Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
B/F/TAF · 7 trials · 3 indications
The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. Percentages were rounded-off.
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.
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.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Cmax is defined as the maximum observed concentration of drug.
Tmax is defined as the time (observed time point) of Cmax.
Cmin is defined as the minimum observed concentration of drug.
C24h is defined as the concentration of drug at time 24 hours.
t1/2 is defined as the terminal elimination half-life.
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
| Arm | Type | Description |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | Participants will receive B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. |
| Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF | ACTIVE_COMPARATOR | Participants will stay on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. |
| Blinded Phase: B/F/TAF | EXPERIMENTAL | Participants who are HIV-1 and HBV co-infected and treatment-naïve will receive Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet in addition to placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet for 96 weeks. |
| Blinded Phase: DTG+F/TDF | ACTIVE_COMPARATOR | Participants who are HIV-1 and HBV co-infected and treatment-naïve will receive DTG and FDC F/TDF in addition to PTM B/F/TAF for 96 weeks. |
| Open-label Extension Phase: B/F/TAF from B/F/TAF | EXPERIMENTAL | After Week 96, 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 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 48 weeks, or 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 Extension Phase: B/F/TAF from DTG+F/TDF | EXPERIMENTAL | After Week 96, 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 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 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| DTG + F/TAF | ACTIVE_COMPARATOR | DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks. |
| Open-label Phase B/F/TAF from B/F/TAF | EXPERIMENTAL | Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. |
| Open-label Phase B/F/TAF from DTG + F/TAF | EXPERIMENTAL | Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. |
| Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) | EXPERIMENTAL | * Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48. |
| Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) | EXPERIMENTAL | * Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48. |
| Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | EXPERIMENTAL | * Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48. * Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48. |
| Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | EXPERIMENTAL | Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2. Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48. |
| Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) | EXPERIMENTAL | Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48. |
| Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) | EXPERIMENTAL | Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48. |
| Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) | EXPERIMENTAL | Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48. |
| Open-Label Extension | EXPERIMENTAL | Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program. |
| Cohort 1: Group A of B/F/TAF | EXPERIMENTAL | Full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B. Neonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
| Cohort 1: Group B of B/F/TAF | EXPERIMENTAL | Once enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A. Participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
| Neonates | NO_INTERVENTION | Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug. |
| Name | Type | Description |
|---|---|---|
| B/F/TAF | DRUG | 50/200/25 mg FDC tablets administered orally once daily without regard to food |
| NRTIs | DRUG | The following NRTIs will be administered as prescribed until Week 24 without regard to food: abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT) |
| Third Agent | DRUG | Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. : * Non-nucleoside reverse transcriptase inhibitors (NNRTIs) * delavirdine (DLV) * efavirenz (EFV) * nevirapine (NVP) * rilpivirine (RPV) * doravirine (DOR) * Integrase inhibitors * dolutegravir (DTG) * elvitegravir (EVG) * raltegravir (RAL) * Protease inhibitors (PIs) * atazanavir (ATV) * darunavir (DRV) * lopinavir (LPV) * nelfinavir NFV) * saquinavir (SQV) * tipranavir (TPV) * Chemokine co-recptor 5 (CCR5) antagonist --maraviroc (MVC) |
| Placebo to match DTG | DRUG | Tablet administered orally once daily, without regard to food |
| Placebo to match F/TDF | DRUG | Tablet administered orally once daily, without regard to food |
| DTG | DRUG | 50 mg tablet administered orally once daily, without regard to food |
| F/TDF | DRUG | 200/300 mg tablet administered orally once daily, without regard to food |
| Placebo to match B/F/TAF | DRUG | Tablet administered orally once daily, without regard to food |
| F/TAF | DRUG | 200/25 mg FDC tablet(s) administered orally once daily |
| DTG Placebo | DRUG | Tablet(s) administered orally once daily |
| F/TAF Placebo | DRUG | Tablet(s) administered orally once daily |
| B/F/TAF Placebo | DRUG | Tablet(s) administered orally once daily |
| B/F/TAF (Adult Strength) | DRUG | 50/200/25 mg FDC tablets administered orally once daily without regard to food. |
| B/F/TAF (Low Dose) | DRUG | 30/120/15 mg FDC tablets administered orally once daily without regard to food. |
| B/F/TAF (TOS) | DRUG | 2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily. |
Key Inclusion Criteria: * Self-describes as Black, African American, or mixed race, including Black * Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months * Allowed 3rd agents include any FDA-approved INSTI,...
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B/F/TAF is a fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide used for the treatment of HIV-1 infection, including in adults who are virologically suppressed, and for HIV-1/HBV co-infection. It is also being studied in pregnant women and newborns exposed to HIV.
B/F/TAF combines bictegravir, an integrase strand transfer inhibitor, with emtricitabine and tenofovir alafenamide, both nucleoside reverse transcriptase inhibitors. This combination targets multiple steps in the HIV-1 replication cycle to suppress viral load.
B/F/TAF is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is responsible for the clinical development and manufacturing of this fixed-dose combination therapy for HIV-1 infection.
B/F/TAF is in Phase 3 clinical development for HIV-1 infection and HIV-1/HBV co-infection. It is an investigational drug and has not been approved by regulatory authorities. Additional Phase 1 studies are evaluating its use in pregnant women and newborns.
B/F/TAF has been studied in several clinical trials. NCT03110380 evaluated switching to B/F/TAF in virologically suppressed HIV-1 infected adults. NCT03547908 compared B/F/TAF to dolutegravir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1/HBV co-infected adults. NCT03960645 studied pharmacokinetics in pregnant women, and NCT07055451 is evaluating B/F/TAF in newborns exposed to HIV.
Yes, B/F/TAF is also known as B/F/TAF (Adult Strength). This alternative name distinguishes the adult formulation from pediatric or other strength versions of the same fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide.