All posts by Deb Schmitz

2017 Liver Meeting Highlights

The 2017 Liver Meeting HighlightsAttending the Liver Meeting 2017, the American Association for the Study of Liver Diseases (AASLD)‘s 68th annual meeting, this year were not only researchers and physicians, but also a number of different blog writers. The below are links to some abstracts and blog posts about information presented at this year’s Liver Meeting.

A Few 2017 Liver Meeting Highlights

A Sampling of Blog Posts by Clinical Care Options
A Sampling of Meeting Abstracts Published by Hepatology

 

 

 

Gilead Receives Health Canada Approval for VOSEVI™, the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment

Please note:  VOSEVI is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans).  VOSEVI is included in Gilead’s Momentum Patient Support Program (information, including contact information, is available below and here).

See the Hep C Treatment Diagram on the left hand side of this page (homepage has 2 versions) for a picture of Canada’s drug approval system and where hep C treatments are at in it.  VOSEVI is at Step 3 and will be progressing through the approval process.  That takes time.  VOSEVI will be added to the pipeline diagram the week of August 21 2017.  Please check back.

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Gilead Receives Approval in Canada for VOSEVI™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-treatment of Certain Patients with Chronic Hepatitis C Virus (HCV) Infection

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

MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ – 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.

“HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients.  However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option,” said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta.  “VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients.”

VOSEVI is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV infection, with the convenience associated with once-daily single-tablet regimens.  Since 2013, Gilead has brought to market four HCV treatments, including three single-tablet regimens. To date, more than an estimated 1.5 million patients worldwide have been prescribed sofosbuvir-based regimens.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said Kennet Brysting, General Manager, Gilead Canada. “The approval of VOSEVI in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030.”

The approval of VOSEVI is supported by Phase 3 data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 infection with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as Phase 3 data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3 or 4 infection with or without compensated cirrhosis who had failed prior treatment with a DAA-containing regimen that did not include an NS5A inhibitor.  In these populations across the two studies, 431 of the 445 patients treated with VOSEVI (97%) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (≥10 per cent of patients) among patients who received VOSEVI were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2 per cent for subjects who received VOSEVI for 12 weeks.

“As Canada moves forward with its World Health Organization commitment to eliminate hepatitis C by 2030, it is important for all patients to have the opportunity to access a cure, regardless if they are new to treatment, or they have failed a previous therapy,” said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital.  “Treatment should be an option for everyone, including to those still seeking a cure.  The CLF is pleased to see that additional effective therapies are available, and are becoming more accessible to all patients, regardless of where someone lives, or their ability to pay.”

Patient Support Program
To assist eligible HCV patients in Canada with access to VOSEVI, Gilead Canada has added VOSEVI to the Gilead Momentum Support Program™, which provides information to patients and healthcare providers to help facilitate patient access to medication.  For more information regarding the Momentum Support Program in Canada, please call 1-855-447-7977.

Important Safety Information
The VOSEVI Product Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX REGARDING THE RISKS OF HEPATITIS B VIRUS (HBV) REACTIVATION IN HCV/HBV CO-INFECTED PATIENTS.  For further details, please see the Canadian Product Monograph at www.gilead.ca.

Contraindications
VOSEVI is contraindicated with the following drugs products: dabigatran etexilate, phenobarbital, phenytoin, rifampin, rosuvastatin.  VOSEVI is also contraindicated with the herbal product, St. John’s wort.

Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with VOSEVI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Drug Interactions
Coadministration of VOSEVI is not recommended with carbamazepine, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, efavirenz, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir and/or voxilaprevir, and/or the other agent.

For additional important safety information for VOSEVI, including the complete warnings and precautions, adverse reactions and drug-drug interactions, please see the Canadian Product Monograph at www.gilead.ca.

About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases.  Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.  Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2006.

Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing VOSEVI for the treatment of adults with chronic HCV infection. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Canadian Product Monograph for VOSEVI, including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.gilead.ca.

VOSEVI is a trademark of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

SOURCE Gilead Sciences, Inc.

 

 

 

 

AbbVie’s MAVIRET™ Approved by Health Canada for the Treatment of Chronic Hepatitis C in All Major Genotypes

Please note:  MAVIRET is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans).  MAVIRET is included in AbbVie’s patient support program, AbbVie Care. Information, including contact information, is available here and here.

See the Hep C Treatment Diagram on the left hand side of this page (homepage has 2 versions) for a picture of Canada’s drug approval system and where hep C treatments are at in it.  MAVIRET is at Step 3 and will be progressing through the approval process.  That takes time.  MAVIRET (glecaprevir/pibrentasvir) information will be updated on the pipeline diagram the week of August 21 2017.  Please check back.

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  • MAVIRET is the first and only 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment*1
  • The approval is supported by a 97 percent (n=639/657) cure** rate across GT1-6 patients without cirrhosis and who are new to treatment2
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, Aug. 17, 2017 /CNW/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 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.

“Despite recent advances in HCV treatment, physicians still face challenges treating patients with less common genotypes and those with other complicating health conditions,” said Dr. Morris Sherman, MD, FRCPC, Chairperson, Canadian Liver Foundation. “In order to eliminate hepatitis C in Canada, we need to identify all those living with the virus and have effective treatment options for everyone. This new therapy provides another tool for physicians to expand treatment to a greater number of patients while at the same time shortening the duration which may lead to cost savings for the health care system.”

MAVIRET is also approved for use in patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD), those GT1 patients not previously cured with certain direct-acting antiviral (DAA) treatment, and those with GT3 chronic HCV infection.2 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.2

“With the approval of MAVIRET, we are proud to bring the hope of a new cure to people living with hepatitis C in Canada, reflecting AbbVie’s dedication to addressing critical unmet needs for patients,” said Stéphane Lassignardie, General Manager, AbbVie Canada. “MAVIRET is designed to deliver a virologic cure for most HCV patients including those with specific treatment challenges. AbbVie will continue to work with local health authorities and stakeholders across Canada to get our treatment to as many patients as possible.”

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

Approximately 300,000 Canadians are infected with hepatitis C.3 In 2012 alone, more than 10,000 new cases of hepatitis C were reported, but 40 percent of patients are estimated to be living unaware of their disease.4 GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.3,5 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years6 of infection. Additionally, HCV is common among people with severe CKD, and some of these patients previously did not have a DAA-based treatment option.7

With 8 weeks of treatment, 97 percent (n= 639/657) of GT1-6 patients without cirrhosis and who were new to treatment achieved a virologic cure.1 These high cure rates were achieved in patients with varied patient and viral characteristics and including those with CKD.2 Additionally, 97.5 percent (n=274/281) of patients with compensated cirrhosis achieved a virologic cure with the recommended duration of treatment, including patients with CKD.2 In registrational studies for MAVIRET, less than 0.1 percent of patients permanently discontinued treatment due to adverse reactions.2 The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.2

“In an extensive clinical trial program, patients achieved high cure rates with MAVIRET regardless of genotype, fibrosis score, viral load, and even in patients with resistant virus strains and those with chronic kidney disease,” said Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist, Director of the Toronto Liver Centre. “In clinical practice, MAVIRET has the potential to simplify treatment decisions for physicians, offering, in one therapy, a cure for the majority of HCV patients and cutting out pre-testing before treatment initiation.”

MAVIRET combines two new, potent direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus.2 The presence of most genotypes or baseline mutations that are commonly associated with resistance have been shown to have no relevant impact on efficacy.2

Canadians prescribed MAVIRET will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature patient support program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support. AbbVie Care will support people living with HCV throughout their treatment journey to achieve high cure rates in the real world.

Approval of MAVIRET followed Health Canada’s Priority Review process, which is granted to new medicines intended for patients with a life-threatening disease where there is no existing treatment with the same profile or where the new product represents a significant improvement in the benefit/risk profile over existing products.8 AbbVie’s investigational, pan-genotypic regimen was also recently approved by the European Commission and the U.S. Food and Drug Administration.

About MAVIRET™
MAVIRET™ is approved in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).2 MAVIRET is a new, pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.2

MAVIRET is an 8-week, pan-genotypic virologic cure** for use in patients without cirrhosis and who are new to treatment,*  such patients comprising the majority of people living with HCV.1 MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) and those with genotype 3 infection.2 It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.2

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. 

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience.  In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.
2 MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017.
3 Messina, JP et al. “The global distribution of HCV genotypes.” Hepatology, 2015; 61: 77–87. Supporting information hep27259-sup-0001-suppinfo.pdf. Accessed August, 2017.
4 Hepatitis C: Get the Facts. Government of Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/poster-hepatitis-c-get-facts.html. Accessed August, 2017.
5 Wyles, D et al. SURVEYOR-II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis. Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, US on November 11-15, 2016.
6 Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed August, 2017.
7 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
8 Priority Review of Drug Submissions. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/priority-review-drug-submissions-therapeutic-products.html. Accessed August, 2017.

SOURCE AbbVie Canada

For further information: Media: Muriel Haraoui, AbbVie Canada, (514) 717-3764, muriel.haraoui@abbvie.com

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