Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use

The SIMPLIFY study

on behalf of the SIMPLIFY study group

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection. Methods: SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1–6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics. Results: Among 103 participants, 97% (n = 100) completed treatment. Median adherence to therapy was 94%. Overall, 32% (n = 33) were considered non-adherent (<90% adherence). Adherence significantly decreased over the course of therapy. Recent stimulant injecting (cocaine and/or amphetamines) at treatment initiation and during treatment was independently associated with non-adherence. Inconsistent dose timing (standard deviation of daily dose timing of ≥240 min) was also independently associated with non-adherence to therapy. Factors associated with inconsistent dose timing included lower levels of education and recent stimulant injecting. SVR was similar among adherent and non-adherent populations (94% vs. 94%, P = 0.944). Conclusion: This study demonstrated high adherence to once-daily sofosbuvir/velpatasvir therapy among a population of people with recent injecting drug use. Recent stimulant injecting prior to and during DAA therapy and inconsistent dose-timing during treatment was associated with non-adherence. However, there was no impact of non-adherence on response to therapy, suggesting that adherence is not a significant barrier to successful DAA therapy in people with recent injecting drug use.

Original languageEnglish (US)
Pages (from-to)14-23
Number of pages10
JournalInternational Journal of Drug Policy
Volume62
DOIs
StatePublished - Dec 1 2018

Fingerprint

Injections
Infection
Pharmaceutical Preparations
Therapeutics
Blister
velpatasvir
Sofosbuvir
Amphetamines
Cocaine
Population
Multicenter Studies
Logistic Models
Genotype
Education

Keywords

  • Amphetamine
  • Blister pack
  • Cocaine
  • Compliance
  • Drug use
  • HCV
  • Injecting drug users
  • OST
  • PWID
  • Stimulants
  • Treatment

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Health Policy

Cite this

Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use : The SIMPLIFY study. / on behalf of the SIMPLIFY study group.

In: International Journal of Drug Policy, Vol. 62, 01.12.2018, p. 14-23.

Research output: Contribution to journalArticle

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title = "Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study",
abstract = "Background: This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection. Methods: SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1–6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (<90{\%} adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics. Results: Among 103 participants, 97{\%} (n = 100) completed treatment. Median adherence to therapy was 94{\%}. Overall, 32{\%} (n = 33) were considered non-adherent (<90{\%} adherence). Adherence significantly decreased over the course of therapy. Recent stimulant injecting (cocaine and/or amphetamines) at treatment initiation and during treatment was independently associated with non-adherence. Inconsistent dose timing (standard deviation of daily dose timing of ≥240 min) was also independently associated with non-adherence to therapy. Factors associated with inconsistent dose timing included lower levels of education and recent stimulant injecting. SVR was similar among adherent and non-adherent populations (94{\%} vs. 94{\%}, P = 0.944). Conclusion: This study demonstrated high adherence to once-daily sofosbuvir/velpatasvir therapy among a population of people with recent injecting drug use. Recent stimulant injecting prior to and during DAA therapy and inconsistent dose-timing during treatment was associated with non-adherence. However, there was no impact of non-adherence on response to therapy, suggesting that adherence is not a significant barrier to successful DAA therapy in people with recent injecting drug use.",
keywords = "Amphetamine, Blister pack, Cocaine, Compliance, Drug use, HCV, Injecting drug users, OST, PWID, Stimulants, Treatment",
author = "{on behalf of the SIMPLIFY study group} and Cunningham, {Evan B.} and Janaki Amin and Feld, {Jordan J.} and Julie Bruneau and Olav Dalgard and Jeff Powis and Margaret Hellard and Curtis Cooper and Phillip Read and Brian Conway and Dunlop, {Adrian J.} and Norton, {Brianna L.} and Litwin, {Alain H.} and Behzad Hajarizadeh and Thurnheer, {Maria Christine} and Dillon, {John F.} and Martin Weltman and David Shaw and Philip Bruggmann and Edward Gane and Chris Fraser and Philippa Marks and Applegate, {Tanya L.} and Sophie Quiene and Sharmila Siriragavan and Matthews, {Gail V.} and Dore, {Gregory J.} and Jason Grebely",
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T1 - Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use

T2 - The SIMPLIFY study

AU - on behalf of the SIMPLIFY study group

AU - Cunningham, Evan B.

AU - Amin, Janaki

AU - Feld, Jordan J.

AU - Bruneau, Julie

AU - Dalgard, Olav

AU - Powis, Jeff

AU - Hellard, Margaret

AU - Cooper, Curtis

AU - Read, Phillip

AU - Conway, Brian

AU - Dunlop, Adrian J.

AU - Norton, Brianna L.

AU - Litwin, Alain H.

AU - Hajarizadeh, Behzad

AU - Thurnheer, Maria Christine

AU - Dillon, John F.

AU - Weltman, Martin

AU - Shaw, David

AU - Bruggmann, Philip

AU - Gane, Edward

AU - Fraser, Chris

AU - Marks, Philippa

AU - Applegate, Tanya L.

AU - Quiene, Sophie

AU - Siriragavan, Sharmila

AU - Matthews, Gail V.

AU - Dore, Gregory J.

AU - Grebely, Jason

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Background: This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection. Methods: SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1–6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics. Results: Among 103 participants, 97% (n = 100) completed treatment. Median adherence to therapy was 94%. Overall, 32% (n = 33) were considered non-adherent (<90% adherence). Adherence significantly decreased over the course of therapy. Recent stimulant injecting (cocaine and/or amphetamines) at treatment initiation and during treatment was independently associated with non-adherence. Inconsistent dose timing (standard deviation of daily dose timing of ≥240 min) was also independently associated with non-adherence to therapy. Factors associated with inconsistent dose timing included lower levels of education and recent stimulant injecting. SVR was similar among adherent and non-adherent populations (94% vs. 94%, P = 0.944). Conclusion: This study demonstrated high adherence to once-daily sofosbuvir/velpatasvir therapy among a population of people with recent injecting drug use. Recent stimulant injecting prior to and during DAA therapy and inconsistent dose-timing during treatment was associated with non-adherence. However, there was no impact of non-adherence on response to therapy, suggesting that adherence is not a significant barrier to successful DAA therapy in people with recent injecting drug use.

AB - Background: This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection. Methods: SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1–6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics. Results: Among 103 participants, 97% (n = 100) completed treatment. Median adherence to therapy was 94%. Overall, 32% (n = 33) were considered non-adherent (<90% adherence). Adherence significantly decreased over the course of therapy. Recent stimulant injecting (cocaine and/or amphetamines) at treatment initiation and during treatment was independently associated with non-adherence. Inconsistent dose timing (standard deviation of daily dose timing of ≥240 min) was also independently associated with non-adherence to therapy. Factors associated with inconsistent dose timing included lower levels of education and recent stimulant injecting. SVR was similar among adherent and non-adherent populations (94% vs. 94%, P = 0.944). Conclusion: This study demonstrated high adherence to once-daily sofosbuvir/velpatasvir therapy among a population of people with recent injecting drug use. Recent stimulant injecting prior to and during DAA therapy and inconsistent dose-timing during treatment was associated with non-adherence. However, there was no impact of non-adherence on response to therapy, suggesting that adherence is not a significant barrier to successful DAA therapy in people with recent injecting drug use.

KW - Amphetamine

KW - Blister pack

KW - Cocaine

KW - Compliance

KW - Drug use

KW - HCV

KW - Injecting drug users

KW - OST

KW - PWID

KW - Stimulants

KW - Treatment

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U2 - 10.1016/j.drugpo.2018.08.013

DO - 10.1016/j.drugpo.2018.08.013

M3 - Article

VL - 62

SP - 14

EP - 23

JO - International Journal of Drug Policy

JF - International Journal of Drug Policy

SN - 0955-3959

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