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, Carolina de la Flor, John Marshall, Cindy Zoellner, Grace Thompson, Lisa Quirk, Christian Mayorga, Barbara J. Turner, Amit G. Singal, Mamta K. Jain

Research output: Contribution to journalArticle

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Abstract

Background: Direct-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. Methods: This 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. Results: DAA-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. Conclusions: Effective outcomes with DAA-based therapy can be achieved in difficult-to-treat underinsured populations followed in resource-constrained safety-net health systems.

Original languageEnglish (US)
Article number204
JournalBMC Medicine
Volume15
Issue number1
DOIs
StatePublished - Nov 20 2017

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Hepatitis C
Antiviral Agents
Cohort Studies
Retrospective Studies
Safety
Health
Vulnerable Populations
Lost to Follow-Up
Therapeutics
Recurrence
Alcohols
Retreatment
Insurance Coverage
Medicaid
Chronic Hepatitis C
Substance P
Treatment Failure
Mental Disorders
Observational Studies
Mental Health

Keywords

  • Chronic hepatitis C
  • Direct-acting antiviral therapy
  • Indigent population
  • Real-world cohort
  • Safety-net hospital

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system : A retrospective cohort study. / Yek, Christina; de la Flor, Carolina; Marshall, John; Zoellner, Cindy; Thompson, Grace; Quirk, Lisa; Mayorga, Christian; Turner, Barbara J.; Singal, Amit G.; Jain, Mamta K.

In: BMC Medicine, Vol. 15, No. 1, 204, 20.11.2017.

Research output: Contribution to journalArticle

Yek, Christina ; de la Flor, Carolina ; Marshall, John ; Zoellner, Cindy ; Thompson, Grace ; Quirk, Lisa ; Mayorga, Christian ; Turner, Barbara J. ; Singal, Amit G. ; Jain, Mamta K. / Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system : A retrospective cohort study. In: BMC Medicine. 2017 ; Vol. 15, No. 1.
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abstract = "Background: Direct-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. Methods: This 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. Results: DAA-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. Conclusions: Effective outcomes with DAA-based therapy can be achieved in difficult-to-treat underinsured populations followed in resource-constrained safety-net health systems.",
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T2 - A retrospective cohort study

AU - Yek, Christina

AU - de la Flor, Carolina

AU - Marshall, John

AU - Zoellner, Cindy

AU - Thompson, Grace

AU - Quirk, Lisa

AU - Mayorga, Christian

AU - Turner, Barbara J.

AU - Singal, Amit G.

AU - Jain, Mamta K.

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N2 - Background: Direct-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. Methods: This 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. Results: DAA-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. Conclusions: Effective outcomes with DAA-based therapy can be achieved in difficult-to-treat underinsured populations followed in resource-constrained safety-net health systems.

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