{"id":"sofosbuvir-and-daclatasvir-for-24-weeks","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Sofosbuvir is a nucleotide analog that acts as a chain terminator of HCV RNA synthesis by inhibiting the NS5B polymerase. Daclatasvir is a non-structural protein 5A (NS5A) inhibitor that disrupts viral replication and assembly. Together, this combination directly targets two essential HCV enzymes, providing potent antiviral activity across multiple HCV genotypes.","oneSentence":"Sofosbuvir inhibits hepatitis C virus (HCV) NS5B RNA polymerase while daclatasvir inhibits NS5A protein, together blocking viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:38:02.062Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus (HCV) infection, treatment-naïve and treatment-experienced patients"}]},"trialDetails":[{"nctId":"NCT04943588","phase":"","title":"Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs","status":"RECRUITING","sponsor":"Queen Mary University of London","startDate":"2021-11-01","conditions":"Hepatitis C, Chronic","enrollment":25000},{"nctId":"NCT03537196","phase":"PHASE4","title":"DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2018-11-13","conditions":"Hepatitis C, Drug Use, Viral Hepatitis C","enrollment":979},{"nctId":"NCT03483987","phase":"NA","title":"Re-treatment of HCV Following DAA Failure","status":"TERMINATED","sponsor":"Sanjay Gandhi Postgraduate Institute of Medical Sciences","startDate":"2018-02-10","conditions":"Chronic Hepatitis C","enrollment":18},{"nctId":"NCT03158857","phase":"","title":"Hepatitis C Treatment Study in Myanmar","status":"WITHDRAWN","sponsor":"Myanmar Oxford Clinical Research Unit","startDate":"2022-01","conditions":"Hepatitis C","enrollment":""},{"nctId":"NCT04211844","phase":"","title":"Metabolic Changes in Chronic HCV Patients Receiving DAAS","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2019-10-01","conditions":"Chronic Hepatitis C","enrollment":100},{"nctId":"NCT03063879","phase":"PHASE4","title":"Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2017-04-01","conditions":"Hepatitis C, Chronic, Chronic Renal Failure","enrollment":95},{"nctId":"NCT03488485","phase":"NA","title":"Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model","status":"UNKNOWN","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2016-06-18","conditions":"Chronic Hepatitis c","enrollment":50000},{"nctId":"NCT02304159","phase":"PHASE4","title":"Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics","status":"COMPLETED","sponsor":"Tarek I. Hassanein, M.D., FACP, FAG, AGAF","startDate":"2015-01","conditions":"Hepatitis C, Cirrhosis","enrollment":39},{"nctId":"NCT03369327","phase":"PHASE3","title":"Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2017-01-01","conditions":"Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus","enrollment":232},{"nctId":"NCT03200184","phase":"PHASE4","title":"Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2016-09-01","conditions":"Hepatitis C","enrollment":1448},{"nctId":"NCT02673489","phase":"PHASE3","title":"A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2016-03-15","conditions":"Hepatitis C","enrollment":106},{"nctId":"NCT02772744","phase":"","title":"Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4","status":"UNKNOWN","sponsor":"Zagazig University","startDate":"2017-11-01","conditions":"Hepatitis C","enrollment":250},{"nctId":"NCT03268317","phase":"","title":"Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2018-01","conditions":"Hepatitis C","enrollment":100},{"nctId":"NCT03133065","phase":"PHASE4","title":"Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2014-09","conditions":"Liver Transplantation","enrollment":89},{"nctId":"NCT02032875","phase":"PHASE3","title":"Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-03","conditions":"Hepatitis C","enrollment":116},{"nctId":"NCT02771405","phase":"PHASE3","title":"Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC","status":"UNKNOWN","sponsor":"National Hepatology & Tropical Medicine Research Institute","startDate":"2016-03","conditions":"Hepatitis C, Chronic, Hepatocellular Carcinoma","enrollment":150}],"_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":[],"phase":"marketed","status":"active","brandName":"Sofosbuvir and Daclatasvir for 24 weeks","genericName":"Sofosbuvir and Daclatasvir for 24 weeks","companyName":"ANRS, Emerging Infectious Diseases","companyId":"anrs-emerging-infectious-diseases","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sofosbuvir and Daclatasvir are small molecule inhibitors of the Nonstructural protein 5A, used to treat Hepatitis C, specifically in a 24-week regimen for patients with cirrhosis and Genotype 3 Hepatitis C infection. This treatment combination has been studied in clinical trials, including NCT02673489, which evaluated the efficacy of Daclatasvir and Sofosbuvir with Ribavirin in this patient population.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}