Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DRV/COBI · 2 trials · 2 indications
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
The percentage of participants that is able to swallow the medication fully versus partially or not at all, based on the questionnaire for the observer will be reported.
| Arm | Type | Description |
|---|---|---|
| DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC | EXPERIMENTAL | Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit. |
| Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC) | EXPERIMENTAL | Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1. |
| Name | Type | Description |
|---|---|---|
| DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC | DRUG | Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit. |
| DRV/COBI FDC | DRUG | DRV/COBI FDC tablet dispersed in water will be administered orally. |
Inclusion Criteria: * Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) vira...
DRV/COBI is a fixed-dose combination of darunavir and cobicistat developed by Johnson & Johnson for the treatment of HIV-1 infection. It combines the protease inhibitor darunavir with cobicistat, a pharmacokinetic booster, in a single tablet. The regimen is also studied as part of a four-drug fixed-dose combination with emtricitabine and tenofovir alafenamide.
DRV/COBI is used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. It is a fixed-dose combination of darunavir and cobicistat, and it has also been evaluated as part of a once-daily four-drug fixed-dose combination regimen including emtricitabine and tenofovir alafenamide for newly diagnosed, antiretroviral treatment-naive adults with HIV-1.
DRV/COBI is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is responsible for the darunavir and cobicistat fixed-dose combination and for the related four-drug fixed-dose combination regimen containing darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
DRV/COBI has been studied in Phase 3 clinical development. A Phase 3 trial evaluated the efficacy and safety of a once-daily fixed-dose combination regimen containing darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in newly diagnosed, antiretroviral treatment-naive adults with HIV-1. The drug is investigational and is not described as approved.
DRV/COBI has been evaluated in completed clinical trials including NCT05197075, a Phase 1 study assessing acceptability of the darunavir/cobicistat fixed-dose combination tablet in HIV-1 infected children, and NCT03227861, a Phase 3 study of a once-daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide fixed-dose combination in newly diagnosed, treatment-naive adults with HIV-1.