Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02603107 | Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults | PHASE3 | COMPLETED | 578 | — | — | Nov 20, 2015 | Dec 23, 2019 | Dec 29, 2020 | 119 | United States, Australia +9 |
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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 |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Stay on Baseline Regimen (SBR) | EXPERIMENTAL | Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| RTV | DRUG | 100 mg capsule coadministered orally with ATV or DRV once daily with food |
| ATV | DRUG | 300 mg capsule administered orally once daily with food |
| DRV | DRUG | 800 mg tablet administered orally once daily with food |
| COBI | DRUG | 150 mg tablet coadministered orally with ATV or DRV once daily with food |
| ATV/co | DRUG | 300/150 mg FDC tablet administered orally once daily with food |
| DRV/co | DRUG | 800/150 mg FDC tablet administered orally once daily with food |
| FTC/TDF | DRUG | 200/300 mg FDC tablet administered orally once daily without regard to food |
| ABC/3TC | DRUG | 600/300 mg tablet administered orally once daily with or without regard to food |
| B/F/TAF | DRUG | 50/200/25 mg FDC tablet administered orally once daily without regard to food |
Key Inclusion Criteria: * Currently receiving a once daily antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for ≥ 6 months preceding the screening visit * Adequate renal function: * Estimated glomerular filtration rate ≥ 50 mL/min (≥ ...