Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.

<h4>Background & aims</h4>We evaluated the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in difficult-to-treat PWIDs with presumed high risk for non-adherence to antiviral therapy using an innovative concept involving their opioid agonist therapy (OAT) facility.<h4>Methods&...

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Autores principales:	Caroline Schmidbauer, Michael Schwarz, Angelika Schütz, Raphael Schubert, Cornelia Schwanke, Enisa Gutic, Roxana Pirker, Tobias Lang, Thomas Reiberger, Hans Haltmayer, Michael Gschwantler
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/9b1adb9e5f5f407f81472ebb32218777
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spelling	oai:doaj.org-article:9b1adb9e5f5f407f81472ebb322187772021-11-25T06:23:37ZDirectly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.1932-620310.1371/journal.pone.0252274https://doaj.org/article/9b1adb9e5f5f407f81472ebb322187772021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0252274https://doaj.org/toc/1932-6203<h4>Background & aims</h4>We evaluated the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in difficult-to-treat PWIDs with presumed high risk for non-adherence to antiviral therapy using an innovative concept involving their opioid agonist therapy (OAT) facility.<h4>Methods</h4>N = 221 patients (m/f: 168/53; median age: 44.7 years (IQR 16.9); HCV-genotype 3: 45.2%; cirrhosis: 33.9%) treated with SOF/VEL were included. PWIDs at high risk for non-adherence to DAA therapy (n = 122) received HCV treatment alongside OAT under the supervision of medical staff ("directly observed therapy", DOT). These patients were compared to patients with presumed excellent drug compliance, who were treated in a "standard setting" (SS) of SOF/VEL prescription at a tertiary care center (n = 99).<h4>Results</h4>DOT-patients (n = 122/221; 55.2%) were younger than SS-patients (median age: 41.3 vs. 53.0 years), all had psychiatric comorbidities and most had a poor socioeconomic status. 83/122 (68.0%) reported ongoing intravenous drug use. Within the DOT-group, SVR12 was achieved in 99.1% (95% CI: 95.0-100; n = 109/110) with one patient experiencing treatment failure, while n = 12/122 (9.8%) patients were excluded due to loss of follow-up (FU). 5 patients showed HCV reinfection after achieving SVR12. SS-patients achieved SVR in 96.6% (95% CI: 90.3-99.3%; n = 84/87) after exclusion of 10/99 (10.1%) patients who were lost to FU and 2 patients who died prior to SVR12 due to reasons not related to DAA therapy.<h4>Conclusions</h4>SOF/VEL given as DOT along with OAT in PWIDs at high risk of non-adherence to antiviral therapy including those with ongoing intravenous drug use resulted in excellent SVR rates similar to patients with presumed "excellent compliance" under standard drug intake.Caroline SchmidbauerMichael SchwarzAngelika SchützRaphael SchubertCornelia SchwankeEnisa GuticRoxana PirkerTobias LangThomas ReibergerHans HaltmayerMichael GschwantlerPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0252274 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Caroline Schmidbauer Michael Schwarz Angelika Schütz Raphael Schubert Cornelia Schwanke Enisa Gutic Roxana Pirker Tobias Lang Thomas Reiberger Hans Haltmayer Michael Gschwantler Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
description	<h4>Background & aims</h4>We evaluated the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in difficult-to-treat PWIDs with presumed high risk for non-adherence to antiviral therapy using an innovative concept involving their opioid agonist therapy (OAT) facility.<h4>Methods</h4>N = 221 patients (m/f: 168/53; median age: 44.7 years (IQR 16.9); HCV-genotype 3: 45.2%; cirrhosis: 33.9%) treated with SOF/VEL were included. PWIDs at high risk for non-adherence to DAA therapy (n = 122) received HCV treatment alongside OAT under the supervision of medical staff ("directly observed therapy", DOT). These patients were compared to patients with presumed excellent drug compliance, who were treated in a "standard setting" (SS) of SOF/VEL prescription at a tertiary care center (n = 99).<h4>Results</h4>DOT-patients (n = 122/221; 55.2%) were younger than SS-patients (median age: 41.3 vs. 53.0 years), all had psychiatric comorbidities and most had a poor socioeconomic status. 83/122 (68.0%) reported ongoing intravenous drug use. Within the DOT-group, SVR12 was achieved in 99.1% (95% CI: 95.0-100; n = 109/110) with one patient experiencing treatment failure, while n = 12/122 (9.8%) patients were excluded due to loss of follow-up (FU). 5 patients showed HCV reinfection after achieving SVR12. SS-patients achieved SVR in 96.6% (95% CI: 90.3-99.3%; n = 84/87) after exclusion of 10/99 (10.1%) patients who were lost to FU and 2 patients who died prior to SVR12 due to reasons not related to DAA therapy.<h4>Conclusions</h4>SOF/VEL given as DOT along with OAT in PWIDs at high risk of non-adherence to antiviral therapy including those with ongoing intravenous drug use resulted in excellent SVR rates similar to patients with presumed "excellent compliance" under standard drug intake.
format	article
author	Caroline Schmidbauer Michael Schwarz Angelika Schütz Raphael Schubert Cornelia Schwanke Enisa Gutic Roxana Pirker Tobias Lang Thomas Reiberger Hans Haltmayer Michael Gschwantler
author_facet	Caroline Schmidbauer Michael Schwarz Angelika Schütz Raphael Schubert Cornelia Schwanke Enisa Gutic Roxana Pirker Tobias Lang Thomas Reiberger Hans Haltmayer Michael Gschwantler
author_sort	Caroline Schmidbauer
title	Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
title_short	Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
title_full	Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
title_fullStr	Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
title_full_unstemmed	Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
title_sort	directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent svr12 rates in pwids at high risk for non-adherence to daa therapy.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/9b1adb9e5f5f407f81472ebb32218777
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Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.

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