Abstract
BACKGROUND: Phase 3 trials evaluating direct-acting antivirals (DAA) consistently report high sustained virologic responses (SVR). The strict eligibility criteria applied to these studies may affect the reproducibility in clinical practice. It has been demonstrated that drug use generally does not affect SVR. This retrospective cohort study sought to estimate the proportion of patients followed in a tertiary addiction clinic that would meet eligibility criteria for clinical trials, if drug use was not considered as a rejection criteria. METHODS: The sample population consists of patients with active HCV genotypes (GT) 1-3, seen at the clinic between 01/2013 and 09/2015. Information from clinical charts was retrieved to examine how participants would meet the eligibility criteria of 14 studies. Individual patient’s data were compared with the studies’ eligibility criteria. RESULTS: A total of 234 patients met the inclusion criteria (GT 1: 58.1%; GT 2: 8.5%, GT 3: 34.2%; experienced: 16.2%; cirrhotic: 14.5%) and 53% (124/234) of patients could have been included in at least one study. Table shows individual study results. The most inclusive study was COSMOS (31/49; 63%). The most frequent exclusion criteria were the presence of significant diseases (cardiac, pulmonary, hepatic, porphyria or other), contraindicated medication and haemoglobin level. CONCLUSION: Even without considering drug use, only half of the patients of the addiction clinic would have been eligible for at least one study. This under-representation stems from strict eligibility criteria that promote a healthier population. Our study suggests that the DAA might prove less effective when administered to infected populations followed in specialized clinics for drug. DISCLOSURES: J. Bruneau, Gilead: Consultant, Consulting fee. Merck: Consultant, Consulting fee. V. Martel-Laferrière, Gilead Inc.: Consultant and Grant Investigator, Consulting fee and Research grant. Abbvie: Grant Investigator, Research grant Merck: Consultant, Consulting fee