No abstract

Background: Simple, affordable diagnostic tools are essential to facilitate global hepatitis C virus (HCV) elimination efforts. Objectives: This study evaluated the clinical performance of core antigen (HCVcAg) assay from plasma samples to monitor HCV treatment efficacy and HCV viral recurrence. Study design: Plasma samples from a study of response-guided pegylated-interferon/ribavirin therapy for people who inject drugs with chronic HCV genotype 2/3 infection were assessed for HCV RNA (AmpliPrep/COBAS Taqman assay, Roche) and HCVcAg (ARCHITECT HCV Ag, Abbott Diagnostics) during and after therapy. The sensitivity and specificity of the HCVcAg assay was compared to the HCV RNA assay (gold standard). Results: A total of 335 samples from 92 enrolled participants were assessed (mean 4 time-points per participant). At baseline, end of treatment response (ETR) and sustained virological response (SVR) visits, the sensitivity of the HCVcAg assay with quantifiable HCV RNA threshold was 94% (95% CI: 88%, 98%), 56% (21%, 86%) and 100%, respectively. The specificity was between 98 to 100% for all time-points assessed. HCVcAg accurately detected all six participants with viral recurrence, demonstrating 100% sensitivity and specificity. One participant with detectable (non-quantifiable) HCV RNA and non-reactive HCVcAg at SVR12 subsequently cleared HCV RNA at SVR24. Conclusions: HCVcAg demonstrated high sensitivity and specificity for detection of pre-treatment and posttreatment viraemia. This study indicates that confirmation of active HCV infection, including recurrent viraemia, by HCVcAg is possible. Reduced on-treatment sensitivity of HCVcAg may be a clinical advantage given the moves toward simplification of monitoring schedules.

No abstract

No abstract

AASLD ABSTRACTS 889A mal protocol to define candidacy for down-staging, 27.5% did not. No specific threshold in terms of number and size of tumors was used to define candidacy for down-staging by 42.5% of programs. Portal vein tumor thrombus was not a contra-indication to down-staging for 27.5% of programs. Most programs (84%) did not use a specific alpha fetoprotein (AFP) threshold to determine down-staging candidacy. For those programs which used an AFP threshold, this ranged from 400 to 5000. Almost all programs (97%) used the Milan Criteria to define down-staging success. A period of observation to demonstrate stability after successful down-staging was not required by 30%. When a period of stability was required, this ranged from 1 to 9 months, with 3 months being most common. Most programs considered trans-arterial radio-embolization as a down-staging modality, but chemo-embolization remained the dominant modality in all but a single program. Overall, most respondents expressed neutral feelings towards each of these practices, although 25% felt that use of the Milan Criteria to define successful down-staging was too restrictive. Conclusions: Practices vary across the country in terms of defining candidacy for down-staging, and for defining success of down-staging. Despite the range of practices, most individual practitioners reported comfort with the practice pattern at their own institution. Data on the efficacy of down-staging should be interpreted in the context of this wide range of down-staging practices.