Eliminating hepatitis C in a rural Appalachian county: Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C

Jennifer R. Havens; Takako Schaninger; Hannah Fraser; Michelle Lofwall; Michele Staton; April M. Young; Ardis Hoven; Sharon L. Walsh; Peter Vickerman

doi:10.1136/bmjopen-2020-041490

Eliminating hepatitis C in a rural Appalachian county: Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C

Jennifer R. Havens, Takako Schaninger, Hannah Fraser, Michelle Lofwall, Michele Staton, April M. Young, Ardis Hoven, Sharon L. Walsh, Peter Vickerman

Research output: Contribution to journal › Article › peer-review

Abstract

Objectives The overall goal of the Kentucky Viral Hepatitis Treatment Study (KeY Treat) is to eliminate hepatitis C transmission from a county in Appalachian Kentucky by removing the barriers to accessing hepatitis C virus (HCV) treatment. Methods/analysis KeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections. Those eligible for KeY Treat are at least 18 years of age, viraemic and are residents of the target county. Pregnant women are not eligible. Rapid HCV RNA screening is used to determine eligibility, and those with a quantifiable viral load (VL) consenting to participate initiate SOF/VEL on the same day. All pharmacologic treatment and related medical care is provided free of charge using a non-specialist provider model. Follow-up visits occur at 2, 6 and 12 weeks during treatment to assess medication adherence (measured via VL and self-report), side effects and engagement in risk behaviours. Post-treatment visits occur at 12 weeks (sustained virologic response (SVR12) visit), 6 months and 12 months post-treatment completion to assess re-infection. A control county has also been identified, and prevalence and incidence of chronic HCV infections will be compared with the target community longitudinally. The primary outcome to assess elimination is SVR12. However, several outcomes will be measured to assess the effectiveness of removing the barriers to HCV treatment, including treatment entry, completion and re-infection. Analyses will be conducted via a generalised linear model framework that can incorporate flexible covariate adjustment and multiple outcome types with a compatible link function. Mathematical modelling will be completed assessing the impact and cost-effectiveness of the intervention. Ethics and dissemination KeY Treat has been approved by the Institutional Review Board at the University of Kentucky. Results from KeY Treat will be presented at conferences and published in peer-reviewed journals. Trial registration number NCT03949764.

Original language	English
Article number	e041490
Journal	BMJ Open
Volume	11
Issue number	7
DOIs	https://doi.org/10.1136/bmjopen-2020-041490
State	Published - Jul 5 2021

Bibliographical note

Funding Information:
All authors provided editorial support for the manuscript. JH obtained funding, wrote the study protocol and developed study materials, and drafted the manuscript. TS, AH and ML provided clinical support for KeY Treat related to hepatitis and substance use disorders. TS is the study physician and contributed to developing the laboratory procedures. TS and ML also provided substantive clinical expertise to the study protocol. HF and PV drafted the modelling portion of the manuscript. MS, AY and SLW were integral in obtaining funding, drafting of the protocol and development of the study questionnaires and other outcome measures.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

epidemiology
hepatology
public health

ASJC Scopus subject areas

Medicine (all)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Havens, J. R., Schaninger, T., Fraser, H., Lofwall, M., Staton, M., Young, A. M., Hoven, A., Walsh, S. L., & Vickerman, P. (2021). Eliminating hepatitis C in a rural Appalachian county: Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C. BMJ Open, 11(7), [e041490]. https://doi.org/10.1136/bmjopen-2020-041490

@article{3dacddb609dd4de4911d48ae2e2a1c46,

title = "Eliminating hepatitis C in a rural Appalachian county: Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C",

abstract = "Objectives The overall goal of the Kentucky Viral Hepatitis Treatment Study (KeY Treat) is to eliminate hepatitis C transmission from a county in Appalachian Kentucky by removing the barriers to accessing hepatitis C virus (HCV) treatment. Methods/analysis KeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections. Those eligible for KeY Treat are at least 18 years of age, viraemic and are residents of the target county. Pregnant women are not eligible. Rapid HCV RNA screening is used to determine eligibility, and those with a quantifiable viral load (VL) consenting to participate initiate SOF/VEL on the same day. All pharmacologic treatment and related medical care is provided free of charge using a non-specialist provider model. Follow-up visits occur at 2, 6 and 12 weeks during treatment to assess medication adherence (measured via VL and self-report), side effects and engagement in risk behaviours. Post-treatment visits occur at 12 weeks (sustained virologic response (SVR12) visit), 6 months and 12 months post-treatment completion to assess re-infection. A control county has also been identified, and prevalence and incidence of chronic HCV infections will be compared with the target community longitudinally. The primary outcome to assess elimination is SVR12. However, several outcomes will be measured to assess the effectiveness of removing the barriers to HCV treatment, including treatment entry, completion and re-infection. Analyses will be conducted via a generalised linear model framework that can incorporate flexible covariate adjustment and multiple outcome types with a compatible link function. Mathematical modelling will be completed assessing the impact and cost-effectiveness of the intervention. Ethics and dissemination KeY Treat has been approved by the Institutional Review Board at the University of Kentucky. Results from KeY Treat will be presented at conferences and published in peer-reviewed journals. Trial registration number NCT03949764. ",

keywords = "epidemiology, hepatology, public health",

author = "Havens, {Jennifer R.} and Takako Schaninger and Hannah Fraser and Michelle Lofwall and Michele Staton and Young, {April M.} and Ardis Hoven and Walsh, {Sharon L.} and Peter Vickerman",

note = "Funding Information: All authors provided editorial support for the manuscript. JH obtained funding, wrote the study protocol and developed study materials, and drafted the manuscript. TS, AH and ML provided clinical support for KeY Treat related to hepatitis and substance use disorders. TS is the study physician and contributed to developing the laboratory procedures. TS and ML also provided substantive clinical expertise to the study protocol. HF and PV drafted the modelling portion of the manuscript. MS, AY and SLW were integral in obtaining funding, drafting of the protocol and development of the study questionnaires and other outcome measures. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2021",

month = jul,

day = "5",

doi = "10.1136/bmjopen-2020-041490",

language = "English",

volume = "11",

number = "7",

}

Havens, JR, Schaninger, T, Fraser, H, Lofwall, M , Staton, M , Young, AM, Hoven, A, Walsh, SL & Vickerman, P 2021, 'Eliminating hepatitis C in a rural Appalachian county: Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C', BMJ Open, vol. 11, no. 7, e041490. https://doi.org/10.1136/bmjopen-2020-041490

Eliminating hepatitis C in a rural Appalachian county : Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C. / Havens, Jennifer R.; Schaninger, Takako; Fraser, Hannah et al.

In: BMJ Open, Vol. 11, No. 7, e041490, 05.07.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Eliminating hepatitis C in a rural Appalachian county

T2 - Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C

AU - Havens, Jennifer R.

AU - Schaninger, Takako

AU - Fraser, Hannah

AU - Lofwall, Michelle

AU - Staton, Michele

AU - Young, April M.

AU - Hoven, Ardis

AU - Walsh, Sharon L.

AU - Vickerman, Peter

N1 - Funding Information: All authors provided editorial support for the manuscript. JH obtained funding, wrote the study protocol and developed study materials, and drafted the manuscript. TS, AH and ML provided clinical support for KeY Treat related to hepatitis and substance use disorders. TS is the study physician and contributed to developing the laboratory procedures. TS and ML also provided substantive clinical expertise to the study protocol. HF and PV drafted the modelling portion of the manuscript. MS, AY and SLW were integral in obtaining funding, drafting of the protocol and development of the study questionnaires and other outcome measures. Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/7/5

Y1 - 2021/7/5

N2 - Objectives The overall goal of the Kentucky Viral Hepatitis Treatment Study (KeY Treat) is to eliminate hepatitis C transmission from a county in Appalachian Kentucky by removing the barriers to accessing hepatitis C virus (HCV) treatment. Methods/analysis KeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections. Those eligible for KeY Treat are at least 18 years of age, viraemic and are residents of the target county. Pregnant women are not eligible. Rapid HCV RNA screening is used to determine eligibility, and those with a quantifiable viral load (VL) consenting to participate initiate SOF/VEL on the same day. All pharmacologic treatment and related medical care is provided free of charge using a non-specialist provider model. Follow-up visits occur at 2, 6 and 12 weeks during treatment to assess medication adherence (measured via VL and self-report), side effects and engagement in risk behaviours. Post-treatment visits occur at 12 weeks (sustained virologic response (SVR12) visit), 6 months and 12 months post-treatment completion to assess re-infection. A control county has also been identified, and prevalence and incidence of chronic HCV infections will be compared with the target community longitudinally. The primary outcome to assess elimination is SVR12. However, several outcomes will be measured to assess the effectiveness of removing the barriers to HCV treatment, including treatment entry, completion and re-infection. Analyses will be conducted via a generalised linear model framework that can incorporate flexible covariate adjustment and multiple outcome types with a compatible link function. Mathematical modelling will be completed assessing the impact and cost-effectiveness of the intervention. Ethics and dissemination KeY Treat has been approved by the Institutional Review Board at the University of Kentucky. Results from KeY Treat will be presented at conferences and published in peer-reviewed journals. Trial registration number NCT03949764.

AB - Objectives The overall goal of the Kentucky Viral Hepatitis Treatment Study (KeY Treat) is to eliminate hepatitis C transmission from a county in Appalachian Kentucky by removing the barriers to accessing hepatitis C virus (HCV) treatment. Methods/analysis KeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections. Those eligible for KeY Treat are at least 18 years of age, viraemic and are residents of the target county. Pregnant women are not eligible. Rapid HCV RNA screening is used to determine eligibility, and those with a quantifiable viral load (VL) consenting to participate initiate SOF/VEL on the same day. All pharmacologic treatment and related medical care is provided free of charge using a non-specialist provider model. Follow-up visits occur at 2, 6 and 12 weeks during treatment to assess medication adherence (measured via VL and self-report), side effects and engagement in risk behaviours. Post-treatment visits occur at 12 weeks (sustained virologic response (SVR12) visit), 6 months and 12 months post-treatment completion to assess re-infection. A control county has also been identified, and prevalence and incidence of chronic HCV infections will be compared with the target community longitudinally. The primary outcome to assess elimination is SVR12. However, several outcomes will be measured to assess the effectiveness of removing the barriers to HCV treatment, including treatment entry, completion and re-infection. Analyses will be conducted via a generalised linear model framework that can incorporate flexible covariate adjustment and multiple outcome types with a compatible link function. Mathematical modelling will be completed assessing the impact and cost-effectiveness of the intervention. Ethics and dissemination KeY Treat has been approved by the Institutional Review Board at the University of Kentucky. Results from KeY Treat will be presented at conferences and published in peer-reviewed journals. Trial registration number NCT03949764.

KW - epidemiology

KW - hepatology

KW - public health

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DO - 10.1136/bmjopen-2020-041490

M3 - Article

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AN - SCOPUS:85109188791

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ER -

Eliminating hepatitis C in a rural Appalachian county: Protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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Fingerprint

Cite this