Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)

Archives 2017-2015 - Research & Media Articles
Before FDA Approval Of Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
View key data collected online from peer-reviewed journals, liver meetings/conferences, media coverage, commentary and interactive learning activities.

FDA APPROVED Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
HIGHLIGHTS OF PRESCRIBING INFORMATION
Prescribing Information: Vosevi


Hepatitis C OnlineVosevi: Drug Summary, Clinical Trial Data/and Slide Deck

NATAP - HCV Treatment-Exoerienced - Sofosbuvir+Velpatasvir+Voxilaprevir - (09/05/17)

UPDATES
Nov 24, 2017

Nov 20, 2017
Vosevi & Mavyret: The Impact of New Options for DAA-Experienced Patients With HCV

Nov 13, 2017
Review - Labeling for Several HCV Drugs Updated With New Drug Interactions
Updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin

Oct 25, 2017
Benefit-Risk Assessment for Sofosbuvir/Velpatasvir/Voxilaprevir Based on Patient Population and HCV genotype: FDA's Evaluation
Shared by Henry E. Chang via Twitter

Sept 22, 2017
Genotype 1 & 3
New Treatment-Naïve & Treatment-Experienced

Sept 15,2017
HCV TGIF: Patient Voice Lacking in HCV Cost-effectiveness Research, Baby Boomers, and Liver Cancer

Sept 14, 2017
Systematic review: cost-effectiveness of DAAs for treatment of HCV genotypes 2-6

Aug 18, 2017
Surprising price break for newly-approved hepatitis C drug
The U.S. Food and Drug Administration (FDA) has approved two new once-daily combination pills to treat all genotypes of hepatitis C virus (HCV). Gilead Sciences’ Vosevi (sofosbuvir/velpatasvir/voxilaprevir) was approved on July 18 and AbbVie’s Mavyret (glecaprevir/pibrentasvir) was approved on August 3. Both combos cure more than 95% of treated people in two or three months, and Mavyret is priced well below existing therapies.

Aug 17, 2017
Canada
VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments
Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

Aug 6, 2017
August Newsletters Vosevi and Mavyret: Have We Reached the End of HCV Drug Development?

July 28, 2017
Gilead's Vosevi® European Commission Grants Marketing Authorization

New At Hepatitis C Online - Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
View clinical trial data in either slide decks, in your browser or download PDF.

July 26, 2017
Diplomat Now Dispensing VOSEVI™ to Treat Chronic Hepatitis C Virus

BioPlus Specialty Pharmacy Releases Updated Version of ‘HCV Treatment Path’ App for Prescribers; Includes Latest Hepatitis C Medication Guidelines for Vosevi

July 23, 2017
Vosevi - Frequently Asked Questions & Gilead's My Support Path® VOSEVI Program
On July 18, 2017 the Food and Drug Administration (FDA) approved Gilead’s HCV medication sofosbuvir/velpatasvir/voxilaprevir (400mg/100mg/100mg), brand name “Vosevi” for the re-treatment of HCV in treatment-experienced people. This single tablet medication comprises sofosbuvir (SOF), a nucleotide polymerase inhibitor, velpatasvir (VEL), an NS5A inhibitor, and voxilaprevir (VOX),…

July 19, 2017
Gilead Once Again Puts The Hurt On Hepatitis C, as Vosevi Is Approved
Having spent a decade (of pure futility) in hepatitis C (HCV) research in my former career, I have spent a fair amount of time since then writing about the astounding progress made over a 25-year period. Very effective antiviral drugs, Sovaldi being the first, stopped the virus its tracks. Most of the time.

Gilead Vosevi’s (Sofosbuvir/Velpatasvir/Voxilaprevir) price at $24,920 per bottle
Tuesday, U.S. regulators green-lighted Vosevi, a three-drug cocktail combining sofosbuvir and velpatasvir—already marketed together as pan-genotype medication Epclusa—with new compound voxilaprevir. As Leerink Partners analyst Geoffrey Porges figures, the product will largely be used among patients who have already been treated with Gilead’s Harvoni or Epclusa or a competing regimen from rivals AbbVie or Merck.

FDA News Release
FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm

HEP
FDA Approves Gilead’s Vosevi for Re-treatment of Hepatitis C
The triple-drug regimen comes in a once-daily single tablet.
More specifically, the approval is for a second hep C treatment for those with genotypes 1, 2, 3, 4, 5 or 6 who were previously treated with an HCV regimen containing a direct-acting antiviral (DAA) from the NS5A inhibitor class or for those with genotype 1a or 3 who were previously treated with a Sovaldi (sofosbuvir)-containing regimen that did not include an NS5A inhibitor....
Continue reading....

Medscape Free Registration Required
FDA Clears Pan-Genotypic Vosevi for Chronic Hepatitis C
Vosevi is contraindicated in patients taking the drug rifampin.
The FDA notes that patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation when taking direct-acting antivirals HCV infection.  The agency requires boxed warning for the drugs advising clinicians to screen patients for evidence of a past or current HBV infection before ordering antiviral treatment for HCV.

July 18, 2017
Vosevi is the First Once-daily Single-Tablet HCV Regimen Approved as Salvage Therapy for Certain Patients and Completes Gilead's Portfolio of Sofosbuvir-based HCV Direct-acting Antiviral (DAA) Treatments

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 18, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved VoseviTM (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

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