Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
F/TAF · 3 trials · 3 indications
The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or * Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or * Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
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.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
| Arm | Type | Description |
|---|---|---|
| F/TAF | EXPERIMENTAL | F/TAF+ F/TDF placebo for at least 96 weeks |
| F/TDF | EXPERIMENTAL | F/TDF+ F/TAF placebo for at least 96 weeks |
| Open-label | EXPERIMENTAL | Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment for 96 weeks. |
| Open-Label Extension | EXPERIMENTAL | Participants who remain on study at Open-label Week 96 will have the option to continue on open-label F/TAF treatment in the Open-label extension phase for 408 weeks. |
| F/TAF (Double-Blind) | EXPERIMENTAL | F/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded. |
| ABC/3TC (Double-Blind) | ACTIVE_COMPARATOR | ABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded. |
| Open-Label F/TAF | EXPERIMENTAL | After the unblinding visit, in countries where F/TAF FDC is not commercially available, participants (except in certain countries such as the UK) will be given the option to receive open-label F/TAF (200/10 mg or 200/25 mg) FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country. |
| F/TAF+3rd ARV Agent (Cohort 1) | EXPERIMENTAL | Participants between 12 to \< 18 years of age and ≥ 35 kg in body weight will switch their current 2-NRTI containing regimen to F/TAF (200/25 mg for unboosted 3rd agent and 200/10 mg for boosted 3rd agent) while continuing on their 3rd ARV agent for 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | EXPERIMENTAL | Participants between 6 to \< 12 years of age and ≥ 25 kg in body weight must be on a boosted protease inhibitor (PI) as their 3rd ARV agent and will switch their current 2-NRTI regimen to F/TAF 200/25 mg while continuing on their boosted PI for 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | EXPERIMENTAL | Participants between 2 to \< 12 years of age and between 17 kg to \< 25 kg in body weight must be on a boosted protocol specified 3rd ARV agent and will switch their current 2-NRTI containing regimen to F/TAF 120/15 mg while continuing their 3rd ARV agent for 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 3, Part A) | EXPERIMENTAL | Participants between 2 to \< 6 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 4, Part A) | EXPERIMENTAL | Participants between 1 month to \< 2 years of age will receive F/TAF plus a 3rd ARV agent through 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part B - Group 1) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| F/TAF+3rd ARV Agent (Cohort 2, Part B - Group 2) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 3, Part B) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Cohort 4, Part B) | EXPERIMENTAL | Screening will be initiated for Part B following confirmation of TAF dose in Part A. Approximately 10 additional total participants will be enrolled across all Part B cohorts and will receive F/TAF while continuing their 3rd ARV agent through 48 weeks. |
| FTC/TAF+3rd ARV Agent (Extension Phase) | EXPERIMENTAL | After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) the participant turns 18 and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or, b) F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elects to terminate development of F/TAF in the applicable country. |
| Name | Type | Description |
|---|---|---|
| F/TAF | DRUG | 200/25 mg tablet administered orally once daily |
| F/TDF | DRUG | 200/300 mg tablet administered orally once daily |
| F/TAF Placebo | DRUG | Tablet administered orally once daily |
| F/TDF Placebo | DRUG | Tablet administered orally once daily |
| ABC/3TC | DRUG | 600/300 mg FDC tablets administered orally once daily |
| ABC/3TC Placebo | DRUG | Tablets administered orally once daily |
| 3rd ARV agent | DRUG | An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP). |
| Boosted PIs | DRUG | Allowed boosted PIs: LPV, ATV, DRV. |
Key Inclusion Criteria: * Must be at high risk of sexual acquisition of HIV * HIV-1 negative status * MSM and TGW (male at birth) who have at least one of the following: * condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infecte...
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F/TAF is a fixed-dose combination of emtricitabine and tenofovir alafenamide being developed by Gilead Sciences for the treatment of HIV-1 infection and for pre-exposure prophylaxis (PrEP) of HIV-1 infection. It is an investigational small molecule in clinical development.
F/TAF combines two antiretroviral drugs: emtricitabine, a nucleoside reverse transcriptase inhibitor, and tenofovir alafenamide, a nucleotide reverse transcriptase inhibitor. Both work by inhibiting the HIV reverse transcriptase enzyme, which is essential for viral replication.
F/TAF is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The drug is being studied for HIV-1 treatment and prevention.
F/TAF is in Phase 2 clinical development for HIV-1 infection. It is also being studied in Phase 3 trials for HIV-1 infection and for pre-exposure prophylaxis of HIV-1 infection. It is investigational and not yet approved.
F/TAF has been studied in several trials. NCT02285114 is a completed Phase 2 trial in HIV-1 infected children and adolescents. NCT02469246 is a completed Phase 3 switch study in HIV-1 infected adults. NCT02842086 is an active Phase 3 trial for PrEP in men and transgender women at risk of HIV-1.
F/TAF is also known as F/TDF. Both names refer to the same drug combination of emtricitabine and tenofovir alafenamide. The drug is being developed by Gilead Sciences for HIV-1 treatment and prevention.