{"id":"viekira-pak-ribavirin","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Fatigue"},{"rate":"15-25","effect":"Headache"},{"rate":"10-20","effect":"Nausea"},{"rate":"10-15","effect":"Pruritus"},{"rate":"10-20","effect":"Anemia (when ribavirin added)"},{"rate":"5-15","effect":"Elevated bilirubin"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ombitasvir targets the NS5A protein essential for HCV RNA replication and virion assembly. Paritaprevir inhibits the NS3/4A serine protease required for viral polyprotein processing. Ritonavir acts as a pharmacokinetic booster to increase paritaprevir levels. Ribavirin, when added, is a nucleoside analog that increases mutation rates in the viral genome. Together, these agents prevent hepatitis C virus from replicating and spreading.","oneSentence":"Viekira Pak is a fixed-dose combination of three direct-acting antivirals (ombitasvir, paritaprevir, and ritonavir) that inhibit hepatitis C virus NS5A and NS3/4A proteases to block viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:15:19.902Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus (HCV) genotype 1 infection, with or without cirrhosis"},{"name":"HCV genotype 4 infection (in combination with ribavirin)"}]},"trialDetails":[{"nctId":"NCT02634008","phase":"PHASE3","title":"Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P","status":"COMPLETED","sponsor":"Kirby Institute","startDate":"2016-06","conditions":"Hepatitis C, Acute","enrollment":83},{"nctId":"NCT02786537","phase":"PHASE4","title":"Study of Oral Treatments for Hepatitis C","status":"COMPLETED","sponsor":"University of Florida","startDate":"2016-06","conditions":"Chronic Hepatitis C","enrollment":1275},{"nctId":"NCT02946034","phase":"PHASE4","title":"Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2017-02-01","conditions":"Chronic Kidney Disease, Chronic Hepatitis C","enrollment":10},{"nctId":"NCT02555943","phase":"PHASE2, PHASE3","title":"DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)","status":"COMPLETED","sponsor":"Humanity and Health Research Centre","startDate":"2015-02","conditions":"Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation","enrollment":23},{"nctId":"NCT01715415","phase":"PHASE3","title":"A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2012-11","conditions":"Chronic Hepatitis C 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Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)","status":"COMPLETED","sponsor":"AbbVie","startDate":"2013-11","conditions":"Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis","enrollment":89},{"nctId":"NCT01704755","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2012-10","conditions":"Chronic Hepatitis C Infection, Compensated Cirrhosis","enrollment":381},{"nctId":"NCT01833533","phase":"PHASE3","title":"A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection","status":"COMPLETED","sponsor":"AbbVie","startDate":"2013-03","conditions":"Chronic Hepatitis C 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Infection","enrollment":148},{"nctId":"NCT01854697","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before","status":"COMPLETED","sponsor":"AbbVie","startDate":"2013-03","conditions":"Chronic Hepatitis C Infection","enrollment":311},{"nctId":"NCT01911845","phase":"PHASE2","title":"An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine","status":"COMPLETED","sponsor":"AbbVie","startDate":"2013-04","conditions":"Chronic Hepatitis C Infection, Chronic Hepatitis C","enrollment":38},{"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},{"nctId":"NCT02356562","phase":"PHASE2","title":"A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection","status":"COMPLETED","sponsor":"AbbVie","startDate":"2015-02-03","conditions":"Chronic Hepatitis C Infection","enrollment":29},{"nctId":"NCT02504099","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma","status":"TERMINATED","sponsor":"AbbVie","startDate":"2015-07","conditions":"Chronic Hepatitis C Infection","enrollment":3},{"nctId":"NCT02207088","phase":"PHASE3","title":"Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease","status":"COMPLETED","sponsor":"AbbVie","startDate":"2014-09-23","conditions":"Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis","enrollment":68},{"nctId":"NCT01782495","phase":"PHASE2","title":"A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients","status":"COMPLETED","sponsor":"AbbVie","startDate":"2013-02-25","conditions":"Chronic Hepatitis C Infection","enrollment":129},{"nctId":"NCT02442284","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection","status":"COMPLETED","sponsor":"AbbVie","startDate":"2015-05-13","conditions":"Chronic Hepatitis C, Cirrhosis, Hepatitis C Virus","enrollment":99},{"nctId":"NCT02442271","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either 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1)","enrollment":10}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":13,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["AbbVie 3D regimen"],"phase":"marketed","status":"active","brandName":"Viekira Pak ± ribavirin","genericName":"Viekira Pak ± ribavirin","companyName":"Massachusetts General Hospital","companyId":"massachusetts-general-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Viekira Pak is a fixed-dose combination of three direct-acting antivirals (ombitasvir, paritaprevir, and ritonavir) that inhibit hepatitis C virus NS5A and NS3/4A proteases to block viral replication. Used for Chronic hepatitis C virus (HCV) genotype 1 infection, with or without cirrhosis, HCV genotype 4 infection (in combination with ribavirin).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}