Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study

TY - JOUR

T1 - Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use

T2 - The SIMPLIFY study

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, Briana

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

N1 - his work was supported by funding from Gilead Sciences. The Kirby Institute, which sponsored this study, is funded by the Australian Government Department of Health and Ageing. The views expressed in this publication do not necessarily represent the position of the Australian Government. EBC holds a UNSW Sydney Tuition Fee Scholarship. JG is supported by a National Health and Medical Research Council Career Development Fellowship. GJD is supported by a National Health and Medical Research Council Practitioner Research Fellowship. BH is supported by a National Health and Medical Research Council Early Career Fellowship. JG, GVM, and GJD have received funding from the US National Institute on Drug Abuse, US National Institutes of Health for an unrelated project (1R01DA040506-01).

PY - 2018/12

Y1 - 2018/12

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

U2 - 10.1016/j.drugpo.2018.08.013

DO - 10.1016/j.drugpo.2018.08.013

M3 - Article

C2 - 30352330

SN - 0955-3959

VL - 62

SP - 14

EP - 23

JO - International Journal of Drug Policy

JF - International Journal of Drug Policy

ER -