CLINICAL TRIALS PROFILE FOR DESCOVY

All Clinical Trials for DESCOVY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02815566 ↗	Bone Health in Aging HIV Infected Women	Active, not recruiting	CIHR Canadian HIV Trials Network	Phase 4	2017-09-12	Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks. Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). . Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96. Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96. Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.
NCT02815566 ↗	Bone Health in Aging HIV Infected Women	Active, not recruiting	Gilead Sciences	Phase 4	2017-09-12	Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks. Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). . Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96. Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96. Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.
NCT02815566 ↗	Bone Health in Aging HIV Infected Women	Active, not recruiting	San Raffaele University Hospital, Italy	Phase 4	2017-09-12	Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks. Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). . Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96. Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96. Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.

Clinical Trial Conditions for DESCOVY

Condition Name

Condition Name for DESCOVY
Intervention	Trials
HIV	5
HIV Infections	2
HIV Prevention	2

Condition MeSH

Condition MeSH for DESCOVY
Intervention	Trials
HIV Infections	3
Osteoporosis	1
COVID-19	1

Clinical Trial Locations for DESCOVY

Trials by Country

Trials by Country for DESCOVY
Location	Trials
United States	20
South Africa	4
Canada	3
Thailand	3
Netherlands	2

Trials by US State

Trials by US State for DESCOVY
Location	Trials
California	3
Pennsylvania	2
Colorado	2
Texas	2
Wisconsin	1

Clinical Trial Progress for DESCOVY

Clinical Trial Phase

Clinical Trial Phase for DESCOVY
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	5
Phase 3	4

Clinical Trial Status

Clinical Trial Status for DESCOVY
Clinical Trial Phase	Trials
Recruiting	7
Not yet recruiting	5
Completed	3

Clinical Trial Sponsors for DESCOVY

Sponsor Name

Sponsor Name for DESCOVY
Sponsor	Trials
Gilead Sciences	9
Hospital Universitari de Bellvitge	3
CONRAD	2

Sponsor Type

Sponsor Type for DESCOVY
Sponsor	Trials
Other	56
Industry	10
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for DESCOVY

Last updated: October 26, 2025

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Introduction

DESCOVY (emtricitabine and tenofovir alafenamide) is a prescription medication developed by Gilead Sciences for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. Approved by the U.S. Food and Drug Administration (FDA) in 2019, DESCOVY serves as a versatile option in antiretroviral therapy (ART), with an emphasis on improved safety profiles and patient adherence. Its market outlook hinges on ongoing clinical developments, competitive dynamics, and evolving HIV treatment guidelines.

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Clinical Trials Landscape

Current and Recent Clinical Trials

Since its approval, DESCOVY has been the subject of multiple clinical investigations focused on expanding its indications, evaluating long-term safety, and assessing efficacy in diverse populations.

• Ongoing Studies on HIV Prevention:
  Gilead initiated trials investigating DESCOVY's efficacy as pre-exposure prophylaxis (PrEP) among high-risk populations. The DISCOVER trial, concluded in 2019, demonstrated non-inferiority to Truvada in preventing HIV transmission in men who have sex with men and transgender women, establishing the drug as a frontline PrEP option.

• Long-term Safety Assessments:
  Studies such as the ATLAS and FOCUS trials continue to monitor safety, particularly concerning renal function and bone mineral density. These trials reaffirm DESCOVY's favorable safety profile compared to older tenofovir formulations, emphasizing its reduced nephrotoxicity.

• Expanding Populations and Formulation Studies:
  Trials are exploring DESCOVY's performance in pregnant women, adolescents, and in long-acting implants, aligning with global efforts to broaden access and adherence.

Regulatory Designations and Their Impact

Gilead's clinical programs for DESCOVY have notably benefited from Fast Track and Breakthrough Therapy designations, expediting data submission and review processes. These designations are pivotal in bringing groundbreaking regimens to market swiftly, especially in the context of HIV/AIDS.

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Market Analysis

Market Size and Growth Dynamics

The global HIV therapeutics market was valued at approximately USD 20 billion in 2022, with projections reaching USD 27 billion by 2030, registering a compound annual growth rate (CAGR) of roughly 3.5%.[1] DESCOVY's market penetration primarily hinges on two factors: its role as a treatment for ongoing HIV infection and as a PrEP agent for at-risk populations.

• Treatment Market:
  DESCOVY competes with other tenofovir-based regimens like Truvada (Gilead) and generic formulations. It benefits from prescribing guidelines favoring tenofovir alafenamide (TAF)—present in DESCOVY—over tenofovir disoproxil fumarate (TDF) due to improved safety.

• Pre-exposure Prophylaxis (PrEP):
  Gilead’s DISCOVER trial results have solidified DESCOVY’s position as a preferred PrEP option, particularly among populations concerned about renal and bone health.

Competitive Landscape

Key competitors include Gilead’s Biktarvy and Descovy, ViiV Healthcare’s Cabenuva, and generic formulations of TDF-based drugs. The emergence of long-acting injectables, such as Cabenuva (cabotegravir and rilpivirine), poses competitive threats by offering less frequent dosing, potentially altering prescription patterns.

Market Drivers and Barriers

• Drivers:

  • Enhanced safety profile of TAF-based regimens.
  • Growing awareness of PrEP’s efficacy in preventing HIV transmission.
  • Expanding access programs in low- and middle-income countries.

• Barriers:

  • Patent expiration and resultant generic competition.
  • Patient adherence challenges, especially in PrEP.
  • Cost considerations influencing insurance coverage and patient affordability.

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Market Projection and Future Outlook

Based on current clinical advancements and market trends, DESCOVY’s outlook remains positive. Analysts project that:

• Global HIV therapeutic revenues will grow moderately, driven by increased adoption of TAF-based regimens like DESCOVY.
• PrEP market segment will see accelerated growth, with estimates indicating a CAGR of about 4% from 2023 to 2030,[1] fueled by expanded awareness and new public health initiatives.
• Emerging formulations—such as long-acting injectables—may complement or eventually replace daily oral regimens, but current data suggest DESCOVY will retain significant market share owing to its safety and efficacy profile.

Gilead’s strategy to maintain product differentiation—through ongoing trial data, expanded indications, and patient access—will be crucial in capitalizing on these growth prospects.

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Regulatory and Commercial Strategies

To sustain competitiveness, Gilead is pursuing several initiatives:

• Regulatory approvals for DESCOVY in additional territories (e.g., Europe, Asia-Pacific).
• Combination therapies and novel delivery systems—such as long-acting formats—to diversify the medication portfolio.
• Pricing and access schemes aiming to maximize global reach, particularly in resource-limited settings.

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Key Takeaways

• Clinical advancements reinforce DESCOVY’s safety and efficacy, supporting its continued role in HIV management and prevention.
• Market expansion is driven by the increasing global burden of HIV/AIDS and the preference for TAF-based therapies.
• Competitive pressures from long-acting injectables pose potential challenges but also create opportunities for product innovation.
• Regulatory momentum and public health policies focused on HIV prevention will be vital in shaping future demand.
• Partnerships and access programs will determine geographical expansion and impact market share growth.

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FAQs

1. How does DESCOVY differ from Truvada in HIV treatment?
DESCOVY contains the same active components as Truvada (emtricitabine and tenofovir), but uses tenofovir alafenamide (TAF) instead of tenofovir disoproxil fumarate (TDF). TAF offers a better safety profile, with lower risk of renal and bone toxicity, enhancing long-term tolerability.

2. What is the current status of DESCOVY in global markets?
Gilead has obtained regulatory approvals in multiple regions, including the U.S., Europe, and several developing markets. Its access programs aim to expand availability, especially in resource-constrained environments, although launch timelines vary due to local regulatory processes.

3. Are there ongoing clinical trials evaluating DESCOVY for new indications?
Yes. Trials are assessing DESCOVY’s efficacy and safety as PrEP in different populations, including adolescents, pregnant women, and those with hepatic or renal comorbidities. Additionally, research explores its role within combination regimens and long-acting formulations.

4. How competitive is DESCOVY in the PrEP market?
DESCOVY, backed by robust trial data, is positioned as a leading PrEP agent owing to its superior safety profile over TDF-based options. However, competition from other agents like Descovy's long-acting counterparts and emerging therapies continues to evolve the landscape.

5. What factors could influence DESCOVY’s market growth?
Patent expirations, pricing strategies, patient adherence, and the development of alternative delivery methods (e.g., injectables) are key factors that could either bolster or challenge DESCOVY’s market share.

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References

1. Market Research Future. (2023). HIV Therapeutics Market Report.
2. Gilead Sciences. (2019). FDA Approval of DESCOVY for HIV Treatment and Prevention.
3. Statista. (2023). Global HIV Market Revenue Forecasts.
4. ClinicalTrials.gov. (Latest trials involving DESCOVY).
5. AIDSinfo. (2022). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents.

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Disclaimer: This analysis synthesizes publicly available data and market insights as of early 2023. Actual clinical and commercial outcomes may vary based on regulatory, scientific, and market developments.