{"id":"sofosbuvir-ledipasvir-plus-ribavirin-24w","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Fatigue"},{"rate":"15-25","effect":"Headache"},{"rate":"10-20","effect":"Nausea"},{"rate":"10-15","effect":"Anemia (ribavirin-related)"},{"rate":"10-15","effect":"Insomnia"},{"rate":"5-10","effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Sofosbuvir is a nucleotide analog that directly inhibits the hepatitis C virus RNA-dependent RNA polymerase (NS5B), blocking viral replication. Ledipasvir is a non-structural protein 5A (NS5A) inhibitor that prevents viral protein complex formation and RNA replication. Ribavirin is a nucleoside analog that increases mutation rates in the viral genome and enhances immune responses, working synergistically with the direct-acting antivirals.","oneSentence":"Sofosbuvir inhibits HCV NS5B polymerase while ledipasvir inhibits HCV NS5A protein, and ribavirin enhances viral clearance through multiple mechanisms to achieve sustained virologic response in hepatitis C.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:35:24.099Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus infection (genotype 1-6)"},{"name":"Treatment-experienced and treatment-naïve patients with hepatitis C"}]},"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 plus Ribavirin 24W","genericName":"Sofosbuvir/Ledipasvir plus Ribavirin 24W","companyName":"Iran Hepatitis Network","companyId":"iran-hepatitis-network","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sofosbuvir inhibits HCV NS5B polymerase while ledipasvir inhibits HCV NS5A protein, and ribavirin enhances viral clearance through multiple mechanisms to achieve sustained virologic response in hepatitis C. Used for Chronic hepatitis C virus infection (genotype 1-6), Treatment-experienced and treatment-naïve patients with hepatitis C.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}