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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02607930 | Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 631 | — | — | Nov 13, 2015 | Jul 2, 2021 | Mar 2, 2022 | 121 | United States, Belgium +8 |
| NCT02603120 | Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed | PHASE3 | COMPLETED | 567 | — | — | Nov 11, 2015 | Oct 23, 2019 | Nov 12, 2020 | 94 | United States, Australia +8 |
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.
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 + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks. |
| ABC/DTG/3TC | ACTIVE_COMPARATOR | ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks. |
| Open-label Phase B/F/TAF to 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 ABC/DTG/3TC to 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 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. |
| Blinded Phase: B/F/TAF | EXPERIMENTAL | B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks |
| Blinded Phase: ABC/DTG/3TC | ACTIVE_COMPARATOR | ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks |
| Open-Label Phase | EXPERIMENTAL | At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| ABC/DTG/3TC | DRUG | 600/50/300 milligrams (mg) tablets administered orally, once daily |
| B/F/TAF | DRUG | 50/200/25 mg tablets administered orally, once daily, without regard to food |
| ABC/DTG/3TC 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...