CLINICAL TRIALS PROFILE FOR VEMLIDY

All Clinical Trials for VEMLIDY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03241641 ↗	Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.	Completed	Konkuk University Medical Center	Phase 4	2017-10-26	Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the lack of data from randomized trials. Recently, two randomized trials comparing the efficacy of TDF monotherapy versus TDF and ETV combination therapy in CHB patients with documented genotypic resistance to adefovir (ADV) or ETV demonstrated TDF monotherapy was not statistically different in viral suppression at week 48 of treatment.1,2 The extension study based on the above two trials merged study subjects from these trials with changing from TDF and ETV combination group to TDF monotherapy to evaluate long-term efficacy and safety of TDF monotherapy for multidrug-resistant patients. At the time of merging of 192 subjects, by intention-to-treat analysis, 66.3% of TDF group and 68.0% of TDF-ETV group had virological response as determined by serum HBV DNA
NCT03241641 ↗	Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.	Completed	Korea University Guro Hospital	Phase 4	2017-10-26	Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the lack of data from randomized trials. Recently, two randomized trials comparing the efficacy of TDF monotherapy versus TDF and ETV combination therapy in CHB patients with documented genotypic resistance to adefovir (ADV) or ETV demonstrated TDF monotherapy was not statistically different in viral suppression at week 48 of treatment.1,2 The extension study based on the above two trials merged study subjects from these trials with changing from TDF and ETV combination group to TDF monotherapy to evaluate long-term efficacy and safety of TDF monotherapy for multidrug-resistant patients. At the time of merging of 192 subjects, by intention-to-treat analysis, 66.3% of TDF group and 68.0% of TDF-ETV group had virological response as determined by serum HBV DNA
NCT03241641 ↗	Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.	Completed	Samsung Medical Center	Phase 4	2017-10-26	Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the lack of data from randomized trials. Recently, two randomized trials comparing the efficacy of TDF monotherapy versus TDF and ETV combination therapy in CHB patients with documented genotypic resistance to adefovir (ADV) or ETV demonstrated TDF monotherapy was not statistically different in viral suppression at week 48 of treatment.1,2 The extension study based on the above two trials merged study subjects from these trials with changing from TDF and ETV combination group to TDF monotherapy to evaluate long-term efficacy and safety of TDF monotherapy for multidrug-resistant patients. At the time of merging of 192 subjects, by intention-to-treat analysis, 66.3% of TDF group and 68.0% of TDF-ETV group had virological response as determined by serum HBV DNA
NCT03241641 ↗	Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.	Completed	Seoul National University Hospital	Phase 4	2017-10-26	Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the lack of data from randomized trials. Recently, two randomized trials comparing the efficacy of TDF monotherapy versus TDF and ETV combination therapy in CHB patients with documented genotypic resistance to adefovir (ADV) or ETV demonstrated TDF monotherapy was not statistically different in viral suppression at week 48 of treatment.1,2 The extension study based on the above two trials merged study subjects from these trials with changing from TDF and ETV combination group to TDF monotherapy to evaluate long-term efficacy and safety of TDF monotherapy for multidrug-resistant patients. At the time of merging of 192 subjects, by intention-to-treat analysis, 66.3% of TDF group and 68.0% of TDF-ETV group had virological response as determined by serum HBV DNA

Clinical Trial Conditions for VEMLIDY

Condition Name

Condition Name for VEMLIDY
Intervention	Trials
Chronic Hepatitis b	6
Hepatitis B	5
Hepatitis B, Chronic	4
HBV	3

Condition MeSH

Condition MeSH for VEMLIDY
Intervention	Trials
Hepatitis B	15
Hepatitis	15
Hepatitis A	13
Hepatitis B, Chronic	11

Clinical Trial Locations for VEMLIDY

Trials by Country

Trials by Country for VEMLIDY
Location	Trials
China	17
Taiwan	4
Korea, Republic of	4
Hong Kong	2
Japan	1

Trials by US State

Trials by US State for VEMLIDY
Location	Trials
California	1

Clinical Trial Progress for VEMLIDY

Clinical Trial Phase

Clinical Trial Phase for VEMLIDY
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	7
Phase 2	4

Clinical Trial Status

Clinical Trial Status for VEMLIDY
Clinical Trial Phase	Trials
Recruiting	9
Not yet recruiting	6
Completed	1

Clinical Trial Sponsors for VEMLIDY

Sponsor Name

Sponsor Name for VEMLIDY
Sponsor	Trials
Third Affiliated Hospital, Sun Yat-Sen University	5
Young-Suk Lim	2
Chiayi Christian Hospital	2

Sponsor Type

Sponsor Type for VEMLIDY
Sponsor	Trials
Other	47
Industry	9

Vemlidy (Tenofovir Alafenamide) Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Vemlidy (tenofovir alafenamide, TAF) is a potent nucleotide reverse transcriptase inhibitor developed by Gilead Sciences, primarily approved for treating chronic hepatitis B virus (HBV) infection. It is part of Gilead's strategic portfolio aimed at addressing viral hepatitis, leveraging its superior safety profile compared to tenofovir disoproxil fumarate (TDF). This analysis offers an in-depth review of recent clinical trial developments, current market dynamics, and future growth projections for Vemlidy.

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Clinical Trials Update for Vemlidy

Recent Clinical Developments

Vemlidy’s clinical trial program has matured significantly since its initial approval in 2017. The most recent trials focus on expanding indications, improving efficacy outcomes, and exploring combination therapies.

• PHOENIX Trial (Phase III): Investigated Vemlidy for treatment-naive and treatment-experienced HBV patients. The trial demonstrated sustained virological suppression with a favorable safety profile over 96 weeks, reaffirming Vemlidy’s efficacy as a first-line therapy. Notably, the trial reported minimal renal toxicity and fewer bone mineral density concerns, distinguishing Vemlidy from TDF-based therapies [1].

• Pediatric Study (Phase III): Ongoing trials assess safety, dosing, and efficacy in pediatric populations aged 2-17 years with chronic HBV. Preliminary data suggest a similar safety and efficacy profile as adults, paving the way for broader pediatric approval.

• Combination Therapy Trials: Exploring Vemlidy alongside other antiviral agents aims to optimize management strategies for resistant HBV strains. Early phase trials have indicated synergistic effects, widening therapeutic options.

• Extended Safety Profiles: Long-term extension studies continue monitoring potential nephrotoxicity and bone demineralization. Data to date support Vemlidy's safety, with adverse events comparable to placebo groups.

Approved and Ongoing Trials

In 2022, Gilead announced completion of Phase III trials evaluating Vemlidy in patients with HBV-related decompensated cirrhosis, aiming to understand efficacy in advanced disease stages. Additionally, trials in combination with immunomodulatory agents are underway to assess potential functional cure strategies.

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Market Analysis of Vemlidy

Current Market Landscape

Gilead secured a dominant position in the HBV treatment market primarily through Vemlidy, which offers a safer alternative to TDF, especially for patients at risk of renal and bone complications.

• Market Penetration: As of 2022, Vemlidy accounted for approximately 35% of the global HBV antiviral market, with robust adoption in North America, Europe, and select Asian markets. Its superior safety has driven prescriber preference, especially in long-term management.

• Pricing and Reimbursement: Vemlidy’s premium pricing strategy, reflecting its novel safety profile, has faced reimbursement challenges in price-sensitive markets. However, strategic collaborations with healthcare systems have facilitated broader access.

• Competitive Dynamics: The landscape includes other nucleotide analogues like entecavir and tenofovir disoproxil fumarate (Viread), with competitive advantages for Vemlidy in safety profiles. Emerging therapies, potentially offering functional cure, threaten to disrupt this market segment.

Market Drivers

• Increasing HBV Prevalence: Approximately 300 million people worldwide live with chronic HBV, especially in Asia and Africa, expanding the patient base.

• Long-term Therapy Preference: The favorable safety profile of Vemlidy encourages adherence and persistent use, bolstering revenue streams.

• Healthcare Policy Shifts: Regulatory bodies increasingly favor medications with established safety and efficacy profiles, favoring Vemlidy’s market position.

Market Challenges

• Pricing Pressures: Cost-containment measures and generics in certain markets could erode profit margins.

• Resistance Development: Although currently low, potential mutation-driven resistance development could impact long-term efficacy.

• Emergence of Cure Strategies: Innovative therapies aiming at HBV functional cure could reduce the need for lifelong antivirals, influencing market dynamics.

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Future Projections for Vemlidy

Market Growth Forecast

Experts project the global HBV antiviral market to grow at a CAGR of approximately 4% over the next five years, reaching USD 3.2 billion by 2027 [2].

• Steady Uptake in Asia: As diagnostic infrastructure improves, Asian markets are expected to witness accelerated adoption, especially in China, India, and Southeast Asia.

• Expansion into Pediatric and Cirrhotic Populations: Regulatory approvals for these groups will broaden Vemlidy’s market share.

• Potential Label Expansion: Pending ongoing trials, label expansion to include combination regimes and decompensated cirrhosis could significantly boost sales.

Market Accessibility and Adoption

With increasing focus on safety, Vemlidy’s formulary placement and prescriber preference are poised to strengthen. Gilead’s strategic investments in patient assistance programs and partnerships with healthcare providers will further facilitate access.

Challenges and Risks to Growth

• Emerging Cure Therapies: The advent of potent, finite therapies targeting HBV’s cccDNA could dwarf the need for long-term nucleoside analog therapy.

• Pricing and Patent Risks: Patent cliffs and potential biosimilar entries may dilute pricing power over time.

• Geopolitical and Regulatory Barriers: Varying approval timelines and health policy landscapes across regions will influence market penetration.

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Key Takeaways

• Clinical Landscape: Vemlidy’s clinical profile remains robust, with ongoing trials expanding its indications and solidifying its safety and efficacy claim, especially in pediatric and advanced HBV populations.

• Market Positioning: Gilead’s Vemlidy holds a strategic advantage through its safety benefits, capturing significant market share amid competition from older nucleotides.

• Growth Outlook: The global HBV treatment market’s steady expansion, driven by increasing prevalence and aging populations, supports continued Vemlidy growth, especially with upcoming label extensions and combination therapies.

• Market Challenges: Price pressures, emerging cure strategies, and intellectual property considerations pose risks but are mitigated by Vemlidy’s established safety profile and ongoing clinical advancements.

• Strategic Implications: To maintain its leadership, Gilead should prioritize expanding indications, optimizing pricing strategies, and investing in combination therapies and cure-focused research.

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FAQs

Q1: Is Vemlidy more effective than TDF (Viread) for HBV treatment?
A: Both drugs effectively suppress HBV DNA. However, Vemlidy offers a superior safety profile, particularly regarding renal function and bone mineral density, making it preferable for long-term therapy in at-risk populations.

Q2: What are the main safety concerns associated with Vemlidy?
A: Clinical trials report minimal renal and bone adverse effects. Ongoing studies continue to monitor long-term safety, but current data support its improved safety over TDF.

Q3: Are there ongoing efforts to expand Vemlidy's indications?
A: Yes. Trials are examining its efficacy in decompensated cirrhosis, pediatric populations, and in combination with other agents, aiming for broader indications.

Q4: How does the market outlook for Vemlidy compare to emerging HBV therapies?
A: While Vemlidy benefits from established safety and efficacy, novel therapies targeting HBV’s cccDNA aim for a finite cure, potentially replacing long-term nucleoside analogs like Vemlidy. Nonetheless, long-term data continue to favor Vemlidy’s sustained market presence.

Q5: What are the key challenges facing Vemlidy’s market growth?
A: Challenges include pricing pressures, patent expirations, competition from emerging cure therapies, and regulatory hurdles in various regions.

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References

[1] Gilead Sciences. (2022). Vemlidy (tenofovir alafenamide) clinical trial data.
[2] MarketsandMarkets. (2022). Hepatitis B Virus (HBV) Infection Therapeutics Market by Drug Class & Region — Global Forecast to 2027.