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Last Updated: December 7, 2022

CLINICAL TRIALS PROFILE FOR SOFOSBUVIR; VELPATASVIR


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT02201940 ↗ Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection Completed Gilead Sciences Phase 3 2014-07-01 The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sofosbuvir; Velpatasvir

Condition Name

Condition Name for Sofosbuvir; Velpatasvir
Intervention Trials
Hepatitis C Virus Infection 27
Hepatitis C 23
Hepatitis C, Chronic 8
Chronic Hepatitis C 6
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Condition MeSH

Condition MeSH for Sofosbuvir; Velpatasvir
Intervention Trials
Hepatitis C 68
Hepatitis 47
Hepatitis A 29
Virus Diseases 29
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Clinical Trial Locations for Sofosbuvir; Velpatasvir

Trials by Country

Trials by Country for Sofosbuvir; Velpatasvir
Location Trials
United States 360
Canada 37
Australia 32
United Kingdom 21
Germany 19
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Trials by US State

Trials by US State for Sofosbuvir; Velpatasvir
Location Trials
Pennsylvania 28
Maryland 21
California 21
Texas 19
New York 19
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Clinical Trial Progress for Sofosbuvir; Velpatasvir

Clinical Trial Phase

Clinical Trial Phase for Sofosbuvir; Velpatasvir
Clinical Trial Phase Trials
Phase 4 17
Phase 3 21
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Sofosbuvir; Velpatasvir
Clinical Trial Phase Trials
Completed 41
Recruiting 12
Active, not recruiting 8
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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
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Sponsor Type

Sponsor Type for Sofosbuvir; Velpatasvir
Sponsor Trials
Other 63
Industry 46
NIH 4
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