Theme: Clinical Research Year: 2016
EFFICACY OF SOFOSBUVIR/LEDIPASVIR WITH AND WITHOUT RIBAVIRIN IN PATIENTS WITH CHRONIC HCV GENOTYPE 1 INFECTION RECEIVING OPIOID SUBSTITUTION THERAPY: ANALYSIS OF PHASE 3 ION TRIALS
Grebely J1, Mauss S2, Brown A3, Bronowicki J4, Puoti M5, Wyles D6, Natha M7, Zhu Y7, Yang J7, Kreter B7, Brainard DM7, Yun C7, Carr V8, and Dore GJ1
1The Kirby Institute, UNSW Australia, Sydney, NSW, Australia;
2Center for HIV and Hepatogastroenterology, Düsseldorf, Germany;
3Liver Unit, Department of Medicine, St Mary’s Hospital, London, United Kingdom;
4Hépato-gastroentérologie, INSERM U954, CHU Nancy, France;
5Azienda Ospedaliera Ospedale Niguarda Ca’ Granda, Milan, Italy;
6Division of Infectious Diseases University of California, San Diego, USA;
7Gilead Sciences, Foster City, USA;
8Gilead Sciences, Stockley Park, United Kingdom
Background and Aims: Interferon-based 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 sofosbuvir/ledipasvir (± ribavirin).
Methods: The Phase III ION studies evaluated a fixed-dose combination of sofosbuvir/ledipasvir + 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 1,952 patients enrolled in the ION studies, 4% (n=70) were receiving OST. Among those receiving (n=70) and not receiving OST (n=1,882), 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). Among participants in the ION-1 trial, 23% (n=196) had illicit drug use 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 have been 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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