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 Online - Vosevi: Drug Summary, Clinical Trial Data/and Slide Deck
NATAP - HCV Treatment-Exoerienced - Sofosbuvir+Velpatasvir+Voxilaprevir - (09/05/17)
November 2018
Liver Meeting® 2018 - SOF/VEL/VOX Successful for Hepatitis C Virus Retreatment in Patients With and Without HIV
October 2018
Oct 10, 2018
Hepatitis C - Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV
PHILADELPHIA – The direct-acting antiviral Vosevi demonstrated an average sustained virologic response rate of 87% among patients who were “triple-infected” with hepatitis C genotype 3, hepatitis B and HIV, as presented at the American College of Gastroenterology Annual Meeting.
June 15, 2018
Sofosbuvir-velpatasvir-voxilaprevir effective in previously treated chronic hepatitis C
March 23, 2018
Patient-Reported Outcomes After HCV Treatment With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir
This is an extensive evaluation of Patient-Reported Outcomes (PROs) during and after treatment with 2 pangenotypic regimens for HCV. Our data clearly show that both regimens improve several PRO scores shortly after initiation of treatment. This improvement in PROs persisted throughout treatment and was even more considerable after achieving SVR-12. Moreover, the gains in PROs were not only sustained 12 weeks post-treatment but continued to further improve by Week 24 of follow-up.
Feb 21, 2018
Gilead’s pan-genotypic treatment for hepatitis C Vosevi has won the National Institute for Health and Care Excellence’s seal of approval for use on the NHS.
Gilead’s pan-genotypic treatment for hepatitis C Vosevi has won the National Institute for Health and Care Excellence’s seal of approval for use on the NHS
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
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
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
CanadaVOSEVI 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
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
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....
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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
Gilead Press Release
U.S. Food and Drug Administration Approves Gilead's VoseviTM (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
U.S. Food and Drug Administration Approves Gilead's VoseviTM (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
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.
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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