{"id":"sofosbuvir-ledipasvir-24w","safety":{"commonSideEffects":[{"rate":"15-20","effect":"Headache"},{"rate":"10-15","effect":"Fatigue"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Sofosbuvir inhibits the HCV NS5B RNA-dependent RNA polymerase, preventing viral RNA synthesis. Ledipasvir inhibits the HCV NS5A protein, which is essential for viral replication and assembly. Together, they provide direct-acting antiviral activity against hepatitis C virus across multiple genotypes.","oneSentence":"Sofosbuvir/Ledipasvir is a fixed-dose combination of a nucleotide polymerase inhibitor and a non-structural protein 5A inhibitor that blocks hepatitis C virus replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:35:23.535Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6)"},{"name":"Hepatitis C virus infection in treatment-naïve and treatment-experienced patients"}]},"trialDetails":[{"nctId":"NCT03061032","phase":"PHASE3","title":"Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients","status":"UNKNOWN","sponsor":"Iran Hepatitis Network","startDate":"2017-03","conditions":"Hepatitis C","enrollment":200}],"_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":"phase_3","status":"active","brandName":"Sofosbuvir/Ledipasvir 24W","genericName":"Sofosbuvir/Ledipasvir 24W","companyName":"Iran Hepatitis Network","companyId":"iran-hepatitis-network","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sofosbuvir/Ledipasvir 24W is a treatment for Hepatitis C virus infection. It works by inhibiting the nonstructural protein 5A, a key enzyme in the virus's replication process, through a small molecule mechanism.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}