Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D/C/F/TAF · 1 trial · 2 indications
The snapshot algorithm was used which defines a patient'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 |
|---|---|---|
| D/C/F/TAF | EXPERIMENTAL | D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo |
| DRV+COBI+FTC/TDF | ACTIVE_COMPARATOR | DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo |
| Name | Type | Description |
|---|---|---|
| D/C/F/TAF | DRUG | DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily |
| DRV | DRUG | DRV 800 mg (2 × 400 mg tablets) administered orally once daily |
| COBI | DRUG | COBI 150 mg tablet administered orally once daily |
| FTC/TDF | DRUG | FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily |
| D/C/F/TAF Placebo | DRUG | D/C/F/TAF placebo tablet administered orally once daily |
| DRV Placebo | DRUG | DRV placebo tablet administered orally once daily |
| COBI Placebo | DRUG | COBI placebo tablet administered orally once daily |
| FTC/TDF Placebo | DRUG | FTC/TDF placebo tablet administered orally once daily |
Inclusion Criteria: * Adult (≥ 18 years) males or non-pregnant females * Ability to understand and sign a written informed consent form * General medical condition which does not interfere with the assessments and the completion of the trial * Plasma HIV-1 RNA levels ≥ 5,000 copies/mL * CD4+ cell c...
D/C/F/TAF is an investigational small molecule being developed for the treatment of Acquired Immunodeficiency Syndrome (AIDS) and HIV infections. It is being studied in antiretroviral treatment-naive adults with HIV-1 infection. The drug is currently in Phase 2 clinical development and has not been approved for any use.
D/C/F/TAF is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of HIV and AIDS.
D/C/F/TAF is in Phase 2 clinical development. It has received accelerated approval designation from the FDA, but it remains investigational and is not yet approved for commercial use. The drug is being studied in a completed Phase 2 trial involving 153 participants.
D/C/F/TAF has been studied in one completed Phase 2 clinical trial, identified as NCT01565850. This randomized, double-blind, active-controlled study compared D/C/F/TAF to COBI-boosted DRV plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. The trial enrolled 153 participants in the United States and Puerto Rico.
D/C/F/TAF has received accelerated approval designation from the FDA, but it is not yet approved. The drug is still in clinical development, with a completed Phase 2 trial. Accelerated approval designation indicates a potential pathway for approval, but the drug remains investigational until further regulatory review.