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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.

Identifieur interne : 001457 ( PubMed/Corpus ); précédent : 001456; suivant : 001458

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.

Auteurs : Jason Grebely ; Stefan Mauss ; Ashley Brown ; Jean-Pierre Bronowicki ; Massimo Puoti ; David Wyles ; Macky Natha ; Yanni Zhu ; Junming Yang ; Bruce Kreter ; Diana M. Brainard ; Chohee Yun ; Val Carr ; Gregory J. Dore

Source :

RBID : pubmed:27553375

English descriptors

Abstract

 Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim 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.

DOI: 10.1093/cid/ciw580
PubMed: 27553375

Links to Exploration step

pubmed:27553375

Le document en format XML

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<front>
<div type="abstract" xml:lang="en"> Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim 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.</div>
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<Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title>
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<ArticleTitle>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.</ArticleTitle>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND"> Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim 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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS"> The phase 3 ION studies evaluated a fixed-dose combination of ledipasvir/sofosbuvir ± ribavirin administered for 8, 12, or 24 weeks in patients with chronic HCV genotype 1. People with clinically significant drug use (prior 12 months) or noncannabinoids 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 enzyme-linked immunosorbent assay.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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 = .40), ≥80% adherence (93% vs 92%; P = 1.00), SVR12 (94% vs 97%; P = .28), and serious adverse events (4% vs 3%; P = .43), respectively. Among participants in the ION-1 trial, 23% (n = 196) used illicit drugs during therapy (15% cannabinoids alone; 8% other illicit 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.</AbstractText>
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<AbstractText Label="CLINICAL TRIALS REGISTRATION" NlmCategory="BACKGROUND"> ION-1 (NCT01701401); ION-2 (NCT01768286); and ION-3 (NCT01851330).</AbstractText>
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