Format

Send to

Choose Destination
See comment in PubMed Commons below
Am J Gastroenterol. 2011 Oct;106(10):1777-86. doi: 10.1038/ajg.2011.219. Epub 2011 Jul 19.

A randomized controlled trial of an integrated care intervention to increase eligibility for chronic hepatitis C treatment.

Author information

  • 1Division of Gastroenterology and Hepatology, UNC School of Medicine, University of North Carolina at Chapel Hill, 27599, USA. donna_evon@med.unc.edu

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.

[PubMed - indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Nature Publishing Group Icon for PubMed Central
    Loading ...
    Write to the Help Desk