TY - JOUR
T1 - Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in patients with chronic hepatitis C virus genotype 1 infection receiving opioid substitution therapy
T2 - A post hoc analysis of 12 clinical trials
AU - Grebely, Jason
AU - Puoti, Massimo
AU - Wedemeyer, Heiner
AU - Cooper, Curtis
AU - Sulkowski, Mark S.
AU - Foster, Graham R.
AU - Berg, Thomas
AU - Villa, Erica
AU - Rodriguez-Perez, Federico
AU - Wyles, David L.
AU - Schnell, Gretja
AU - Alami, Negar N.
AU - Zhang, Zhenzhen
AU - Dumas, Emily
AU - Dore, Gregory J.
N1 - Funding Information:
Financial support. AbbVie provided funding for this study and participated in the design, research, data collection and interpretation, writing, reviewing, and approval of the publication. The Kirby Institute 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. Jason Grebely is supported by a National Health and Medical Research Council Career Development Fellowship. Gregory Dore is supported through National Health and Medical Research Council of Australia Practitioner Fellowships. Medical writing support was provided by Nazneen Siddiqui, PhD, of Medical Expressions, funded by AbbVie.
Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2018/11/1
Y1 - 2018/11/1
N2 - Background. We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. Methods. Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. Results. Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. Conclusions. Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.
AB - Background. We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. Methods. Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. Results. Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. Conclusions. Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.
KW - Drug use
KW - Hepatitis C virus
KW - Opioid substitution therapy
KW - PWID
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UR - http://www.scopus.com/inward/citedby.url?scp=85061012326&partnerID=8YFLogxK
U2 - 10.1093/ofid/ofy248
DO - 10.1093/ofid/ofy248
M3 - Article
C2 - 30430131
AN - SCOPUS:85061012326
SN - 2328-8957
VL - 5
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 11
ER -