Tag Archives: Health Canada

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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Glecaprevir/Pibrentasvir Granted Priority Review

Glecaprevir/Pibrentasvir Priority Review GrantedAbbVie, the developer of glecaprevir (ABT-493) / pibrentasvir (ABT-530), has submitted a New Drug Submission to Health Canada for the treatment of chronic hepatitis C and has been granted a priority review for it. This means that it will receive a priority review from Health Canada.*

A couple of weeks ago, the same hepatitis C treatment received a Breakthrough Therapy Designation (BTD) from the FDA for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to Health Canada as a short term, eight week, treatment, made up of a once-daily three pill regimen. The treatment is for patients with chronic hepatitis C virus (HCV) genotypes 1-6, all major genotypes, without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A).

Glecaprevir/pibrentasvir is intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease and those not cured with previous direct acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Submission to Health Canada can be found here.

Sampling of Phase III Clinical Trials for Glecaprevir / Pibrentasvir:

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
ENDURANCE-1 GT1 without cirrhosis, new to treatment or not cured with previous treatment 8 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
12 weeks
ENDURANCE-2 GT2 without cirrhosis, new to treatment or not cured with previous treatment 12 weeks G/P vs Placebo 99%
ENDURANCE-3 GT3 without cirrhosis (NC), new to treatment (TN), treatment experienced (TE) 12 weeks G/P Ongoing
12 weeks SOF + DCV
8 weeks G/P 95%
ENDURANCE-4 GT4-6 NC, TN, TE 12 weeks G/P GT4 99%, GT5 100%, GT6 100%
SURVEYOR-2 (Part 3) GT3 TN, TE 12 weeks G/P 91%
Compensated cirrhosis (CC), TE 16 weeks 96%
GT3 TN 12 weeks G/P 98%
GT3 TE 16 weeks 96%
SURVEYOR-2 (Part 4) GT2, GT4-6 NC, TN, TE 8 weeks G/P GT2 98%, GT4 93%, GT5 100%, GT6 90%
EXPEDITION-4 CKD4/5, GT1-6, +/- CC 12 weeks G/P 98%
EXPEDITION-1 GT1, 2, 4-6 CC, TN, and TE 12 weeks G/P Ongoing
CERTAIN-1 GT1 without cirrhosis, some with the resistance-associated Y93H virus variant 8 weeks G/P 99%
12 weeks Technivie 100%
MAGELLAN-1 (Part 2) GT1, 4, 6 +/- liver cirrhosis, DAA treatment experienced 12 weeks G/P + RBV Ongoing
16 weeks G/P – RBV
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

“HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis,” said Dr. Curtis Cooper, Director of the Regional Hepatitis Program at the Ottawa Hospital. “Recent clinical trial results are a positive development in AbbVie’s investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options.”

*For more information about the drug approval system in Canada please see Approval Process.

Health Canada Summary Safety Review – DAAs – Assessing the Potential Risk of Hepatitis B Virus Reactivation

December 1, 2016

Product

Direct-acting antivirals (DAAs)

Potential Safety Issue

Hepatitis B virus (HBV) reactivation

Key Messages

  • Direct-acting antivirals (DAAs) are drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection, a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) and liver cancer.
  • Health Canada carried out a review of the potential risk of hepatitis B virus (HBV) reactivation with the use of DAAs. The review was triggered by reports that patients infected with both HBV and HCV may experience a reactivation of their HBV infection if DAAs are used to treat their HCV infection. These reports were identified by the European Medicines Agency (EMA).
  • Health Canada’s review concluded that there is a potential risk of HBV reactivation in patients co-infected with both HBV and HCV, and the use of DAAs. Health Canada has recommended that the safety information for all DAAs be updated to inform about this potential risk.

Overview

Health Canada carried out this safety review after becoming aware of reports of HBV reactivation in patients infected with both HBV and HCV treated with DAAs. Reactivation refers to the return of an active infection and, in the case of HBV, it can lead to serious complications such as liver disease (hepatitis).

Use in Canada

  • DAAs are prescription drugs authorized for sale in Canada to treat chronic HCV infection in adult patients.
  • This review included the following products available in Canada and they contain either a single DAA or multiple DAAs together: Daklinza (daclatasvir), Sovaldi (sofosbuvir), Harvoni (sofosbuvir, ledipasvir), Epclusa (sofosbuvir, velpatasvir), Holkira Pak (dasabuvir, paritaprevir, ombitasvir, ritonavir), Technivie (paritaprevir, ombitasvir, ritonavir), Galexos (simeprevir), Sunvepra (asunaprevir), and Zepatier (grazoprevir, elbasvir).
  • The first DAA available in Canada was Galexos (simeprevir), introduced in 2013.

Safety Review Findings

  • At the time of the review, Health Canada had not received any Canadian reports of HBV reactivation related to DAA use in patients infected with both HBV and HCV.
  • A total of 13 international reports of HBV reactivation were retrieved from different sources. Of these, 12 reports were considered to be possibly related to the use of these DAAs: 11 reports where sofosbuvir or sofosbuvir with ledipasvir was used and one report where daclatasvir was used. The remaining report (with sofosbuvir use) could not be reviewed further because it did not provide enough information. Of the reports, 3 described symptoms of moderate HBV reactivation. One of the cases reported severe HBV reactivation resulting in liver failure and the patient needed a liver transplant.
  • Potential processes have been proposed in the scientific literature to explain how HBV infection could become reactivated in patients that are being treated for their HCV infection.
  • Two studies of the use of DAAs in patients infected with both HCV and HBV reported an increase in viral genes (HBV DNA) in some of the patients. This could lead to a reactivation of the HBV infection.

Conclusions and Actions

  • Health Canada’s review concluded that there may be a link between the risk of HBV reactivation in patients infected with both HBV and HCV that have been treated with certain DAAs.
  • Health Canada has recommended that the safety information for all DAAs be updated to inform about this risk, as a precaution. In addition, an Information Update will be published to further inform Canadians and health care professionals.
  • Health Canada will continue to monitor safety information involving DAAs, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Original Health Canada post, posted December 1, 2016, can be found here.

Additional Information about this Not from Health Canada

Epclusa: An Information Sheet for an Approved Treatment

Epclusa: An Information SheetEpclusa (generic name sofosbuvir / velpatasvir) is the first pan-genotypic hepatitis C treatment* to be approved for use in Canada against all six hep C virus types! In celebration, the Hepatitis C Treatment Information Project has put together the following Epclusa information sheet.

Epclusa (PDF)

Treatment Description: Epclusa is a short-course, interferon-free, hepatitis C treatment. It is one pill taken once a day and can be prescribed with or without ribavirin.

Targeted Genotypes1-6

Doses and Treatment Lengths:

  • 12 weeks of the once-daily pill Epclusa for patients without liver cirrhosis and patients with compensated liver cirrhosis
  • 12 weeks of the once-daily pill Epclusa and ribavirin for patients with more serious liver cirrhosis

Possible Side Effects when Taken Without Ribavirin:

  • Headache
  • Fatigue (Tiredness)

Possible Side Effects when Taken With Ribavirin:

Fatigue (Tiredness) Anemia Nausea Headache
Insomnia (Can’t sleep) Diarrhea

Usage Warning: Patients with Bradycardia taking amiodarone can not take Epclusa. There have been reports of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart). Don’t take rifampin, St. John’s wort, or carbamazepine while taking Epclusa.

Clinical Trial Results for Epclusa

Clinical Trial Patients Treatment Regimen SVR
ASTRAL-1, ASTRAL-2, ASTRAL-3 1,035 with hep C genotypes 1-6 with or without cirrhosis (Child-Pugh A) EPCLUSA (12 weeks) 98%
ASTRAL-4 267 patients with genotype 1-6 hep C infection, with decompensated cirrhosis (Child-Pugh B) EPCLUSA with Ribavirin (12 weeks) 94%
EPCLUSA without Ribavirin (12 or 24 weeks) 83% or 86%

Momentum Support Program

Epclusa has been added to Gilead Canada’s Momentum Support Program. This support program provides information to patients and healthcare providers to help patients access Epclusa and Gilead’s other hepatitis C treatments. In Canada, please call 1-855-447-7977 for more information.

More Information

“We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history.” ~Dr. Jordan Feld

*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

Epclusa: Approved treatment for all hep C types

Epclusa, the first hep C treatment for all virus types, is approved in CanadaEpclusa (generic name sofosbuvir / velpatasvir), the first pan-genotypic treatment*, has been approved for use in Canada against all six hep C virus types! Health Canada has issued Epclusa a Notice of Compliance!

The Importance of a Notice of Compliance (NOC)

Receiving a Notice of Compliance from Health Canada allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

The Importance of Epclusa

Epclusa, the first hep C pan-genotypic treatment, is amazing as it has the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explained, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

Also, Epclusa is the first treatment for patients with a hep C genotype 2 or 3 infection that doesn’t need ribavirin to achieve best treatment results.

Response by the Pacific Hepatitis C Network’s President, Daryl Luster

“The Pacific Hepatitis C Network is certainly pleased to hear that the first hepatitis C pan-genotypic, single pill, treatment has been approved for use in Canada.” said Daryl Luster, president of the Pacific Hepatitis C Network. “It is our hope that this approval signifies an end to interferon-based therapies. We also hope that this drug approval will lead to more people being able to access interferon-free treatment, regardless of their hep C genotype, treatment histories, or their access to local hepatitis C specialists.”

Epclusa

Epclusa is a short-course (12 weeks), interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day. With or without ribavirin, it cured 83-98% of patients in clinincal trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

Global and CTV News Report that Health Canada has Approved Epclusa

Global and CTV News Reports Health Canada Approved EpclusaGlobal News and CTV News are reporting that Health Canada has approved the hepatitis C treatment sofosbuvir / velpatasvir (American brand name Epclusa) for use in Canada. If this news is correct, Health Canada has just approved the first hep C treatment that can cure all 6 hep C virus types with high success rates!

A treatment able to cure all virus types is amazing as it has the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explains, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

News Reports Remain Unverified

The Hepatitis C Treatment Information Project tried to double check that this treatment has indeed been approved, and approved as the articles have said. However, we were unable to reach Gilead, the treatment’s developer, and Health Canada before this blog post was published. This failure to reach the two parties was probably because it was early evening in BC and so passed business hours in the East when this post was written.

We will follow this story and share additional information as it becomes available.

Sofosbuvir / Velpatasvir

Description: Sofosbuvir / velpatasvir is a short-course, interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day.

Treatment Lengths Approved in America:

  • 12 weeks for patients without liver cirrhosis and patients with compensated liver cirrhosis (Child-Pugh A)
  • 12 weeks for patients with more serious  liver cirrhosis (Child-Pugh B or C) when it is combined with ribavirin.

Most Common Side Effects when Treatment is Taken Without Ribavirin:

  • Headache
  • Fatigue (Tiredness)

Most Common Side Effects when Treatment is Taken With Ribavirin:

  • Fatigue (Tiredness)
  • Anemia
  • Nausea
  • Headache
  • Insomnia (Can’t sleep)
  • Diarrhea

Clinical Trial Results for Sofosbuvir / Velpatasvir

In Phase III clinical trials, the treatment’s safety and effectiveness as a 12 week treatment was evaluated on 1,558 patients without liver cirrhosis or with mild cirrhosis. With or without ribavirin, it cured 95–99% of those patients. In trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment.” ~Dr. Jordan Feld, a liver specialist at Toronto Western Hospital

Sunvepra (asunaprevir) Approved in Canada

Sunvepra (asunaprevir) Approved in CanadaSunvepra (asunaprevir) has been approved as a hepatitis C treatment in Canada!* Health Canada granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C, genotype 1 or 4, in adult patients with compensated liver disease, including liver cirrhosis (liver scarring).

Health Canada has stated that Sunvepra is to be taken in combination with other hep C direct-acting antivirals/treatments. It has also stated that:

  • Treatment with Sunvepra should be initiated and monitored by a physician experienced in treating hep C.
  • Sunvepra must not be administered by itself.
  • Treatment length depends on the viral genotype and subtype.
  • Sunvepra has not been studied in treatment experienced patients who have tried to treat their hep C already with a treatment regimen that included Sunvepra or other hep C protease inhibitors.
  • Sunvepra should not be taken by those with moderate or severe hepatic impairment (Child-Pugh B or C, score 7 or greater) and by patients with decompensated liver disease.

For more information, please see Sunvepra’s product monograph, available through Health Canada, or Health Canada’s Summary Basis of Decision (SBD) document for Sunvepra.

What a Notice of Compliance (NOC) Means for Sunvepra (asunaprevir)

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/cure) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

*Health Canada granted Sunvepra a Notice of Compliance (NOC) on March 9th, 2016. A CADTH Common Drug Review for Sunvepra began in 2015 and patient input was sent in by Canadian patient groups, including the Pacific Hepatitis C Network, for this review then. After the input was sent, the review was temporarily suspended as the manufacturer, Bristol Myers Squibb Canada Inc., requested time to provide additional information. This temporary suspension was lifted in early 2016.

Holkira Pak approved to treat more patients

Holkira Pak approved to treat more patientsOn April 11, 2016, Health Canada approved Holkira Pak to treat patients who are HCV/HIV-1 co-infected and those with hep C (HCV) who have had liver transplants.

The efficacy and safety of Holkira Pak to treat patients with hep C genotype 1 co-infected with HIV-1 has been established. The efficacy and safety of Holkira Pak with ribavirin has also been proven when used to treat liver transplant recipients with normal hepatic function and a Metavir fibrosis score of ≤ 2, regardless of whether the virus is hepatitis C genotype 1a or 1b.

Holkira Pak

Holkira Pak is a treatment for patients with chronic genotype 1 hepatitis C without severe liver damage. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of those with genotype 1 hep C and was found to be well tolerated by patients. 98% of clinical trial participates completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to side effects were low (0.2%).

Holkira Pak for Patients HCV/HIV-1 Co-Infected

In the clinical trial Turquoise-I, 94% of patients who were HCV/HIV-1 co-infected were cured of hep C, achieved a sustained virologic response, with Holkira Pak and ribavirin.

Holkira Pak for Liver Transplant Recipients

Holkira Pak cured 97% of liver transplant recipients in clinical trial. Those clinical trial results and additional information about the trial can be found in The New England Journal of Medicine.

For more information about Holkira Pak, hep C treatments for those HCV/HIV co-infected, or for those who have had liver transplants, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Summary Safety Review – Galexos (simeprevir)

Summary Safety Review - Galexos (simeprevir)January 27, 2016 – Health Canada – Summary Safety Review – GALEXOS (simeprevir) – Assessing the Potential Risk of Severe Liver Problems

Product

Galexos (simeprevir)

Potential Safety Issue

Severe liver problems

Key Messages

  • Galexos (simeprevir) is a drug used to treat chronic hepatitis C.
  • A safety review was carried out by Health Canada after Japan published a risk communication on severe liver problems and related death with simeprevir use.
  • The prescribing information for Galexos has been updated with warnings about the risk of severe liver problems and related death. It also reminds healthcare professionals to frequently monitor patients for liver problems when using this drug.

Overview

Health Canada carried out a safety review after Japan published a risk communication on severe liver problems and related death with the use of simeprevir. In patients with liver damage due to advanced chronic hepatitis C, increased levels of bilirubin in the blood can be a sign that the liver is not functioning properly. The use of simeprevir can further increase bilirubin levels in the blood; this risk is already included in the prescribing information.

Use in Canada

  • Simeprevir has been marketed in Canada under the brand name of Galexos since 2013.
  • Simeprevir is a drug used for the treatment of chronic hepatitis C. It is taken as an oral tablet for 12 weeks in combination with other medicinal products such as peginterferon alfa and ribavirin or with sofosbuvir.
  • Recently, the number of prescriptions in Canada for simeprevir has gone from 1700 prescriptions between July and September 2014, to 16 prescriptions between July and September 2015.

Safety Review Findings

  • At the time of the review, Health Canada had received 11 Canadian reports of severe liver problems, including 2 deaths, suspected of being linked with simeprevir. Upon review of these cases, no conclusions could be made regarding what role, if any, the drug may have played, due to limited information from these cases.
  • In Japan, 8 cases of severe blood bilirubin levels and 3 deaths had been reported in association with simeprevir. Ethnic differences in susceptibility to liver problems exist, therefore the information from these cases needs to be interpreted with caution when considering the risk of simeprevir for other populations.
  • Information was also received from the manufacturer about cases of severely abnormal bilirubin levels suspected of being linked with simeprevir. In some of these cases, the contribution of simeprivir to the side effect could not be ruled out.

Conclusions and Actions

  • Based on all the information reviewed, Health Canada concluded that the prescribing information should be updated to reflect the level of evidence related to the risk of severe liver problems.
  • The manufacturer of Galexos (simeprevir) has updated the prescribing information to:
    • Warn about the risk of severe liver problems and related death,
    • Advise healthcare professionals to do blood tests to check for liver function before and during treatment, and
    • Not use Galexos (simeprevir) in patients who have moderate or severe liver damage.
  • Health Canada will publish a labelling update notice in the January 2016 issue of the Health Product InfoWatch to raise awareness of the labelling update for simeprevir.
  • Health Canada will continue to monitor side effect information involving simeprevir, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate or contact the manufacturer, Janssen Inc., at 1-800-567-3331 or 1-800-387-8781.