STRIBILD (cobicistat)
STRIBILD is a four-drug fixed-dose combination 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. It is indicated for patients with no prior antiretroviral treatment history or to replace a current stable regimen in patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) for at least 6 months, have no history of treatment failure, and no known resistance to the individual components of STRIBILD.
How STRIBILD Works
STRIBILD achieves antiretroviral activity through the synergistic effect of three active drugs and one pharmacokinetic enhancer: 1. **Elvitegravir:** An integrase strand transfer inhibitor (INSTI) that prevents the integration of HIV-1 DNA into the host cell genome. 2. **Cobicistat:** A selective CYP3A inhibitor that serves as a pharmacokinetic enhancer ("booster") to increase the systemic exposure of elvitegravir. 3. **Emtricitabine and Tenofovir Disoproxil Fumarate (TDF):** Both are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that inhibit HIV-1 reverse transcriptase, leading to DNA chain termination and blocking viral replication.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-08-27
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
STRIBILD Approval History
What STRIBILD Treats
1 indicationsSTRIBILD is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
STRIBILD Boxed Warning
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued EMTRIVA or VIREAD, which are components of STRIBILD. Hepatic function should be monitored closely, with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted ...
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued EMTRIVA or VIREAD, which are components of STRIBILD. Hepatic function should be monitored closely, with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued EMTRIVA or VIREAD, two of the components of STRIBILD. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted. ( 5.1 )
STRIBILD Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to STRIBILD
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02016924 | GS-US-216-0128 2013-001402-28, IS000883 | Ph 2, Ph 3 | active not recruiting | Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV |
| NCT06385119 results posted | F8394-101 | Ph 1 | completed | A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants. |
| NCT04065399 AUGMENT-101 | SNDX-5613-0700 2020-004104-34 | Ph 1, Ph 2 | recruiting | A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation |
| NCT03480646 results posted | 1205-201 | Ph 1, Ph 2 | completed | ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer |
| NCT04718805 | CR108955 TMC114IFD1004, 2020-003397-43 | Ph 1 | completed | A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions |
| NCT04661397 | CR108922 2020-003396-18, TMC114FD2HTX1007 | Ph 1 | completed | A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents |
| NCT02578550 | CR107887 TMC114FD2HTX1001, 2015-001264-18 | Ph 1 | completed | A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants |
| NCT05458102 results posted | GS-US-382-1587 | Ph 1 | terminated | Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels |
| NCT05748093 OSIBOOST 2 | OSIBOOST 2 2023-505700-35-00 | Ph 4 | recruiting | Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat |
| NCT05078671 PROACTIVE | PROACTIVE | Ph 4 | recruiting | Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness |
| NCT06014489 HO171 | HO171 | Ph 2 | recruiting | A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML |
| NCT03864406 results posted | 190063 19-CC-0063 | Ph 1 | completed | Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers |
| NCT05716854 | SCR-014 | Ph 1 | completed | Electrophysiological Effects of Potential QT Prolonging Drugs |
| NCT05236738 | AI424-578 | Ph 1 | completed | A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions |
| NCT02307656 | AI424-517 | Ph 1 | completed | Taste Properties of Atazanavir and Cobicistat |
| NCT04263350 | AI424-567 | Ph 1 | completed | A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time |
| NCT02325934 CRUSTRI | UMCN AKF 14.03 | Ph 1 | completed | Bioequivalence of Crushed Stribild With a Normal Breakfast or With Drip Feed Compared to the Whole Tablet |
| NCT02565888 DATE-4 | UMCN-AKF 14.12 | Ph 1 | completed | A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat |
| NCT04236453 | CR108649 2019-002245-37, TMC114FD2HTX1005 | Ph 1 | terminated | A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents |
| NCT03045861 results posted | 200911 | Ph 2 | completed | Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults |
| NCT02661373 | BUZZOFF | Ph 1 | completed | First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor |
| NCT02277600 | 206285 AI438-044 | Ph 1 | completed | A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI) |
| NCT02556268 | 17957 | Ph 1 | completed | Interaction With HIV Antiretroviral Agents |
| NCT02475135 | CR107430 2015-001213-27, TMC114FD2HTX1002 | Ph 1 | completed | Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination |
| NCT02477527 results posted | EB001JP001 | Ph 4 | completed | Atripla to Stribild Switch Study to Evaluate Sleep Disturbances |
| NCT01896622 | 130160 13-CC-0160 | Ph 1 | completed | The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers |
| NCT02503462 | DRVCOBI | Ph 4 | terminated | Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals |
| NCT01475838 results posted | GS-US-236-0115 2011-004483-30 | Ph 3 | completed | Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
| NCT01495702 results posted | GS-US-236-0121 2011-004963-56 | Ph 3 | completed | Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
| NCT01106586 results posted | GS-US-236-0103 | Ph 3 | completed | Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
| NCT01095796 results posted | GS-US-236-0102 | Ph 3 | completed | Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
| NCT01533259 results posted | GS-US-236-0123 | Ph 3 | completed | Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients |
| NCT01837719 Atazanavir results posted | AI424-511 | Ph 1 | completed | Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat |
| NCT00869557 results posted | GS-US-236-0104 | Ph 2 | completed | Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults |
| NCT01619527 | CR100699 TMC114IFD1003, 2012-000273-23 | Ph 1 | completed | A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
STRIBILD FDA Label Details
Indications & Usage
FDA Label (PDF)STRIBILD is indicated for the treatment of HIV-1 Infection.
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued EMTRIVA or VIREAD, which are components of STRIBILD. Hepatic function should be monitored closely, with both c...
STRIBILD Patents & Exclusivity
Patents (14 active)
Pro Intelligence Preview
Deep insights for STRIBILD
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 14 active patents
Trial Analysis
- • 9 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment