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.
NCT02815566 ↗	Bone Health in Aging HIV Infected Women	Active, not recruiting	University of Modena and Reggio Emilia	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	University Health Network, Toronto	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.
NCT02957864 ↗	Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide	Recruiting	Gilead Sciences	Phase 4	2016-10-01	Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV. Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another drug that can be used for the treatment of HIV and is not associated with renal toxicity. In this study the investigators will compare the effect on renal function of a switch from TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.
NCT02957864 ↗	Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide	Recruiting	Erasmus Medical Center	Phase 4	2016-10-01	Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV. Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another drug that can be used for the treatment of HIV and is not associated with renal toxicity. In this study the investigators will compare the effect on renal function of a switch from TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.

Clinical Trial Conditions for DESCOVY

Condition Name

Condition Name for DESCOVY
Intervention	Trials
Hiv	5
HIV Infections	2
HIV Prevention	2
HIV-1-infection	2

Condition MeSH

Condition MeSH for DESCOVY
Intervention	Trials
HIV Infections	3
Acquired Immunodeficiency Syndrome	1
Renal Insufficiency, Chronic	1
Infections	1

Clinical Trial Locations for DESCOVY

Trials by Country

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

Trials by US State

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−

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

Clinical Trial Progress for DESCOVY

Clinical Trial Phase

Clinical Trial Phase for DESCOVY
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for DESCOVY
Clinical Trial Phase	Trials
Recruiting	6
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
Fundacio Lluita Contra la SIDA	2

Sponsor Type

Sponsor Type for DESCOVY
Sponsor	Trials
Other	55
Industry	10
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projections for Descovy

Introduction to Descovy

Descovy, a combination of emtricitabine and tenofovir alafenamide (TAF), is a pre-exposure prophylaxis (PrEP) medication designed to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents. Here, we will delve into the recent clinical trial updates, market analysis, and future projections for Descovy.

Clinical Trials Update

The DISCOVER Trial

The DISCOVER trial is a pivotal multi-year global Phase 3 registrational clinical trial that compares the safety and efficacy of Descovy with Truvada (emtricitabine and tenofovir disoproxil fumarate, TDF) for PrEP. Here are some key findings:

• Efficacy and Non-Inferiority: At both 48 and 96 weeks, Descovy demonstrated non-inferior efficacy to Truvada in preventing HIV infection among men and transgender women who have sex with men[1][4].
• Renal Safety: The 96-week data showed statistically significant differences in renal safety favoring Descovy, particularly in older participants and those with moderate renal impairment. Descovy users had smaller decreases in estimated glomerular filtration rate (eGFR) and better markers of proximal tubular function compared to Truvada users[1].
• Bone Mineral Density (BMD): Descovy was associated with favorable changes in BMD, especially in younger participants. At 96 weeks, spine and hip BMD increased in the Descovy group, while they decreased in the Truvada group[1].
• Adherence and Pharmacokinetics: The trial also analyzed adherence and the impact of concomitant hormone therapy on Descovy and Truvada. High adherence rates were observed, and there was no significant effect of gender-affirming hormone therapy on the pharmacokinetics of Descovy or Truvada[1].

Additional Studies and Findings

• Lenacapavir Study: Recent data from studies involving lenacapavir, an investigational twice-yearly subcutaneous PrEP option, showed high adherence rates to both lenacapavir and placebo injections. However, the study did not find significant differences in HIV incidence between Descovy and Truvada groups, with both being generally well-tolerated[3].

Market Analysis

Current Market Performance

• Sales and Market Share: Despite a 5-6% year-over-year decline in sales due to lower average realized prices and channel mix, Descovy maintains over 40% of the U.S. PrEP market share. The overall PrEP market has seen robust growth, up by over 11% in the first quarter of 2024[5].
• Competitive Landscape: Biktarvy, another Gilead product, continues to dominate the HIV treatment market with over 49% market share, while Descovy remains a significant player in the PrEP segment[5].

Market Trends and Growth

• Growing Demand: The PrEP market is expected to continue growing, driven by increasing awareness and adoption of HIV prevention strategies. Gilead's strong commercial foundation positions Descovy well for future growth[5].
• Emerging Competition: The introduction of generics and new long-acting PrEP options, such as lenacapavir, could impact Descovy's market share. However, Gilead's plans to launch lenacapavir as early as late 2025 could help maintain their leadership in the HIV prevention market[5].

Projections and Future Outlook

Sales Projections

• Short-Term: Despite current sales declines, Descovy is expected to see sequential growth due to favorable inventory and pricing dynamics. The overall HIV prevention market is projected to grow 4% year-over-year in 2024[2][5].
• Long-Term: With the potential launch of lenacapavir and continued growth in the PrEP market, Gilead is well-positioned to maintain its leadership in HIV prevention. The company expects total product sales excluding Veklury to grow in the 4-6% range versus 2023[2].

Regulatory and Clinical Developments

• Lenacapavir Approval: The anticipated approval and launch of lenacapavir could significantly impact the PrEP market, offering a twice-yearly subcutaneous option that may appeal to patients seeking less frequent dosing[5].
• Ongoing Trials: Continued clinical trials and analyses will provide further insights into the long-term efficacy and safety of Descovy and other PrEP options, influencing market dynamics and patient preferences[3].

Key Takeaways

• Clinical Efficacy and Safety: Descovy has demonstrated non-inferior efficacy to Truvada and favorable renal and bone safety profiles.
• Market Performance: Despite current sales declines, Descovy maintains a significant market share in the U.S. PrEP market.
• Future Outlook: The PrEP market is expected to grow, with Descovy and upcoming products like lenacapavir playing key roles.
• Regulatory and Clinical Developments: Ongoing trials and potential approvals will shape the future of HIV prevention.

Frequently Asked Questions (FAQs)

What is Descovy used for?

Descovy is used as a pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents.

How does Descovy compare to Truvada in terms of safety?

Descovy has shown favorable renal and bone safety profiles compared to Truvada, particularly in older participants and those with moderate renal impairment[1].

What are the key findings from the DISCOVER trial?

The DISCOVER trial demonstrated non-inferior efficacy of Descovy to Truvada, with favorable renal and bone safety outcomes, and stable lipid levels through 96 weeks[1][4].

How is the market for Descovy performing?

Despite a decline in sales, Descovy maintains over 40% of the U.S. PrEP market share, with the overall PrEP market showing robust growth[5].

What are the future projections for Descovy and the PrEP market?

The PrEP market is expected to grow, with Descovy and upcoming products like lenacapavir contributing to this growth. Gilead expects total product sales excluding Veklury to grow in the 4-6% range versus 2023[2][5].

Cited Sources

1. Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy for HIV PrEP - Gilead Sciences.
2. Q224 Yr/Yr Qtr/Qtr Management Commentary - Gilead Sciences.
3. Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024 - Gilead Sciences.
4. DESCOVY FOR PrEP® (pre-exposure prophylaxis) Efficacy Data - Descovy HCP.
5. GILEAD SCIENCES FIRST QUARTER 2024 EARNINGS - Gilead Sciences.