HCV Integrated Care: A Randomized Trial to Increase Treatment Initiation and SVR with Direct Acting Antivirals.

Erik J Groessl,Marisa Sklar,Lin Liu,Samuel B Ho

doi:10.1155/2017/5834182

Abstract

Background and Aims Psychiatric or substance use disorders are barriers to successful HCV antiviral treatment. In a randomized, controlled trial (RCT), the effects of HCV Integrated Care (IC) for increasing treatment rates and sustained viral response (SVR) were studied with direct acting antivirals (DAA). Methods In 2012-13, VA patients, whose screening was positive for depression, PTSD, or substance use (N = 79), were randomized to IC or Usual Care (UC). IC consisted of brief psychological interventions and case management. The primary endpoint was SVR among patients followed for an average of 16.6 months. Results 42% of the study participants were previously homeless and 79% had HCV genotype 1. Twice as many IC participants (45%) initiated treatment compared with UC participants (23%) (χ2 = 4.59, p = 0.032). Among those treated, SVR rates did not significantly differ (IC: 12/18 = 67%; UC: 5/9 = 55%; p = 0.23). Among all randomized participants, IC participants trended toward better SVR rates (30.0% versus 12.8% in UC; p = 0.07). Conclusions Although first-generation DAAs are no longer used, this smaller RCT helps confirm the results of a larger multisite RCT showing that Integrated Care results in higher treatment initiation and SVR rates among HCV-infected persons with comorbid psychological disorders. Integrated mental health services can facilitate treatment among the most challenging HCV patients, many of whom have not been successfully treated. This trial is registered with ClinicalTrials.gov number NCT00722423.

Highlights

Almost three million people remain chronically infected with hepatitis C virus (HCV) in the US [1, 2] with 80 million infected globally [3]
High sustained viral response (SVR) rates (>90%) in clinical trials [8] and reduced side effect profiles of the latest direct acting antiviral (DAA) regimens have led some to declare this as a “golden era” in the fight to eradicate HCV [5]
A recent VA medical center study found that 45% of current HCV patients were deemed poor candidates for interferon-free treatment based on their comorbidity profiles [11]

Summary

Introduction

Almost three million people remain chronically infected with hepatitis C virus (HCV) in the US [1, 2] with 80 million infected globally [3]. A recent VA medical center study found that 45% of current HCV patients were deemed poor candidates for interferon-free treatment based on their comorbidity profiles (psychiatric and substance use disorders) [11]. Treatment initiation increased 2- to 3-fold and on-site patients receiving more services had higher odds of initiating treatment [16] Another recent study used a multidisciplinary team focused on educating patients before antiviral treatment and facilitating medication adherence in an HMO setting [17]. The study lacked a comparison group but obtained SVR rates in an outpatient HMO setting similar to those found in highly controlled clinical trials These recent studies build upon previous research on HCV self-management [18,19,20,21] and the Hepatitis C Integrated Care Program [22,23,24,25]. We hypothesized that HCV patients receiving Integrated Care would have higher treatment initiation and SVR rates than patients receiving care as usual

Methods

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Results

Discussion