{"id":"cab-oli","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_fixedAt":"2026-03-30T13:20:37.294623","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cabotegravir is an integrase strand transfer inhibitor (INSTI) that prevents HIV from integrating its genetic material into host cell DNA. Bictegravir is a nucleotide reverse transcriptase inhibitor (NtRTI) that blocks the enzyme responsible for converting viral RNA to DNA. Together, these agents provide dual-mechanism antiretroviral activity in a long-acting formulation administered via intramuscular injection.","oneSentence":"CAB OLI is a long-acting injectable combination of cabotegravir and bictegravir that inhibits HIV integrase and reverse transcriptase to suppress viral replication.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:44.014Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-naive and treatment-experienced adults (long-acting injectable maintenance therapy)"}]},"_fixedFields":["pubmed(4)"],"trialDetails":[{"nctId":"NCT05514509","phase":"PHASE4","title":"A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2022-10-28","conditions":"HIV Infections","enrollment":370},{"nctId":"NCT05546242","phase":"PHASE3","title":"Improving HIV-1 Control in Africa with Long Acting Antiretrovirals","status":"ACTIVE_NOT_RECRUITING","sponsor":"MRC/UVRI and LSHTM Uganda Research Unit","startDate":"2022-12-08","conditions":"HIV-1-infection","enrollment":540},{"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},{"nctId":"NCT04399551","phase":"PHASE3","title":"A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2020-09-28","conditions":"HIV Infections","enrollment":437}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"recentPublications":[{"date":"2025 Dec","pmid":"41110828","title":"Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR study.","journal":"Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy"},{"date":"2025 Jul 2","pmid":"40470947","title":"Influence of patient characteristics and oral lead-in on long-acting cabotegravir and rilpivirine pharmacokinetics and outcomes in people with HIV: a real-world study.","journal":"Antimicrobial agents and chemotherapy"},{"date":"2022 Nov 26","pmid":"36435793","title":"Realizing the promise of long-acting antiretroviral treatment strategies for individuals with HIV and adherence challenges: an illustrative case series.","journal":"AIDS research and therapy"},{"date":"2021 Aug","pmid":"34130357","title":"Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic.","journal":"Pharmacotherapy"}],"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":"CAB OLI","genericName":"CAB OLI","companyName":"ViiV Healthcare","companyId":"viiv-healthcare","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CAB OLI is a long-acting injectable combination of cabotegravir and bictegravir that inhibits HIV integrase and reverse transcriptase to suppress viral replication. Used for HIV-1 infection in treatment-naive and treatment-experienced adults (long-acting injectable maintenance therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}