Safety And Efficacy Of Glecaprevir/Pibrentasvir In Patients With Chronic Hepatitis C Genotypes 1–6 Receiving Opioid Substitution Therapy

Author: Grebely J, Dore GJ, Alami NN, Conway B, Dillon J, Gschwantler M, Felizarta F, Hézode C, Tomasiewicz K, Wang S, Liu R, Dumas E, Mensa F

Theme: Clinical Research Year: 2017

Background: International guidelines recommend prioritizing hepatitis C virus (HCV)
treatment in injection drug users, including those on opioid substitution therapy
(OST). The once-daily, all-oral, ribavirin-free, pangenotypic combination of
glecaprevir (identified by AbbVie and Enanta) and pibrentasvir has shown high
sustained virologic response at post-treatment week 12 (SVR12) in clinical trials. In
this analysis, we evaluate the safety and efficacy of glecaprevir/pibrentasvir in
people receiving OST.
Methods: Data were pooled from patients with HCV genotypes (GT) 1–6 who were
enrolled in 8 Phase 2 or 3 trials of glecaprevir/pibrentasvir for 8, 12, or 16 weeks.
Concomitant medications at study enrolment were reviewed for OST use. Treatment
completion, adherence (≥90% compliance by pill count), SVR12, adverse events
(AEs), and laboratory abnormalities were evaluated for patients receiving OST
versus non-OST patients.
Results: Among 2256 patients, 157 (7%) were receiving OST. Compared with nonOST patients, OST patients were more often male (69% vs 54%), <65 years of age (96% vs 85%), treatment naïve (86% vs 72%), had HCV GT3a (60% vs 26%), or had a history of depression or bipolar disorder (43% vs 19%). Most patients completed (OST: 98% [n/N=154/157]; non-OST: 99% [n/N=2070/2099]) and were adherent to (OST: 98% [n/N=121/123]; non-OST: 99% [n/N=1884/1905] among patients with available data) glecaprevir/pibrentasvir treatment. SVR12 rates in OST and non-OST patients were: ITT, 96% (n/N=151/157) and 98% (n/N=2055/2099); mITT (excluding nonvirologic failures), 99% (n/N=151/152) and 99% (n/N=2055/2077). For OST patients, reasons for nonresponse included relapse (n=1), premature study drug discontinuation (n=1), and missing SVR12 data (n=4). AEs occurring in ≥10% of patients were headache, fatigue, and nausea. Drug-related serious AEs, AEs leading to study drug discontinuation, and grade 3 or higher laboratory abnormalities were infrequent (<1%). No HCV reinfections occurred through post-treatment week 12. Conclusion: Glecaprevir/pibrentasvir is highly efficacious and well tolerated in HCVinfected patients receiving OST. Disclosure of interest statement: AbbVie sponsored the studies; contributed to their design and to data collection, analysis, and interpretation; and participated in the writing, review, and approval of the abstract. All authors had access to all relevant data and participated in writing, review, and approval of the abstract. This abstract contains information on the investigational products glecaprevir (ABT-493) and pibrentasvir (ABT-530). Medical writing support was provided by Paul MacCallum, of Fishawack, funded by AbbVie.

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