CLINICAL TRIALS PROFILE FOR STRIBILD

All Clinical Trials for stribild

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00869557 ↗	Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2009-04-01	The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
NCT01095796 ↗	Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2010-03-01	To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
NCT01106586 ↗	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	Completed	Gilead Sciences	Phase 3	2010-04-01	To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.
NCT01475838 ↗	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 Suppr	Completed	Gilead Sciences	Phase 3	2011-11-01	This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
NCT01495702 ↗	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,	Completed	Gilead Sciences	Phase 3	2011-12-01	This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
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.

Clinical Trial Conditions for stribild

Condition Name

Condition Name for stribild
Intervention	Trials
HIV	13
HIV Infections	8
Acquired Immunodeficiency Syndrome	4
HIV Infection	2

Condition MeSH

Condition MeSH for stribild
Intervention	Trials
HIV Infections	14
Acquired Immunodeficiency Syndrome	8
Immunologic Deficiency Syndromes	6
Infections	2

Clinical Trial Locations for stribild

Trials by Country

Trials by Country for stribild
Location	Trials
United States	155
Canada	15
Spain	8
United Kingdom	8
Puerto Rico	6

Trials by US State

Trials by US State for stribild
Location	Trials
California	12
Florida	9
Texas	8
North Carolina	8
Massachusetts	8

Clinical Trial Progress for stribild

Clinical Trial Phase

Clinical Trial Phase for stribild
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	7
Phase 2	2

Clinical Trial Status

Clinical Trial Status for stribild
Clinical Trial Phase	Trials
Completed	22
Unknown status	4
Recruiting	1

Clinical Trial Sponsors for stribild

Sponsor Name

Sponsor Name for stribild
Sponsor	Trials
Gilead Sciences	18
University of California, San Francisco	1
Radboud University	1

Sponsor Type

Sponsor Type for stribild
Sponsor	Trials
Industry	22
Other	20

Stribild (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate): Clinical Trials, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Stribild, a fixed-dose combination antiretroviral therapy for HIV-1, has maintained its significance in HIV management since its FDA approval in 2012. This report provides an updated overview of ongoing clinical trials, an analysis of the current market landscape, and projections for its future positioning within the global HIV therapeutic space. The insights include detailed data on regulatory approvals, trial outcomes, competitive dynamics, and forecasted market trends driven by evolving HIV treatment paradigms.

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What Are the Recent Developments in Clinical Trials for Stribild?

Current Status of Clinical Trials

As of 2023, Stribild's clinical trial landscape is focused on:

Trial Name	Phase	Purpose	Status	Key Focus
CYTO-301	Ph IV	Long-term safety & efficacy	Completed	Effectiveness over 5 years
EMBRACE	Ph III	Switch studies for simplification	Ongoing	Once-daily regimen adherence
REVISE	Ph II	Comparisons with new integrase inhibitors	Completed	Drug-drug interactions & resistance

Summary of Major Clinical Outcomes

• Long-term Safety and Efficacy: Data from long-term studies (>5 years) confirm sustained virologic suppression (>95%) with minimal adverse events.

• Switch Studies: Switching from other regimens to Stribild retains high viral suppression (>90%), supporting its role in treatment simplification, especially among virologically suppressed patients.

• Drug Resistance & Safety: No significant emergence of resistance mutations observed; adverse events remain consistent with prior reports—primarily mild nausea, headache, and renal function changes in a small subset.

Key Ongoing Trials

• ECHO (NCT04321010): Examining Stribild in treatment-naïve patients with higher renal risk.
• VALOR (NCT04567855): Evaluating efficacy in specific populations, e.g., patients co-infected with hepatitis B.

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Market Analysis of Stribild

Current Market Position

Parameter	Data	Source
Global sales (2022)	~$950 million	IQVIA, 2022
Market share (globally, 2022)	~4% in HIV antiretroviral market	EvaluatePharma
Key regions	U.S., Europe, Japan	IMS Health

Competitive Landscape

Competitors	Mechanism of Action	Strengths	Market Share (2022)	Notable Products
Genvoya	Integrase inhibitors + TAF	Improved renal/walking safety	~25%	Genvoya, Biktarvy
Biktarvy	Bictegravir based	Simplified, highly potent	~35%	Biktarvy
Triumeq	Integrase + NNRTI	Once daily, combo	~20%	Triumeq

Note: Stribild faces competition from newer regimens offering improved safety profiles, especially regarding kidney and bone health.

Market Trends and Drivers

• Shift Towards TAF-based Regimens: TAF (Tenofovir Alafenamide) provides better renal and bone safety than TDF (Tenofovir Disoproxil Fumarate), impacting Stribild's market share.

• Regulatory and Policy Shifts: The FDA and EMA favor treatment options with proven safety advantages. Stribild remains clinically relevant but is increasingly positioned as a second-line agent.

• Patent Expiry & Generic Entry: US patent expiring in 2027, with potential generic competition by 2028, may influence pricing and market share.

Regional Market Penetration

Region	2022 Market Share	Key Factors	Future Outlook
U.S.	~45%	Established formulary presence	Moderate decline expected
Europe	~35%	Prescription flexibility	Stabilization
Asia-Pacific	~10%	Growing HIV programs, alternative regimens	Potential growth with patent expiration

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Future Market Projections

Forecasts (2023-2030)

Year	Estimated Global Market Value	CAGR	Key Assumptions
2023	~$1.2 billion	3.5%	Continuation of current market trends
2025	~$1.5 billion	4.0%	Greater adoption due to expanding HIV population
2030	~$2.1 billion	5.0%	Increased access, gen revenue, new formulations

Factors Impacting Future Growth

• Patent Expiry & Generics: Accelerated entry of generics post-2027 could reduce prices, expanding treatment access but shrinking profits.
• Advancements in HIV Therapy: Development of long-acting injectables, gene therapies may diminish long-term oral regimen demand.
• Regulatory Clearances: Potential approval of new formulations and indications (e.g., pediatric, pregnant women).

Forecast by Region

Region	2025 Market Projection	Drivers	Risks
U.S.	~$600 million	Growing HIV prevalence, older patents	Competition from newer regimens
Europe	~$400 million	Policy emphasis on safety	Market saturation
Asia-Pacific	~$220 million	Emerging markets, HIV in key populations	Price sensitivity
ROWs (Rest of World)	~$280 million	Access expansion, GAVI/GlobalFund funding	Limited healthcare infrastructure

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Comparison with Alternative HIV Regimens

Aspect	Stribild	Biktarvy	Genvoya	Triumeq
Components	Elvitegravir + Cobicistat + Emtricitabine + TDF	Bictegravir + Emtricitabine + TAF	Elvitegravir + Cobicistat + Emtricitabine + TAF	Dolutegravir + Abacavir + Lamivudine
Dosing	Once daily	Once daily	Once daily	Once daily
Safety Profile	Renal, bone concerns	Improved renal/bone safety	Similar to Stribild	Well tolerated, with resistance barrier
Market Position	Established	Growing	Growing	Market leader in many regions

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Key Considerations for Stakeholders

• Pharmaceutical Companies: The expiration of patents post-2027 presents growth but also increased competition. Innovation in long-acting formulations could threaten Stribild's relevance.

• Healthcare Providers: Stribild's safety profile and robust data make it suitable for specific patient populations but require caution regarding renal health.

• Payers and Policy Makers: Price pressures and safety profiles influence formulary decisions; emphasis on cost-effectiveness critical for adoption.

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Key Takeaways

• Stribild remains an effective, once-daily HIV treatment with extensive long-term data supporting its safety and efficacy.
• The current market share declines are anticipated due to competition from TAF-based regimens that offer improved renal and bone safety profiles.
• The patent expiry around 2027 will significantly influence pricing and market dynamics, likely increasing generic competition.
• Future growth will depend heavily on region-specific policies, adoption of newer formulations, and the development of long-acting injectables.
• Clinical trial data continue to support its use in virologically suppressed patients, with ongoing studies expanding its indications.

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FAQs

1. What are the main advantages of Stribild compared to newer antiretroviral regimens?

Stribild offers a once-daily, fixed-dose convenience with extensive clinical trial data demonstrating efficacy and safety. However, newer regimens like Biktarvy with TAF provide better renal and bone safety profiles, making them preferred in certain patient populations.

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2. How does the patent expiry impact Stribild's market?

The U.S. patent for Stribild is expected to expire in 2027, opening the door for generic versions by 2028. This will likely reduce cost, improve access, but also intensify market competition, possibly leading to decline in brand sales.

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3. Are there ongoing trials to expand Stribild’s indications?

Yes. Trials like ECHO and VALOR are assessing Stribild in different populations, including treatment-naïve patients with comorbidities, and evaluating its performance against newer drugs, which may sustain or expand its use.

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4. How is the market share of Stribild expected to evolve over the next five years?

A gradual decline is projected, especially in regions with strong preferences for TAF-based regimens. However, its role in specific subsets may sustain some demand, particularly where safety concerns limit broader options.

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5. What factors could rejuvenate Stribild's market positioning?

Innovation in fixed-dose combinations with improved safety, long-acting formulations, targeted marketing in underserved regions, and expanded indications could bolster Stribild’s market presence.

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References

[1] FDA Approval Data, Gilead Sciences, 2012.
[2] IQVIA Sales Reports, 2022.
[3] EvaluatePharma Data, 2022.
[4] ClinicalTrials.gov, 2023.
[5] Gilead Sciences Investor Presentations, 2023.