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Label indication STRIBILD ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of… FDA label
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 fixed-dose combination tablet used for the treatment of HIV-1 infection in adults. It is indicated for patients who are antiretroviral treatment-naive, meaning they have not previously received HIV therapy. The drug is designed to suppress viral replication and is administered as a once-daily single-tablet regimen.
Stribild contains four active ingredients: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. Elvitegravir is an integrase inhibitor that blocks viral DNA integration, while emtricitabine and tenofovir are nucleoside reverse transcriptase inhibitors that interfere with viral RNA transcription. Cobicistat boosts elvitegravir levels by inhibiting its metabolism.
Stribild is developed and manufactured by Gilead Sciences, Inc., a biopharmaceutical company headquartered in Foster City, California. Gilead is a major player in HIV therapeutics and markets Stribild as part of its portfolio of single-tablet regimens for the management of HIV infection.
Stribild has completed Phase 3 clinical trials and is approved by the U.S. Food and Drug Administration for the treatment of HIV-1 infection. It is no longer in active clinical development, as all three registered trials have been completed. The drug is commercially available and has been widely used in clinical practice.
Stribild has been evaluated in three completed clinical trials. NCT01095796 and NCT01106586 were Phase 3 studies comparing Stribild to Atripla or ritonavir-boosted atazanavir plus Truvada in treatment-naive HIV patients. NCT00869557 was a Phase 2 study versus Atripla. NCT01533259 assessed switching from raltegravir-based therapy in virologically suppressed patients.
Stribild is not the same as Genvoya. While both are single-tablet regimens from Gilead containing elvitegravir, cobicistat, emtricitabine, and tenofovir, Stribild uses tenofovir disoproxil fumarate (TDF), whereas Genvoya contains tenofovir alafenamide (TAF). TAF has a different safety profile, with less impact on bone and kidney function compared to TDF.