title: A randomized controlled trial of an integrated care intervention to increase eligibility for chronic hepatitis C treatment.
abstract: OBJECTIVE
  Mental health and substance abuse (MH/SA) comorbidities are the most oft-cited reasons for deferral from peginterferon (PegIFN) therapy for chronic hepatitis C virus (HCV). We sought to determine whether an integrated care intervention (INT) for patients deferred from PegIFN owing to MH/SA could improve subsequent treatment eligibility rates.
  
  
  METHODS
  In this randomized controlled trial, 101 HCV patients who were evaluated at two hepatology centers and deferred from antiviral therapy owing to MH/SA were enrolled. Participants were randomized to an INT (N=50) or standard of care (SC; N=51). The INT group received counseling and case management for up to 9 months. All participants underwent 3-, 6-, and 9-month clinical follow-up visits, where hepatologists, masked to group, re-evaluated patients for treatment eligibility. Standardized mood and alcohol use instruments were administered to all participants to aid clinicians in treatment decisions.
  
  
  RESULTS
  Of 101 participants, the mean age was 48 years and 50% were men, 61% Caucasian, and 77% genotype 1. Patients were initially deferred owing to psychiatric issues (35%), alcohol abuse (31%), drug abuse (9%), or more than one of these reasons (26%). In an intent-to-treat analysis, 42% (21/50) of INT participants became eligible for therapy compared to 18% (9/51) of SC participants (P=0.009, relative risk (RR)=2.38, 95% confidence interval (CI) (1.21, 4.68)). When baseline predictors significant at P<0.10 in univariate models were entered into multivariate models adjusted for treatment group, only baseline depression remained significant (P=0.05, RR=0.98, 95% CI (0.96, 1.00)). With the exception of a model adjusted for genotype, treatment group remained significant in all models.
  
  
  CONCLUSIONS
  This trial suggests that INTs can increase eligibility for HCV treatment and expand treatment to the underserved population with MH/SA comorbidities.
authors.affiliation: Division of Gastroenterology and Hepatology, UNC School of Medicine, University of North Carolina at Chapel Hill, 27599, USA. donna_evon@med.unc.edu
authors.forename: Donna M
authors.initials: DM
authors.lastname: Evon
authors.forename: Kelly
authors.initials: K
authors.lastname: Simpson
authors.forename: Scott
authors.initials: S
authors.lastname: Kixmiller
authors.forename: Joseph
authors.initials: J
authors.lastname: Galanko
authors.forename: Karen
authors.initials: K
authors.lastname: Dougherty
authors.forename: Carol
authors.initials: C
authors.lastname: Golin
authors.forename: Michael W
authors.initials: MW
authors.lastname: Fried
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D015897:Comorbidity; D019033:Delivery of Health Care, Integrated / Q000706:statistics & numerical data*; D004608:Eligibility Determination / Q000592:standards*; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D001523:Mental Disorders / Q000453:epidemiology*; D008875:Middle Aged; D015999:Multivariate Analysis; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011994:Recombinant Proteins / Q000008:administration & dosage; D019966:Substance-Related Disorders / Q000453:epidemiology*; D011795:Surveys and Questionnaires; D014481:United States / Q000453:epidemiology
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a