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...