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D/C/F/TAF · 1 trial · 1 indication
Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (\>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.
| Arm | Type | Description |
|---|---|---|
| Experimental Treatment Regimen | EXPERIMENTAL | Participants will receive a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily, up to Week 48. After Week 48, all participants will continue to receive the D/C/F/TAF tablet in a 48 week extension phase (up to Week 96). |
| Current Treatment Regimen | ACTIVE_COMPARATOR | Participants will receive a boosted protease inhibitor (bPI) (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) up to Week 52. After Week 52, all participants will receive the D/C/F/TAF tablet in a 44 week extension phase (up to Week 96). |
| Name | Type | Description |
|---|---|---|
| D/C/F/TAF | DRUG | Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg. |
| Boosted Protease Inhibitor (bPI) | DRUG | Boosted protease inhibitor (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) as per current treatment regimen. |
| FTC/TDF | DRUG | Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). |
Inclusion Criteria: * Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) combined with emtricitabine/tenofovir disopr...
D/C/F/TAF is an investigational small molecule regimen being developed for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1). It is a fixed-dose combination being studied in virologically-suppressed HIV-1 infected participants. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
D/C/F/TAF is a combination regimen containing darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. Darunavir is a protease inhibitor, cobicistat is a pharmacokinetic enhancer, and emtricitabine and tenofovir alafenamide are nucleoside/nucleotide reverse transcriptase inhibitors. Together they target multiple steps in the HIV-1 replication cycle.
D/C/F/TAF is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the safety and efficacy of this combination regimen for the treatment of HIV-1 infection.
D/C/F/TAF is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of drugs for serious conditions with unmet medical need.
D/C/F/TAF is being studied in a Phase 3 clinical trial with the identifier NCT02269917. This completed trial enrolled 1,149 participants and evaluated the efficacy and safety of D/C/F/TAF versus a boosted protease inhibitor along with emtricitabine/tenofovir disoproxil fumarate in virologically-suppressed HIV-1 infected participants.
Yes, D/C/F/TAF is the abbreviation for the combination of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. This fixed-dose combination is being developed for the treatment of HIV-1 infection and is currently in Phase 3 clinical trials.