Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...