Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial

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.

Trial registration: ClinicalTrials.gov Identifier: NCT03214679.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Eckhardt reported grants from the National Institutes of Health (NIH) and Gilead during the conduct of the study. Dr Kapadia reported grants from Gilead Sciences Inc during the conduct of the study. Dr Pai reported grants from Gilead Sciences Inc and the National Institute on Drug Abuse (NIDA) during the conduct of the study as well as grants from Gilead Sciences Inc and NIDA outside the submitted work. Dr Edlin reported grants from NIH during the conduct of the study. Dr Marks reported grants from Gilead Sciences that were paid to Weill Cornell Medicine outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Consolidated Standards of Reporting Trials Diagram of Accessible Care Study Participants

HCV indicates hepatitis C virus.

Figure 2.. Hepatitis C Virus (HCV) Infection Treatment Cascade Comparing the Accessible Care Arm With Usual Care

SVR12 indicates sustained virologic response at 12 months.

Figure 3.. Comparison of Participant Characteristics With Sustained Virologic Response Rates at 12 Months (SVR12)

HCV indicates hepatitis C virus; LESHRC, Lower East Side Harm Reduction Center; NA, not applicable; SSP, syringe service program.