Point-of-care HCV RNA testing in the setting of DAA therapy: HCV-FiS (HEpatitis C Virus Fingerstick Study)

Liver Int. 2019 Dec;39(12):2240-2243. doi: 10.1111/liv.14242. Epub 2019 Sep 20.

Abstract

HCV-RNA assessment during therapy with Direct-Acting Antiviral (DAA) regimens still relies on assays requiring blood collection and transport to a specialised laboratory, which may compromise linkage to care. GeneXpert-HCV Viral Load (GXHVL) (Cepheid) is a plasma-based assay used at point of care (POC) with a sensitivity of ≤10 IU/mL, and, results available within 2 hours. Fifty-nine consecutive HCV-patients ready for DAAs treatment were enrolled. HCV-RNA was simultaneously tested using Roche TaqMan RT-PCR (venous blood sample) and GXHVL (capillary blood collected by fingerstick), at baseline (BL), week 4 (W4) of therapy, end of therapy (EOT) and week 12 of follow-up (W12FU). Both assays demonstrated undetectable HCV-RNA in all patients at EOT and identified the single case of HCV-relapse at W12FU. GXHVL used as a point-of-care assay in the outpatient setting provides results fully comparable to the laboratory-based test. Its excellent performance and ease of use suggest its adoption in non-specialist settings where simplicity of care is paramount to implement HCV eradication campaigns.

MeSH terms

  • Aged
  • Antiviral Agents / therapeutic use
  • Female
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification*
  • Hepatitis C / blood*
  • Hepatitis C / drug therapy
  • Humans
  • Male
  • Middle Aged
  • Point-of-Care Testing*
  • RNA, Viral / blood*
  • Viral Load*

Substances

  • Antiviral Agents
  • RNA, Viral