{"id":"lamiduvine-epivir","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Zidovudine","interaction":"Increased risk of hematologic toxicity"},{"drug":"Ribavirin","interaction":"Reduced lamivudine levels"}],"commonSideEffects":[{"effect":"Headache","drugRate":"20%","severity":"Mild"},{"effect":"Nausea","drugRate":"15%","severity":"Mild"},{"effect":"Fatigue","drugRate":"10%","severity":"Mild"},{"effect":"Dizziness","drugRate":"5%","severity":"Mild"},{"effect":"Insomnia","drugRate":"3%","severity":"Mild"}],"contraindications":["Hypersensitivity to lamivudine or any component of the formulation"],"specialPopulations":{"lactation":"Use with caution; lamivudine is excreted in human milk","renalImpairment":"Dose adjustment may be required","hepaticImpairment":"No dose adjustment necessary","pregnancyCategory":"B"}},"trials":[],"_chembl":{"chemblId":"CHEMBL141","moleculeType":"Small molecule","molecularWeight":"229.26"},"aliases":[],"patents":[{"number":"US5446054A","issueDate":"1995-08-29","expirationDate":"2015-08-29"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1995","type":"Approval","milestone":"First approval outside the US","regulator":"European Medicines Agency"},{"date":"1996","type":"Approval","milestone":"First approval in the US","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Lamiduvine, also known as Epivir, is an antiretroviral medication primarily used in the treatment of HIV infection. It is a nucleoside reverse transcriptase inhibitor (NRTI) that works by blocking the enzyme reverse transcriptase, which is essential for viral replication. The drug is often used in combination with other antiretrovirals to enhance its effectiveness and reduce the risk of resistance. Despite its efficacy, Lamiduvine has several side effects, including headache, nausea, and fatigue. The drug is not approved by the FDA, and its use is primarily in clinical settings or under specific guidelines.","ecosystem":[],"mechanism":{"target":"HIV reverse transcriptase","novelty":"Lamiduvine was one of the earlier NRTIs developed and has been a cornerstone in HIV therapy since its introduction.","modality":"Small molecule","drugClass":"Nucleoside Reverse Transcriptase Inhibitor (NRTI)","explanation":"Lamiduvine is a nucleoside analog that is phosphorylated intracellularly to its active triphosphate form. This active form competes with natural deoxynucleotides for incorporation into the growing viral DNA chain, leading to chain termination and inhibition of viral replication.","oneSentence":"Lamiduvine inhibits the HIV reverse transcriptase enzyme, preventing viral RNA from being converted into DNA, thus halting viral replication.","technicalDetail":"The active metabolite of Lamiduvine, lamivudine triphosphate, binds to the active site of HIV reverse transcriptase and acts as a competitive inhibitor, causing premature termination of the viral DNA chain."},"_scrapedAt":"2026-03-27T23:51:31.305Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"Not available","annualCostUS":"Not available","currentRevenue":"Not available","patientPopulation":"HIV-infected individuals","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Tenofovir Disoproxil Fumarate (Viread)","Emtricitabine (Emtriva)","Abacavir (Ziagen)"],"indications":{"approved":["HIV infection"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00885482","phase":"PHASE4","title":"Atazanavir and Lamivudine for Treatment Simplification","status":"COMPLETED","sponsor":"Catholic University of the Sacred Heart","startDate":"2009-05","conditions":"HIV Infections","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[{"company":"Teva Pharmaceuticals","filingDate":"2014-01-01"},{"company":"Mylan Pharmaceuticals","filingDate":"2014-02-01"}],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Lamiduvine (Epivir)","genericName":"Lamiduvine (Epivir)","companyName":"Catholic University of the Sacred Heart","companyId":"catholic-university-of-the-sacred-heart","modality":"Small molecule","firstApprovalDate":"Not available","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}