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

Sofosbuvir: Clinical Trials Update, Market Analysis, and Profit Projection

Last updated: April 27, 2026

What is sofosbuvir and what is its current clinical position?

Sofosbuvir is an oral, direct-acting antiviral (DAA) for chronic hepatitis C (HCV). It is a nucleotide analog NS5B polymerase inhibitor. Core clinical role:

• Used in multiple HCV genotypes, typically in combination with other DAAs.
• Considered a backbone agent across many modern DAA regimens because it improves cure rates (SVR12) and tolerability versus older interferon-based therapies.
• A substantial portion of the current “clinical trials update” landscape is post-approval evidence: fixed-dose combinations, special populations (renal impairment), real-world effectiveness, drug interaction evaluations, and regimen optimization rather than new mechanism discovery.

Key efficacy end point and regulatory framing

Across pivotal and subsequent clinical programs, the standard efficacy end point is:

• Sustained virologic response at 12 weeks (SVR12), used as a surrogate for cure in HCV trials.

Regulatory approvals for sofosbuvir-based regimens are grounded in SVR12 and safety/tolerability, as reflected in prescribing and review materials for Sofosbuvir-containing products. [1], [2]

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What does the clinical trials update show after approval?

Because sofosbuvir is an established DAA, the “update” trend is ongoing optimization and evidence generation rather than first-in-class trials. The highest-yield themes in the clinical evidence base include:

1) Combination regimens expand scope and simplify therapy

Sofosbuvir has been repeatedly studied in combination with other DAAs to enable:

• Shorter course durations in selected populations
• Pan-genotypic or near-pan-genotypic coverage (depending on the companion drug)
• Interferon-free treatment

Clinical evidence on combinations is reflected in major drug labels and FDA review documents for sofosbuvir-containing regimens. [1], [2]

2) Special populations: renal impairment, cirrhosis, prior treatment

Post-approval evidence focuses on:

• Patients with compensated and decompensated cirrhosis (depending on regimen and era)
• Renal impairment populations
• Patients previously treated with other DAAs or interferon-based therapy

These studies inform label dosing rules and regimen selection logic used in practice. [1]

3) Safety and tolerability: on-treatment discontinuation and adverse events

Across clinical development and subsequent experience, the safety profile centers on:

• Low rates of discontinuation for adverse events
• Predominantly mild-to-moderate adverse events, with important regimen-dependent risks driven by ribavirin or interferon use when those combinations apply

Sofosbuvir-containing product safety information is summarized in labeling. [1]

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What are the primary clinical trial data anchors used by the market?

Market and reimbursement decisions track SVR12 rates and tolerability more than mechanism novelty. The data anchors typically come from:

• Pivotal sofosbuvir clinical programs (SVR12 across genotype strata and prior treatment status)
• Regimen studies in cirrhosis and special populations
• Post-marketing safety and effectiveness studies

Sofosbuvir product labeling provides the structured evidence summaries that payers and clinicians reference for expected outcomes. [1]

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Which sofosbuvir products drive revenue and how is the competitive landscape structured?

Sofosbuvir’s commercial impact historically leaned on:

• High cure rates in combination regimens
• Broad prescriber adoption across genotype and disease stages
• Later consolidation through fixed-dose combinations

Commercial competition shifts in waves:

• Early DAA era competed on cure rates and interferon elimination
• Later waves competed on pan-genotypic coverage, shorter courses, fixed-dose simplicity, and price

In practice, sofosbuvir’s long-run economics have been pressured by:

• Price erosion across DAAs
• Switching to later-generation pan-genotypic regimens where they offer similar efficacy with simpler logistics

Still, sofosbuvir remains in major regimen families and in combination products that continued to be used well into the pan-genotypic era, as reflected in evolving labeling and regimen availability records. [1], [2]

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How big is the hepatitis C market and what portion is addressable to sofosbuvir?

The hepatitis C therapeutics market is shaped by:

• Diagnosed prevalence and treatment uptake
• Re-treatment needs (rare in modern DAA era due to high SVR12)
• Competitive substitution by newer regimens

From a business perspective, sofosbuvir’s addressable market is the subset of HCV treatment that still uses sofosbuvir-containing combinations in each geography under:

• Formulary access
• Tender and procurement contracts
• Clinical pathways for cirrhosis and special populations

The commercial footprint is constrained by the rapid maturation of DAAs and the shift to simplified, fixed-dose, pan-genotypic regimens.

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What is the current competitive advantage of sofosbuvir in market terms?

Sofosbuvir’s “advantage” is no longer about being first. It is about being:

• A proven cure backbone with extensive clinical and real-world evidence
• A component of regimens with strong SVR12 across patient subgroups
• A drug with entrenched clinical familiarity and guideline incorporation

Those points show up in labeling evidence and the continued inclusion of sofosbuvir in regimen families. [1]

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What is the projection for sofosbuvir revenue and profit through market life?

A defensible projection must separate:

• Gross revenue exposure (units, pricing, tender access)
• Margin profile (manufacturing economics, royalties, and generic erosion)
• Timing of patent and exclusivity-driven substitution

1) Patent and exclusivity phase impact on projections

Sofosbuvir entered the market in the DAA wave and later faced broad generic entry dynamics. In most countries, generic competition compresses price quickly once key exclusivity barriers clear, driving revenue down while volume may remain.

Because this prompt does not supply country-by-country patent expiration, exclusivity, and generic entry timing data in the evidence bundle, a quantified profit projection tied to a specific timetable cannot be produced without risking inaccuracy.

2) What can be projected reliably without fabricating numbers

A directional and operational projection can be established from known market behavior of DAAs:

• Peak-to-decline curve after exclusivity loss
• Continued but reduced commercial role through combination/regimen inclusion and procurement inertia
• Margin compression due to price erosion and generic substitution

That direction is consistent with the labeling-centric evidence environment and the observed competitive market structure for DAAs. [1], [2]

Business-probable revenue shape (qualitative, decision-grade)

• Near term: modest residual demand where sofosbuvir-containing combinations remain in formularies and tenders.
• Medium term: continued contraction as payers and clinicians shift toward pan-genotypic fixed-dose options and lowest-cost procurement winners.
• Long term: sofosbuvir remains a component in legacy regimen pathways but does not lead new market growth.

Profitability implication (qualitative)

• Gross margin declines as pricing aligns to generic benchmarks.
• Profit is constrained by competitive pricing, tender volatility, and mix shift away from premium combination positioning.

No numeric profit forecast is provided here because the request requires market sizing and timing inputs that are not present in the supplied source evidence set.

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What is the practical market outlook by stakeholder?

Payers

• Emphasize lowest total cost of treatment for SVR12-equivalent outcomes.
• Prefer simpler pan-genotypic regimens with favorable procurement pricing.

Providers

• Use sofosbuvir-containing options where they remain in pathway recommendations or where specific regimen features fit patient needs.
• Favor evidence-backed regimens with predictable tolerability.

Industry (sponsors and competitors)

• Focus on lifecycle management: combination selection, line extensions, and contracting strategy.
• Compete on logistics and price rather than discovery differentiation.

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What are the key risks to any sofosbuvir market projection?

• Generic substitution speed by geography and procurement cycle.
• Switching behavior from sofosbuvir-containing regimens to newer pan-genotypic fixed-dose options.
• Tender price compression.
• Guideline changes that alter regimen selection logic.

These risks tie directly to how DAAs are purchased and reimbursed and to how labeling evidence is translated into pathways. [1], [2]

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Key Takeaways

• Sofosbuvir is an established NS5B polymerase inhibitor for HCV, with clinical evidence anchored on SVR12 and regimen combinations. [1]
• The “clinical trials update” post-approval is dominated by combination optimization and special-population evidence rather than mechanism changes. [1], [2]
• The market outlook for sofosbuvir is contraction-focused after exclusivity-driven peak demand, with residual volume supported mainly by formulary and tender inclusion.
• A quantified revenue/profit projection cannot be produced from the provided evidence set without risking fabricated timing and pricing inputs.

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FAQs

1. What endpoints define sofosbuvir trial success?
   SVR12 (sustained virologic response at 12 weeks) is the core efficacy endpoint used in pivotal and labeling evidence. [1]

2. Is sofosbuvir used as monotherapy?
   Sofosbuvir is used in combination DAA regimens for HCV rather than as a standalone therapy across standard practice frameworks. [1]

3. What patient groups does sofosbuvir evidence cover?
   Labeling evidence includes data across key subgroups such as cirrhosis status and prior treatment history, with regimen-dependent recommendations. [1]

4. Why has sofosbuvir’s market role changed over time?
   DAA market competition shifted toward simpler pan-genotypic fixed-dose regimens and lower procurement prices after exclusivity dynamics matured.

5. What drives prescribing and reimbursement today?
   Real-world effectiveness approximating SVR12 and total cost of treatment via formulary and tender decisions, typically favoring lowest-cost regimen options with strong efficacy. [1]

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References

[1] Gilead Sciences. Sovaldi (sofosbuvir) prescribing information. U.S. FDA label (accessed via FDA labeling records).
[2] U.S. Food and Drug Administration (FDA). Regulatory review and approval materials for sofosbuvir-containing therapies (accessed via FDA drug approval and review documentation).