the treatment of OUD by eliminating in-person exams and UDT for patients initiating buprenorphine and allowing increasing amounts of take-home dosing for methadone and buprenorphine in stabilized patients; however, methadone required in-person visits. Telehealth counseling was introduced in April of 2020 and reimbursement guidance followed soon thereafter (Substance Abuse & Mental Health Services Administration, 2020). Despite the relaxation of guidelines, many treatment programs either did not accept new patients or did so less often, reducing access to MOUD (Joudrey et al., 2021).
Initiation of medications for both HCV and OUD in PWID, however, still became significantly more challenging during COVID-19 due to patient and clinic factors, thus requiring a differentiated model of care. Differentiated care models have emerged as "client-centered approaches" to optimize HIV care for specialized subpopulations, and have been applied to HCV treatment in PWID, especially in the context of co-treatment of HCV and OUD (Norton et al., 2018). Where "in-person" services were eliminated or markedly reduced during COVID-19, we describe an innovative model of treating HCV and OUD (and HIV for those co-infected) that exemplifies the differentiated care model.
Our findings support real-world, successful simplified service delivery for both HCV and OUD in a non-traditional venue. Added value for HIV care was also observed, perhaps because of the added contribution of MOUD, which has been documented to improve HIV treatment outcomes along the HIV care continuum (Low et al., 2016; Mazhnaya et al., 2018). This differentiated care model may be pertinent to future service delivery even after COVID case rates decrease and patients can resume in-person visits. This is especially crucial for individuals who may not be able to maintain steady access to regular in-person monitoring due to various socioeconomic or structural factors (e.g. housing instability, lack of health insurance, stigmatization by the healthcare system) and confirms that the can be successfully treated for HCV and achieve high SVR rates. These findings also provide reassurance for clinicians who are concerned about non-adherence even in the absence of enhanced in-person monitoring. Here, findings suggest that by placing minimal demands on PWID with HCV that patients are able to self-manage their care adequately. A study in Ukraine found that by reducing demands on patient receiving methadone by giving patients take-home dosing to over 85% of patients, retention outcomes improved and mortality did not increase (Meteliuk et al., 2021). Clinicians often perceive that results from clinical trials do not reflect outcomes in real-world settings and findings here confirm high SVR rates that are similar to those found in clinical trials.
In addition, MOUD treatment was also initiated with limited clinician monitoring. Aside from the in-person induction for MMT, which continued to be required by regulation during the public health emergency caused by COVID-19, patients had minimal physical contact with MOUD providers. In the case of buprenorphine, there were no in-person contacts and for methadone, there were initial in-person induction and stabilization visits that were required, but such patients could be transitioned early to take-home dosing when deemed clinically stable. Counseling and social support was provided through SSP outreach workers and when needed, via telehealth (mostly by telephone). Thus, physical distancing guidelines were implemented while maintaining appropriate care for their OUD. This suggests that reduced demands on patients treated with MOUD is feasible. As many of the relaxed regulations that allowed for this low-contact care (including allowing the use of telemedicine for MOUD) may be removed with the expiration of the public health emergency, it is critical to consider whether or not maintaining these policy changes may ensure improved care moving forward. Moreover, such a model could be considered for other prevention methods like prescribing pre-exposure prophylaxis (PrEP) to prevent HIV infection.
Over a third (N = 12) of those treated in this sample were unstably housed, but most (N = 10; 83.3%) of this group were able to achieve SVR. Our initial results support the hypothesis that low-contact HCV treatment can achieve results in populations that are less easily reached or less likely to receive treatment. This is a critical finding, as PWID are also among the most likely to further transmit HCV to others (Page, Morris, Hahn, Maher & Prins, 2013).
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