Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Atripla®
EFV/FTC/TDF · 1 trial · 2 indications
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, 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 |
|---|---|---|
| E/C/F/TAF | EXPERIMENTAL | Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. |
| Stay on Baseline Treatment Regimen (SBR) | ACTIVE_COMPARATOR | Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. |
| Name | Type | Description |
|---|---|---|
| E/C/F/TAF | DRUG | 150/150/200/10 mg FDC tablet administered orally once daily |
| E/C/F/TDF | DRUG | 150/150/200/300 mg FDC tablet administered orally once daily |
| EFV/FTC/TDF | DRUG | 600/200/300 mg FDC tablet administered orally once daily |
| RTV | DRUG | 100 mg tablet administered orally once daily |
| ATV | DRUG | 300 mg capsule administered orally once daily |
| FTC/TDF | DRUG | 200/300 mg tablet administered orally once daily |
| COBI | DRUG | 150 mg tablet administered orally once daily |
Key Inclusion Criteria: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months...
EFV/FTC/TDF is a fixed dose combination of three small molecule antiretroviral drugs used to treat HIV. It combines efavirenz, emtricitabine, and tenofovir disoproxil fumarate in a single regimen. Gilead Sciences, Inc. (ticker GILD) is the developer. It is a TDF-containing combination regimen studied in virologically suppressed, HIV-1 positive participants.
EFV/FTC/TDF is used for the treatment of HIV and HIV infections. It is a TDF-containing combination regimen given to HIV-1 positive participants, including those who are virologically suppressed. The Phase 3 trial enrolled adults 18 years and older of all sexes, and it was not limited to healthy volunteers.
Gilead Sciences, Inc., which trades under the ticker GILD, is the developer of EFV/FTC/TDF. The company sponsored the Phase 3 study of the fixed dose combination. The trial was conducted across the United States, Australia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.
EFV/FTC/TDF has been studied in a Phase 3 clinical trial. The single Phase 3 study, NCT01815736, is completed and enrolled 1,443 participants. The trial was randomized and active controlled, comparing a switch from a TDF-containing combination regimen to a TAF-containing fixed dose combination in virologically suppressed, HIV-1 positive participants.
EFV/FTC/TDF was evaluated in one Phase 3 trial, NCT01815736, titled a study to evaluate switching from a TDF-containing combination regimen to a TAF-containing fixed dose combination in virologically-suppressed, HIV-1 positive participants. The trial is completed, enrolled 1,443 participants, was randomized and active controlled, and covered HIV and HIV infections.