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.
Hepatitis C Online - Mavyret: Drug Summary, Clinical Trial Data, and Slide Deck

 March 2019
Glecaprevir/Pibrentasvir Unaffected by Acid-Reducing Drugs for Hepatitis C
A new analysis of multiple studies with glecaprevir/pibrentasvir (G/P; Mavyret) confirms that pan-genotypic efficacy for hepatitis C virus (HCV) is achieved regardless of whether patients are concurrently receiving gastric acid-reducing drugs.

February 2019
New Zealanders living with all major genotypes of hepatitis C access to a high certainty of viral cure.

In Case You Missed It
A large number of patients with hepatitis C virus have been treated with glecaprevir/pibrentasvir (G/P) within the NAVIGATORE-Lombardia Network, in Italy. This is the first real-world study evaluating effectiveness and safety of G/P in patients with hepatitis C virus treated according to international recommendations. This study demonstrated excellent effectiveness (with sustained virological response rates of 99.3%) and safety profiles.

January 2019
Hepatitis C: Mavyret (glecaprevir/pibrentasvir) in patients aged 65 years or older

December 2018
Glecaprevir/Pibrentasvir Is Safe, Effective in Treatment of HCV in Real-World Setting
December 22, 2018 – Samantha DiGrande

Dec 17, 2018
Great news for New Zealanders pangenotypic regimen Maviret unrestricted access from Feb 2019 with $0 co-payment - PHARMAC funding decision gives Kiwis with hepatitis C access to a potential cure

 November 2018
Nov 20, 2018
Mavyret for HCV/HIV Coinfection and Genotype 3: A Report of Three Cases

The Liver Meeting® 2018
Nov 10, 2018
On This Blog
Link to key data from the meeting with a focus on viral hepatitis, NASH, liver cancer and liver transplantation

Liver Meeting
November 9, 2018
Data from a new study presented this week at The Liver Meeting® found the combination of glecaprevir and pibrentasvir is highly effective and well tolerated in patients with chronic hepatitis C virus (commonly called HCV) genotype-1 infections who have prior treatment experience with sofosbuvir/NS5A inhibitor.
October
October 28, 2018

September
Sept 25, 2018
Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials

September 11, 2018
Korean physicians and patients have expressed high expectations for AbbVie Korea’s Maviret (ingredient: glecaprevir/pibrentasvir), a chronic hepatitis C therapy that reduced the treatment time by one month, the company said.

August 9, 2018
FDA updates Mavyret label for new safety, efficacy data

June 13, 2018

April 12, 2018
Liver Congress™ 2018 First real-world studies report glecaprevir/pibrentasvir to be effective and well tolerated in chronic HCV infection

First real-world data on Mavyret showing safety & effectiveness in HCV Genotype 1-6
First real-world data from the Deutsches Hepatitis C-Register (DHC-R) showing favorable safety & excellent effectiveness of G/P in HCV GT1-6 patients with 97% SVR12 & no virologic failures to date.

April 3, 2018
Media Coverage
Glecaprevir/pibrentasvir treats hepatitis C in HIV-coinfected individuals
Last Updated: 2018-04-02
By Reuters Staff
NEW YORK (Reuters Health) - The direct-acting antiviral (DAA) combination glecaprevir/pibrentasvir is effective for treating hepatitis C virus (HCV) infection in individuals coinfected with HIV-1, according to results from the non-randomized, open-label phase 3 EXPEDITION-2 trial. As many as 3 million of the 80 million individuals infected with HCV worldwide are coinfected with HIV-1. Most guidelines recommend these patients be treated like those with HCV monoinfection, with careful monitoring for drug-drug interactions with antiretroviral therapy (ART).


March 23, 2018
Can switching statins impact hepatitis c treatment?
Switching statins, compared with maintained or interrupted use, did not impact total cholesterol or the rates of adverse events in patients with hepatitis C taking glecaprevir/pibrentasvir (G/P), according to a recent study.

March 21, 2018
Adding Sovaldi and Ribavirin to Retreatment With Mavyret Beats Hep C
Those for whom Mavyret did not work the first time had a high cure rate with this intensified retreatment regimen.

March 10,2018
8-weeks Mavyret therapy effective regardless of patient characteristics
Hepatitis C treatment with Mavyret for 8 weeks had an overall sustained virologic response rate of 98% regardless of baseline patient or viral characteristics in a cohort of patients with genotypes 1 through 6, according to a recently published study.

Feb 6, 2018
MONTREAL, Feb. 6, 2018 /CNW/ - AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that the CADTH Canadian Drug Expert Committee (CDEC) issued a positive recommendation 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)2. 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.

Jan 25, 2018
Full Text

Jan 6, 2018
Genotype 3
Full Text
In summary, SURVEYOR-II Part 3 enrolled and treated some of the most difficult-to-cure HCV patients: those with GT3 infection and prior treatment experience and/or cirrhosis. Overall, the fixed-dose combination of once-daily RBV-free G/P was well tolerated and demonstrated high SVR12 rates (≥95%) in treatment-naive patients with cirrhosis treated for 12 weeks and treatment-experienced patients with or without cirrhosis treated for 16 weeks. Therefore, G/P provides an efficacious and well-tolerated once-daily RBV-free treatment option for patients with HCV genotype 3 and prior treatment experience and/or cirrhosis.

January 1, 2018

2017
Dec 6, 2017

Dec 1, 2017

Nov 21, 2017
Mavyret effective for HCV genotypes 1, 4 in DAA-experienced patients

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 24, 2017
An integrated analysis of clinical trial data showed that glecaprevir/pibrentasvir taken for 8 weeks cured 98% of people without cirrhosis with hard-to-treat genotype 3, while a 12-week course cured 100% of people with genotype 3 with cirrhosis. A related analysis showed that the combination taken for 12 or 16 weeks cured 96% of people with compensated cirrhosis across all genotypes.

Conference Coverage - NATAP
Genotype 3
Slides
Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis

Oct 23, 2017
The Liver Meeting® 2017 - Mavyret (Glecaprevir/Pibrentasvir) for Treatment-Naive Patients With HCV Genotype 3

Navigate This Blog
Updates From - The Liver Meeting® 2017
Patient-Friendly Links
HCV Sites With Key Data, Expert Review & Summary of the Liver Meeting

Oct 12, 2017
Mavyret (Glecaprevir and Pibrentasvir) - Combo confirmed as safe and effective for HCV patients with chronic kidney disease

World Congress of Gastroenterology at ACG 2017, October 13-18, 2017, Orlando, Florida, United States - Integrated Efficacy, Pharmacokinetics, and Safety of Glecaprevir/Pibrentasvir in Patients Taking Concomitant Proton Pump Inhibitors and Other Acid-Reducing Drugs

Oct 11, 2017
AbbVie Demonstrates Leadership in HCV with New MAVYRET™ Data to be Presented at The Liver Meeting® 2017
16 HCV abstracts to be presented including 12 data presentations on the safety and efficacy of MAVYRET

- MAVYRET is recommended in new AASLD guidelines as a first line treatment option for 8 weeks in treatment-naïve non-cirrhotic HCV patients across all genotypes (GT1-6)...

Sep 28. 2017
Hepatitis C Formulary Choices for 2018: Will CVS Risk Looking Bad?
If CVS chooses not to add Mavyret, it will be a sign that CVS is so desperate for rebate income that it is willing incur a very public case of misaligned interests.

Sep 27, 2017

Sept 26, 2017
Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret
Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

Sept 22, 2017
Genotype 1 & 3
New Treatment-Naïve & Treatment-Experienced
HCV Guidance Updates - Recommendations Reflecting Vosevi and Mavyret

Sept 20, 2017
Genotype 3
Full Text Article
Glecaprevir/Pibrentasvir for HCV Genotype 3 Patients with Cirrhosis and/or Prior Treatment Experience
Patients with HCV GT3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated

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

Sept 14, 2017
HCV NEXT September/October Issue - Two Approvals Offer Even More Options for HCV Treatment

FDA approves Mavyret, the first pan-genotypic 8-week treatment for HCV

Aug 26, 2017
Systematic review: cost-effectiveness of DAAs for treatment of HCV genotypes 2-6

Commentary:
Nearly all patients in study achieved sustained virologic response after 12 weeks of new HCV treatment
The drug combination appeared effective in adults with HCV genotypes 1, 2, 4, 5, or 6 infection and compensated cirrhosis in the industry-funded trial.

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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