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Curing Hepatitis C-Requires More Than a Prescription
- 'accessible care model for injection drug users
focused on low-threshold, collocated, destigmatized &
flexible care with facilitated referral'
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Download the PDF here
Download the PDF here
March 14, 2022
Editor's Note
March 14, 2022
JAMA Intern Med.
Asha Choudhury, MD, MPH, MS; Mitchell H. Katz, MD
Treatment for hepatitis C has improved substantially with the availability of direct antigen antiviral therapy, which results in eradication of the virus in approximately 90% of persons in 8 to 12 weeks of treatment.1 However, it can be particularly challenging to provide treatment for persons who inject drugs because the US health care system is not oriented around the needs of this population.
In this issue of JAMA Internal Medicine, Eckhardt et al2 evaluate the effectiveness of a novel low-barrier model designed to facilitate treatment for persons who inject drugs with hepatitis C. The program, accessible care, colocated hepatitis C treatment opportunities at a local syringe service program. The investigators recruited participants at community sites that persons who inject drugs frequent and randomized them to either the accessible care intervention or to a facilitated referral arm, where participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program. Patients enrolled in the accessible care arm were more likely to be referred to a hepatitis C clinician, attend an initial visit, complete baseline laboratory testing, and initiate treatment.2 Using an intention-to-treat analysis, those enrolled in the accessible care arm achieved sustained viral eradication at 12 months (ie, were cured) at significantly higher rates than those in the facilitated referral arm (67.1% vs 22.9%, P < .001).2 Once patients initiated treatment, cure rates were the same in both groups, indicating that the major benefit of the accessible care program was facilitating treatment, not adherence to treatment.2
It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience. On-site phlebotomy and flexible scheduling were provided, accommodating drop-in visits, and colocation with a syringe service program facilitated provision of other wraparound services. Patients at the syringe service program were treated in a comfortable harm reduction framework to help them "identify their own goals," with staff focused on creating a "friendly, informal, nonjudgmental atmosphere."2
The success of the accessible care arm raises 2 dueling questions: Is this model replicable across the US? And, conversely, why isn't all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?
No question, creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C. The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs. However, all patients would benefit from a health care system that provided more patient-centered environments.
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Colocated at syringe exchange progam
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.
The results of this randomized clinical trial supported the efficacy of a low-threshold, destigmatized HCV treatment program that was colocated in an SSP. The accessible care intervention achieved superior HCV cure rates compared with a robust control of facilitated referral to local HCV clinicians. Despite perceptions of people who inject drugs as being difficult to engage in HCV treatment while actively injecting drugs, these findings indicate that when provided with HCV treatment that was tailored to their needs, people who inject drugs successfully engaged in treatment, and two-thirds achieved an HCV cure.
Prescreening occurred via telephone or at various locations around New York, New York, including the LESHRC. For patients who required an HCV antibody or HCV polymerase chain reaction (PCR) test, free walk-in phlebotomy services were available at the LESHRC.
The results of this randomized clinical trial supported the efficacy of a low-threshold, destigmatized HCV treatment program that was colocated in an SSP. The accessible care intervention achieved superior HCV cure rates compared with a robust control of facilitated referral to local HCV clinicians. Despite perceptions of people who inject drugs as being difficult to engage in HCV treatment while actively injecting drugs, these findings indicate that when provided with HCV treatment that was tailored to their needs, people who inject drugs successfully engaged in treatment, and two-thirds achieved an HCV cure.
The percentage of participants achieving SVR12 within 1 year of study enrollment was significantly higher in the accessible care arm (67.1%) compared with the usual care arm (22.9%) (Table 2)…..it was because of the earlier steps in the care cascade. The percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care arm compared with the usual care arm from participant-reported referral to a HCV clinician (92.7% vs 44.6%), attendance of the initial HCV clinical visit (86.6% vs 37.4%), completion of baseline laboratory testing (86.6% vs 31.3%), and treatment initiation (78.0% vs 26.5%). A significantly higher percentage of participants in the accessible care arm attended a visit with an HCV clinician. Of the subset of patients in each arm that attended a visit with an HCV clinician, a significantly higher percentage of participants in the accessible care arm initiated therapy. No patient in either arm was denied treatment with DAA therapy by their insurance provider. A subgroup analysis showed a consistent trend of higher rates of SVR12 achievement in the accessible care arm compared with the usual care arm regardless of age, sex, race and ethnicity, homeless status, prior HCV treatment, and daily injection drug use (among others) (Figure 3). Overall loss to follow-up was similar between the 2 arms (12 of 82 [14.6%] in the accessible care arm and 14 of 83 [16.9%] in the usual care arm).
The DAAs prescribed included glecaprevir/pibrentasvir (46 [71.9%]), sofosbuvir/velpatasvir (8 [12.5%]), elbasvir/grazoprevir (5 [7.8%]), sofosbuvir/ledipasvir (3 [4.7%]), and sofosbuvir/velpatasvir/voxilaprevir (2 [3.1%]).
Of the 55 participants in the accessible care arm who achieved SVR12, 4 were reinfected during 57.9 patients-years of follow-up for a reinfection rate of 6.9 per 100 patient-years (95% CI, 2.7-17.8).
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.
Methods
Participants and Setting
Participants were recruited at various settings and sites around New York, New York, that people who inject drugs frequent and enrolled at 1 site, the Lower East Side Harm Reduction Center (LESHRC), from July 2017 through March 2020 (Supplement 1). The LESHRC site is a community-based, nonprofit organization whose mission is to reduce the spread of HIV/AIDS, HCV, and other drug-related harm among people who inject drugs and the community located in the Lower East Side in New York, New York. The site is a New York State Department of Health-authorized SSP that offers services, including injection equipment distribution, overdose prevention training and medication, on-site access to clinicians who provide treatment with buprenorphine, HIV and HCV screening, case management, and other harm reduction services.
Eligible participants were 18 years or older, spoke English or Spanish, had injected illicit drugs for at least 1 year, reported at least 1 illicit drug injection within the last 90 days, and had a detectable HCV RNA within the last 90 days. Pregnant women, individuals with advanced liver disease (decompensated cirrhosis or hepatocellular carcinoma), and those currently engaged in HCV treatment (defined as having at least 2 medical visits with a HCV treatment clinician during the last 6 months) were excluded. All participants provided written informed consent, and the study was conducted in accordance with Good Clinical Practice and the ethical principles that originated in the Declaration of Helsinki. The study was approved by the Weill Cornell Medicine and NYU School of Medicine institutional review boards.
Study Design
Prescreening occurred via telephone or at various locations around New York, New York, including the LESHRC. For patients who required an HCV antibody or HCV polymerase chain reaction (PCR) test, free walk-in phlebotomy services were available at the LESHRC. Neither HCV antibody nor HCV PCR testing were incentivized, and HCV PCR testing was billed to the individual's insurance. After providing written informed consent, enrolled participants underwent a baseline interview and were then randomized 1:1 to receive either accessible care or usual care. Participants randomized to the accessible care arm were connected to an on-site HCV treatment team comprising a study physician and study HCV care coordinator, whereas participants randomized to the usual care arm were connected with a separate, nonstudy, on-site HCV patient navigator.
Study Interventions
Accessible Care (Intervention)
The accessible care model is a low-threshold, nonstigmatizing model that features flexible appointment scheduling and a supportive harm reduction framework that works with clients to help them identify and pursue their own personal health goals without pressuring them to adopt or reject any specific behavior (such as engaging in drug treatment or attaining illicit drug abstinence). Study staff attempted to maintain a friendly, informal, and nonjudgmental atmosphere to reduce the stigma associated with health care. Accessible care participants received medical evaluations, follow-up, phlebotomy for laboratory testing, and care coordination at the LESHRC site. Flexible appointments and drop-ins were welcome and encouraged, with proactive outreach for missed visits. The cost of DAA therapy was covered by either the participant's insurance or through pharmaceutical drug assistance programs (for those ineligible for insurance). The on-site treatment team helped obtain medical insurance for participants who were eligible for insurance but not actively enrolled. Medications were prescribed in accordance with Infectious Diseases Society of American/American Association for the Study of Liver Diseases HCV management guidelines and accounted for insurance formulary preference.31 Medications were delivered to the LESHRC, where participants decided their own dispensing schedule (eg, daily, weekly, or monthly). The HCV care coordinators provided on-site education and logistical, insurance, social, and adherence support. Additionally, all participants who were treated with DAA therapy were offered on-site reinfection prevention training that was adapted from a validated HCV prevention tool.32
Usual Care (Control)
Usual care participants were referred to the on-site HCV patient navigator, who was funded through the New York City Department of Health's Check Hep C Patient Navigation Program.33 The Check Hep C program provides HCV RNA-positive individuals supportive services, connections to HCV care, accompaniment to medical appointments, adherence support, and medication access support at no cost. The HCV patient navigator for the usual care arm provided similar education and logistical, insurance, and social support as the care coordinator in the accessible care arm while working with participants to facilitate linkage and engage with care with an HCV treatment clinician at surrounding hospital-, clinic-, and/or harm reduction-based HCV treatment programs.
Study Assessment and Compensation
Research visits were conducted at baseline, 3 months, 6 months, 9 months, and 12 months. Participants underwent structured interviews eliciting sociodemographic characteristics, current and past injection and noninjection drug use, substance use disorder treatment, HIV and HCV risk behavior, health care utilization, and hepatitis C treatment linkage. Participants were compensated equally in both arms for partaking in the quarterly research visits through 12 months at $50 to $70 per visit. Participants were not compensated for engaging in clinical care or receiving HCV treatment; however, accessible care and usual care participants were compensated $40 for undergoing HCV PCR testing 12 weeks after completing treatment (for those who initiated treatment) and 12 months after enrollment (for all participants). Ribonucleic acid testing for reinfection testing was offered to all participants who achieved an HCV cure every 3 months after a sustained virologic response (SVR12) through study closure (June 30, 2021).
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