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Accessible Hepatitis C Care for People Who Inject Drugs
- A Randomized Clinical Trial - 67% vs 23% SVR
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JAMA Intern Med. Published online March 14, 2022.
Benjamin Eckhardt, MD; Pedro Mateu-Gelabert, PhD; Yesenia Aponte-Melendez, PhD; Chunki Fong, MS;
Shashi Kapadia, MD; Melinda Smith, MA; Brian R. Edlin, MD; Kristen M. Marks, MD
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In this single-site randomized clinical trial of patients with HCV, 167 adults with recent injection drug use were enrolled. (67%) Sixty-seven percent of participants who received accessible care treatment vs 23% of those who received usual care (facilitated referral) achieved a hepatitis C virus cure (sustained virologic response), which was a significant difference.
Eliminating HCV is possible in the US, but the obstacles that limit people who inject drugs from receiving HCV treatment need to be overcome.
Complicating HCV elimination efforts has been the high rates of HCV infections in people who inject drugs6,7 and the poor health infrastructure and investment to care for this patient population. People who inject drugs represent most HCV cases in the US, where injection drug use is a reported risk factor in more than two-thirds of new HCV infections.7-12Obstacles for engaging people who inject drugs in HCV care include their competing priorities (eg, housing, food access, the need to stave off withdrawal), comorbid psychiatric illness, addiction, fear of stigma, and historically poor relations with health care clinicians.13-16 Additionally, health care networks and insurance providers have created barriers to people who inject drugs accessing HCV care through requiring abstinence before initiating and reimbursing treatment.17-20 These policies exist despite numerous studies demonstrating high rates of HCV cure in people who inject drugs21 and low rates of reinfection22 and modeling studies suggesting that treating people who inject drugs, even in the setting of moderate reinfection rates, has a large public health effect on elimination because of the prevention of continued viral transmission.23
Key Points
Question Is the accessible care model, which is characterized by low-threshold, nonstigmatizing care that is colocated in a syringe service program, better at curing people who inject drugs of hepatitis C virus (HCV) infection compared with facilitated referral?
Findings In this single-site randomized clinical trial of patients with HCV, 167 adults with recent injection drug use were enrolled. Sixty-seven percent of participants who received accessible care treatment vs 23% of those who received usual care (facilitated referral) achieved a hepatitis C virus cure (sustained virologic response), which was a significant difference.
Meaning The results of this randomized clinical trial suggest that the accessible care model provides a framework for developing treatment programs geared toward engaging, treating, and curing HCV infection in people who inject drugs.
Abstract
Importance To achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs.
Objective To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care).
Design, Setting, and Participants This single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA–positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021).
Interventions Participants were randomized 1:1 to the accessible care or usual care arm.
Main Outcomes and Measures The primary end point was achieving sustained virologic response within 12 months of enrollment.
Results Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n = 165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P = .51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit.
Conclusions and Relevance In this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount.
Introduction
Hepatitis C virus (HCV) is a major public health problem domestically and globally and is associated with substantial morbidity and mortality.1-3 With the introduction of direct-acting antiviral (DAA) therapy considerable progress has been made in reducing the health effects of HCV. These new therapies have removed the most difficult aspects of prior interferon-based HCV therapy, including the need for injections, adverse effects, long duration of treatment, and adherence burden, and have substantially increased treatment efficacy, giving rise to international and national discussion about HCV elimination.4,5
Complicating HCV elimination efforts has been the high rates of HCV infections in people who inject drugs6,7 and the poor health infrastructure and investment to care for this patient population. People who inject drugs represent most HCV cases in the US, where injection drug use is a reported risk factor in more than two-thirds of new HCV infections.7-12 Obstacles for engaging people who inject drugs in HCV care include their competing priorities (eg, housing, food access, the need to stave off withdrawal), comorbid psychiatric illness, addiction, fear of stigma, and historically poor relations with health care clinicians.13-16 Additionally, health care networks and insurance providers have created barriers to people who inject drugs accessing HCV care through requiring abstinence before initiating and reimbursing treatment.17-20 These policies exist despite numerous studies demonstrating high rates of HCV cure in people who inject drugs21 and low rates of reinfection22 and modeling studies suggesting that treating people who inject drugs, even in the setting of moderate reinfection rates, has a large public health effect on elimination because of the prevention of continued viral transmission.23
Eliminating HCV is possible in the US, but the obstacles that limit people who inject drugs from receiving HCV treatment need to be overcome.24,25 The onus lies on health care clinicians to develop and implement systems and strategies to make HCV treatment accessible to people who inject drugs. Integrating HCV care into settings where people who inject drugs frequent and/or feel accepted is one such intervention. Prior studies demonstrated effective integration of HCV treatment in community primary care clinics, mobile health units, correctional settings, and methadone maintenance.26-29 Syringe service programs (SSPs) are potential sites for community-based treatment because of high levels of engagement with people who inject drugs. However, these community programs do not traditionally provide direct clinical services; therefore, they may not have the infrastructure to effectively treat HCV. Prior research that informing this model (accessible care model) demonstrated that integrating low-threshold HCV treatment at an SSP yielded high rates of cure among those treated, but this work lacked a comparison group.30
To assess the effectiveness of the accessible care model for HCV treatment in people who inject drugs within a harm reduction program in the US, we designed a single-site, unblinded, randomized clinical trial that compared accessible care intervention with usual care. Accessible care for people who inject drugs is a low-threshold care model designed specifically for people who inject drugs that is colocated within a community-based SSP with a goal of providing comfortable and flexible access to HCV care without the fear of the shame or stigma that people who inject drugs often experience in mainstream institutions.
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