Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Stribild · 4 trials · 3 indications
The FDA-defined 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.
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
| Arm | Type | Description |
|---|---|---|
| Stribild | EXPERIMENTAL | Participants will switch to Stribild for 48 weeks. |
| ATV/r + FTC/TDF | ACTIVE_COMPARATOR | - |
| Atripla | ACTIVE_COMPARATOR | Atripla plus placebo to match Stribild |
| Name | Type | Description |
|---|---|---|
| Stribild | DRUG | Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food |
| ATV | DRUG | Atazanavir 300 mg capsule administered orally once daily |
| Ritonavir | DRUG | Ritonavir (RTV; /r) 100 mg tablet administered orally once daily |
| FTC/TDF | DRUG | FTC/TDF 200/300 mg tablet administered orally once daily |
| Stribild Placebo | DRUG | Placebo to match Stribild administered orally once daily |
| ATV Placebo | DRUG | Placebo to match ATV administered orally once daily |
| RTV Placebo | DRUG | Placebo to match RTV administered orally once daily |
| FTC/TDF Placebo | DRUG | Placebo to match FTC/TDF administered orally once daily |
| Atripla | DRUG | Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime |
| Atripla Placebo | DRUG | Placebo to match Atripla tablet administered orally once daily prior to bedtime |
Inclusion Criteria: * Ability to understand and sign a written informed consent form * Virologically stable on the current first antiretroviral regimen consisting only of raltegravir twice daily plus FTC/TDF continuously for ≥ 6 months preceding the screening visit and * have documented undetect...
Stribild is a small molecule drug developed by Gilead Sciences for the treatment of Acquired Immunodeficiency Syndrome (AIDS) and HIV infection. It is intended for use in antiretroviral treatment-naive adults with HIV-1. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Stribild is a combination antiretroviral therapy that contains elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. It works by inhibiting HIV replication through multiple mechanisms, including integrase inhibition by elvitegravir and reverse transcriptase inhibition by emtricitabine and tenofovir, while cobicistat boosts the effectiveness of elvitegravir.
Stribild is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is responsible for the clinical development and manufacturing of the drug for the treatment of HIV infection and AIDS.
Stribild is in Phase 3 clinical development. The drug has completed three Phase 3 trials and one Phase 2 trial, with no active trials currently ongoing. It is an investigational drug and has not received FDA approval for the treatment of HIV infection.
Stribild has been evaluated in several completed clinical trials, including NCT01095796 and NCT01106586, which compared Stribild to Atripla and ritonavir-boosted atazanavir plus Truvada, respectively, in treatment-naive adults with HIV-1. Another trial, NCT01533259, studied switching from a raltegravir-based regimen to Stribild in virologically suppressed patients.
Yes, Stribild is the brand name for the fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. This single-tablet regimen combines these four antiretroviral agents to treat HIV-1 infection in adults.