Journal
AMERICAN JOURNAL OF GASTROENTEROLOGY
Volume 106, Issue 10, Pages 1777-1786Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1038/ajg.2011.219
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Funding
- Roche/Genetech
- National Center for Research Resources [KL2RR025746]
- Center for Gastrointestinal Biology and Disease [DK34987]
- Clinical Translational Research Center [M01 RR00046]
- Mentoring Grant [K24 DK066144-01]
- Center for Aids Research [P30-AI50410]
- UNC
- Roche
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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.
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