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Efficacy and safety of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic HCV genotype 1 infection receiving opioid substitution therapy: Analysis of Phase 3 ION trials.

Efficacy and safety of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic HCV genotype 1 infection receiving opioid substitution therapy: Analysis of Phase 3 ION trials.
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Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ,


Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ, (click to view)

Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ,

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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2016 8 23() pii

Abstract
BACKGROUND
 Interferon-based HCV therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. The aim of this post-hoc analysis was to evaluate the impact of OST and drug use during therapy on completion, adherence, sustained virologic response (SVR12) and safety of ledipasvir/sofosbuvir±ribavirin.

METHODS
 The Phase 3 ION studies evaluated a fixed-dose combination of ledipasvir/sofosbuvir±ribavirin administered for 8/12/24 weeks in patients with chronic HCV genotype 1. People with clinically significant drug use (prior 12 months) or non-cannabinoids detected at screening by urine drug tests (not explained by prescriptions) were ineligible. Stored samples were available from ION-1 for retrospective testing for illicit drugs by ELISA.

RESULTS
 Among 1952 patients enrolled in the ION studies, 4% (n=70) were receiving OST. Among those receiving (n=70) and not receiving OST (n=1882), there was no difference in treatment completion (97% vs 98%, P=0.40) ≥80% adherence (93% vs 92%, P=1.00), SVR12 (94% vs 97%, P=0.28), and serious AEs (4% vs 3%, P=0.43), respectively. Among participants in the ION-1 trial, 23% (n=196) used illicit drugs during therapy (15% cannabinoids alone; 8% other illict drugs±cannabinoids). There was no difference in treatment completion, ≥80% adherence, SVR12 or serious AEs in those with no drug use during treatment compared with those who used cannabinoids and/or other illicit drugs. No cases of HCV reinfection were observed in the 24 weeks following treatment.

CONCLUSIONS
 OST and drug use during HCV therapy did not impact treatment completion, adherence, SVR12 or safety.

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