Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Baseline DRV- containing ARV regimen · 1 trial · 3 indications
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will receive E/C/F/TAF FDC + DRV once daily with food for 48 weeks. Based on safety and efficacy data from Cohort 1 at Week 4, the participants will be randomized into Cohort 2. The participants in Cohort 1 will continue receiving E/C/F/TAF FDC + DRV through 48 weeks. |
| Cohort 2, Treatment Group 1 | EXPERIMENTAL | Participants will be randomized to receive E/C/F/TAF FDC+DRV once daily with food for 48 weeks. |
| Cohort 2, Treatment Group 2 | ACTIVE_COMPARATOR | Participants will be randomized to continue on their baseline DRV-containing ARV regimen for 48 weeks. |
| Name | Type | Description |
|---|---|---|
| E/C/F/TAF | DRUG | 150/150/200/10 mg FDC tablet administered orally once daily |
| DRV | DRUG | 800 mg tablet administered orally once daily |
| Baseline DRV- containing ARV regimen | DRUG | Participants will take their baseline DRV- containing ARV regimen as prescribed. |
Key Inclusion Criteria: * Ability to understand and sign a written informed consent form * History of at least two prior antiretroviral regimens, and history of resistance to at least two different classes of antiretroviral agents * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. Virologicall...
It refers to a stable optimized antiretroviral regimen that contains darunavir (DRV) and is used as the starting comparator regimen in a Phase 3 HIV-1 study. In that trial, treatment-experienced HIV-1 positive adults on a stable DRV-containing regimen were switched to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide plus darunavir.
Gilead Sciences, Inc. (ticker GILD) is the developer associated with this program. The company sponsored the Phase 3 study that evaluated switching from a stable darunavir-containing antiretroviral regimen to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide plus darunavir in treatment-experienced HIV-1 positive adults.
It is in Phase 3 development. The single registered trial, NCT01968551, is a completed Phase 3 open-label study. The regimen is investigational and is not described as FDA approved.
It was evaluated in NCT01968551, a Phase 3 open-label study titled a study to evaluate switching from optimized stable antiretroviral regimens containing darunavir to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed dose combination plus darunavir in treatment-experienced HIV-1 positive adults. The trial enrolled 158 participants across the United States and Canada and is completed.
NCT01968551 was a randomized, active-controlled, open-label Phase 3 study in treatment-experienced HIV-1 positive adults aged 18 years and older. It enrolled 158 participants in the United States and Canada and compared switching from a stable darunavir-containing antiretroviral regimen to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide plus darunavir. The study is completed.