{"id":"peg-ifn-sa-rbv","safety":{"commonSideEffects":[{"rate":"50-80","effect":"Flu-like symptoms (fever, fatigue, myalgia)"},{"rate":"20-50","effect":"Hematologic toxicity (anemia, thrombocytopenia, leukopenia)"},{"rate":"10-30","effect":"Psychiatric effects (depression, anxiety)"},{"rate":"5-15","effect":"Thyroid dysfunction"},{"rate":"10-20","effect":"Injection site reactions"},{"rate":null,"effect":"Teratogenicity (ribavirin)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pegylated interferon-alpha (PEG-IFN-SA) enhances the half-life and immunogenicity of interferon-alpha, which activates natural killer cells and macrophages to combat viral infections. Ribavirin (RBV) is a nucleoside analog that inhibits viral RNA synthesis. Together, they work synergistically to suppress viral replication and promote immune clearance of infected cells.","oneSentence":"PEG-IFN-SA is a pegylated interferon-alpha combined with ribavirin to stimulate antiviral immune responses and inhibit viral replication.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:26:09.609Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus (HCV) infection"}]},"trialDetails":[{"nctId":"NCT01605513","phase":"PHASE1, PHASE2","title":"Safety Study of Recombinant Interferon Variant(PEG-IFN-SA) to Treat HCV Disease","status":"COMPLETED","sponsor":"The First Hospital of Jilin University","startDate":"2011-06","conditions":"Hepatitis C Virus","enrollment":80},{"nctId":"NCT01903278","phase":"PHASE3","title":"Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C","status":"COMPLETED","sponsor":"Beijing Kawin Technology Share-Holding Co., Ltd.","startDate":"2013-06","conditions":"Chronic Hepatitis c","enrollment":719},{"nctId":"NCT01908335","phase":"PHASE2","title":"A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C","status":"COMPLETED","sponsor":"Beijing Kawin Technology Share-Holding Co., Ltd.","startDate":"2012-10","conditions":"Chronic Hepatitis C","enrollment":212}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"PEG-IFN-SA /RBV","genericName":"PEG-IFN-SA /RBV","companyName":"Beijing Kawin Technology Share-Holding Co., Ltd.","companyId":"beijing-kawin-technology-share-holding-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PEG-IFN-SA is a pegylated interferon-alpha combined with ribavirin to stimulate antiviral immune responses and inhibit viral replication. Used for Chronic hepatitis C virus (HCV) infection.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}