P711 A NOVEL GENETIC MAKER TO IMPROVE THE PREDICTION OF HCV SPONTANEOUS CLEARANCE: POLYMORPHISMS CONSISTING OF (TA)N DINUCLEOTIDE REPEAT NEAR IL28B GENE

irreversible CYP3A4 inhibitor, and inhibitor of multiple cellular uptake and efflux transporters. This study evaluated the interaction between ALV and methadone to assess potential clinical risks for methadone withdrawal or toxicity. Methods: Open-label screening (Part 1) and randomized, placebocontrolled, double blind (Part 2) investigation. Healthy subjects received a single 5mg dose of methadone before and after ALV (Part 1). Then, opioid-dependent patients on stable MMT (≤150mg daily) were randomized (2:1) to receive ALV 600mg BID or placebo for 7 days (Part 2). Safety assessments included daily vitals and 12lead ECGs, laboratory tests, and continuous pulse oximetry. Blood samples were collected for Rand S-methadone concentrations prior to and after dose administration on D1 (before ALV) and D8. Non-compartmental PK analysis was performed. Results: 16 healthy and 22 MMT subjects (14 active; 8 placebo) were enrolled. Two healthy and 2 MMT subjects withdrew consent before study completion. Dizziness (37.5%), headache (18.8%), and nausea (18.8%) were the most commonly reported AEs among healthy subjects; somnolence (30.8% vs. 25.0%), headache (30.8% vs. 12.5%), nausea (15.4% vs. 0%), and tremor (15.4% vs. 0%) among MMT subjects receiving ALV vs. placebo.