536. Patients Followed in an Addiction Medicine Clinic Are Less Likely to Be Eligible to Hepatitis C Drug Studies Regardless of Drug Use
Session: Poster Abstract Session: Hepatitis B and C in Varied Settings
Thursday, October 5, 2017
Room: Poster Hall CD
Posters
  • Poster IDWeek Gabrielle.pdf (1.1 MB)
  • 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.
    Study Genotype Treatment history Cirrhosis Eligibility
    ION-1 1 Naive w/wo 37/119 (31%)
    ION-2 1 Experienced w/wo  4/19 (21%)
    ION-3 1 Naive wo 34/108 (32%)
    SAPPHIRE-I 1 Naive wo 17/108 (16%)
    SAPPHIRE-II 1 Experienced wo 1/15 (7%)

    PEARL-II

    1b Experienced wo 0/1 (0%)
    PEARL-III 1b Naive wo 2/14 (14%)
    PEARL-IV 1a Naive wo 15/95 (16%)
    TURQUOISE-II 1

    Naive

    Experienced

    w 6/37 (16%)
    COSMOS 1

    Naive

    Experienced

    w/wo  31/49 (63%)
    FISSION 2-3 Naive w/wo 30/81 (37%)
    POSITRON 2-3

    Naive

    Experienced

    w/wo 24/100 (24%)
    FUSION 2-3 Experienced w/wo 5/19 (26%)
    ALLY-III 3

    Naive

    Experienced

    w/wo 31/78 (40%)

    Gabrielle Doré, BS1, Julie Bruneau, MD2 and Valérie Martel-Laferrière, MD2, (1)Université Laval, Québec, QC, Canada, (2)Centre de Recherche du Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada

    Disclosures:

    G. Doré, None

    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

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.