logo
Science Portal
Copyright © Médecins Sans Frontières
v2.1.5145.produseast1
About MSF Science Portal
About
Contact Us
Frequently Asked Questions (FAQs)
Privacy Policy
Terms of Use
Copyright © Médecins Sans Frontières
v2.1.5145.produseast1
Journal Article
|Research

Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral based treatment regimens: evidence from a global dataset

Morgan JR, Marsh E, Savinkina A, Shilton S, Shadaker S, Tsertsvadze T, Kamkamidze G, Alkhazashvili M, Morgan T, Belperio P, Backus L, Doss W, Esmat G, Hassany M, Elsharkawy A, Elakel W, Mehrez M, Foster GR, Wose K, Chew KW, Chasela CS, Sanne IM, Thanung YM, Loarec A, Aslam K, Balkan S, Easterbrook PJ, Linas BP
Download

Similar Content
Loading...
Loading...
Loading...
Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral based treatment regimens: evidence from a global dataset | Journal Article / Research | MSF Science Portal
Abstract
Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12-weeks post-treatment (SVR12). We assembled a global dataset of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique), and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90th , 95th, 97th, and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5,973 cases of detectable viremia at SVR12 from the combined dataset. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95th percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viremia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR=1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure

Countries

Cambodia Egypt Georgia Mozambique Myanmar Pakistan Ukraine United Kingdom United States of America

Subject Area

diagnosticshepatitis Cfilovirus

Languages

English
DOI
10.1111/jvh.13672
Published Date
12 Mar 2022
PubMed ID
35278339
Journal
Journal of Viral Hepatitis
Volume | Issue | Pages
Online ahead of print
Dimensions Badge