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.
NCT01533259 ↗	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,	Completed	Gilead Sciences	Phase 3	2012-01-01	This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.

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
Vancouver Infectious Diseases Centre	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for stribild
Sponsor	Trials
Industry	22
Other	20

Clinical Trials Update, Market Analysis, and Projection for Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide)

Last updated: October 28, 2025

Introduction

Stribild, a fixed-dose combination antiretroviral therapy (ART), has been a significant player in HIV treatment since its approval. Combining four components—elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide—Stribild offers a convenient once-daily regimen aimed at improving adherence and patient outcomes. This analysis provides an up-to-date overview of its ongoing clinical trials, the current market landscape, and future growth projections, reflecting the evolving dynamics in HIV pharmacotherapy.

Clinical Trials Update

Recent and Ongoing Clinical Trials

Although Stribild was approved by the FDA in 2014, its clinical development continued in various forms, including comparative studies and real-world effectiveness assessments. Recently, the focus has shifted toward long-term safety and efficacy, drug-drug interaction profiles, and special population studies.

• Long-term efficacy and safety:
  Multiple open-label extension studies have demonstrated sustained viral suppression (viral load <50 copies/mL) over 5–7 years. These studies affirm the durability of Stribild, with minimal resistance development and favorable renal and bone safety profiles, consistent with its components [1].

• Special populations:
  Clinical trials have evaluated Stribild's use in elderly patients, pregnant women, and those with comorbidities such as hepatitis B/C co-infection. Data indicate comparable efficacy, with a focus on renal monitoring, given tenofovir alafenamide's (TAF) improved renal safety profile over tenofovir disoproxil fumarate (TDF) [2].

• Comparative studies:
  Trials contrasting Stribild with other regimens, such as Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), have shown non-inferiority in viral suppression. These studies underscore ongoing efforts to optimize treatment options and tailor therapy to patient needs.

Upcoming Trials and Developments

• Drug-drug interaction assessments:
  As HIV-infected patients often require concomitant medications, trials are evaluating Stribild in combination with agents for HCV, HBV, and comorbid conditions to ensure safety and minimize adverse interactions.

• Real-world effectiveness studies:
  Post-marketing, observational registries are collecting data to assess adherence, resistance profiles, and quality of life (QoL) metrics in diverse populations.

No new pivotal trials on Stribild are currently listed on ClinicalTrials.gov, reflecting its established status; however, ongoing real-world data collection continues to inform best practices.

Market Analysis

Current Market Landscape

Stribild holds a prominent position in the HIV ART market, primarily targeting treatment-naïve patients. Its advantages include simplified dosing, once-daily administration, and reduced pill burden, which enhance adherence and viral suppression rates.

Market Share and Revenue

As of 2022, Stribild's market share has remained significant, though somewhat challenged by newer formulations like Genvoya and Biktarvy. Genvoya, a successor product with an improved safety profile, has gained preference among prescribers, especially for long-term treatment due to its better renal and bone safety parameters.

Annual revenues for Stribild peaked shortly after approval but declined marginally to approximately $700 million globally in 2022 [3]. Still, it commands a substantial segment of the HIV treatment market, especially in regions where formulary inclusion favors older, well-established regimens.

Competitive Landscape

• Genvoya:
  Launched in 2015, Genvoya features an optimized formulation with TAF instead of TDF, offering a superior safety profile. It is increasingly prescribed over Stribild in many regions.

• Biktarvy:
  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), introduced in 2018, has rapidly gained market share due to its high efficacy, low pill burden, and favorable safety profile.

• Other Combination Therapies:
  Dolutegravir-based regimens are gaining preference owing to their potent antiviral activity and tolerability.

Regulatory and Reimbursement Factors

Prescribers favor newer formulations with demonstrated safety advantages. Reimbursement policies increasingly favor these as well, impacting Stribild’s market penetration. Nevertheless, Stribild retains its role due to cost considerations in certain regions, patent protections, and formulary legacy effects.

Future Market Projections

Growth Drivers

• Global HIV burden:
  The World Health Organization estimates 38 million people living with HIV globally, with substantial treatment gaps, particularly in Africa and Asia. The ongoing need for effective, simplified ART supports steady demand for drugs like Stribild.

• Patient adherence:
  Fixed-dose combinations continue to be preferred, especially in resource-limited settings, underscoring the importance of Stribild’s once-daily formulation.

• Regulatory approvals and pipeline:
  Although no new studies elevate Stribild as a front-line contender, its ongoing refinements and integration into combination regimens ensure sustained relevance.

Challenges and Opportunities

• Market erosion from newer formulations:
  The shift favoring Genvoya and Biktarvy is expected to continue, potentially reducing Stribild’s market share by approximately 10–15% annually over the next five years.

• Patent expirations:
  Patent expiry looming in 2025 could open generics markets, possibly halving prices and expanding access in low-resource settings.

• Emerging therapies:
  Long-acting injectables like cabotegravir/rilpivirine are expected to reshape HIV management, possibly limiting the role of oral regimens like Stribild.

Estimated Revenue Trajectory

By 2027, global revenues for Stribild are projected to decline to approximately $300–400 million annually, primarily driven by sales in emerging markets and legacy treatment settings. Nonetheless, niche uses and specific patient populations may sustain modest sales.

Conclusion

Stribild remains an important component in the landscape of HIV treatment, especially in settings prioritizing simplified regimens. Despite being somewhat eclipsed by newer formulations offering enhanced safety profiles, it continues to benefit from established efficacy, favorable dosing, and ongoing clinical validation.

The drug's future trajectory hinges on market dynamics, evolving treatment standards, and regulatory developments. Its longevity will likely depend on strategic positioning within combination therapy portfolios, potential biosimilar entry post-patent expiry, and the broader adoption of long-acting antiretroviral therapies.

Key Takeaways

• Clinical stability: Longitudinal data affirm Stribild's sustained efficacy and safety, notably in long-term use.
• Market positioning: Stribild maintains relevance in certain regions and subpopulations due to cost and formulary legacy but faces stiff competition from newer agents.
• Future outlook: Revenue forecasts indicate moderate decline, with growth prospects tied to global HIV treatment expansion and emerging therapeutic alternatives.
• Strategic opportunities: Patent expirations and market adaptation could enhance accessibility and renew uptake, especially in resource-constrained settings.
• Competitive landscape: Advances in long-acting injectables and safer oral formulations are transforming HIV treatment paradigms, impacting Stribild’s market share.

FAQs

1. Is Stribild still recommended as a first-line therapy for HIV?
   While it continues to be an effective option, current guidelines favor newer formulations like Genvoya and Biktarvy due to improved safety profiles and longer-acting options, thereby reducing its preference in many settings.

2. What are the primary safety considerations for Stribild?
   Renal function and bone mineral density require monitoring, primarily due to cobicistat's potential to impair renal clearance and TDF-related bone demineralization, although TAF in Stribild mitigates some risks.

3. How does Stribild compare to Genvoya?
   Genvoya replaces TDF with TAF, offering better renal and bone safety. Efficacy remains comparable, but Genvoya's improved safety profile makes it the preferred option for long-term management.

4. What is the impact of patent expiration on Stribild?
   Patent expiry in 2025 could lead to generic manufacturing, significantly reducing costs and potentially expanding access, especially in low-income countries.

5. Are there ongoing clinical trials exploring new uses for Stribild?
   Currently, the focus has shifted to post-marketing data collection; no new major clinical trials are underway for Stribild specifically, but real-world evidence continues to shape its utilization.

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Sources

[1] CDC, HIV Surveillance Reports, 2022.
[2] World Health Organization, HIV/AIDS Treatment Guidelines, 2021.
[3] IQVIA, Global HIV Market Data, 2022.