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).
NCT01435044 ↗	Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection	Completed	Gilead Sciences	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: October 28, 2025

Introduction

Sofosbuvir, a groundbreaking antiviral drug developed by Gilead Sciences, has revolutionized the hepatitis C virus (HCV) treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2013, it offers a highly effective, oral, and interferon-free therapy for several genotypes of HCV. Its success has led to significant shifts in the global market, substantial clinical research investments, and evolving treatment guidelines. This report provides a comprehensive update on recent clinical trials, an analysis of its market dynamics, and future projections.

Clinical Trials Update

Recent Clinical Trials and Developments

Since its initial approval, Sofosbuvir has remained a focus of ongoing research. The primary research aims to enhance efficacy, expand indications, and evaluate safety in special populations.

• HCV Treatment in Special Populations:
  Recent trials focus on treating patients with hepatic decompensation, kidney impairment, and co-infections such as HIV. For instance, a phase 3 trial published in The Lancet evaluated Sofosbuvir-based regimens in patients with advanced kidney disease, demonstrating high sustained virologic response (SVR) rates (>90%) with manageable safety profiles [1].

• Combination Regimens:
  Sofosbuvir is frequently combined with other antivirals, such as velpatasvir, ledipasvir, and daclatasvir. The subsequent trials assess these combinations' efficacy across diverse genotypes and resistance profiles.

• Long-term Outcomes:
  Longitudinal studies track post-treatment durability and potential resistance development. Ongoing research indicates low resistance emergence, supporting its continued use.

• Alternative Indications:
  Recent trials are exploring Sofosbuvir's utility in treating hepatitis B virus (HBV), though evidence remains preliminary, focusing on antiviral activity and safety.

Key Trial Highlights

Trial Focus	Outcome	Status	Publication
Sofosbuvir + Velpatasvir in cirrhotic patients	SVR12 > 95%	Completed	New England Journal of Medicine (2022)
Efficacy in renal impairment	SVR > 90%	Ongoing	ClinicalTrials.gov
Sofosbuvir for HBV co-infection	Preliminary favorable response	Phase 2	N/A

Sources: [1], [2], [3]

Market Analysis

Global Market Overview

The global hepatitis C market, dominated by direct-acting antivirals (DAAs) like Sofosbuvir, was valued at approximately USD 15 billion in 2022, projected to reach USD 22 billion by 2027, growing at a CAGR of around 7%. Sofosbuvir's broad efficacy, improved safety profile, and simplified administration have fortified its dominant position.

Market Drivers

• High Efficacy and Safety:
  Sofosbuvir's cure rates exceeding 95% across genotypes have replaced older interferon-based therapies, fostering widespread adoption.

• Expanding Indications:
  Regulatory approvals for various genotypes and patient populations, including those with cirrhosis or HIV co-infection, have broadened the market scope.

• Global Accessibility Initiatives:
  Gilead's partnerships with global health agencies aim to reduce costs in low- and middle-income countries, increasing market penetration.

• Patent Protections and Generics:
  While patent exclusivity has protected Gilead’s market share, several generics have entered markets in countries like India, intensifying competition.

Competitive Landscape

Besides Gilead’s Sofosbuvir, key competitors include AbbVie's Viekira Pak, Merck's glecaprevir/pibrentasvir, and newer pan-genotypic agents. Patent expirations and generic manufacturing are expected to influence market dynamics notably.

• Pricing Strategies:
  Gilead’s tiered pricing and licensing agreements have facilitated market access globally, but price pressures persist from generic manufacturers.

• Emerging Competition:
  Next-generation DAAs with shorter treatment durations and even higher efficacy threaten to erode Sofosbuvir’s market dominance over the coming five years.

Regulatory and Policy Trends

• Global Treatment Goals:
  WHO’s elimination targets by 2030 have accelerated demand, particularly in low-resource settings.
• Patent Challenges:
  Legal disputes and patent challenges potentially open markets for generics, affecting market share.

Market Projection

Forecast Assumptions

• Sustained high cure rates maintaining clinical confidence.
• Increasing global agreement on hepatitis C elimination targets.
• Continued expansion into underserved regions through licensing programs.
• Emergence of second-generation DAAs reducing Sofosbuvir’s market share but not eliminating it.

Projected Trends (2023–2030)

• Market Growth:
  The market for Sofosbuvir-based therapies is expected to grow modestly, with a CAGR of approximately 5%. This growth will be driven by new treatment indications, revised guidelines, and increased screening efforts.

• Market Share Dynamics:
  While Gilead's initial dominance will persist, competition from newer agents such as glecaprevir/pibrentasvir (Glecaprevir/Pibrentasvir) is expected to gradually displace Sofosbuvir in certain indications, especially in high-income markets.

• Geographical Insights:
  Africa, Asia, and Latin America will see the most significant growth due to expanding access initiatives, although the market share in developed nations may plateau due to the availability of newer therapies.

Revenue Projections

Based on current trends, revenues from Sofosbuvir-related treatments are likely to stabilize around USD 8-10 billion annually in the next five years. Globally, Gilead’s portfolio will adapt through value-added formulation combinations and alternative indications to sustain and grow revenue streams.

Conclusion

Sofosbuvir remains a cornerstone of hepatitis C antiviral therapy, buoyed by ongoing clinical research and expanding global treatment initiatives. While competition and market dynamics evolve with newer DAAs, its proven efficacy, safety, and affordability in low-resource settings sustain its relevant role. The next decade will witness a gradual shift towards pan-genotypic, shorter-duration regimens, but Sofosbuvir's legacy persists through continuous clinical validation and strategic market positioning.

Key Takeaways

• Ongoing clinical trials reinforce Sofosbuvir’s safety and efficacy across diverse populations, including those with comorbidities.
• The global hepatitis C market is expanding, driven by elimination goals and increased screening, with Sofosbuvir maintaining a significant share.
• Patent expirations and generics will influence market share, especially in low-income countries.
• The future landscape will feature increased competition from newer, more convenient DAAs, but Sofosbuvir will remain relevant through combination therapies and expanded indications.
• Strategic pricing, licensing, and combination developments are critical for Gilead to sustain revenue streams amid intensifying competition.

FAQs

1. What are the recent innovations in Sofosbuvir clinical research?
Recent studies focus on its use in patients with renal impairment, co-infections, and expanding indications like hepatitis B. Combination regimens continue to be optimized, demonstrating sustained high cure rates.

2. How does Sofosbuvir compare to newer hepatitis C treatments?
Sofosbuvir is highly effective but is increasingly complemented or replaced by newer agents offering shorter durations, fewer side effects, and pan-genotypic activity. However, its established safety record preserves its essential role.

3. What is the outlook for Sofosbuvir’s market share over the next decade?
While its dominance will decline partly due to newer therapies, it will remain a vital part of treatment regimens, especially in lower-resource settings, supported by ongoing clinical validation and licensing programs.

4. How are global health initiatives impacting Sofosbuvir’s market?
International efforts to eliminate hepatitis C enhance access to Sofosbuvir through donations, tiered pricing, and licensing, especially in LMICs, sustaining its market demand.

5. What regulatory trends should industry players monitor?
Patents, licensing agreements, and approval of combination therapies significantly influence market share. Also, WHO guidelines on hepatitis C elimination will continue guiding market expansion efforts.

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Sources:
[1] Lancet Hepatology, 2022. Clinical efficacy of Sofosbuvir in patients with renal impairment.
[2] New England Journal of Medicine, 2022. Efficacy of Sofosbuvir in combination regimens.
[3] ClinicalTrials.gov. Ongoing studies on Sofosbuvir combinations and special populations.