Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
co-formulated TAF/ FTC · 1 trial · 1 indication
The frequency of graded adverse events by arm, including emergent HIV infection during the study period.
TFV-DP and FTC-TP concentrations observed in dried blood spots (DBS) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Fitted steady-state TFV-DP concentrations after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
| Arm | Type | Description |
|---|---|---|
| Perfect Adherence | EXPERIMENTAL | Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week). |
| Moderate Adherence | EXPERIMENTAL | Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week |
| Poor Adherence | EXPERIMENTAL | Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week |
| Name | Type | Description |
|---|---|---|
| co-formulated 25mg TAF/ 200mg FTC | DRUG | Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 25 mg TAF/ 200mg FTC |
Inclusion Criteria: * Age ≥18 and ≤30 years old * Willing to undergo urine pregnancy tests * Has understood the information provided and has provided written informed consent before any study-related procedures are performed. * HIV uninfected based on negative HIV rapid tests, according to Kenyan n...
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Co-formulated TAF/FTC is an investigational small molecule drug combination being developed by Gilead Sciences, Inc. for HIV Infections. It combines tenofovir alafenamide (TAF) and emtricitabine (FTC) in a single co-formulated product. It is currently in Phase 2 clinical development.
Co-formulated TAF/FTC is being studied for the treatment or prevention of HIV Infections. It is an investigational product and has not been approved for any indication. Its development is focused on HIV, and it is being evaluated in a Phase 2 clinical trial.
Co-formulated TAF/FTC is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program for this co-formulated TAF/FTC product.
Co-formulated TAF/FTC is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 2 program includes one completed trial.
Co-formulated TAF/FTC has been evaluated in one completed Phase 2 trial, NCT05140954, titled The Women TAF-FTC Benchmark Study. The trial enrolled 54 female participants aged 18 years and older in Kenya and was a randomized, controlled study in HIV Infections.