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Last Updated: October 23, 2020

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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. Not yet recruiting 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.
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.
>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 26
Hepatitis C 17
Hepatitis C, Chronic 7
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Condition MeSH

Condition MeSH for Sofosbuvir; Velpatasvir
Intervention Trials
Hepatitis C 56
Hepatitis 37
Virus Diseases 28
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Clinical Trial Locations for Sofosbuvir; Velpatasvir

Trials by Country

Trials by Country for Sofosbuvir; Velpatasvir
Location Trials
United States 306
Canada 34
Australia 28
United Kingdom 17
Germany 17
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Trials by US State

Trials by US State for Sofosbuvir; Velpatasvir
Location Trials
Pennsylvania 20
Maryland 18
Massachusetts 17
California 17
Florida 16
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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 11
Phase 3 21
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Sofosbuvir; Velpatasvir
Clinical Trial Phase Trials
Not yet recruiting 22
Recruiting 18
Completed 14
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Clinical Trial Sponsors for Sofosbuvir; Velpatasvir

Sponsor Name

Sponsor Name for Sofosbuvir; Velpatasvir
Sponsor Trials
Gilead Sciences 38
Kirby Institute 3
University of Maryland 2
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Sponsor Type

Sponsor Type for Sofosbuvir; Velpatasvir
Sponsor Trials
Industry 40
Other 39
NIH 3
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