{"id":"boceprevir","rwe":[],"tags":[{"label":"Hepatitis C Virus NS3/4A Protease Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Chymase","category":"target"},{"label":"CMA1","category":"gene"},{"label":"CTSK","category":"gene"},{"label":"CTSV","category":"gene"},{"label":"J05AP03","category":"atc"},{"label":"LOE Approaching","category":"status"},{"label":"Chronic hepatitis C","category":"indication"},{"label":"Merck Sharp Dohme","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":567.924,"date":"","count":308,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 308 times (LLR=568)"},{"llr":191.658,"date":"","count":134,"signal":"Neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 134 times (LLR=192)"},{"llr":132.67,"date":"","count":61,"signal":"Dysgeusia","source":"DrugCentral FAERS","actionTaken":"Reported 61 times (LLR=133)"},{"llr":105.841,"date":"","count":91,"signal":"Thrombocytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 91 times (LLR=106)"},{"llr":83.018,"date":"","count":48,"signal":"Ascites","source":"DrugCentral FAERS","actionTaken":"Reported 48 times (LLR=83)"},{"llr":75.723,"date":"","count":54,"signal":"Leukopenia","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=76)"},{"llr":68.597,"date":"","count":33,"signal":"Hepatic cirrhosis","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=69)"},{"llr":56.705,"date":"","count":104,"signal":"Rash","source":"DrugCentral FAERS","actionTaken":"Reported 104 times (LLR=57)"},{"llr":52.722,"date":"","count":15,"signal":"Viral load increased","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=53)"},{"llr":50.204,"date":"","count":32,"signal":"Hepatic failure","source":"DrugCentral FAERS","actionTaken":"Reported 32 times (LLR=50)"},{"llr":48.885,"date":"","count":57,"signal":"Depression","source":"DrugCentral FAERS","actionTaken":"Reported 57 times (LLR=49)"},{"llr":43.686,"date":"","count":16,"signal":"Hepatocellular carcinoma","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=44)"},{"llr":41.951,"date":"","count":43,"signal":"Pancytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=42)"},{"llr":38.773,"date":"","count":45,"signal":"White blood cell count decreased","source":"DrugCentral FAERS","actionTaken":"Reported 45 times (LLR=39)"},{"llr":38.292,"date":"","count":11,"signal":"Anorectal disorder","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=38)"}],"drugInteractions":[{"url":"/drug/cyp3a4-substrates","drug":"CYP3A4 Substrates","action":"Use caution","effect":"Strong CYP3A4 Inhibitors - CYP3A4 Substrates","source":"DrugCentral","drugSlug":"cyp3a4-substrates"},{"url":"/drug/p-glycoprotein-substrates","drug":"P-glycoprotein Substrates","action":"Use caution","effect":"P-glycoprotein Inhibitors - P-glycoprotein Substrates","source":"DrugCentral","drugSlug":"p-glycoprotein-substrates"},{"url":"/drug/alfentanil","drug":"alfentanil","action":"Monitor closely","effect":"May interact with Alfentanil","source":"DrugCentral","drugSlug":"alfentanil"},{"url":"/drug/alfuzosin","drug":"alfuzosin","action":"Avoid combination","effect":"May interact with Alfuzosin","source":"DrugCentral","drugSlug":"alfuzosin"},{"url":"/drug/alprazolam","drug":"alprazolam","action":"Monitor closely","effect":"May interact with Alprazolam","source":"DrugCentral","drugSlug":"alprazolam"},{"url":"/drug/atazanavir","drug":"atazanavir","action":"Avoid combination","effect":"May interact with Atazanavir","source":"DrugCentral","drugSlug":"atazanavir"},{"url":"/drug/atorvastatin","drug":"atorvastatin","action":"Avoid combination","effect":"May interact with Atorvastatin Calcium","source":"DrugCentral","drugSlug":"atorvastatin"},{"url":"/drug/bromocriptine","drug":"bromocriptine","action":"Avoid combination","effect":"May interact with Bromocriptine","source":"DrugCentral","drugSlug":"bromocriptine"},{"url":"/drug/buprenorphine","drug":"buprenorphine","action":"Monitor closely","effect":"May interact with Buprenorphine","source":"DrugCentral","drugSlug":"buprenorphine"},{"url":"/drug/cabergoline","drug":"cabergoline","action":"Avoid combination","effect":"May interact with Cabergoline","source":"DrugCentral","drugSlug":"cabergoline"},{"url":"/drug/carbamazepine","drug":"carbamazepine","action":"Avoid combination","effect":"May interact with Carbamazepine","source":"DrugCentral","drugSlug":"carbamazepine"},{"url":"/drug/ciclosporin","drug":"ciclosporin","action":"Avoid combination","effect":"May interact with Cyclosporine","source":"DrugCentral","drugSlug":"ciclosporin"},{"url":"/drug/colchicine","drug":"colchicine","action":"Monitor closely","effect":"May interact with Colchicine","source":"DrugCentral","drugSlug":"colchicine"},{"url":"/drug/darunavir","drug":"darunavir","action":"Avoid combination","effect":"May interact with Darunavir","source":"DrugCentral","drugSlug":"darunavir"},{"url":"/drug/dexamethasone","drug":"dexamethasone","action":"Avoid combination","effect":"May interact with Dexamethasone","source":"DrugCentral","drugSlug":"dexamethasone"},{"url":"/drug/drospirenone","drug":"drospirenone","action":"Avoid combination","effect":"May interact with Drospirenone","source":"DrugCentral","drugSlug":"drospirenone"},{"url":"/drug/escitalopram","drug":"escitalopram","action":"Monitor closely","effect":"May interact with Escitalopram Oxalate","source":"DrugCentral","drugSlug":"escitalopram"},{"url":"/drug/estradiol","drug":"estradiol","action":"Monitor closely","effect":"May interact with Estradiol","source":"DrugCentral","drugSlug":"estradiol"},{"url":"/drug/ethinylestradiol","drug":"ethinylestradiol","action":"Monitor closely","effect":"May interact with Ethinyl Estradiol","source":"DrugCentral","drugSlug":"ethinylestradiol"},{"url":"/drug/etonogestrel","drug":"etonogestrel","action":"Monitor closely","effect":"May interact with Etonogestrel","source":"DrugCentral","drugSlug":"etonogestrel"}],"commonSideEffects":[],"contraindications":["Anemia","Neutropenic disorder"]},"trials":[],"aliases":[],"company":"Merck & Co.","patents":[{"applNo":"N202258","source":"FDA Orange Book","status":"Active","expires":"Nov 11, 2027","useCode":"U-1128","territory":"US","drugProduct":true,"patentNumber":"7772178","drugSubstance":false},{"applNo":"N202258","source":"FDA Orange Book","status":"Active","expires":"Mar 17, 2027","useCode":"U-1233","territory":"US","drugProduct":false,"patentNumber":"8119602","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BOCEPREVIR","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:42:59.033664+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:42:59.033576+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Boceprevir","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:43:05.694793+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:43:04.240525+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BOCEPREVIR","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:43:04.620046+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4868590/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:43:05.334366+00:00"}},"allNames":"victrelis","offLabel":[],"synonyms":["boceprevir","victrelis","SCH 503034"],"timeline":[{"date":"2011-05-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Merck Sharp Dohme)"}],"aiSummary":"Victrelis (BOCEPREVIR) is a small molecule Hepatitis C Virus NS3/4A Protease Inhibitor developed by MERCK SHARP DOHME. It targets Chymase and was FDA approved in 2011 for the treatment of chronic hepatitis C. As a patented medication, it is not yet available as a generic. Key safety considerations include potential interactions with other medications and monitoring for liver function. Victrelis is a critical component in the treatment of hepatitis C, but its use should be carefully managed due to its potential side effects.","brandName":"Victrelis","ecosystem":[{"indication":"Chronic hepatitis C","otherDrugs":[{"name":"daclatasvir","slug":"daclatasvir","company":"Bristol Myers Squibb"},{"name":"dasabuvir","slug":"dasabuvir","company":"Abbvie Inc"},{"name":"elbasvir","slug":"elbasvir","company":"Merck Sharp Dohme"},{"name":"glecaprevir","slug":"glecaprevir","company":"Abbvie Inc"}],"globalPrevalence":58000000}],"mechanism":{"target":"Chymase","novelty":"Follow-on","targets":[{"gene":"CMA1","source":"DrugCentral","target":"Chymase","protein":"Chymase"},{"gene":"CTSK","source":"DrugCentral","target":"Cathepsin K","protein":"Cathepsin K"},{"gene":"CTSV","source":"DrugCentral","target":"Cathepsin L2","protein":"Cathepsin L2"},{"gene":"CTSS","source":"DrugCentral","target":"Cathepsin S","protein":"Cathepsin S"},{"gene":"CTSL","source":"DrugCentral","target":"Cathepsin L1","protein":"Cathepsin L1"},{"gene":"CTSA","source":"DrugCentral","target":"Lysosomal protective protein","protein":"Lysosomal protective protein"},{"gene":"CTSF","source":"DrugCentral","target":"Cathepsin F","protein":"Cathepsin F"},{"gene":"CTSB","source":"DrugCentral","target":"Cathepsin B","protein":"Cathepsin B"},{"gene":"ELANE","source":"DrugCentral","target":"Neutrophil elastase","protein":"Neutrophil elastase"}],"moaClass":"Cytochrome P450 3A4 Inhibitors","modality":"Small Molecule","drugClass":"Hepatitis C Virus NS3/4A Protease Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Victrelis (BOCEPREVIR) is a competitive inhibitor of the NS3/4A protease enzyme, which is a critical component of the Hepatitis C virus replication complex. By binding to the active site of the enzyme, Victrelis prevents the virus from replicating and ultimately leads to the clearance of the virus from the body."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Boceprevir","title":"Boceprevir","extract":"Boceprevir is a protease inhibitor used to treat hepatitis caused by hepatitis C virus (HCV) genotype 1. It binds to the HCV nonstructural protein 3 active site."},"commercial":{"launchDate":"2011","_launchSource":"DrugCentral (FDA 2011-05-13, MERCK SHARP DOHME)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4172","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BOCEPREVIR","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BOCEPREVIR","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Boceprevir","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T09:01:23.897061","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:43:06.990600+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ribavirin","drugSlug":"ribavirin","fdaApproval":"1985-12-31","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"telaprevir","drugSlug":"telaprevir","fdaApproval":"2011-05-23","patentExpiry":"May 30, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"simeprevir","drugSlug":"simeprevir","fdaApproval":"2013-11-22","patentExpiry":"Sep 5, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"daclatasvir","drugSlug":"daclatasvir","fdaApproval":"2015-07-24","patentExpiry":"Jun 13, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sofosbuvir","drugSlug":"sofosbuvir","fdaApproval":"2013-12-06","patentExpiry":"Sep 26, 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C","source":"DrugCentral","snomedId":128302006,"regulator":"FDA","usPrevalence":2400000,"globalPrevalence":58000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2024"}],"offLabel":[],"pipeline":[]},"drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"ribavirin","brandName":"ribavirin","genericName":"ribavirin","approvalYear":"1985","relationship":"same-class"},{"drugId":"telaprevir","brandName":"telaprevir","genericName":"telaprevir","approvalYear":"2011","relationship":"same-class"},{"drugId":"simeprevir","brandName":"simeprevir","genericName":"simeprevir","approvalYear":"2013","relationship":"same-class"},{"drugId":"daclatasvir","brandName":"daclatasvir","genericName":"daclatasvir","approvalYear":"2015","relationship":"same-class"},{"drugId":"sofosbuvir","brandName":"sofosbuvir","genericName":"sofosbuvir","approvalYear":"2013","relationship":"same-class"},{"drugId":"dasabuvir","brandName":"dasabuvir","genericName":"dasabuvir","approvalYear":"2014","relationship":"same-class"},{"drugId":"elbasvir","brandName":"elbasvir","genericName":"elbasvir","approvalYear":"2016","relationship":"same-class"},{"drugId":"grazoprevir","brandName":"grazoprevir","genericName":"grazoprevir","approvalYear":"2016","relationship":"same-class"},{"drugId":"ledipasvir","brandName":"ledipasvir","genericName":"ledipasvir","approvalYear":"2014","relationship":"same-class"},{"drugId":"ombitasvir","brandName":"ombitasvir","genericName":"ombitasvir","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01718301","phase":"PHASE3","title":"HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin","status":"TERMINATED","sponsor":"Anna Cruceta","startDate":"2013-03-10","conditions":["Hepatitis C","HIV Infections","COINFECTION"],"enrollment":108,"completionDate":"2015-06-30"},{"nctId":"NCT01353911","phase":"PHASE2","title":"Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-06-27","conditions":["Hepatitis C, Chronic"],"enrollment":368,"completionDate":"2015-03-10"},{"nctId":"NCT01949077","phase":"","title":"Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.","status":"WITHDRAWN","sponsor":"University of North Carolina, Chapel Hill","startDate":"2011-12","conditions":["Hepatitis C"],"enrollment":0,"completionDate":"2016-01"},{"nctId":"NCT02333292","phase":"","title":"Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions","status":"COMPLETED","sponsor":"Valme University Hospital","startDate":"2014-12","conditions":["Chronic Hepatitis C Infection"],"enrollment":1128,"completionDate":"2017-06-30"},{"nctId":"NCT01482767","phase":"PHASE3","title":"Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2012-04","conditions":["HIV Infections","Hepatitis C"],"enrollment":262,"completionDate":"2015-04"},{"nctId":"NCT00910624","phase":"PHASE3","title":"Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-06-22","conditions":["Hepatitis C, 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Dohme LLC","startDate":"2013-01-28","conditions":["Chronic Hepatitis C"],"enrollment":0,"completionDate":"2021-08-18"},{"nctId":"NCT01288417","phase":"PHASE1","title":"Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2011-08","conditions":["HIV Infections","HCV Infections"],"enrollment":24,"completionDate":"2011-12"},{"nctId":"NCT01470690","phase":"PHASE1","title":"Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2011-10","conditions":["HCV Infections","Gastric Acid-related Disorders"],"enrollment":24,"completionDate":"2012-01"},{"nctId":"NCT01821625","phase":"PHASE2,PHASE3","title":"Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C","status":"TERMINATED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2013-04","conditions":["Thrombocytopenia","Hepatitis C"],"enrollment":7,"completionDate":"2016-04"},{"nctId":"NCT01499498","phase":"PHASE1","title":"The Boceprevir and Sildenafil Pharmacokinetics Study","status":"COMPLETED","sponsor":"Imperial College London","startDate":"2012-12","conditions":["Hepatitis C"],"enrollment":13,"completionDate":"2014-05"},{"nctId":"NCT01390844","phase":"PHASE3","title":"Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-10-21","conditions":["Hepatitis C, Chronic"],"enrollment":282,"completionDate":"2015-06-19"},{"nctId":"NCT01544920","phase":"PHASE3","title":"Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme 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Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-02-06","conditions":["Hepatitis C"],"enrollment":58,"completionDate":"2015-11-17"},{"nctId":"NCT01945294","phase":"PHASE3","title":"Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-10-10","conditions":["Hepatitis C, Chronic"],"enrollment":257,"completionDate":"2015-11-04"},{"nctId":"NCT02758509","phase":"","title":"Impact of Antiviral Therapy on Gastroesophageal Varices.","status":"COMPLETED","sponsor":"Parc de Salut Mar","startDate":"2010-01-01","conditions":["Chronic Hepatitis C","Cirrhosis"],"enrollment":237,"completionDate":"2017-10-15"},{"nctId":"NCT02060058","phase":"PHASE3","title":"Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy","status":"COMPLETED","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","startDate":"2013-11","conditions":["Hepatitis C, Chronic"],"enrollment":12,"completionDate":"2016-09"},{"nctId":"NCT01627717","phase":"PHASE1","title":"The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers","status":"COMPLETED","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","startDate":"2012-06","conditions":["Healthy"],"enrollment":11,"completionDate":"2014-02"},{"nctId":"NCT01657552","phase":"PHASE1","title":"Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-08-01","conditions":["Thrombocytopaenia"],"enrollment":56,"completionDate":"2012-10-26"},{"nctId":"NCT01396005","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-09","conditions":["Hepatitis C Virus"],"enrollment":21,"completionDate":"2011-12"},{"nctId":"NCT00959699","phase":"PHASE2","title":"A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-11","conditions":["HIV Infections","Hepatitis C","HCV Infection"],"enrollment":99,"completionDate":"2012-10"},{"nctId":"NCT00708500","phase":"PHASE3","title":"Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-08","conditions":["Hepatitis C, 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