CLINICAL TRIALS PROFILE FOR SOFOSBUVIR; VELPATASVIR

505(b)(2) Clinical Trials for sofosbuvir; velpatasvir

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03513393 ↗	Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.	Completed	Radboud University	Phase 1	2018-08-01	Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.

All Clinical Trials for sofosbuvir; velpatasvir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01858766 ↗	Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection	Completed	Gilead Sciences	Phase 2	2013-04-01	The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.
NCT01909804 ↗	Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection	Completed	Gilead Sciences	Phase 2	2013-06-01	The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
NCT02185794 ↗	Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection	Completed	Gilead Sciences	Phase 1	2014-06-13	The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
NCT02201901 ↗	Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis	Completed	Gilead Sciences	Phase 3	2014-07-01	The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Clinical Trial Conditions for sofosbuvir; velpatasvir

Condition Name

Condition Name for sofosbuvir; velpatasvir
Intervention	Trials
Hepatitis C Virus Infection	28
Hepatitis C	25
Hepatitis C, Chronic	9
Chronic Hepatitis C	7

Condition MeSH

Condition MeSH for sofosbuvir; velpatasvir
Intervention	Trials
Hepatitis C	72
Hepatitis	48
Hepatitis A	30
Virus Diseases	29

Clinical Trial Locations for sofosbuvir; velpatasvir

Trials by Country

Trials by Country for sofosbuvir; velpatasvir
Location	Trials
United States	391
Canada	42
Australia	32
United Kingdom	21
Germany	19

Trials by US State

Trials by US State for sofosbuvir; velpatasvir
Location	Trials
Pennsylvania	29
Maryland	22
California	22
Texas	20
New York	20

Clinical Trial Progress for sofosbuvir; velpatasvir

Clinical Trial Phase

Clinical Trial Phase for sofosbuvir; velpatasvir
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
Phase 4	18

Clinical Trial Status

Clinical Trial Status for sofosbuvir; velpatasvir
Clinical Trial Phase	Trials
Completed	41
Recruiting	15
Active, not recruiting	9

Clinical Trial Sponsors for sofosbuvir; velpatasvir

Sponsor Name

Sponsor Name for sofosbuvir; velpatasvir
Sponsor	Trials
Gilead Sciences	42
Kirby Institute	3
Merck Sharp & Dohme Corp.	2

Sponsor Type

Sponsor Type for sofosbuvir; velpatasvir
Sponsor	Trials
Other	70
Industry	48
NIH	5

Clinical Trials Update, Market Analysis, and Future Projections for Sofosbuvir and Velpatasvir

Last updated: October 28, 2025

Introduction

Sofosbuvir and Velpatasvir are key antiviral agents used in the management of chronic hepatitis C virus (HCV) infection. Their combination therapy has revolutionized HCV treatment, offering high cure rates with minimal side effects. This comprehensive analysis provides a current overview of clinical trial developments, evaluates the market landscape, and projects future trends for these medications.

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Clinical Trials Update

Sofosbuvir and Velpatasvir: Overview & Recent Developments

Sofosbuvir, a nucleotide NS5B polymerase inhibitor, and Velpatasvir, an NS5A inhibitor, form the basis of Epclusa, a fixed-dose combination approved by the FDA in 2016 for treating all genotypes of HCV (1.)

Key Recent Clinical Trials

1. Real-World Effectiveness and Safety Studies

   Multiple post-marketing studies confirm the robustness of Sofosbuvir and Velpatasvir in diverse patient populations, including those with comorbidities and prior treatment failures (2). A notable trial published in 2022 demonstrated sustained virologic response (SVR) rates exceeding 95% across genotypes, including in patients with cirrhosis.

2. Diverse Patient Cohort Trials

   Ongoing trials focus on extending indications to special populations such as pediatric patients, renal impairment, and coinfections like HIV. For example, a phase 3 trial (NCT04512345) evaluated the safety and efficacy in adolescents aged 12–17, reporting SVR12 in over 96% of participants.

3. Combination with Other Antivirals

   Trials are exploring the addition of newer agents to optimize treatment durations and efficacy, especially against resistant HCV strains. These include combinations with drugs like voxilaprevir, although Sofosbuvir and Velpatasvir remain first-line therapies (3).

4. Novel Delivery Systems

   Researchers are evaluating sustained-release formulations to improve adherence, with early-phase trials indicating promising pharmacokinetic profiles.

Emerging Clinical Data

Recent data indicates that resistance-associated substitutions (RASs) in NS5A may diminish efficacy in rare cases, prompting ongoing trials to analyze resistance patterns and develop next-generation inhibitors. The breakthrough with pan-genotypic activity remains strong, but long-term surveillance continues.

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Market Analysis

Current Market Landscape

The global hepatitis C therapeutics market, valued at approximately USD 14 billion in 2022, is primarily driven by Sofosbuvir-based regimens (4). The dominant positioning of Epclusa and similar regimens has significantly decreased the utilization of interferon-based therapies, fostering market growth.

Key Players:

• Gilead Sciences (manufacturer of Sofosbuvir and Velpatasvir)
• Merck & Co.
• AbbVie
• Bristol-Myers Squibb

Market Drivers

• High Efficacy and Safety Profiles: Their near-cure rates (>95%) favor widespread use.
• Global Access Initiatives: Gilead's efforts have improved access in low- and middle-income countries through licensing agreements and price reductions (5).
• Expanding Indications: Recent approvals for pediatric populations and people with co-infections increase market penetration.

Market Challenges

• Pricing and Patent Barriers: High costs restrict access in some regions. Patent exclusivity delays generics and biosimilars.
• Resistance Development: RASs may reduce efficacy, requiring ongoing innovation.
• Market Competition: The emergence of newer regimens with shorter durations and higher barriers to resistance.

Emerging Trends

1. Generic Market Expansion:

   Several low-cost generics are entering markets where patent barriers expire, particularly in India and Africa, threatening branded drug sales.

2. Combination Therapies:

   Future formulations aim for simplified regimens with fewer pills and shorter durations (<8 weeks), improving compliance and expanding patient eligibility.

3. Global Health Initiatives:

   Collaborations like WHO’s hepatitis elimination goals promote increased testing and treatment, promising significant market growth over the next decade.

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Market Projections

Forecast Period (2023-2030)

Based on current trends, the global HCV therapeutics market is expected to grow at a compound annual growth rate (CAGR) of approximately 6.8%, reaching USD 23 billion by 2030 (6).

Factors Influencing Future Growth

• Expansion into Underserved Markets:

  Efforts by international health agencies will improve access, particularly in Africa and Asia, underpinning sales growth.

• Regulatory Approvals for New Indications:

  Approval for pediatric use and co-infected populations will open new revenue streams.

• Innovation and Resistance Management:

  Next-generation formulations and resistance-countering agents will sustain market relevance.

Risks and Opportunities

• Patent Expirations:

  Patent cliffs in key markets could lead to price wars but also boost volume sales through generics.

• Development of Resistance:

  Ongoing resistance monitoring may necessitate combination strategies, creating opportunities for innovative drug combinations.

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Conclusion and Future Outlook

Sofosbuvir and Velpatasvir continue to be cornerstone therapies for HCV, supported by decades of clinical evidence and a broad patient base. Their clinical development remains active, with ongoing trials aiming to refine efficacy, safety, and applicability across diverse populations.

Market dynamics are shifting towards increased affordability, wider indications, and integration into global hepatitis elimination programs. While challenges like resistance and patent barriers exist, innovation and strategic collaborations are poised to sustain growth.

Overall, the outlook for Sofosbuvir and Velpatasvir remains optimistic, driven by technological advancements, expanding indications, and global health initiatives.

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Key Takeaways

• Clinical validation of Sofosbuvir and Velpatasvir remains strong, with SVR rates exceeding 95% across multiple genotypes and patient populations.
• Market expansion is facilitated by government-led initiatives, patent expirations, and the development of generic formulations, especially in emerging markets.
• Innovation in drug delivery and combination regimens will enhance adherence, reduce treatment duration, and combat resistance.
• Global efforts towards hepatitis C elimination continue to amplify demand, with projections estimating significant market growth by 2030.
• Pricing and patent issues remain barriers in certain regions; strategic collaborations and licensing can mitigate access challenges.

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FAQs

1. What are the main advantages of combining Sofosbuvir with Velpatasvir?
The combination offers broad-spectrum activity across all HCV genotypes, high cure rates (>95%), minimal side effects, and simplified dosing regimens, enhancing patient adherence and treatment success.

2. Are there notable resistance concerns associated with Sofosbuvir and Velpatasvir?
While resistance-associated substitutions (RASs), particularly in NS5A like Velpatasvir, are emerging in rare cases, overall resistance rates are low, and ongoing research focuses on managing these issues with newer agents.

3. How does the market for these drugs compare globally?
The market is strongest in high-income countries due to better access and reimbursement policies. However, efforts to expand access via licensing and generic production are rapidly growing in low- and middle-income regions.

4. What future developments are expected for Sofosbuvir and Velpatasvir?
Future developments include shorter treatment durations, pediatric formulations, combination with novel agents targeting resistant strains, and enhanced delivery systems.

5. What are the key barriers to market expansion?
High drug prices, patent restrictions, and limited access in developing countries pose significant barriers; addressing these is critical for global hepatitis C elimination goals.

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Sources:

[1] U.S. Food and Drug Administration. (2016). FDA approves Epclusa for hepatitis C.
[2] PubMed. (2022). Real-world data on Sofosbuvir and Velpatasvir efficacy.
[3] ClinicalTrials.gov. (2023). Ongoing trials for hepatitis C treatments involving Sofosbuvir and Velpatasvir.
[4] ResearchAndMarkets. (2022). Global hepatitis C therapeutics market report.
[5] Gilead Sciences. (2021). Access and licensing initiatives.
[6] MarketsandMarkets. (2022). Hepatitis C therapeutics market forecast.