Performance of simple serum‐based tests to exclude cirrhosis prior to hepatitis C treatment in non‐hospital settings in Australia

Abstract

Background Current guidelines suggest using transient elastography (TE) or aspartate aminotransferase to platelet ratio index (APRI) score <1 to exclude cirrhosis prior to commencing treatment for hepatitis C virus (HCV). Recently, fibrosis‐4 (FIB‐4) <0.93 has been shown to have a high negative predictive value (NPV) for the presence of cirrhosis. Aims To assess FIB‐4 and APRI in a cohort of HCV patients and to validate FIB‐4 <0.93 in populations of HCV‐infected individuals with differing cirrhosis prevalence, including secondary care, primary care and prisons. Methods From our treatment database, we identified patients with complete data (n = 793). We calculated FIB‐4 and APRI and correlated this with the presence of cirrhosis, determined by TE. We analysed the performance of FIB‐4 and APRI using area under the receiver operating curve analysis. We calculated sensitivity, specificity, positive predictive value, NPV and number of patients misclassified using published cut‐offs in populations with varying cirrhosis prevalence. Results FIB‐4 was superior to APRI for the diagnosis of cirrhosis (area under the receiver operating curve 0.868 vs 0.802). In secondary care (cirrhosis prevalence 32%), APRI <1 had a NPV of 80% and misclassified 14% of patients. FIB‐4 <0.93 had a NPV of 97% and misclassified 1%. In primary care and prison (cirrhosis prevalence 13% and 8%), the NPV for APRI <1 was 93% and 96%, respectively, but 5% of patients with cirrhosis were misclassified. FIB‐4 <0.93 had excellent NPV in both primary care (97%) and prisoners (100%). Conclusions FIB‐4 <0.93 is highly efficient at ruling out cirrhosis in HCV patients and allows TE to be appropriately avoided, thereby streamlining treatment algorithms.

Hepatitis C Treatment Among People Who Use Drugs in an Office-Based Opioid Treatment Program Versus a Syringe Exchange Program: A Real-World Prospective Clinical Trial

“…Participants in the prospective trial were eligible to participate if they were at least 18 years of age; current or previous history of injection drug use; confirmed HCV viremia and genotype 1b or 1a without baseline NS5a (nonstructural protein 5a) resistance-associated variants (RAVs); low fibrosis, defined as an Aspartate Aminotransferase Platelet Ratio Index (APRI) of less than 0.7 (10)(11)(12) or transient elastography (FibroScan) or Fibrosure suggesting metavir fibrosis score of F2 or less; and ability to make two of three sequential office visits. Participants were excluded if there was laboratory or clinical evidence of cirrhosis; elevated prothrombin time unrelated to anticoagulation, hemoglobin level less than 12.3g/L in females and less than 14g/L in males, platelet count < 150 cells × 10 9 /L, white blood cells (WBCs) < 4.0 × 10 3 /mm 3 , aminotransferase levels more than 10 times the upper limit of normal, or albumin levels < 3.5 g/L; previous treatment for hepatitis C infection; known hepatocellular carcinoma; human immunodeficiency virus (HIV) or hepatitis B virus coinfection; pregnancy, or contraindicated drug interactions (i.e., strong CYP3A inducers) with elbasvir-grazoprevir and inability to change regimens to avoid interaction.…”