Su1058 Early Stopping Rules for Faldaprevir Plus Pegylated Interferon α-2A and Ribavirin in Treatment-Naïve Patients: Exploratory Study of Pooled Data From Phase III Trials

Abstract

Background: The HCV-PRO is a validated disease-specific patient reported outcome (PRO) instrument. This analysis reports on HCV-infected patient response in a trial of oral DAA therapy and assesses psychometric properties of the French-translated HCV-PRO. Method: French Genotype 1 patients in the multinational AVIATOR trial of interferon-free DAA therapy responded to theHCV-PRO, SF-36v.2, and EQ-5D 5L+VAS. HCV-PROwas translated under Harmonization standards. Approved French-language SF-36 and EQ-5Dwere included for psychometric comparison. Analyses of response were performed at Baseline, week 8 (Wk8), End of Treatment (EOT), and 24 week follow-up (PTW24), and included change from baseline. Internal consistency/reliability of HCV-PRO items and total score were evaluated using Cronbach's alpha. Convergent validity was assessed through Pearson's correlation (0.5-0.9=moderate-strong) to SF-36 MCS/PCS and EQ-5D VAS. Discriminant validity was assessed by dichotomizing HCV-PRO score on EQ-5D Anxiety/Depression and Pain/Discomfort dimensions (none versus some). Results: Demographics (N=58): 48% female, 88% white, 45% ≥50 years of age, 45% Genotype 1a, 86% IL28B non-CC. Clinical response (SVR24) was 93.1%. All PRO scores were minimally changed during treatment (Wk8, EOT). Mean HCV-PRO score at PTW24 was improved (p<0.03) over baseline. Cronbach's alpha for HCV-PRO items and total scores were 0.44-0.95. HCV-PRO total score exhibited moderateto-high correlation with SF-36 MCS/PCS and EQ-5D VAS total scores (r=0.54-0.87). HCVPRO scores were lower in patients with anxiety/depression or pain/discomfort (p<0.01). Conclusion: The French-translated HCV-PRO is a valid, responsive, disease-specific instrument. HCV-PRO score changed minimally during oral DAA treatment and improved over baseline after therapy.