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

被引:64
作者
Cunningham, Evan B. [1 ]
Amin, Janaki. [1 ,2 ]
Feld, Jordan J. [3 ]
Bruneau, Julie [4 ]
Dalgard, Olav [5 ,6 ]
Powis, Jeff [7 ]
Hellard, Margaret [8 ,9 ]
Cooper, Curtis [10 ]
Read, Phillip [1 ,11 ]
Conway, Brian [12 ]
Dunlop, Adrian J. [13 ,14 ,15 ]
Norton, Briana [16 ,17 ]
Litwin, Alain H. [16 ,17 ]
Hajarizadeh, Behzad [1 ]
Thurnheer, Maria Christine [18 ]
Dillon, John F. [19 ]
Weltman, Martin [20 ]
Shaw, David [21 ]
Bruggmann, Philip [22 ]
Gane, Edward [23 ]
Fraser, Chris [24 ]
Marks, Philippa [1 ]
Applegate, Tanya L. [1 ]
Quiene, Sophie [1 ]
Siriragavan, Sharmila [1 ]
Matthews, Gail V. [1 ,25 ]
Dore, Gregory J. [1 ,25 ]
Grebely, Jason [1 ]
机构
[1] UNSW Sydney, Kirby Inst, Sydney, NSW, Australia
[2] Macquarie Univ, Fac Med & Hlth Sci, Sydney, NSW, Australia
[3] Toronto Gen Hosp, Toronto, ON, Canada
[4] Ctr Hosp Univ Montreal, Montreal, PQ, Canada
[5] Akershus Univ Hosp, Oslo, Norway
[6] Univ Oslo, Inst Clin Med, Oslo, Norway
[7] South Riverdale Community Hlth Ctr, Toronto, ON, Canada
[8] Burnet Inst, Melbourne, Vic, Australia
[9] Alfred Hosp, Dept Infect Dis, Melbourne, Vic, Australia
[10] Ottawa Hosp Res Inst, Ottawa, ON, Canada
[11] Kirketon Rd Ctr, Sydney, NSW, Australia
[12] Vancouver Infect Dis Ctr, Vancouver, BC, Canada
[13] Hunter New England Local Hlth Dist, Drug & Alcohol Clin Serv, New Lambton Hts, NSW, Australia
[14] Hunter Med Res Inst, Ctr Translat Neurosci & Mental Hlth, Newcastle, NSW, Australia
[15] Univ Newcastle, Newcastle, NSW, Australia
[16] Montefiore Med Ctr, New York, NY USA
[17] Albert Einstein Coll Med, New York, NY USA
[18] Bern Univ Hosp, Dept Infect Dis, Bern, Switzerland
[19] Univ Dundee, Ninewells Hosp & Med Sch, Dundee, Scotland
[20] Nepean Hosp, Penrith, NSW, Australia
[21] Royal Adelaide Hosp, Adelaide, SA, Australia
[22] Arud Ctr Addict Med, Zurich, Switzerland
[23] Auckland City Hosp, Auckland, New Zealand
[24] Coolaid Community Hlth Ctr, Victoria, BC, Canada
[25] St Vincents Hosp, Sydney, NSW, Australia
基金
英国医学研究理事会; 美国国家卫生研究院;
关键词
HCV; Treatment; PWID; Drug use; Injecting drug users; Compliance; OST; Blister pack; Stimulants; Amphetamine; Cocaine; C VIRUS-INFECTION; CHRONIC HEPATITIS-C; SUBSTITUTION THERAPY ANALYSIS; GENOTYPE 1-INFECTED PATIENTS; MEDICAID REIMBURSEMENT; EFFICACY; RIBAVIRIN; SAFETY; RESTRICTIONS; DASABUVIR;
D O I
10.1016/j.drugpo.2018.08.013
中图分类号
R194 [卫生标准、卫生检查、医药管理];
学科分类号
摘要
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.
引用
收藏
页码:14 / 23
页数:10
相关论文
共 37 条
[1]  
[Anonymous], NATURE REV GASTROENT
[2]  
[Anonymous], 2016, 5 INT S HEP CAR SUBS
[3]  
[Anonymous], INT J DRUG POLICY
[4]  
[Anonymous], LANCET GASTROENTEROL
[5]  
[Anonymous], LANCET
[6]  
[Anonymous], INT J DRUG POLICY
[7]   Treatment of Hepatitis C Virus Infection Among People Who Are Actively Injecting Drugs: A Systematic Review and Meta-analysis [J].
Aspinall, Esther J. ;
Corson, Stephen ;
Doyle, Joseph S. ;
Grebely, Jason ;
Hutchinson, Sharon J. ;
Dore, Gregory J. ;
Goldberg, David J. ;
Hellard, Margaret E. .
CLINICAL INFECTIOUS DISEASES, 2013, 57 :S80-S89
[8]   Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States [J].
Barua, Soumitri ;
Greenwald, Robert ;
Grebely, Jason ;
Dore, Gregory J. ;
Swan, Tracy ;
Taylor, Lynn E. .
ANNALS OF INTERNAL MEDICINE, 2015, 163 (03) :215-+
[9]   Belgian experience with direct acting antivirals in people who inject drugs [J].
Bielen, Rob ;
Moreno, Christophe ;
Van Vlierberghe, Hans ;
Bourgeois, Stefan ;
Mulkay, Jean-Pierre ;
Vanwolleghem, Thomas ;
Verlinden, Wim ;
Brixko, Christian ;
Decaestecker, Jochen ;
De Galocsy, Chantal ;
Janssens, Filip ;
Cool, Mike ;
Van Overbeke, Lode ;
Van Steenkiste, Christophe ;
D'heygere, Francois ;
Cools, Wilfried ;
Nevens, Frederik ;
Robaeys, Geert .
DRUG AND ALCOHOL DEPENDENCE, 2017, 177 :214-220
[10]   Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study [J].
Cunningham, Evan B. ;
Hajarizadeh, Behzad ;
Dalgard, Olav ;
Amin, Janaki ;
Hellard, Margaret ;
Foster, Graham R. ;
Bruggmann, Philip ;
Conway, Brian ;
Backmund, Markus ;
Robaeys, Geert ;
Swan, Tracy ;
Marks, Philippa S. ;
Quiene, Sophie ;
Applegate, Tanya L. ;
Weltman, Martin ;
Shaw, David ;
Dunlop, Adrian ;
Bruneau, Julie ;
Midgard, Havard ;
Bourgeois, Stefan ;
Thurnheer, Maria Christine ;
Dore, Gregory J. ;
Grebely, Jason .
BMC INFECTIOUS DISEASES, 2017, 17