Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system: a retrospective cohort study

Christina Yek,Christian Mayorga,Grace Thompson,Mamta K Jain,Carolina De La Flor,Cindy Zoellner,Lisa Quirk,Barbara J Turner,Amit G Singal,John Marshall

doi:10.1186/s12916-017-0969-3

Abstract

BackgroundDirect-acting antivirals (DAAs) have revolutionized chronic hepatitis C (HCV) treatment, but real-world effectiveness among vulnerable populations, including uninsured patients, is lacking. This study was conducted to characterize the effectiveness of DAAs in a socioeconomically disadvantaged and underinsured patient cohort.MethodsThis retrospective observational study included all patients undergoing HCV treatment with DAA-based therapy between April 2014 and June 2016 at a large urban safety-net health system (Parkland Health and Hospital System, Dallas, TX, USA). The primary outcome was sustained virologic response (SVR), with secondary outcomes including treatment discontinuation, treatment relapse, and loss to follow-up.ResultsDAA-based therapy was initiated in 512 patients. The cohort was socioeconomically disadvantaged (56% uninsured and 13% Medicaid), with high historic rates of alcohol (41%) and substance (50%) use, and mental health disorders (38%). SVR was achieved in 90% of patients (n = 459); 26 patients (5%) were lost to follow-up. SVR was significantly lower in patients with decompensated cirrhosis (82% SVR; OR 0.37, 95% CI 0.16–0.85) but did not differ by insurance status (P = 0.98) or alcohol/substance use (P = 0.34). Reasons for treatment failure included loss to follow-up (n = 26, 5%), viral relapse (n = 16, 3%), non-treatment-related death (n = 7, 1%), and treatment discontinuation (n = 4, 1%). Of patients with viral relapse, 6 reported non-compliance and have not been retreated, 5 have been retreated and achieved SVR, 4 have undergone resistance testing but not yet initiated retreatment, and 1 was lost to follow-up.ConclusionsEffective outcomes with DAA-based therapy can be achieved in difficult-to-treat underinsured populations followed in resource-constrained safety-net health systems.

Highlights

Direct-acting antivirals (DAAs) have revolutionized chronic hepatitis C (HCV) treatment, but real-world effectiveness among vulnerable populations, including uninsured patients, is lacking
The aim of our study is to describe the effectiveness of DAA-based hepatitis C virus (HCV) therapy in a racially diverse, socioeconomically disadvantaged, underinsured population seen in a large urban safety-net health system
Study setting and population This is a retrospective study of patients starting IFNfree, DAA-based treatment for chronic HCV in the Parkland Health and Hospital System (PHHS), the safety-net health system of Dallas, TX, USA

Summary

Introduction

Direct-acting antivirals (DAAs) have revolutionized chronic hepatitis C (HCV) treatment, but real-world effectiveness among vulnerable populations, including uninsured patients, is lacking. Deaths related to HCV infection have been on the rise for the past decade [3], with cirrhosis-related complications, including hepatocellular carcinoma (HCC), accounting for the increased morbidity and mortality [4, 5]. Prior to the advent of direct-acting antiviral (DAA) therapy, the mainstay of HCV therapy involved interferon (IFN)-based regimens that had frequent contraindications, were poorly tolerated, and achieved at best a 50% SVR rate [7]. SVR rates for DAA therapy exceed 90% in registration trials and are better tolerated than IFN-based regimens [8]. Real-world data suggests high rates of effectiveness in clinical practice; studies far have described outcomes primarily in academic centers treating wellinsured, primarily Caucasian populations [9,10,11,12]

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