{"id":"bictegravir-emtricitabine-tenofovir-alafenamide-pill","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Elevated creatinine"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bictegravir is an integrase strand transfer inhibitor (INSTI) that prevents HIV from inserting its genetic material into human chromosomes. Emtricitabine and tenofovir alafenamide are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that block the enzyme responsible for converting viral RNA into DNA. Together, these three agents target multiple steps of the HIV replication cycle.","oneSentence":"This combination pill inhibits HIV reverse transcriptase and integrase to block viral replication and prevent the virus from integrating into host cell DNA.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:28:27.917Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-naïve and treatment-experienced adults"}]},"trialDetails":[{"nctId":"NCT04884139","phase":"PHASE4","title":"DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:","status":"COMPLETED","sponsor":"Fundacion SEIMC-GESIDA","startDate":"2021-07-14","conditions":"HIV-1-infection","enrollment":554},{"nctId":"NCT04442737","phase":"PHASE4","title":"A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2020-07-01","conditions":"HIV-1","enrollment":103},{"nctId":"NCT04585737","phase":"PHASE4","title":"Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF","status":"COMPLETED","sponsor":"Charlotte-Paige Rolle, MD","startDate":"2020-10-05","conditions":"HIV I Infection","enrollment":222},{"nctId":"NCT05592613","phase":"PHASE3","title":"Next Generation Ingestible Sensors for Medication Adherence Measurement","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2023-02-06","conditions":"HIV Infection, Adherence, Medication, Adherence, Treatment","enrollment":15},{"nctId":"NCT03502005","phase":"PHASE4","title":"Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1","status":"COMPLETED","sponsor":"Midland Research Group, Inc.","startDate":"2018-03-01","conditions":"Human Immunodeficiency Virus","enrollment":100},{"nctId":"NCT06465862","phase":"NA","title":"Development of a Silica Microparticle Taggant System to Measure ART Adherence","status":"NOT_YET_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2024-09-15","conditions":"Hiv, Medication Adherence, Compliance, Medication","enrollment":15},{"nctId":"NCT05243602","phase":"PHASE4","title":"BFTAF Elderly Switch Study","status":"COMPLETED","sponsor":"University of Nairobi","startDate":"2022-02-01","conditions":"HIV-1-infection","enrollment":520},{"nctId":"NCT03532425","phase":"PHASE4","title":"B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults","status":"TERMINATED","sponsor":"University of Alberta","startDate":"2018-10-29","conditions":"HIV-1-infection","enrollment":28},{"nctId":"NCT03348163","phase":"PHASE4","title":"(mo)BETTA Trial in Transwomen for Optimization of ART","status":"TERMINATED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2018-06-06","conditions":"HIV Infections","enrollment":26},{"nctId":"NCT03499483","phase":"PHASE4","title":"Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)","status":"COMPLETED","sponsor":"Fenway Community Health","startDate":"2019-01-24","conditions":"HIV Prevention","enrollment":52},{"nctId":"NCT04483674","phase":"PHASE2","title":"Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection","status":"UNKNOWN","sponsor":"Anna Cruceta","startDate":"2020-12-04","conditions":"HIV Primary Infection","enrollment":66}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Biktarvy"],"phase":"marketed","status":"active","brandName":"Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill","genericName":"Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill","companyName":"Charlotte-Paige Rolle, MD","companyId":"charlotte-paige-rolle-md","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination pill inhibits HIV reverse transcriptase and integrase to block viral replication and prevent the virus from integrating into host cell DNA. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}