1. In patients with hepatitis C virus who recently injected drugs, 67% in the accessible care arm vs 23% in the usual care arm achieved sustained virologic response, a significant difference.
2. These findings suggest that hepatitis C elimination may be difficult by relying solely on conventional facilitated referrals to local clinicians without encouraging improvements and amendments that focus on reducing stigma and removing barriers to access of care.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Hepatitis C virus (HCV) remains a public health concern associated with substantial morbidity and mortality, particularly among people who inject drugs. The problem is further exacerbated by the poor health infrastructure and stigma faced by this patient population. This randomized clinical trial compared a low threshold, nonstigmatizing HCV treatment program operated from a syringe service program (accessible care) compared to facilitated referral to local clinicians through a patient navigation program (usual care). The main endpoint was the prevalence of participants who achieved sustained virologic response within 12 months of enrollment. Among 167 adults with HCV who recently injected drugs, 67% in the accessible care vs 23% in the usual care arm achieved sustained virologic response, a significant difference. These findings suggest that hepatitis C elimination may be difficult by relying solely on conventional facilitated referrals to HCV clinicians without encouraging improvements and amendments that focus on reducing stigma and removing barriers to access of care. The accessible care model presented in this trial provides a framework for developing novel HCV treatment programs for people who inject drugs. A limitation of this study was the single-center design of this trial in a large metropolitan setting with a high concentration of harm reduction and emergency care services, which may not be generalizable to the rest of the US and internationally.
In-Depth [randomized clinical trial]: This single-center trial enrolled 167 participants (mean [SD] age, 42.0 [10.6] years; 36 (21.8%) female, 1 (0.6) transgender; 8 (4.8%) Black, 97 (58.5%) Hispanic, 53 (32.1%) White; n = 165 postrandomization) who were RNA-positive for HCV and had injected drugs in the past 90 days. The study was conducted at a syringe service program in New York, New York, between July 2017 and March 2020. Participants were randomized 1:1 to an accessible care (n = 82) or usual care (n = 83) arm. In the intention-to-treat analysis, 55 (67.1%) patients in the accessible care arm and 19 (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). In patients who received antiviral therapy, 55 (85.9%) and 19 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Overall, significantly more patients in the accessible care arm achieved all goals within the care cascade, with the greatest attrition in the usual care arm resulting from referral to HCV specialist and attending clinical visit.
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