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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02607956 | Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 657 | — | — | Nov 11, 2015 | Jul 5, 2021 | Mar 7, 2022 | 125 | United States, Australia +9 |
The percentage of participants achieving 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 | B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. |
| DTG + F/TAF | ACTIVE_COMPARATOR | DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks. |
| Open-label Phase B/F/TAF from B/F/TAF | EXPERIMENTAL | After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| Open-label Phase B/F/TAF from DTG + F/TAF | EXPERIMENTAL | After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| DTG | DRUG | 50 mg tablets administered orally, once daily |
| F/TAF | DRUG | 200/25 mg tablets administered orally, once daily |
| B/F/TAF | DRUG | 50/200/25 milligrams (mg) FDC tablets administered orally, once daily |
| DTG Placebo | DRUG | Tablets administered orally, once daily |
| F/TAF Placebo | DRUG | Tablets administered orally, once daily |
| B/F/TAF Placebo | DRUG | Tablets administered orally, once daily |
Key Inclusion Criteria: * Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening * Plasma HIV-1 ribon...