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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

  1. Gregory J. Dore1
  1. 1The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
  2. 2Center for HIV and Hepatogastroenterology, Düsseldorf, Germany
  3. 3Liver Unit, Department of Medicine, St Mary's Hospital, London, United Kingdom
  4. 4Hépato-gastroentérologie, INSERM U954, CHU Nancy, France
  5. 5Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy
  6. 6Division of Infectious Diseases, University of California, San Diego, USA
  7. 7Gilead Sciences, Foster City, USA
  8. 8Gilead Sciences, Stockley Park, United Kingdom
  1. Corresponding author: Jason Grebely, PhD, Associate Professor, Viral Hepatitis Clinical Research Program, The Kirby Institute, UNSW Australia. Phone: +61-2-9385 0957, Fax: +61-2-9385 0876, email: jgrebely{at}kirby.unsw.edu.au
  1. Alternate corresponding author: Gregory J Dore, MBBS, PhD, FRACP, MPH, Professor, Viral Hepatitis Clinical Research Program, The Kirby Institute, UNSW Australia. Phone: +61-2-9385 0898, Fax: +61-2-9385 0876, email: gdore{at}kirby.unsw.edu.au

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.

UNCORRECTED PROOF

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