A Randomized Controlled Trial of an Integrated Care Intervention to Increase Eligibility for Chronic Hepatitis C Treatment
Year: 2011
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVES: 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.
DOI: 10.1038/ajg.2011.219
Authors: Donna M Evon, Kelly Simpson, Scott Kixmiller, Joseph Galanko, Karen Dougherty, Carol Golin, Michael W Fried
Institution: University of North Carolina at Chapel Hill
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: National Institutes of Health, National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: G11465766, Mentoring Junior Faculty: Viral hepatitis Clinical Research, G4057812659, General Clinical Research Center, UNC Clinical Translation Science Award-K12 Scholars Program (KL2), Mentoring Junior Investigators: Comprehensive HIV Prevention, North Carolina Translational & Clinical Sciences Institute (NC TraCS), An Adherence and Depression Intervention for Patients During Hepatitis C Therapy, Center for Gastrointestinal Biology and Disease, The University of North Carolina Center for AIDS Research
OpenAlex ID: W1968691835