@article{744ce4c7cc9d4e998adef417253a541f,
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 Briana Norton 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",
note = "Funding Information: The study (including study medications) was funded by a research grant from Gilead Sciences . The sponsor (The Kirby Institute, UNSW Sydney) designed the study, collected the data, managed study samples, monitored study conduct and performed the statistical analysis. Funding Information: JG reports grants and personal fees from AbbVie, Cepheid, Gilead Sciences, and Merck. OD reports grants from Gilead Sciences during this study and grants from Gilead Sciences, Merck, and AbbVie. PB reports grants and personal fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, and Merck Sharp & Dohme. MH reports grants from Gilead Sciences, Bristol-Myers Squibb, and AbbVie. JBr reports consultant fees from Gilead Sciences and Merck. AHL reports grants and personal fees from Gilead Sciences and Merck. GVM reports grants and personal fees from Gilead Sciences and grants from AbbVie. JP reports personal fees from Janssen and Genetech. CC reports grants and personal fees from Gilead Sciences. JJF reports grants and personal fees from AbbVie, Merck, Gilead Sciences, and Janssen, personal fees from Contravir, and grants from Abbott. CF reports grants and non-financial support from Kirby Institute during this study and grants from Gilead Sciences, ViiV HealthCare, and Merck. GJD reports grants, personal fees, and non-financial support from AbbVie, Merck, Bristol-Myers Squibb, and Roche; grants and personal fees from Janssen; personal fees and non-financial support from Gilead Sciences; and personal fees from GlaxoSmithKline and Abbott Diagnostics. PR reports fees for educational talks from Gilead Sciences, Merck Sharp & Dohme, and AbbVie, and is on the advisory board for Merck Sharp & Dohme. BC reports grants, personal fees, and non-financial support from Gilead Sciences, Merck, and AbbVie. EG reports personal fees from being a Clinical Advisor for Gilead Sciences, Merck, Janssen, and AbbVie, and personal fees from Gilead Sciences Speaker Bureau and AbbVie Speaker Bureau. JFD reports grants and personal fees from Gilead, Merck Sharp & Dohme, Janssen, and AbbVie. All other authors declare no competing interests. Funding Information: This 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 ). Funding Information: We thank the study participants, researchers, and staff for their contribution to the research. We also thank Diana Brainard, John McHutchison, and others at Gilead Sciences for their support. This 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). ",
year = "2018",
month = dec,
doi = "10.1016/j.drugpo.2018.08.013",
language = "English (US)",
volume = "62",
pages = "14--23",
journal = "International Journal of Drug Policy",
issn = "0955-3959",
publisher = "Elsevier",
}