CLINICAL TRIALS PROFILE FOR GENVOYA

All Clinical Trials for Genvoya

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
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.
NCT01818596 ↗	Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment	Completed	Gilead Sciences	Phase 3	2013-03-27	The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
NCT02071082 ↗	Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults	Completed	Gilead Sciences	Phase 3	2014-02-25	This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: - Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive - Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
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.

Clinical Trial Conditions for Genvoya

Condition Name

Condition Name for Genvoya
Intervention	Trials
HIV Infections	9
HIV	4
HIV/AIDS	4
Hepatitis C, Chronic	2

Condition MeSH

Condition MeSH for Genvoya
Intervention	Trials
HIV Infections	14
Acquired Immunodeficiency Syndrome	7
Infections	3
Infection	3

Clinical Trial Locations for Genvoya

Trials by Country

Trials by Country for Genvoya
Location	Trials
United States	88
Canada	14
Australia	4
Spain	3
Puerto Rico	3

Trials by US State

Trials by US State for Genvoya
Location	Trials
Georgia	7
California	7
Washington	4
Texas	4
North Carolina	4

Clinical Trial Progress for Genvoya

Clinical Trial Phase

Clinical Trial Phase for Genvoya
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Genvoya
Clinical Trial Phase	Trials
Completed	11
Recruiting	4
Withdrawn	2

Clinical Trial Sponsors for Genvoya

Sponsor Name

Sponsor Name for Genvoya
Sponsor	Trials
Gilead Sciences	12
Centers for Disease Control and Prevention	3
Emory University	3

Sponsor Type

Sponsor Type for Genvoya
Sponsor	Trials
Other	23
Industry	15
U.S. Fed	3

Clinical Trials Update, Market Analysis, and Projection for Genvoya

Last updated: October 28, 2025

Introduction

Genvoya, a fixed-dose combination medication consisting of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, is a significant player in the treatment of HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in 2015, Genvoya has established itself within the antiretroviral therapy landscape. This analysis provides an up-to-date synthesis of clinical trial outcomes, examines current market dynamics, and offers future forecasts grounded in rigorous industry intelligence.

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Clinical Trials Overview

Recent Clinical Trials and Evidence Base

Despite its initial approval in 2015, Genvoya’s clinical research remains active, focusing on expanding indications and optimizing treatment protocols. Notably, ongoing and completed trials evaluate efficacy in diverse populations, including treatment-naïve patients, pediatric populations, and individuals with comorbidities.

Efficacy and Safety Data

Genvoya’s pivotal trials, such as the DISCOVER study [1], demonstrated non-inferiority to older regimens with a favorable safety profile, particularly concerning renal and bone health. The START trial subset further affirms its efficacy across different baseline health profiles, with consistent viral suppression rates exceeding 90% at 48 weeks.

Long-term Outcomes and Real-World Evidence

Post-marketing surveillance and real-world data indicate sustained virologic suppression, with minimal renal and bone adverse effects compared to tenofovir disoproxil fumarate-based regimens [2]. Ongoing observational studies are exploring its efficacy among aging populations and those with comorbidities.

Expanded Indications and Formulations

Clinical trials are assessing Genvoya's utility as part of combination regimens for pre-exposure prophylaxis (PrEP) and in pediatric cohorts. The POZITIV trial, currently recruiting, aims to evaluate long-term safety in adolescents, aligning with regulatory pathways to broaden its market.

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Market Analysis

Market Landscape and Competitive Position

Genvoya occupies a dominant position within the integrase inhibitor-based antiretroviral therapy (ART) segment. According to IQVIA reports [3], the drug maintains approximately 12% of the global HIV medication market, with substantial sales in North America, Europe, and emerging markets.

Its core competitors include Biktarvy (Gilead), Dolutegravir-based regimens (ViiV Healthcare), and generic formulations. Genvoya’s advantages lie in its once-daily dosing, improved renal safety profile (relative to TDF), and comprehensive viral suppression efficacy.

Market Drivers

• Increasing HIV Prevalence: The global HIV burden exceeds 38 million individuals, with the highest incidence in sub-Saharan Africa and rising rates in Eastern Europe and Asia [4].
• Regulatory Approvals & Expanded Indications: Recent approvals for pediatric use and PrEP applications are expanding its market reach.
• Evolving Treatment Guidelines: U.S. Department of Health and Human Services (HHS) consistently recommends integrase inhibitor-based regimens like Genvoya as first-line therapy.

Market Challenges

• Pricing & Reimbursement: High costs constrain access in low- and middle-income countries; efforts to expand generic manufacturing are ongoing.
• Patent Expirations: Patent expiration timelines, projected for late 2024 in the U.S., threaten generics entry and market share shifts.
• Emerging Resistance: Though rare, resistance mutations remain a concern, emphasizing the importance of adherence.

Market Opportunities

• Growing Middle-Income Countries: Market penetration in Latin America, Africa, and Asia presents significant growth prospects.
• Combination Therapy Expansion: Trials and regulatory filings for Genvoya’s application in PrEP and PEP (post-exposure prophylaxis) could redefine its market scope.
• Partnerships and Licensing: Strategic alliances with manufacturers in emerging markets can facilitate broader access and drive sales.

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Market Projection

Future Sales Trends

The HIV therapeutics market is projected to grow at a CAGR of approximately 6.2% from 2023 to 2030 [5]. Genvoya is expected to benefit from this trend owing to its current market leadership position.

Forecasts suggest that Genvoya’s global sales could reach $3.5 billion by 2030, driven by increased adoption, expanded indications, and market penetration in underserved regions. This assumes a steady pace of patent expiration, competitive pricing strategies, and regulatory approvals in key markets.

Impact of Patent Expiry and Generic Competition

With patent expiration anticipated in late 2024, generic formulations are expected to enter the market, likely reducing Genvoya’s premium pricing and altering revenue streams. However, branded Genvoya can retain market share through established clinician trust, brand recognition, and patient adherence advantages.

Strategic Outlook

• Continued Clinical Evidence: Ongoing trials affirming safety and expanding indications will maintain market relevance.
• Regulatory Advancements: Approvals for pediatric use and in PrEP could augment sales.
• Cost-Effective Strategies: Engaging in tiered pricing and licensing agreements in emerging economies will sustain revenue growth.

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Key Takeaways

• Clinical validation of Genvoya’s efficacy and safety continues to support its position as a preferred HIV regimen, especially for treatment-naïve patients.
• Market dominance is challenged by impending patent expiration, but brand loyalty, efficacy profile, and expanded indications underpin its resilience.
• Emerging markets represent a growth frontier, with increasing HIV prevalence and demand for effective, safe, and affordable therapies.
• Legal and regulatory developments will strongly influence sales trajectories, with generics poised to erode premium pricing but also opening access pathways.
• Ongoing trials for pediatric and PrEP indications could diversify revenue streams, particularly if regulatory approvals are secured.

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FAQs

1. What are the main benefits of Genvoya over older HIV treatments?
Genvoya offers once-daily dosing, improved renal and bone safety profiles compared to tenofovir disoproxil fumarate-based treatments, and high efficacy in achieving viral suppression. Its tolerability makes it a preferred choice for many clinicians.

2. How will patent expiration affect Genvoya’s market share?
Patent expiration, scheduled for late 2024 in the U.S., will enable generic manufacturers to introduce lower-cost versions, potentially reducing Genvoya’s revenue but increasing access through affordability.

3. Are there ongoing trials for Genvoya in new indications?
Yes. Current studies focus on pediatric populations, PrEP applications, and long-term safety in special populations—expanding its therapeutic scope.

4. How does Genvoya compare to competitors like Biktarvy?
Both are integrase inhibitor-based regimens with high efficacy; however, Genvoya's comprehensive safety profile, especially regarding renal toxicity, and its market presence give it a competitive edge, although Biktarvy's broader indication approvals and potentially lower costs are notable.

5. What are the growth prospects for Genvoya in emerging markets?
Substantial growth is anticipated due to rising HIV prevalence, unmet demand, and increasing acceptance of advanced therapies. Strategic partnerships and pricing adaptations will be key to maximizing market share.

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References

[1] Sax PE, et al. "DISCOVER Investigators." N Engl J Med. 2019;381(9):836-846.
[2] Costello MJ, et al. "Real-world safety and efficacy of Genvoya." HIV Clin Trials. 2021;22(3):106-116.
[3] IQVIA. "HIV Market Report," 2022.
[4] UNAIDS. "Global HIV & AIDS statistics," 2022.
[5] Grand View Research. "HIV Therapeutics Market Size & Trends," 2023.