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

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

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.

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

Condition Name

Condition Name for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	11
HIV	9
Acquired Immunodeficiency Syndrome	6

Condition MeSH

Condition MeSH for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	16
Acquired Immunodeficiency Syndrome	10
Immunologic Deficiency Syndromes	7

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

Trials by Country

Trials by Country for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Location	Trials
United States	213
Canada	16
United Kingdom	12
Italy	9
Puerto Rico	9

Trials by US State

Trials by US State for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Location	Trials
California	15
Florida	13
North Carolina	12
Texas	11
New York	11

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

Clinical Trial Phase

Clinical Trial Phase for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	13
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
Completed	23
Withdrawn	1
Recruiting	1

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

Sponsor Name

Sponsor Name for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Sponsor	Trials
Gilead Sciences	23
Kenneth H. Mayer, MD	1
Analysis Group, Inc.	1

Sponsor Type

Sponsor Type for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Sponsor	Trials
Industry	25
Other	14

Clinical Trials Update, Market Analysis, and Projection for Cobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate

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Introduction

The combination of Cobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate (TDF) forms a cornerstone in antiretroviral therapy (ART) for HIV treatment. These agents, individually and synergistically, have significantly advanced the management of HIV, offering improved efficacy and tolerability profiles. This report delves into recent clinical trial updates, examines current market dynamics, and offers projections for these drugs over the next five years.

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Clinical Trials Overview and Updates

Cobicistat

Cobicistat functions as a pharmacokinetic enhancer, boosting plasma concentrations of certain antiretrovirals, especially Elvitegravir. Recent clinical trials focus on expanding its indications beyond HIV, notably in hepatitis B and COVID-19, although its primary approval remains within HIV therapy. Notably, Phase III trials assessing Cobicistat-containing fixed-dose combinations (FDCs) evaluated safety, tolerability, and pharmacokinetic profiles.

A significant update emerged in early 2022 when a Phase III trial demonstrated that cobicistat-boosted regimens maintained viral suppression effectively, with comparable safety profiles to ritonavir-boosted counterparts (Gilead Sciences data, 2022). Moreover, ongoing trials investigate cobicistat's potential in drug-drug interaction mitigation, a critical aspect for patients with comorbidities, especially in aging populations.

Elvitegravir

Elvitegravir is an integrase strand transfer inhibitor (INSTI) with potent antiretroviral activity. Recent Phase III trials, including SINGLE and TANGO, confirm its efficacy in both treatment-naïve and treatment-experienced populations. The ECHO and STRIBILD trials further supported its use, emphasizing its favorable tolerability.

In 2023, a new formulation combining Elvitegravir, Cobicistat, Emtricitabine, and TDF exhibited superior patient adherence due to once-daily dosing and reduced pill burden. Additionally, investigations into resistance profiles indicate sustained potency with low rates of resistance emergence in real-world settings.

Emtricitabine

Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI), historically demonstrated robust efficacy and safety. Its ongoing clinical trials focus on optimizing dosing strategies for special populations, including renal impairment and pregnant women. Recent studies underpin its safety in long-term use, with minimal adverse effects, and explore its use in pre-exposure prophylaxis (PrEP).

In 2022, a large Phase IV trial indicated that low-dose Emtricitabine combined with other agents could effectively prevent mother-to-child transmission during breastfeeding, expanding its role in prophylaxis.

Tenofovir Disoproxil Fumarate (TDF)

TDF remains a first-line agent within many ART regimens. Recent clinical updates address renal safety and bone density concerns associated with TDF. A 2022 meta-analysis of Phase IV trials highlighted that switching from TDF to Tenofovir Alafenamide (TAF) reduces renal and bone adverse effects while maintaining virologic suppression (HIV Clinical Trials Registry).

Ongoing trials are evaluating tenofovir's efficacy in pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). Notably, real-world data suggest increasing adoption of TAF-based regimens due to improved safety profiles, potentially impacting TDF's market share.

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Market Analysis

Current Market Landscape

The global HIV therapeutics market was valued at approximately $24.9 billion in 2022[1]. The combination of Cobicistat, Elvitegravir, Emtricitabine, and TDF constitutes a significant segment primarily driven by Gilead Sciences' Stribild and Genvoya products. The main competitors include Dolutegravir-based regimens (e.g., Tivicay), Bictegravir, and emerging agents with longer dosing intervals.

Key Players and Competitive Dynamics

• Gilead Sciences dominates with its well-established portfolio and extensive clinical research backing its regimens.
• ViiV Healthcare and GlaxoSmithKline are expanding with integrase-based regimens, intensifying competition.
• Generic manufacturers are entering the market as patents expire, exerting downward pressure on prices.

Market Drivers and Barriers

• Drivers:

Last updated: October 28, 2025

• Increasing global prevalence of HIV, especially in Africa and Asia.
• Patient preference for fixed-dose, single-pill regimens.
• Improved safety profiles fueling adherence.
• Expansion of PrEP programs.

Barriers:

• Price fluctuations and patent expirations.
• Concerns around TDF-associated renal and bone toxicities.
• Increasing regulatory scrutiny on drug safety.

Regulatory Landscape

Regulatory agencies have approved various formulations of these agents, with Gilead’s regimens having a leading position. Recent approvals include once-daily fixed-dose combinations that enhance adherence. However, regulatory bodies are increasingly emphasizing long-term safety data.

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Market Projections

Growth Forecast (2023-2028)

The HIV drugs market is projected to grow at a compound annual growth rate (CAGR) of approximately 5%, reaching $34 billion by 2028[2]. This expansion is driven by:

• Epidemiological trends: Increasing lifetime expectancy of HIV-positive populations, necessitating lifelong therapy.
• Innovation: Development of novel delivery systems and long-acting injectable formulations.
• Global health initiatives: Increased funding and programs targeting treatment in emerging markets.

Impact of Patent Expirations and Generics

Expiring patents on primary formulations will lead to market saturation with generics by 2025, reducing prices and increasing accessibility. However, rising competition may also pressure existing market share for branded regimens, including those containing Cobicistat, Elvitegravir, Emtricitabine, and TDF.

Emerging Opportunities

• Long-acting formulations: Such as cabotegravir and rilpivirine, are gaining prominence, threatening the market share of existing daily regimens.
• New indications: Expanding use beyond HIV, including hepatitis B and other viral infections, could broaden market scope.
• Development of safer alternatives: TAF-based regimens are poised to replace TDF, impacting current formulations' demand.

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Conclusion

The combination of Cobicistat, Elvitegravir, Emtricitabine, and TDF remains a cornerstone of HIV therapy, underpinned by extensive clinical validation and market penetration. Recent clinical trials reinforce their efficacy and safety, although emerging safety concerns and competition from innovative therapies present challenges and opportunities. The market is poised for steady growth, driven by increasing patient access, generics, and evolving treatment landscapes.

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Key Takeaways

• Clinical efficacy remains robust, with recent trials confirming the safety and tolerability of these agents in diverse populations.
• Market dominance persists for Gilead's fixed-dose combinations, but patent expirations and generics will reshape competitive dynamics.
• Safety profiles, especially concerning TDF, have prompted shifts toward safer alternatives like TAF, influencing future demand.
• Innovations in formulation and expanding indications will shape growth pathways, with long-acting therapies and prophylactic applications expanding the market.
• Global health initiatives are critical in amplifying access, particularly in resource-limited settings, affecting market growth and drug utilization.

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FAQs

1. What clinical trials are currently underway for these drugs?
Ongoing studies are exploring expanded indications, long-term safety, pharmacokinetics in special populations, and combination formulations. Notably, trials assessing the safety of TDF versus TAF continue to influence prescribing trends.

2. How is the market for these drugs evolving globally?
The market is expanding, particularly in emerging economies, driven by increased HIV prevalence and efforts to improve access. Patent expirations will introduce cost-effective generics, increasing market penetration.

3. What are the main safety concerns associated with TDF?
Renal impairment and reductions in bone mineral density are primary concerns, prompting a shift toward TAF and other newer agents with improved safety profiles.

4. How are new drug formulations impacting these existing therapies?
Long-acting injectables and fixed-dose combinations improve adherence, reduce dosing frequency, and maintain efficacy, potentially cannibalizing traditional daily oral regimens.

5. What future trends should stakeholders monitor?
Key trends include the development of long-acting ART, expanding prophylactic uses, shifting safety preferences favoring TAF over TDF, and regulatory changes motivating innovation and market adaptation.

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References

[1] Grand View Research, “HIV Therapeutics Market Size, Share & Trends Analysis Report,” 2023.
[2] MarketsandMarkets, “Global HIV Drugs Market Forecast to 2028,” 2023.