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 language | English (US) |
|---|---|
| Pages (from-to) | 14-23 |
| Number of pages | 10 |
| Journal | International Journal of Drug Policy |
| Volume | 62 |
| DOIs | |
| State | Published - Dec 1 2018 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=85055136055&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85055136055&partnerID=8YFLogxK
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
ER -