{"id":"abc-dtg-3tc-immediate-release-tablets","safety":{"commonSideEffects":[{"rate":"5-8","effect":"Hypersensitivity reaction (abacavir)"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Headache"},{"rate":"3-7","effect":"Insomnia"},{"rate":"5-10","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL191973","moleculeType":"Small molecule","molecularWeight":"437.40"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Abacavir (ABC) and lamivudine (3TC) are nucleoside reverse transcriptase inhibitors (NRTIs) that block HIV reverse transcriptase, while dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI) that prevents viral DNA integration into the host genome. Together, they provide complementary mechanisms to suppress HIV replication and reduce viral load.","oneSentence":"A fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:58:31.527Z","_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 (age and weight-dependent formulations)"}]},"trialDetails":[{"nctId":"NCT03016533","phase":"PHASE3","title":"Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2017-06-06","conditions":"HIV Infections","enrollment":100},{"nctId":"NCT03760458","phase":"PHASE1, PHASE2","title":"The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-09-09","conditions":"HIV Infections","enrollment":57},{"nctId":"NCT02738931","phase":"PHASE1","title":"Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2016-05","conditions":"Infection, Human Immunodeficiency Virus","enrollment":30}],"_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":"ABC/DTG/3TC immediate release tablets","genericName":"ABC/DTG/3TC immediate release tablets","companyName":"ViiV Healthcare","companyId":"viiv-healthcare","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}