Friday, August 18, 2017

Organ crosstalk: Fatty liver can cause damage to other organs

18.08.2017
Organ Crosstalk: Fatty Liver Can Cause Damage to Other Organs
The consensus among scientists until now has been that overweight people have an increased risk for diabetes, cancer, high blood pressure and heart attack. However, studies show that not only the extent, but above all the location and function of adipose tissue play a decisive role in the development of the disease. Several years ago, scientists of the German Center for Diabetes Research (DZD) in Tübingen discovered that a fatty liver can cause damage to other organs. Now, in two just-published studies they demonstrate the effects of fatty liver disease on the function of the hormone-producing islet cells in the pancreas and on renal function.

Nonalcoholic fatty liver disease is becoming more and more common. Approximately every third adult in the industrialized countries has a morbidly fatty liver. This not only increases the risk of chronic liver diseases (liver cirrhosis and liver cancer), but also in particular type 2 diabetes and cardiovascular diseases. The cause for this is the altered secretion behavior of the fatty liver. It increasingly produces glucose, unfavorable fats and proteins, such as the hepatokine fetuin-A, all of which it releases into the bloodstream. Thus, the secreted substances of the fatty liver enter other organs and trigger reactions there. So far, however, it is not known exactly which effects this "organ crosstalk" has, which organs are most affected, and which "damage" can be caused by the hepatokine fetuin-A.

What effect does the protein fetuin-A, which is produced by the fatty liver, have on the pancreas?
To elucidate the causal mechanisms and the resulting changes, DZD researchers of the Institute for Diabetes Research and Metabolic Diseases (IDM) of Helmholtz Zentrum München at the University of Tübingen studied the influence of fetuin-A on pancreatic adipose tissue. Approximately one-third of the pancreatic adipose tissue consists of adipose precursor cells (a kind of stem cells) in addition to the mature adipose cells. If the pancreatic adipose cells are treated with fetuin-A in cell cultures*, the mature adipose cells – but in particular the adipose precursor cells in interaction with the islet cells – increasingly produce inflammation markers and immune-cell-attracting factors.

In addition, the researchers histologically analyzed tissue samples from 90 patients and found that the proportion of the pancreatic fat varied greatly. The number of defense cells of the immune system (monocytes / macrophages) was significantly increased in areas where many adipose cells had accumulated.

In a cohort of 200 subjects with an increased risk of type 2 diabetes, the pancreatic fat content was measured by means of magnetic resonance imaging and compared with diabetes parameters. It was found that in persons who had already experienced a worsening of blood glucose regulation, an increased pancreatic fatty degeneration was associated with a reduced insulin secretion. The investigations were carried out by Professor Hans Ulrich Häring and the Endocrinology Research Group, together with scientists from the Department of Experimental Radiology at the University of Tübingen.

In summary, these analyses, published in the journals Diabetologia and Diabetes Metab Res Rev, suggest that a fatty liver, together with a fatty degeneration of the pancreas, triggers an increased local immune cell infiltration and inflammation that accelerate the course of the disease.

Fetuin-A leads to pathological changes of the kidney

However, adipose tissue is not harmful per se. It can even have protective effects. For example, adipose tissue located around blood vessels or the kidney has regenerative properties. "The factor that leads to pathological changes is fetuin-A, which is produced by the fatty liver," said Professor Dorothea Siegel-Axel, head of the working group “Adipose Tissue and Complications” in Tübingen. As a result, instead of protecting tissue as before, the adipose tissue now elicits inflammatory processes. This leads to a restriction of renal function. This is demonstrated by studies on arteries and the kidney, which have recently been published by the working group in the journal Scientific Reports (Nature Group).

"The statement that obesity in itself always has a disease-causing effect is too imprecise. Not until further parameters have been determined, such as fatty liver and hepatokine levels, as well as the elicited changes in other organs, can we obtain more exact indications as to whether a person has an increased disease risk or not,” said Professor Häring, board member of the DZD and director of the IDM, summarizing the current results.

Original publications:
Gerst F. et al. (2017): Metabolic crosstalk between fatty pancreas and fatty liver: effects on local inflammation and insulin secretion. Diabetologia, DOI: 10.1007/s00125-017-4385-1

Wagner R. et al (2017): The protective effect of human renal sinus fat on glomerular cells is reversed by the hepatokine fetuin-A. Scientific Reports, DOI: 10.1038/s41598-017-02210-4

Heni M. et al. (2010): Pancreatic fat is negatively associated with insulin secretion in individuals with impaired fasting glucose and/or impaired glucose tolerance: a nuclear magnetic resonance study. Diabetes Metab Res Rev;26(3):200-5. DOI: 10.1002/dmrr.1073

* The cells for the cultures were obtained from residual tissue in the course of surgery, which was no longer required for diagnostics and was explicitly released by the patients.

Source

Novel treatments for HCC in the era of hepatitis C therapies

In Case You Missed It

 

Source - ImedexCME
Published on Apr 17, 2017
In this presentation from the 2017 Great Debates & Updates in GI Malignancies, Dr. Ghassan Abou-Alfa provides an update in novel treatments for hepatocellular carcinoma (HCC) in the era of hepatitis C therapies.       

Which Hepatitis C Treatment to Start in 2017 - Are All Treatments Created Equal?

Which Hepatitis C Treatment to Start in 2017

Article Link - http://www.thebodypro.com/content/77003/which-hepatitis-c-treatment-to-start.html?getPage=1
August 17, 2017

Are All Treatments Created Equal?
Considering the variety of treatments now available, what's the best DAA for each patient? Even with sofosbuvir/velpatasvir/voxilaprevir on the market, picking the right drug will depend on each patient's medical history, level of liver damage, coinfections and, to some extent, insurance coverage.

Continue reading.....

Hepatitis C - Newly Approved Mavyret Has High Response Rates

The Lancet
Download Full Text Article - PDF provided by Henry E. Chang‏ via Twitter:
Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa
Summary Background
The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis......
Continue reading....

The Lancet
Download Full Text Article - PDF provided by Henry E. Chang‏ via Twitter:
Comment 
New anti-HCV drug combinations: who will benefit?
Publication stage: In Press Corrected Proof
DOI: http://dx.doi.org/10.1016/S1473-3099(17)30486-3
In The Lancet Infectious Diseases1 Xavier Forns and colleagues present the results of a phase 3 trial assessing the efficacy and safety of 12 weeks of treatment with glecaprevir (300 mg) coformulated with pibrentasvir (120 mg) in patients with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. Of 146 enrolled patients, 145 (99%, 95% CI 98–100) achieved a sustained virological response. The study did not include patients with decompensated cirrhosis; the same is true for studies of sofosbuvir, velpatasvir, and voxilaprevir.2....
Continue reading......

Newly Approved Hepatitis C Drug Has High Response Rates
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Nearly all patients with chronic hepatitis C virus (HCV) infection treated with glecaprevir-pibrentasvir achieved sustained virologic response after 12 weeks of therapy, according to results of an industry-funded, phase 3 trial in the Lancet Infectious Diseases. The once-daily combination drug (brand name, Mavyret) was approved by the FDA earlier this month to treat all HCV genotypes.

The trial enrolled 146 adults with HCV genotype 1a, 1b, 2, 4, 5, or 6 and compensated cirrhosis who either had not been previously treated, or had not responded to interferon-based treatment or to treatment with sofosbuvir plus ribavirin (with or without pegylated interferon). At 12 weeks after treatment ended, all but one patient had sustained virologic response. A patient with HCV genotype 1a and a history of treatment with pegylated interferon plus ribavirin relapsed at week 8.

Nearly 70% of patients had adverse events, most of which were mild (e.g., fatigue). No serious events were related to the study drug.

Link(s):
The Lancet
Lancet Infectious Diseases article (Free abstract)
Lancet Infectious Diseases comment (Subscription required)
Background: Physician's First Watch coverage of glecaprevir-pibrentasvir (Free)
Source-

Hepatitis C - Medivir licenses exclusive rights to MIV-802 for Greater China to Ascletis

Medivir licenses exclusive rights to MIV-802 for Greater China to Ascletis

Stockholm, Sweden and Hangzhou, China— Medivir AB (Nasdaq Stockholm: MVIR) and Ascletis today announce that Ascletis has licensed the exclusive rights to develop, manufacture and commercialize Medivir’s nucleotide polymerase inhibitor for hepatitis C, MIV-802 (Ascletis code: ASC21), in Greater China.

Under the terms of the agreement, Medivir received an upfront payment, and is entitled to receive milestones based on successful development through commercial launch and tiered royalties on net sales of MIV-802 containing products. Ascletis will fund clinical development, manufacturing and commercialization of MIV-802 in Greater China.

“We are pleased to have Ascletis as a partner with their track record in advancing development of pharmaceuticals in Greater China and their portfolio of antivirals with which to create a combination drug against hepatitis C” said Christine Lind, CEO of Medivir.

“Ascletis has filed an NDA in China for its first HCV NS3/4A medicine, danoprevir, at the end of 2016 and has an HCV NS5A inhibitor in the late stage clinical development. By acquiring MIV-802, a nucleotide NS5B inhibitor, Asceltis is committed to treating, eventually eliminating, hepatitis C in greater China with its multiple leading antiviral combinations including MIV-802,” said Dr. Jinzi J. Wu, CEO of Ascletis.

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
Jianjiong Wang, Associate Director, Corporate Affairs, mobile: +86 181 0650 1929. Email: pr@ascletis.com

About MIV-802
MIV-802 is a potent, pangenotypic nucleotide inhibitor of the HCV NS5B polymerase. Hepatitis C treatments comprise combinations of pharmaceuticals with different antiviral mechanisms. Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral agents for the treatment of HCV, including protease inhibitors, non-nucleoside NS5B inhibitors, and NS5A inhibitors.

About Medivir
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

Thursday, August 17, 2017

Gilead's VOSEVI HCV Regimen for Re-Treatment Receives Health Canada Approval

Gilead Receives Health Canada Approval for the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment
August 17, 2017
Deb Schmitz
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

View all information, here..

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.

AbbVie's MAVIRET Approved by Health Canada

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

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

Hepatitis C Medscape TV -  Hope and Uncertainty

Medscape TV - Hepatitis C Virus: Containing the Threat

August 17, 2017
SEASON 1  

July 17, 2017

June 21, 2017
EPISODE 1 - Strides and Obstacles

Six Episode Series
In the past few years, a new class of direct-acting antiviral agents has made the treatment of HCV easier and more effective than ever before, with cure rates nearing 100%, even among HIV-positive patients. But not all patients with HCV who are eligible for antiviral treatment are identified, and even fewer are being referred for care. Thus, HCV infection remains a significant risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. Liver specialists at two prestigious Chicago medical centers confront the key issues in the management of patients with chronic HCV infection.

Coming Soon
Episode 4 - New Regimens
Episode 5 - Dealing With Chronic Disease
Episode 6 - Strategies for Prevention
Free registration may be required

Wednesday, August 16, 2017

Hepatitis C - DAAs reduces the risk of mortality in the first 18 months after the completion of treatment

Source - infohep

Treatment with DAAs reduces the risk of mortality in the first 18 months after the completion of treatment
Michael Carter
Published:10 August 2017
The study – published in Clinical Infectious Diseases – matched people who received therapy with all-DAA regimens with untreated controls. Mortality rates in the first 18 months after therapy were significantly lower among people who received DAAs. After controlling for other factors, treatment with DAAs was associated with a 57% reduction in the risk of death.

“To our knowledge, this is the first large-scale study to demonstrate the effect of newer DAA regimens upon survival,” write the authors. “Treatment with 2 commonly used DAA regimens…was associated with significant improvements in survival within the first 18 months of treatment, compared with demographically and clinically similar untreated HCV-infected controls.”
Continue reading.....

View full text article online at NATAP
Effect of paritaprevir/ritonavir/ombitasvir/dasabuvir and ledipasvir/sofosbuvir regimens on survival compared with untreated hepatitis C virus-infected persons: results from ERCHIVES

Tuesday, August 15, 2017

How Do Direct-Acting Antivirals for HCV Affect HCC Risk?

COMMENTARY
How Do Direct-Acting Antivirals for Hepatitis C Affect the Risk for Hepatocellular Carcinoma?
Sheila L. Eswaran, MD, MS; Nancy Reau, MD
August 15, 2017

The latest data on the controversial hepatitis C-hepatocellular carcinoma treatment link are examined.

Hepatocellular carcinoma (HCC), which has an annual incidence rate of 1%-4%,[1] is a potential complication of hepatitis C virus (HCV) cirrhosis owing to a multistep carcinogenesis pathway. Previous HCV treatment with interferon was associated with poor cure rates and was limited to individuals with early fibrosis or well-compensated cirrhosis. Such therapy, however, also led to a decrease in HCC after a sustained viral response (SVR).[2,3] Although remarkable progress has occurred in curing HCV in the current direct-acting antiviral (DAA) era, there is controversy regarding the associated risk of patients developing either incident (new, de novo) or recurrent HCC after DAA treatment. Additional data also suggest a lower SVR rate in patients with HCC.

Blogs & Updates: Triple Drug Regimen Succeeds Against Treatment-Resistant HCV

Blogs & Updates
Discover what's new by reading the following popular HCV blogs.

Of Interest - Can anyone treat hepatitis C?

PodMed – Johns Hopkins Medicine Podcasts
Aug 11, 2107
This week’s topics include complications of aortic valve surgery, effectiveness of nasal flu vaccination, testing for Epstein Barr virus and nasopharyngeal cancer, and hepatitis C treatment.
Listen here.....

MD Magazine | Hepatitis C
The MD Magazine Hepatitis C condition center provides clinical news and articles, information about upcoming conferences and meetings, updated clinical trial listings, and other resources.

Triple Drug Regimen Succeeds Against Treatment-Resistant HCV
AUGUST 15, 2017
Kenneth Bender
A triple drug regimen effectively cured patients with hepatitis C virus (HCV) after they had failed to respond to a combination of 2 oral direct-acting antivirals (DAA), according to a report of 2 international trials.

HUFFPOST UK - The Blog
Hep C: Speak Up
Aug 15, 2017
Philip Christopher Baldwin   Human Rights Activist
Hep C does not get the attention it deserves. Many patients are diagnosed by chance. Better screening for Hep C needs to be put in place in the UK. Patients also need more support after initial diagnosis. In the past, some people may not have sought Hep C treatment, due to the problems and uncertainty associated with interferon-based treatments, or because of the length of NHS waiting lists for the new DAA medications. The situation in the UK is now changing and people living with the virus can increasingly get it treated quickly and effectively by the NHS.
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Weekly Bull
HepCBC is a non-profit organization run by and for people infected and affected by hepatitis C. Our mission is to provide education, prevention and support to those living with HCV.

News Recap
Mini livers,  new tests to predict liver transplant outcomes, HBV vaccine shortage and the effectiveness of antiviral therapy in reducing incidence of HCC in people with HBV. Also, check out the great photos from the Vancouver Pride festival.
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HEPATITISC.NET
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals

Certainty 
By Daryl Luster - August 14, 2017
Is there even such a thing as being absolutely certain? Some will argue the issue, and of course, we are all entitled to our own opinions based on whatever we believe in....

Just the Facts Please 
By Daryl Luster - August 11, 2017
There was a TV program in my youth where one of the lead characters was famous for saying “just the facts Ma’am” and for many of us it was and even remains...
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Dry Mouth Causes and Treatment 
By Karen Hoyt - August 10, 2017
Dry mouth is annoying! Your tongue feels like it is getting bigger and bigger, words get stuck to the side of your mouth, and food is hard to swallow! It can be...
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AJKD Blog
The AJKD blog is the official blog of American Journal Of Kidney Diseases.

Hepatitis C and Kidney Transplantation: Past, Present, and Future
August 14, 2017 by AJKDblog
This is Part 1 of a 2-part series on Hepatitis C and kidney transplantation, highlighting some of the exciting breakthroughs impacting this field that have come about as a result of promising antiretroviral therapy.
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HEP - Blog Updates
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

To view a list of all bloggers please click here, and here to read personal stories about HCV.

Hepatitis C News That Isn’t Fake
August 14, 2017 • By Lucinda K. Porter, RN
A couple of months ago, headlines in the Guardian stated, “’Miracle’ hepatitis C drugs costing £30k per patient ’may have no clinical effect’.” These were horrible headlines, first because they were false; second because until you looked at the facts, it was disturbing.

Hepatitis-C Doesn’t Discriminate Neither Should We
August 14, 2017
By Carleen McGuffey
National organizations with influence should avoid making public statements that are political. The Leaders of our Hepatitis-C organizations know that politics are always divisive. Always. Our alliances are predicated on one thing only. Eradicating the Hepatitis-C virus. When we allow our feelings to dictate our advocacy it distorts the purity of the mission and disrupts our congruity of purpose. 

AGA Journals Blog
Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials.

What is the Best Management Strategy for Patients With NAFLD?

Kristine Novak
Management of patients with non-alcoholic fatty liver disease (NAFLD) requires combined efforts of general practitioners, hepatologists, and other experts, Herbert Tilg explains in a Mentoring, Education, and Training Corner article in the August issue of Gastroenterology. NAFLD has become the most common liver disease worldwide. It ranges from simple steatosis in the absence
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Creating a World Free of Hepatitis C
Welcome to my website and blog. My name is Lucinda Porter and I am a nurse committed to raising awareness about hepatitis C. I believe that we can create a world free of hepatitis C. We do this together, one step at a time.

Surviving Illness: Tips for Patients, Family, Friends, and Coworkers

By Lucinda K. Porter, RN
A patient once told me, “Illness is a way to health.” This is a simple but profound concept. We have many responses and approaches to illness and health. Some of us use denial in order to cope. Others respond by feeling scared or overwhelmed. Anger and resentment are common reactions.
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Infectious Disease Advisor
Infectious Disease Advisor offers infectious disease specialists and other healthcare professionals a comprehensive knowledge base of practical information and resources to assist in making the right decisions for their patients.

Steatosis: An Independent Risk Factor for Fibrosis in Chronic HCV

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