{"id":"dcv-asv-bms-791325","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DCV (daclatasvir) inhibits the NS5A protein, ASV (asunaprevir) inhibits the NS3/4A serine protease, and BMS-791325 inhibits the NS5B RNA-dependent RNA polymerase. Together, these three agents target multiple steps of the hepatitis C viral lifecycle, preventing viral replication and clearance of infection. This pan-genotypic combination was designed to achieve high cure rates across different HCV genotypes with a short treatment duration.","oneSentence":"This is a three-drug combination of direct-acting antivirals (DCV, ASV, and BMS-791325) that inhibit hepatitis C virus NS5A, NS3 protease, and NS5B polymerase respectively to block viral replication.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:48.140Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus infection (genotype 1-6)"}]},"trialDetails":[{"nctId":"NCT02170727","phase":"PHASE3","title":"A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-06-26","conditions":"Hepatitis C Virus","enrollment":199},{"nctId":"NCT02175966","phase":"PHASE2","title":"Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-07-28","conditions":"Hepatitis C","enrollment":35},{"nctId":"NCT02124044","phase":"PHASE2","title":"Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2014-02","conditions":"HIV-HCV","enrollment":30},{"nctId":"NCT01455090","phase":"PHASE2","title":"Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2011-11-30","conditions":"Chronic Hepatitis C","enrollment":320},{"nctId":"NCT02098616","phase":"NA","title":"Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus","status":"COMPLETED","sponsor":"Timothy Morgan, MD","startDate":"2014-07","conditions":"Hepatitis C","enrollment":25},{"nctId":"NCT02309450","phase":"PHASE2","title":"Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen","status":"WITHDRAWN","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2014-12","conditions":"Hepatitis C Virus Genotype 4 Infection","enrollment":""},{"nctId":"NCT01979939","phase":"PHASE3","title":"UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2013-12","conditions":"Hepatitis C","enrollment":416},{"nctId":"NCT01973049","phase":"PHASE3","title":"UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2013-12","conditions":"Hepatitis C","enrollment":202},{"nctId":"NCT02123654","phase":"PHASE3","title":"UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-04","conditions":"Hepatitis C Virus Infection","enrollment":297},{"nctId":"NCT02175602","phase":"PHASE1","title":"Study of Drug Combination on Pharmacokinetics in Healthy Volunteers","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-06","conditions":"Hepatitis C Infection","enrollment":41},{"nctId":"NCT02095860","phase":"PHASE1","title":"Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-04","conditions":"Hepatitis C","enrollment":24},{"nctId":"NCT02103569","phase":"PHASE1","title":"Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-04","conditions":"Hepatitis C","enrollment":20},{"nctId":"NCT02104843","phase":"PHASE1","title":"Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-04","conditions":"Hepatitis C","enrollment":18},{"nctId":"NCT02108639","phase":"PHASE1","title":"To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-04","conditions":"Hepatitis C","enrollment":41},{"nctId":"NCT02045966","phase":"PHASE1","title":"Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-02","conditions":"Hepatitis C","enrollment":16},{"nctId":"NCT02045693","phase":"PHASE1","title":"Drug Interaction & Methadone & Buprenorphine","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-02","conditions":"Hepatitis C","enrollment":32}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325"],"phase":"phase_3","status":"active","brandName":"DCV/ASV/BMS-791325","genericName":"DCV/ASV/BMS-791325","companyName":"Bristol-Myers Squibb","companyId":"bristol-myers-squibb","modality":"Small molecule","firstApprovalDate":"","aiSummary":"DCV/ASV/BMS-791325 is a small molecule combination treatment that has been studied in clinical trials for Hepatitis C Infection, Hepatitis C Virus Genotype 4 Infection, and Hepatitis C. This combination treatment has been investigated in a study on its pharmacokinetic effects in healthy volunteers, specifically in relation to the selective serotonin reuptake inhibitors escitalopram and sertraline.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}