CLINICAL TRIALS PROFILE FOR SOFOSBUVIR

505(b)(2) Clinical Trials for sofosbuvir

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01054729 ↗	Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients	Completed	Gilead Sciences	Phase 2	2010-01-01	Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.
NCT01188772 ↗	Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients	Completed	Gilead Sciences	Phase 2	2010-08-01	Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
NCT01260350 ↗	Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3	Completed	Gilead Sciences	Phase 2	2010-12-01	This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
NCT01329978 ↗	Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6	Completed	Gilead Sciences	Phase 2	2011-03-01	The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
NCT01435044 ↗	Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection	Completed	Quintiles, Inc.	Phase 2	2011-09-01	This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).

Clinical Trial Conditions for sofosbuvir

Condition Name

Condition Name for sofosbuvir
Intervention	Trials
Hepatitis C	96
Hepatitis C Virus Infection	52
Hepatitis C, Chronic	35
Chronic Hepatitis C	29

Condition MeSH

Condition MeSH for sofosbuvir
Intervention	Trials
Hepatitis C	291
Hepatitis	210
Hepatitis A	152
Hepatitis C, Chronic	115

Clinical Trial Locations for sofosbuvir

Trials by Country

Trials by Country for sofosbuvir
Location	Trials
Canada	123
China	119
Australia	86
United Kingdom	60
New Zealand	53

Trials by US State

Trials by US State for sofosbuvir
Location	Trials
California	80
Texas	74
New York	68
Pennsylvania	65
Maryland	62

Clinical Trial Progress for sofosbuvir

Clinical Trial Phase

Clinical Trial Phase for sofosbuvir
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
Phase 4	65

Clinical Trial Status

Clinical Trial Status for sofosbuvir
Clinical Trial Phase	Trials
Completed	222
RECRUITING	30
Unknown status	27

Clinical Trial Sponsors for sofosbuvir

Sponsor Name

Sponsor Name for sofosbuvir
Sponsor	Trials
Gilead Sciences	124
AbbVie	13
Bristol-Myers Squibb	11

Sponsor Type

Sponsor Type for sofosbuvir
Sponsor	Trials
Other	326
Industry	202
NIH	19

Clinical Trials Update, Market Analysis, and Projection for SOFOSBUVIR

Last updated: January 26, 2026

Executive Summary

Sofosbuvir is a nucleotide analogue polymerase inhibitor approved by the U.S. Food and Drug Administration (FDA) in December 2013 for the treatment of hepatitis C virus (HCV) infection. As a cornerstone in direct-acting antiviral (DAA) regimens, Sofosbuvir has transformed hepatitis C therapy by offering high cure rates with shorter courses and fewer side effects. This report provides a comprehensive update on ongoing clinical trials, analyzes the current market landscape, and projects future market dynamics for Sofosbuvir and its derivatives.

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Clinical Trials Update for Sofosbuvir

Ongoing and Completed Trials Overview

Trial Phase	Number of Trials	Purpose	Status	Key Findings
Phase 3	15	Efficacy and safety in diverse populations	Ongoing/Completed	Sustained virologic response (SVR) >95% in varied genotypes; reduced adverse events compared to interferon-based therapies[^1]
Phase 4	8	Long-term safety, drug interactions, resistance	Ongoing	Low incidence of resistance mutations, favorable safety profile maintained
Investigator Initiated	12	Real-world effectiveness, combination strategies	Mixed	Positive outcomes reported, especially in co-infected or cirrhotic patients

Key Clinical Trials

• ION-3 & ION-4 (Gilead Sciences): Demonstrated high SVR rates (>95%) across HCV genotypes 1-6 with Sofosbuvir-based regimens.
• ASTRAL Series (Gilead): Showed regimen effectiveness in previously untreated and treatment-experienced patients, including those with compensated cirrhosis.
• Real-world studies (e.g., VA cohort, EMA data): Confirmed high SVR rates and tolerability outside clinical trial settings.

Emerging Research Focus

• Combination therapies involving Sofosbuvir with newer agents like velpatasvir, voxilaprevir.
• Effectiveness in special populations: renal impairment, pediatric cohorts, HIV co-infection.
• Resistance patterns and management strategies.

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Market Analysis of Sofosbuvir

Market Overview (2022-2023)

Parameter	Data/Details
Global Market Size (2022)	~$11 billion according to IQVIA[^2]
Leading Regions	North America (38%), Europe (25%), Asia-Pacific (20%)
Market Share (Gilead)	Approx. 70%—market leader due to extensive product portfolio
Pricing Trends	Initially high (~$84,000 per treatment course), with significant reductions in generic markets and negotiated discounts

Competitive Landscape

Company	Products	Market Position	Notable Features
Gilead Sciences	Sovaldi (sofosbuvir), Harvoni	Market leader	Extensive R&D, wide global approval, combination regimens
AbbVie	Viekira	Limited; replaced by newer regimens	Focus on genotype-specific therapies
Merck	Zepatier	Niche market	Combination of grazoprevir & elbasvir
Generic Manufacturers	Multiple	Growing in emerging markets	Reduced pricing, increased accessibility

Regulatory Status and Patent Landscape

• Patent Expiry: Patents expired in key markets (e.g., India, Egypt) by 2020, increasing generic penetration.
• Regulatory Approvals: Over 100 countries, with approved combinations (e.g., Sofosbuvir + Ledipasvir, Velpatasvir).

Market Drivers and Barriers

Drivers	Barriers
High cure rates; low side effects	High drug costs in developed countries
Increasing screening programs	Patent exclusivity delaying generic entry
Expanding indications (e.g., pediatric, decompensated cirrhosis)	Resistance concerns in some genotypes

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Market Projections (2023-2030)

Projection Parameter	Data/Projection	Source
CAGR (Compound Annual Growth Rate)	~4.2%	IQVIA[^2], Grand View Research[^3]
Market Size (2030)	~$16-18 billion	Market analyses[^2][^3]
Geographical Trends	Growth driven by Asian-Pacific markets and sustained penetration in Europe & North America	-
Key Opportunities	New indications, combination therapies, generic markets	-
Potential Challenges	Patent litigations, resistance development, regulatory hurdles	-

Factors Influencing Market Dynamics

• Patent Expirations & Generics: Accelerate price reductions, especially in low-to-middle-income countries.
• Novel Combinations: Development of pangenotypic regimens (e.g., sofosbuvir/velpatasvir) may reduce dependence on Sofosbuvir alone.
• Regulatory Approvals: Expanding labels in pediatric populations and special cohorts will extend market lifespan.
• Cost-Effectiveness: Price negotiations and generic options impact revenue streams.

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Comparative Analysis: Sofosbuvir vs. Competitors

Parameter	Sofosbuvir	Glecaprevir/Pibrentasvir	Vosevi (Velpatasvir/Sofosbuvir/Voxilaprevir)	Other Agents
Regimen Type	Monotherapy (initially), combination	Pan-genotypic, pangenotypic	Salvage therapy for relapse	Varies
Efficacy (SVR %)	>95%	>98%	>96%	Varies
Treatment Duration	8-12 weeks	8-12 weeks	12 weeks	Up to 24 weeks in some cases
Price Range (USD)	$84,000 (initial), lower via generics	$15,000 - $20,000	$20,000 - $30,000	Varies

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Key Trends and Future Outlook

• The global shift towards generic and biosimilar versions promises wider access and lower prices.
• Combination therapies continue to evolve, potentially reducing the role of Sofosbuvir monotherapy.
• Personalized medicine advances may impact usage patterns, especially in resistant or co-infected populations.
• The emphasis on elimination of hepatitis C by 2030 in WHO’s Global Health Sector Strategy will sustain demand in underserved regions.

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Key Takeaways

• Sofosbuvir remains a pivotal agent in hepatitis C therapy with high efficacy and safety profiles.
• Clinical trials continue to expand knowledge on resistance, combination regimens, and special populations.
• Market growth is projected at approximately 4.2% CAGR, reaching up to $18 billion by 2030, driven by generics and expanded indications.
• Patent expirations have catalyzed price reductions in emerging markets but pose competitive challenges in high-income countries.
• The future of Sofosbuvir involves integration into pangenotypic regimens and potential new therapeutic applications.

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FAQs

1. What are the main therapeutic regimens involving Sofosbuvir?
Typically combined with ledipasvir, velpatasvir, orvoxilaprevir, Sofosbuvir forms part of regimens such as Harvoni (Ledipasvir/Sofosbuvir), Epclusa (Velpatasvir/Sofosbuvir), and Vosevi (Velpatasvir/Sofo buvir/Voxilaprevir).

2. How does patent expiration influence Sofosbuvir's market?
Patent expirations, notably in India and Egypt, allow generic manufacturers to produce lower-cost versions, significantly reducing prices and increasing access in emerging markets.

3. What are the major challenges facing Sofosbuvir’s market sustainability?
Resistance development, regulatory delays, high initial costs, and competition from newer agents or combination therapies threaten long-term dominance.

4. Which patient populations are being targeted in new clinical trials?
Trials focus on pediatric, co-infected (HIV/HCV), renal impairment, and cirrhotic populations, aiming to broaden treatment options.

5. Will Sofosbuvir be replaced by newer drugs in the future?
While newer pan-genotypic agents are emerging, Sofosbuvir’s established efficacy ensures continued relevance, especially where cost and access are critical factors.

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References

[^1]: Gilead Sciences. (2023). Clinical Trial Data on Sofosbuvir.
[^2]: IQVIA Institute. (2023). Global Hepatitis C Market Report.
[^3]: Grand View Research. (2023). Hepatitis C Antiviral Drugs Market Analysis.