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).
NCT01441180 ↗	GS-7977 With Ribavirin for Hepatitis C (SPARE)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2011-09-01	Background: - GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating the hepatitis C virus from the body. However, interferon can have serious side effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin. Objectives: - To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis C infection. Eligibility: - Individuals at least 18 years of age who have hepatitis C with liver disease, and have never received drugs for it. Design: - This study will require multiple clinic visits over 18 months. A liver biopsy will be required before the start of the study if participants have not had one within the past 3 years. - Participants will be screened with a medical history and physical exam. - Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken by mouth once a day. Ribavirin is taken by mouth in the morning and evening. - Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will involve regular blood tests and symptom monitoring. - After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12, 16, and 20. Blood and urine tests will be given to study virus levels in the body, and symptoms will be discussed. - Participants will stop receiving the study drugs at Week 24. - Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and 72. Another liver biopsy will be performed at 48 weeks. - Some participants may also be part of a smaller study. This study involves frequent blood draws to study drug and virus levels in the blood. The study will require a 36-hour hospital inpatient visit.

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 revenue projections

Last updated: July 26, 2026

Sofosbuvir is a first-generation oral, direct-acting antiviral (DAA) in hepatitis C virus (HCV). The clinical-trials period is effectively complete for core regimens; commercial growth now hinges on (1) label-line extensions, (2) combination-regimen adoption across genotypes and fibrosis stages, and (3) competitive displacement from newer NS5A/NS5B backbones and fixed-dose combinations. A reliable, litigation- and market-ready projection requires current market sizing, payer/geo uptake, and the latest FDA label and Orange Book status, none of which are provided in the prompt. Under the constraints, no complete and accurate market and projections can be produced.

What phase 3 trials established sofosbuvir efficacy across HCV genotypes?

Answer: Sofosbuvir’s phase 3 evidence is anchored by pivotal genotype-stratified trials using sofosbuvir-containing combinations, including studies in treatment-naïve and treatment-experienced populations, with and without cirrhosis.

Key regimen patterns used in pivotal studies

• Sofosbuvir + ledipasvir (often ledipasvir/sofosbuvir, “Harvoni” regimen in practice)
• Sofosbuvir + velpatasvir (often sofosbuvir/velpatasvir, “Epclusa” regimen in practice)
• Sofosbuvir + daclatasvir (regional combinations used historically)
• Sofosbuvir + ribavirin in specific settings

Endpoints that drove approvals

• SVR12 (sustained virologic response at 12 weeks) was the primary efficacy endpoint in registration datasets, reported by genotype and prior treatment status.
• Safety was tracked as treatment-emergent adverse events, with anemia signal management where ribavirin was used.

What do recent clinical updates mean for sofosbuvir’s place in therapy?

Answer: Post-approval “updates” for sofosbuvir have primarily been about optimizing combinations and expanding labeled populations. In modern practice, sofosbuvir’s commercial relevance increasingly depends on how it is packaged in branded fixed-dose products and how those products compete against newer DAA combinations.

Common update themes seen in later-label practice

• Use in broader genotype coverage through newer partner drugs
• Use in more advanced fibrosis/cirrhosis settings
• Use in special populations (e.g., those with prior DAA exposure, transplant contexts)

How does sofosbuvir market demand track HCV prevalence and DAA penetration?

Answer: Demand is determined by (1) HCV disease burden in treated regions, (2) payer restrictions and treatment guidelines, and (3) competitive DAA pricing and access. Sofosbuvir’s brand/system sales are sensitive to the pace of DAA adoption and the shift from earlier generations to regimens with improved simplicity and shorter duration.

Market drivers

• National screening and treatment scale-up programs
• Reimbursement policies for DAAs
• Net price pressure from generic entries and negotiated access

Market constraints

• Guideline preference shifts toward newer pan-genotypic regimens
• Generic substitution accelerating after patent and data exclusivity milestones

What are the main competitive substitutes for sofosbuvir in HCV treatment?

Answer: Sofosbuvir regimens compete with newer DAAs, particularly pan-genotypic and once-daily fixed-dose options that simplify treatment and reduce treatment-limiting adverse events.

Competitor clusters (by therapeutic class)

• NS5A inhibitors paired with NS5B inhibitors
• Pan-genotypic combinations that reduce the need for genotype testing
• Newer backbone products that shorten duration or improve tolerability

When does sofosbuvir lose exclusivity, and which products face generic entry risk first?

Answer: A precise exclusivity and patent-expiration schedule is product-specific because sofosbuvir is marketed in different fixed-dose combinations and often has separate IP estates for the combination product and method claims. A complete exclusivity map requires Orange Book and patent-family inputs that are not included in the prompt.

What is the Orange Book status of sofosbuvir-containing products?

Answer: Sofosbuvir itself is not typically evaluated as a standalone reference listed drug in the way many assess a single API versus a fixed-dose combination NDA. Orange Book status must be read for each reference product (e.g., ledipasvir/sofosbuvir and sofosbuvir/velpatasvir) and for each listed patent with expiration dates and exclusivity bars. The prompt provides no product identifiers, NDA/BLA numbers, or Orange Book listings, so an accurate status cannot be produced.

What patent estate protects sofosbuvir-based regimens, and where are Paragraph IV challenges likely?

Answer: Paragraph IV risk is concentrated around key reference products and their listed formulation, method-of-treatment, and combination-specific patents. Whether challenges are likely depends on the exact listed patents, their expiration dates, and any pediatric exclusivity or regulatory exclusivities applied to the combination regimen.

Typical IP claim categories in sofosbuvir regimens

• Formulation and dosage-form patents
• Method-of-use patents tied to specific combinations and durations
• Combination composition patents

What clinical trial evidence supports retreatment options that include sofosbuvir?

Answer: Sofosbuvir-containing regimens have evidence in treatment-naïve and treatment-experienced settings using combination partners and, in some contexts, ribavirin to achieve SVR.

Retreatment considerations

• Virologic response patterns by prior DAA class exposure
• Resistance-associated substitution impacts on choice of NS5A inhibitor partner
• Adherence and treatment duration decisions in cirrhosis

What regulatory milestones affect sofosbuvir’s current market prospects?

Answer: Current market prospects are shaped more by label scope and competitive scheduling than by discovery-stage regulatory milestones. Key regulatory influences include label updates (population expansion) and any post-approval safety communications or dosing refinements, each of which can affect prescribing behavior and payer policies.

Market projection for sofosbuvir: how much revenue could the drug generate through 2030?

Answer: A credible revenue projection requires current baseline revenue (by geography and branded versus generic mix), unit assumptions, pricing and net revenue erosion curves, and the timing of generic launch events by jurisdiction. The prompt does not include those inputs, and no accurate projection can be generated under the “complete and accurate response” constraint.

Key Takeaways

• Sofosbuvir’s clinical development is largely complete; competitive dynamics now depend on combination packaging, label breadth, and payer uptake.
• Market outcomes are driven by HCV treatment scale-up and net pricing pressure, with substitution risk from newer DAA regimens and generics.
• Exclusivity, Orange Book status, patent expiry, and Paragraph IV risk are product-specific and require reference-product identifiers and listed patents.

FAQs

1. How do sofosbuvir combination regimens compare on SVR12 by HCV genotype?
2. What ribavirin-containing sofosbuvir regimens remain relevant in current clinical practice?
3. Which countries typically allow earlier generic substitution of sofosbuvir-containing fixed-dose combinations?
4. How do treatment guidelines change the selection of sofosbuvir versus pan-genotypic competitors?
5. What resistance patterns influence outcomes in sofosbuvir-based retreatment strategies?

References

1. (No sources were provided in the prompt to cite.)