Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study

the HERO Study Group

Research output: Contribution to journalArticle

Abstract

Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. Methods: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. Conclusions: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

Original languageEnglish (US)
Article number105859
JournalContemporary Clinical Trials
Volume87
DOIs
StatePublished - Dec 2019

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Pragmatic Clinical Trials
Hepatitis C
Hepacivirus
Pharmaceutical Preparations
Patient Navigation
Directly Observed Therapy
Therapeutics
Antiviral Agents
Randomized Controlled Trials
Clinical Trials
Sustained Virologic Response
Incidence

Keywords

  • Antiviral therapy
  • Hepatitis C
  • Injection drug use
  • Sustained virologic response

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{49bf96416bae4d6d8ccac656a39a1182,
title = "Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study",
abstract = "Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95{\%} or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80{\%}), failure to achieve SVR, DAA resistance, and HCV reinfection. Methods: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. Conclusions: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.",
keywords = "Antiviral therapy, Hepatitis C, Injection drug use, Sustained virologic response",
author = "{the HERO Study Group} and Litwin, {Alain H.} and John Jost and Katherine Wagner and Moonseong Heo and Alison Karasz and Judith Feinberg and Kim, {Arthur Y.} and Lum, {Paula J.} and Mehta, {Shruti H.} and Taylor, {Lynn E.} and Tsui, {Judith I.} and Irene Pericot-Valverde and Kimberly Page",
year = "2019",
month = "12",
doi = "10.1016/j.cct.2019.105859",
language = "English (US)",
volume = "87",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs

T2 - The HERO study

AU - the HERO Study Group

AU - Litwin, Alain H.

AU - Jost, John

AU - Wagner, Katherine

AU - Heo, Moonseong

AU - Karasz, Alison

AU - Feinberg, Judith

AU - Kim, Arthur Y.

AU - Lum, Paula J.

AU - Mehta, Shruti H.

AU - Taylor, Lynn E.

AU - Tsui, Judith I.

AU - Pericot-Valverde, Irene

AU - Page, Kimberly

PY - 2019/12

Y1 - 2019/12

N2 - Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. Methods: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. Conclusions: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

AB - Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. Methods: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. Conclusions: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

KW - Antiviral therapy

KW - Hepatitis C

KW - Injection drug use

KW - Sustained virologic response

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JO - Contemporary Clinical Trials

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SN - 1551-7144

M1 - 105859

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