Analysis of AST to Platelet Ratio Index (APRI) for Determining Eligibility for 8 Weeks of Glecaprevir/Pibrentasvir

Introduction: Studies have highlighted the usefulness of APRI for assessing liver cirrhosis. APRI ≤1 is currently proposed as a noninvasive blood test to exclude cirrhosis based on WHO guidelines. This posthoc analysis evaluates the sensitivity and specificity of APRI compared to the determination of fibrosis status used in clinical trials with glecaprevir (identified by AbbVie and Enanta) and pibrentasvir (collectively known as G/P), and assesses its usefulness for determining eligibility for 8-week G/P treatment. Methods: Data were pooled from Phase 2 and Phase 3 studies. Classification of F4 fibrosis in the protocols was determined using either liver biopsy (328/2787; 12%), FibroScan (1906/2787; 68%), or the combination of FibroTest and APRI (547/2787; 20%). In part 1 of this post-hoc analysis, all 2,787 patients enrolled in these trials were included, among whom 361 (13%) had compensated cirrhosis by protocol, and the performance of APRI (ranging from 0.55 to 1.3) alone was calculated compared to the protocolspecified methods. In part 2, efficacy was assessed only among the subset of 828 patients without cirrhosis by protocol who received 8 weeks of G/P (GT 1-6 TN or TE-PRS). Efficacy was assessed as the percent of patients achieving SVR12 (HCV RNA < lower limit of quantification) by APRI ≤ each selected cut-off using an intent-to-treat population. Results: Compared to the methodology used in the trials, APRI ≤1 predicted non-cirrhosis with 82% sensitivity, 72% specificity, and positive predictive value (PPV) of 95% with 13% prevalence of cirrhosis in the study population (Table 1). SVR12 is reported in Table 1 for patients with APRI ≤ each cutoff that were without cirrhosis and received 8-week G/P treatment. In patients treated for 8-weeks, differences in APRI did not impact safety findings. Conclusion: APRI ≤1 has high PPV for non-cirrhosis and thus may be clinically useful to exclude cirrhosis and define eligibility for G/P for 8 weeks. However, the usefulness of APRI ≤1 may be limited in populations with higher prevalence of cirrhosis. G/P treatment in noncirrhotics was efficacious (regardless of the APRI cut-off used) among the subset treated for 8 weeks. Using APRI alone may be a way to simplify selection of patients eligible for 8-week G/P treatment without a need for other diagnostic methods to rule out cirrhosis. Further studies are necessary to confirm this finding for all patients with APRI ≤1 in patients with unknown cirrhosis status.840 Figure 1 No Caption available.

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