CLINICAL TRIALS PROFILE FOR COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

All Clinical Trials for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01497899 ↗	Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2011-12-28	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
NCT01780506 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2012-12-26	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
NCT01797445 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2013-03-12	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.
NCT02251236 ↗	Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals	Completed	Gilead Sciences	N/A	2016-01-01	The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B). Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks. *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.
NCT02251236 ↗	Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals	Completed	University at Buffalo	N/A	2016-01-01	The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B). Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks. *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.
NCT02251236 ↗	Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals	Completed	University of California, San Diego	N/A	2016-01-01	The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B). Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks. *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.

Clinical Trial Conditions for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Condition Name

Condition Name for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Intervention	Trials
HIV-1 Infection	4
HIV	3
HIV Infections	3
HIV/AIDS	2

Condition MeSH

Condition MeSH for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Intervention	Trials
HIV Infections	5
Acquired Immunodeficiency Syndrome	3
Immunologic Deficiency Syndromes	1
Drug-Related Side Effects and Adverse Reactions	1

Clinical Trial Locations for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Trials by Country

Trials by Country for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Location	Trials
United States	89
Canada	7
Switzerland	7
Italy	5
Spain	4

Trials by US State

Trials by US State for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Location	Trials
California	7
Missouri	5
Georgia	5
Florida	5
Massachusetts	4

Clinical Trial Progress for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Clinical Trial Phase

Clinical Trial Phase for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Clinical Trial Phase	Trials
Completed	9
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Sponsor Name

Sponsor Name for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Sponsor	Trials
Gilead Sciences	10
Weill Medical College of Cornell University	1
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic	1

Sponsor Type

Sponsor Type for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
Sponsor	Trials
Industry	11
Other	7

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate Market Analysis and Financial Projection

Last updated: April 25, 2026

Clinical Trials Update, Market Analysis and Projection: Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Alafenamide Fumarate (TAF)

What product is this and where is it sold?

The combination targets HIV-1 treatment (antiretroviral therapy) using:

• Elvitegravir (integrase inhibitor, “boosted”)
• Cobicistat (pharmacokinetic enhancer; CYP3A inhibitor, boosts elvitegravir exposure)
• Emtricitabine (FTC) (nucleoside reverse transcriptase inhibitor)
• Tenofovir alafenamide fumarate (TAF) (nucleotide reverse transcriptase inhibitor prodrug)

In the US, the regimen is marketed as Genvoya (fixed-dose combination tablet). European and other markets list similar fixed-dose equivalents under brand and local listings tied to the same components and dose (TAF-based, cobicistat-boosted elvitegravir + FTC).

What clinical trial program updates matter for this fixed-dose regimen?

This combination’s clinical posture is dominated by: 1) On-label optimization trials (switch studies and comparative efficacy/safety vs alternative regimens), and
2) Ongoing pharmacokinetic and special population work (renal impairment, hepatitis coinfection, drug-drug interaction)

Key implications for an investment or R&D read-through:

• The core efficacy of INSTI-based regimens is already established; current trial value concentrates on durability of virologic suppression, tolerability, and real-world alignment (baseline resistance, switching tolerability, comorbidity-specific outcomes).
• For TAF-based regimens, trial work most often addresses renal and bone safety versus older tenofovir disoproxil fumarate (TDF) backbones.

Clinical studies that have historically defined this regimen include:

• Switch vs continuation designs in virologically suppressed patients
• Comparative trials of cobicistat-boosted elvitegravir/FTC/TAF vs elvitegravir/FTC/TDF- or vs other INSTI backbones, depending on geography and time period
• Special populations: hepatitis B coinfection, renal impairment thresholds, and drug-drug interaction assessment due to cobicistat

Actionable status read-across (no further trial onboarding needed for efficacy posture):

• The regimen’s market function does not hinge on a single new pivotal late-stage outcome; it hinges on continued guideline alignment and tolerability endpoints in routine use, with ongoing evidence supporting switch and comorbidity positioning.

How do current competitors change the clinical value proposition?

The fixed-dose combination competes primarily against:

• INSTI-centered single-tablet regimens based on dolutegravir or bictegravir backbones (often preferred in newer guideline pathways due to resistance and tolerability profiles)
• NNRTI- or boosted-protease inhibitor–based regimens for particular patient segments
• Long-acting injectable INSTI strategies in eligible patients (where guideline and payer adoption allow)

Clinical trial impact for investors: the regimen’s incremental differentiation is more likely to be framed around:

• TAF renal and bone outcomes versus older TDF backbones
• Switch safety (patients already suppressed)
• Drug-drug interaction management and adherence simplicity (fixed-dose)

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Market Analysis

What is the market context for this HIV combination?

This regimen sits inside the global HIV antiretroviral market, where:

• Demand is driven by prevalence, treatment coverage, and second-line migration from older regimens.
• Competitive dynamics increasingly favor INSTI regimens with simplified dosing and broad baseline resistance robustness.

Fixed-dose cobicistat-boosted elvitegravir regimens have faced:

• Competitive pressure from unboosted INSTIs and newer INSTI backbones
• Ongoing rationalization by payers using total regimen cost, formulary position, and side-effect risk management costs

What segments matter most for unit demand?

Unit demand is most concentrated in:

• Treatment-naive patients where formularies still include this option
• Switch populations from TDF-containing regimens to TAF-containing regimens
• Virologically suppressed patients switching for tolerability, renal safety, or adherence consolidation into a fixed-dose regimen

TAF-based penetration tends to be supported when patients:

• Have renal risk or show sensitivity to tenofovir-related renal tubular effects (especially compared with TDF)
• Require long-term therapy where bone safety is a practical decision driver

How do pricing and access dynamics shape revenues?

Revenue pressure comes from:

• Patent expiry and generic entry for multi-component HIV fixed-dose combinations across jurisdictions
• Formulary substitution under negotiated procurement cycles
• Payer-driven substitution toward the lowest-cost equivalent that still meets guideline acceptance in the region

A product like this typically sees:

• Peak unit pricing under brand exclusivity
• Declining net price after generic competition
• Continued volume resilience if it remains on formularies for “stable patient” switching or specific clinical profiles

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Projection

What is the forward demand trajectory?

The forward trajectory for cobicistat-boosted elvitegravir / FTC / TAF fixed-dose regimens is shaped by three forces: 1) Long-run HIV treatment expansion (background growth in total treated population) 2) Share shift toward newer INSTI regimens with simpler pharmacology (competitive share erosion) 3) Generic impact (net price erosion in brand markets and accelerated substitution where generics are available)

Base case projection logic (directional):

• Total addressed patients: grows modestly with global treated-population expansion.
• Share of the specific regimen: declines gradually due to preference shifts toward other INSTI backbones.
• Revenue: typically declines as brand net price erodes, offset partially by volume stability in suppressed-switch segments and certain payer formularies.

What specific drivers can extend the life cycle?

• Stable suppressed patient retention: once switching is done, clinicians often keep the regimen if it is tolerated.
• TAF safety positioning: renal and bone safety supports continued usage where TDF alternatives are avoided.
• Formulary lag: updated guideline preferences can take 1 to 3 procurement cycles to fully displace established options, depending on country.

What endpoints will matter most for remaining market share?

Future demand is sensitive to:

• Durability of viral suppression in switch populations
• Renal and bone safety performance under long-term real-world use
• Tolerability and adherence (GI effects, lipid changes, weight trends as patients switch across modern INSTIs)
• Resistance evolution risk profile under regimen interruptions and adherence lapses

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Competitive and Regulatory Landscape (Practical Read-Through)

How is the competitive field structured?

This regimen competes against:

• Fixed-dose INSTI combinations from multiple manufacturers
• Generic and authorized generic substitutes across many markets
• Adjacent branded options still positioned for first-line use based on contemporary guideline preference

From a business perspective:

• The regimen’s most durable position is in stable suppression and switch-to-TAF cohorts.
• Its most challenging area is new starts, where newer INSTI options capture incremental share.

What does “trial to market” usually look like at this stage?

At this maturity level, clinical updates most often translate to:

• Labeling refinements (subpopulations, drug-drug interaction handling)
• Payer-formulary support documents using pooled efficacy and safety evidence
• Real-world evidence publications supporting adherence and tolerability

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Key Takeaways

• The combination cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide (TAF) is the branded HIV fixed-dose regimen Genvoya in the US and related local equivalents globally.
• Clinical activity is now dominated by switch, special population, and real-world alignment rather than new pivotal efficacy differentiation.
• Market growth for the addressed HIV treated population is partly offset by share erosion toward newer INSTI backbones and net price decline from generic penetration.
• The regimen’s most defensible demand base is virologically suppressed patients and switching from TDF to TAF where renal and bone safety matter.

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FAQs

1) Is the clinical value of this regimen mainly efficacy, safety, or adherence?

Safety and adherence. Efficacy is established for INSTI-based suppression; ongoing differentiation is typically tied to tolerability, renal/bone outcomes from TAF, and fixed-dose simplicity.

2) Why does cobicistat matter commercially and clinically?

It enables elvitegravir exposure via pharmacokinetic boosting. That supports once-daily fixed-dose use but also drives drug-drug interaction considerations that can influence prescriber and payer preference.

3) What patient group is most likely to stay on this regimen long term?

Patients who are already virologically suppressed and switching from TDF-based therapy to TAF-based therapy for renal/bone safety reasons.

4) What competitive pressure is most material over the next several years?

Share shift toward other INSTI-centered single-tablet regimens and the economic pressure of generic substitution where available.

5) What evidence will be used to defend formulary placement?

Durability of suppression in switch populations plus long-term renal and bone safety outcomes consistent with TAF and tolerability data that supports adherence.

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References

[1] U.S. Food and Drug Administration. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) Prescribing Information.
[2] European Medicines Agency. Genvoya: Summary of Product Characteristics (SPC).
[3] World Health Organization. Guidelines for the use of antiretroviral drugs for treating and preventing HIV infection (most recent edition).
[4] NIH/Guidelines. Adult and Adolescent Antiretroviral Guidelines (DHHS).
[5] ClinicalTrials.gov. Trials for elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (TAF) (study records and results postings).