{"id":"biktarvy-tablets-bik","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"3-8","effect":"Fatigue"},{"rate":"3-7","effect":"Abdominal pain"},{"rate":"2-5","effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BIKTARVY combines bictegravir (an integrase strand transfer inhibitor), tenofovir alafenamide (a nucleotide reverse transcriptase inhibitor), and emtricitabine (a nucleoside reverse transcriptase inhibitor). Together, these agents target multiple steps of the HIV replication cycle, preventing viral DNA synthesis and integration into the host genome, thereby suppressing viral load and preserving immune function.","oneSentence":"BIKTARVY is a fixed-dose combination of three antiretroviral agents that inhibit HIV replication through complementary mechanisms: reverse transcriptase inhibition, integrase inhibition, and protease inhibition.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:22.066Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-naïve and treatment-experienced adults"},{"name":"HIV-1 infection in adolescents and children (weight-based dosing)"}]},"trialDetails":[{"nctId":"NCT04542070","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2020-11-09","conditions":"HIV Infections","enrollment":687}],"_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":"BIKTARVY Tablets (BIK)","genericName":"BIKTARVY Tablets (BIK)","companyName":"ViiV Healthcare","companyId":"viiv-healthcare","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BIKTARVY is a fixed-dose combination of three antiretroviral agents that inhibit HIV replication through complementary mechanisms: reverse transcriptase inhibition, integrase inhibition, and protease inhibition. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}