糖心vlog

Progress toward hepatitis C virus (HCV) elimination in the US has been stalled by reliance on a multistep diagnostic algorithm to confirm viremia, reducing access to curative treatment.^1,2 In populations at highest risk of infection鈥攊ncluding people who use drugs and those involved in the carceral system鈥攖reatment is often inaccessible owing to substantial barriers along the HCV care cascade.³ Point-of-care (POC) HCV RNA testing increases treatment uptake, reduces time to treatment initiation,² and is feasible, acceptable, and cost-effective in carceral populations.⁴ However, such assays were only recently approved for clinical use in the US.⁵ We examined the feasibility and clinical performance of a POC HCV RNA assay (Xpert HCV Viral Load; Cepheid) in a nonclinical justice setting as part of a larger study that assessed HCV testing and linkage to care for this population.³

This cross-sectional study was approved by the Rhode Island Department of Corrections and the institutional review board of The Miriam Hospital; it followed the guidelines for cross-sectional studies. Study eligibility for the HCV antibody testing study³ was age 18 years or older, English-speaking, active community supervision status (probation or parole), and unknown HCV status or no self-reported prior HCV treatment. Participants provided written informed consent. Demographic information was self-reported by participants, and race and ethnicity data were assessed to characterize potential disparities. Details on the assays used and statistical analysis are shown in the eAppendix in Supplement 1.

Among 482 participants enrolled in the HCV antibody study,³ a convenience sample of 203 participants (median [IQR] age, 38.0 [31.0-48.5] years; 159 men [78.3%]) underwent POC HCV RNA testing. The study sample was racially and ethnically diverse, and approximately one-third had not completed high school or reported homelessness (Table 1).

In total, 190 participants (94%) had valid laboratory HCV RNA results; missing data were due to inconclusive results (1 participant), unavailable results (5 participants), or testing was not performed (7 participants). Using laboratory HCV RNA testing for confirmation, the sensitivity of the POC assay for HCV RNA detection was 96.8% (95% CI, 83.3%-99.9%), and the specificity was 99.4% (95% CI, 96.6%-100%) (Table 2). Two participants had discrepant RNA results: one had reactive HCV antibody, POC HCV RNA detected, and laboratory HCV RNA not detected (interpreted as a false-positive POC HCV RNA); and the other had nonreactive HCV antibody, POC HCV RNA not detected, and laboratory HCV RNA detected (interpreted as a false-negative POC HCV RNA, acute HCV infection). Approximately 9 of 39 participants (23.1%) with reactive HCV antibody did not have detectable HCV RNA (POC and laboratory), suggesting spontaneous HCV clearance. One participant had negative HCV antibody and detectable HCV RNA (POC and laboratory) consistent with acute HCV infection.

This cross-sectional study demonstrated the feasibility of a POC HCV RNA assay in a nonclinical setting for a population at high risk of HCV infection and confirmed the clinical performance of the fingerstick assay in a nontraditional setting.⁶ Availability of a POC HCV RNA assay for clinical use would have enabled 30 participants, including 2 with acute HCV infection, to have immediate HCV diagnosis. However, 1 participant with acute HCV infection was not identified by the POC HCV RNA assay. Study limitations include a single site that may not be generalizable to other settings, the POC assay was not approved for clinical use when the study was conducted, and laboratory-based confirmatory testing was completed through referral and, therefore, could have been delayed.

Multistep diagnostic algorithms cause unnecessary delay in HCV diagnosis, particularly for marginalized populations.^3,4 The recent approval of the first POC HCV RNA assay in the US will facilitate same-day initiation of curative HCV treatment in low-barrier, nontraditional settings.⁵ However, the goals of HCV elimination in the US will remain elusive until such assays are widely accessible.

Accepted for Publication: August 9, 2024.

Published: October 7, 2024. doi:10.1001/jamanetworkopen.2024.38222

Open Access: This is an open access article distributed under the terms of the CC-BY License. 漏 2024 Harvey L et al. 糖心vlog Open.

Corresponding Authors: Leah Harvey, MD, MPH, Division of Infectious Diseases, Alpert School of Medicine at Brown University, 164 Summit Ave, Providence, RI 029060 (lharvey@lifespan.org); Curt G. Beckwith, MD, Division of Infectious Diseases, Alpert School of Medicine at Brown University, 164 Summit Ave, Providence, RI 02906 (cbeckwith@lifespan.org).

Author Contributions: Drs Harvey and Beckwith had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Harvey, Bazerman, Moody, Beckwith.

Acquisition, analysis, or interpretation of data: Harvey, Jacka, Bazerman, Thomas, Irvin, Beckwith.

Drafting of the manuscript: Harvey, Jacka, Beckwith.

Critical review of the manuscript for important intellectual content: Jacka, Bazerman, Thomas, Moody, Irvin, Beckwith.

Statistical analysis: Harvey, Jacka.

Administrative, technical, or material support: Bazerman, Thomas, Moody.

Supervision: Irvin, Beckwith.

Conflict of Interest Disclosures: Dr Irvin reported working part-time on federal detail at the National Institutes of Health on the national hepatitis C elimination plan. No other disclosures were reported.

Funding/Support: We acknowledge funding from Gilead Sciences, Inc (Investigator Sponsored Research Award, IN-US-342鈥�4455), the National Institute on Drug Abuse (grant R25DA03719), institutional support from the Providence/Boston Center for AIDS Research (grant P30AI42853), and the COBRE on Opioids and Overdose (grant P20GM125507). Material support was provided by Cepheid.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2.