Tag Archives: AbbVie

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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Technivie and BC PharmaCare

Technivie and BC PharmaCareTechnivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Technivie is still an approved hepatitis C genotype 4 treatment in Canada. For more information about this, please contact the AbbVie Care program at: 1-844-471-2273.

Technivie (Ombitasvir / Paritaprevir / Ritonavir)

Technivie Background: Hepatitis C genotype 4 only accounts for about 13% of global hep C infections and isn’t as common in Canada as it is in the Middle East and Africa. However, due to increased travel and immigration, the population who have hep C genotype 4 and who live in high-income countries  is growing.

Targeted HCV Genotype:  4

Targeted Patients: Those without liver problems, or with Child-Pughs A, who have never tried hep C treatment or have previously tried peginterferon and ribavirin but weren’t cured by it.

Generic Name:  Ombitasvir / paritaprevir / ritonavir

Treatment Description:  Technivie is made up of 2 direct acting antivirals (ombitasvir and paritaprevir) and ritonavir, a booster for paritaprevir. It is taken without interferon.

Approximate Sustained Viral Response / Cure Rate:  100% with ribavirin, 91% without ribavirin

Daily Dose:  2 pills taken once in the morning with food + ribavirin taken once in the morning and once at night

Length of Treatment:  12 weeks

Thank you to all of those who wrote in for Technivie’s patient input reports that were sent to CADTH and BC PharmaCare. Thank you also to those who worked to develop Technivie, a treatment for hepatitis C genotype 4. Thank you for working in hopes of a better tomorrow for those with hepatitis C genotype 4.

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.

What’s Been Recently Published About Hep C (December/January)

What's Been Recently Published About Hep CThe following highlights a variety of December/January published studies, articles, and press releases about hepatitis C and hepatitis C treatments.

Alimentry Pharmacology & Therapeutis (January 2017)

Summary: This study looked at the effectiveness and predictors of taking pegylated interferon with ribavirin (PR) and patients taking sofosbuvir (SOF) and PR. SVR ranged from 80.9% in the PR group to 96.1% in PR+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90–95% for Daklinza+SOF±RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV based regimens.

Summary: This study looked at the effectiveness and predictors of taking sofosbuvir and ribavirin for 6 months versus taking the treatment sofosbuvir with pegylated interferon with ribavirin for 3 months. Group one achieved a 94% cure rate. In group two 78.7% achieved SVR. These results were similar to those achieved in other clinical trials.

Hepatology (December 2016)

Summary: Combining different DAAs with a variety of mechanisms may help shorten required treatment durations. This study aimed to find the treatment combination promising the best results the fastest. The study gave patients elbasvir/grazoprevir and sofosbuvir for 4-12 weeks. Patients being retreated were given the compound with ribavirin for 12 weeks. Cure rates were as follows:

Patients Treatment Weeks SVR
Without liver cirrhosis hep C genotype 1 4 32%
6 87%
With liver cirrhosis hep C genotype 1 4 80%
6 81%
Without liver cirrhosis hep C genotype 3 6 93%
8 100%
With liver cirrhosis hep C genotype 3 12 83%

The Lancet (December 2016/January 2017)

Summary: This clinical trial looked at the safety and effectiveness of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated anti-miR-122 oligonucleotide. The trial showed that RG-101 could achieve SVR after 4 weeks of treatment.

Recent Press Releases by Pharmaceutical Companies

Patients Treatment Weeks Treatment SVR
GT1 without cirrhosis, some with the resistance-associated Y93H virus variant 8 Glecaprevir / Pibrentasvir 99%
12

Technivie

100%

Glecaprevir/Pibrentasvir Submitted to the US FDA

Glecaprevir/Pibrentasvir Submission to the FDAA New Drug Application was submitted to the U.S. Food and Drug Administration (FDA) late last year for glecaprevir/pibrentasvir, a hepatitis C treatment against all of the virus’s major genotypes. This application was submitted after the FDA grated glecaprevir/pibrentasvir a Breakthrough Therapy Designation (BTD) for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies last September. It also came just weeks after a New Drug Application was submitted for sofosbuvir/velpatasvir/voxilaprevir, another hep C treatment.

There has been no word as to when glecaprevir/pibrentasvir will be submitted for approval in Canada.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to the FDA as a once-daily three pill regimen for the treatment of patients with chronic hepatitis C virus (HCV). The treatment is taken without pegylated interferon or ribavirin. It has achieved high SVR/cure rates in patients with health concerns that limit hep C treatment options, such as those with severe chronic kidney disease. In as little as 12 weeks, it has also been effective for those historically difficult to treat, such as those not cured by other direct-acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Application to the U.S. FDA can be found here.

Sampling of Phase III Clinical Trials

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
ENDURANCE-1 GT1 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN) , and patients co-infected with HIV-1 8 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
ENDURANCE-3 GT3 without cirrhosis, never been treated G/P 95%
SURVEYOR-2 (Part 4) GT2, 4, 5, 6 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF) G/P 97%
*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)

“The results we announced today bring us closer to providing a potential pan-genotypic, once-daily treatment option with 8 weeks of therapy for people living without cirrhosis and who are new to treatment,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

Viekira XR Received US FDA Approval

Viekira XR Received U.S. FDA ApprovalViekira XR has been FDA approved in America. Viekira XR is an extended-release version of the hepatitis C treatment Viekira Pak (American brand name Viekira Pak / Canadian brand name Holkira Pak). This extended-release version is for patients with chronic genotype 1 hepatitis C, including those with compensated cirrhosis (Child-Pugh A). The treatment includes 3 pills, taken daily with food, that may or may not be combined with ribavirin. It may be prescribed for 12 or 24 weeks of therapy.

An extended-release therapy is a treatment made up of pills that were created to slowly release over time. This slow release gives the drugs more time to work and may allow the levels of the drugs in the body to be more consistent than they may be with other treatment types. This may help lower side effects.

For more information about this FDA approval or about the hepatitis C treatment, please see the press release by AbbVie, the developer of Viekira Pak/Holkira Pak and Viekira XR.

Press Releases from January and February 2016

Press Releases in January and February 2016The following highlights press releases about hepatitis C treatments posted in January and the beginning of February 2016.* Give the headlines a skim and find out what’s going on with hep C treatments according to current press releases posted by treatment developers.

2016 Press Releases by Pharmaceutical Companies (International)

U.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C (Bristol-Myers Squibb, Feb 5, 2016)

Merck Receives Approval of ZEPATIER™ (elbasvir/grazoprevir) in Canada for the Treatment of Chronic Hepatitis C for Patients with Genotype 1, 3, or 4 Infection Following Priority Review (Merck, Feb 3, 2016)

Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review (Merck, Jan 28, 2016)

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV (Bristol-Myers Squibb, Jan 28, 2016)

AbbVie Initiates Enrollment of Six Global Phase 3 Clinical Studies for Once-Daily, Pan-Genotypic Hepatitis C Regimen (AbbVie, Jan 11, 2016)

FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis (AbbVie, Jan 7, 2016)

Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection (Gilead, Jan 4, 2016)

* Time period was between January 1st and February 6th, 2016.

Journal Articles Since the Liver Meeting

journalWriting about the hep C research presented at the Liver Meeting 2015 in November started us wondering about what has been published since the meeting. Thus, the following highlights some recent* journal articles and press releases about hep C.

Canadian Medical Association Journal (CMAJ) (December 2015)

Summary: Due to budget cuts, high hep C treatment costs, and an increasing inmate population, the number of inmates in treatment has declined.

Summary: Upcoming health decisions in Canada will center around: a new health accord to replace the lapsed 2004 Health Accord, PharmaCare, assisted death and marijuana, health promotion, indigenous health, foreign aid and refugee health. [This was included in this blog in hopes of helping hep C advocates.]

The Lancet (November 2015)

Summary: In 1992, the British Columbia Centre for Excellence in HIV/AIDS opened in Vancouver. It has worked against HIV/AIDS and now, with help from BC’s provincial government, will also work against HCV.

Summary: A review done to estimate the frequency of blood-borne viral infection in people with serious mental illness.

Hepatology (December 2015)

HCV: Direct-Acting Antiviral Agents Against Vertical Transmission by Tomi T Kanninen, et al.

Summary: Those pregnant can not be prescribed ribavirin and, although the risk is small (2%-10%), can pass HCV onto their babies. This article examines the possibility of  treating pregnant women to eliminate any chance of virus transmission, as recent literature has shown success for those with hep B, and states that more research in this should be collected.

Antibodies to an interfering epitope in hepatitis C virus E2 can mask vaccine-induced neutralizing activity by Alla Kachko, et al.

Summary: So far, a vaccine against HCV remains just a  goal. This article highlights one of the difficulties faced in developing a HCV vaccine and hypothesizes “…that the proximity of the two epitopes [epitopes 1 and 2] leads to physical interference among the antibodies. Epitopes selected for a vaccine should not be in close proximity.” (Dufour)

Summary: The research team compared cure rates of two hep C treatments, Sovaldi-based regimens and historical controls treated with pegylated interferon and ribavirin (PR), in those with mixed cryoglobulinemia syndrome (MCS). Conclusion: The Sovaldi-based regimens decreased the cryoglobulin levels in 89% of patients, 83% achieved SVR12 (cure). Only 10% of those treated with PR achieved SVR12 and 50% had to stop treatment due to side effects.

Liver International (December 2015)

CADTH (November 2015)

Press Releases by Pharmaceutical Companies (International)

*This post concentrated on literature published between November 18th and December 12th, 2015.

Holkira Pak and Technivie Health Canada Update

Health Canada*Please see AbbVie’s response to Health Canada’s Information Update below.

Health Canada’s Information Update

 

November 10, 2015
For immediate release

OTTAWA – In response to new international safety information, Health Canada is advising Canadians that it is working with the manufacturer of Holkira Pak and Technivie to update drug labels (product monographs) to include new information regarding serious liver injury.

Holkira Pak and Technivie are both used to treat chronic Hepatitis C viral infection that can lead to serious liver and health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying, which may slow down the disease.

International safety data has indicated that cases of serious liver injury (such as hepatic failure, including cases that resulted in liver transplantation or death) have been reported in patients treated with Holkira Pak or Technivie. Most patients with these serious outcomes had evidence of advanced liver disease (cirrhosis) prior to initiating therapy.

While Health Canada is working to update the product monographs, healthcare providers are reminded that Holkira Pak and Technivie should not be used in patients with severe hepatic impairment (Child-Pugh Class C) or moderate hepatic impairment (Child-Pugh Class B).

Patients should not stop taking these medications without first talking to their healthcare provider as stopping these medications early may result in drug resistance to other hepatitis C medicines.
Information for Patients and Caregivers

Immediately consult your healthcare provider if:

You experience fatigue, weakness, lack of appetite, nausea and vomiting, as well as yellowing of your skin or eyes, darkening of your urine or discolored feces while on treatment with Holkira Pak or Technivie.

Information for Health Care Professionals

Holkira Pak (fixed dose combination of ombitasvir/paritaprevir/ritonavir; and dasabuvir) and Technivie (fixed dose combination of ombitasvir/paritaprevir/ritonavir) are contraindicated in patients with severe hepatic impairment (Child-Pugh Class C) and should not be used in patients with moderate hepatic impairment (Child-Pugh Class B).

Closely monitor for signs and symptoms of worsening of liver disease such as ascites, hepatic encephalopathy, and/or increases in direct bilirubin in the blood.

Holkira Pak and Technivie should be discontinued if there are clinical signs of liver inflammation that are accompanied by persistent elevations in transaminases, direct bilirubin or international normalized ratio (INR).

Report health or safety concerns

Call toll-free at 1-866-234-2345
Visit MedEffect Canada’s web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Media enquiries

Health Canada
613-957-2983
Public enquiries

613-957-2991
1-866-225-0709

AbbVie’s Response Issued November 11, 2015

AbbVie’s top priority is patient safety. We are committed to providing comprehensive information on the efficacy and safety of our medicines for health care professionals and patients to make informed treatment decisions.

On November 10, Health Canada issued an Information Update regarding HOLKIRA™ PAK and TECHNIVIE™. AbbVie is currently working closely with Health Canada to update the product monographs. As such, the Product Monographs for HOLKIRA PAK (date of revision: October 14, 2015) and TECHNIVIE (date of preparation: October 20, 2015) remain unchanged at this time.

As per the current product monographs, HOLKIRA PAK and TECHNIVIE should not be used in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

Patients should contact their health care provider if they have any concerns.

Advocating for those with Hep C Here and Abroad

AdvocatingThis fall, Daryl Luster, hep C advocate and president of PHCN, will be advocating for those with hepatitis C and their support networks here and abroad. The following is a list of the meetings that Daryl is looking forward to being a part of:

October 13-14 — Toronto, Ontario
Action Hepatitis Canada (AHC) Advocacy Meeting
Action Hepatitis Canada is a group that unites organizations and individuals to advocate for increased attention for hepatitis B and C–diseases that negatively affect the quality of life of up to 600,000 Canadians and support networks.
At the meeting Daryl and Cheryl Reitz, from HepC BC, will speak on hep C advocacy in BC.

October 20 — Windsor, England
Advocacy Meeting Sponsored by AbbVie
This meeting will bring together clinicians, policy, and NGO experts from around the world who are working for hepatitis policy change and development. The meeting will examine the World Health Organization’s HCV action plan and will be facilitated by Dr. Rafael Bengoa from the Health Policy program at the Duesto Business School in Spain. Dr. Bengoa develops strategies/action plans for fighting hepatitis and has successfully implemented them in both Spain and Israel.
At this meeting, Action Hepatitis Canada will be represented by two of its executives, Jeff Potts and Daryl Luster. Daryl may be the only person representing those with hep C who has had the disease.

October 21 — Ottawa, Ontario, via webcam
Canadian Institutes of Health Research (CIHR) Lecture
CIHR is the Government of Canada’s health research investment agency. Its mandate is to build scientific knowledge and to translation it into improved health, more effective health services and products, and a strong Canadian health care system.
Daryl has been invited to speak to CIHR about advocacy as a member of CanHepC, a new group formed to address hep C issues in Canada.

November 11 – 12 — Vancouver, BC
The Hepatitis Cure & Eradication Meeting
The Hepatitis Cure & Eradication Meeting will gather hepatitis experts from different disciplines to learn how science can influence public policy to work to cure and eliminate hepatitis.
Daryl will be one of the meeting’s speakers. He will talk about his role as a hep C advocate who has also been a patient.

“I’m not a lone voice, I’m many and our voices are our most powerful weapons.” Malala Yousafzai