Aug/3/2017 FDA APPROVED Mavyret (glecaprevir/pibrentasvir)

FDA APPROVED
Mavyret  (glecaprevir/pibrentasvir)
HIGHLIGHTS OF PRESCRIBING INFORMATION

AbbVie's drug is sold under the brand name Mavyret in the U.S. and in Europe and Canada under the brand name Maviret.

UPDATES
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.

Hepatitis C - Newly Approved Mavyret Has High Response Rates
Nearly all patients with chronic hepatitis C virus (HCV) infection treated with glecaprevir-pibrentasvir achieved sustained virologic response after 12 weeks of therapy, according to results of an industry-funded, phase 3 trial in the Lancet Infectious Diseases. The once-daily combination drug (brand name, Mavyret) was approved by the FDA earlier this month to treat all HCV genotypes.

Aug 17, 2017
AbbVie's MAVIRET Approved by Health Canada
Health Canada has granted approval for MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who make up a large portion of HCV patients in Canada.

Aug 10, 2017
Priti Krishtel
AbbVie's New Hepatitis C Treatment Won't Cure Patient Access Issue
While AbbVie’s pricing is now the lowest for a curative HCV drug, it is not a radical undercutting of Gilead prices. Millions of Americans with HCV—and tens of millions globally—are already blocked from getting treatment at the current exorbitant prices set by the pharmaceutical industry and the subsequent rationing of treatment approval by payers.

Glecaprevir & Pibrentasvir Yield High Cure Rates in Non-cirrhotic Patients with HCV Genotype 1-6
SAMAR MAHMOUD, MS
Overall, the study demonstrated that the drug regimen consisting of glecaprevir plus pibrentasvir is safe and efficacious. Dr. Mensa and his colleagues determined that this regimen can achieve high SVR rates in non-cirrhotic patients infected with various genotypes within 8 weeks. In addition, this combination can be taken once a day orally, which can be expected to increase patient adherence and tolerance to the regimen.

Aug 8, 2017
Max Nisen
AbbVie Wages HCV Drug-Price War on Gilead

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

AbbVie’s Mavyret: The Hepatitis C Treatment We’ve Been Waiting For?
Lucinda K. Porter, RN

Aug 5, 2017
AbbVie’s new, cheaper hepatitis C drug could launch the drug world’s own Hunger Games
Price is a fraught topic in the drug world, but especially so when it comes to hepatitis C, which affects an estimated 3.2 million people and can cause long-term harm or death.

Aug 4, 2017
FPC Welcomes FDA Approval of AbbVie’s New Pangenotypic HCV Combination Mavyret
“This is very good news for people living with HCV in the United States,” said Tim Horn, co-chair of the Fair Pricing Coalition. “The majority of people using Mavyret will be able to complete treatment in just eight weeks, compared with standard 12-week courses, depending on their treatment history and cirrhosis status.

FDA Hepatitis Updates - MAVYRET Treatment Duration, Overall Adverse Reactions, Drug Interactions
MAVYRET is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both
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As the latest entrant in a competitive market in which commercial insurers mostly have deals giving them discounts of up to 50 percent in exchange for not covering rivals’ hepatitis C drugs, Maryvet is priced well below the other approved drugs.

Mavyret’s price is $13,200 per month or $26,400 per treatment course before discounts for most patients, according to a Thursday note from Evercore ISI analyst Umer Raffat. That’s significantly lower than other monthly prices, such as $28,000 per month for Sovaldi, $31,500 per month for Harvoni and $27,773 for AbbVie’s own Viekira Pak and Viekira XR. Merck’s Zepatier is priced at $18,200 per month. All prices listed are before discounts and rebates. Importantly, Mavyret boasts the shortest treatment duration of the group.

Aug 3
Aug 3, 2017
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. 
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