Management of Patients With HCV Who Have Achieved SVR - With recommendations for HCC monitoring

Clinical Care Options

Recently Clinical Care Options launched a new slideset reviewing the management of patients with HCV after achieving SVR, with recommendations for monitoring liver cancer: Which patients need it? 

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Hepatitis Alert: Management of Patients With HCV Who Have Achieved SVR
In this downloadable slideset, Ira M. Jacobson, MD, and Paul Y. Kwo, MD, review optimal management of patients with HCV who have achieved SVR, including recommendations for HCV RNA and HCC monitoring.

Downloadable Slidesets
New: Alert 4: Post-SVR Management

Date posted: 2/6/2018

Begin here.......

Related:

Alert 1: First-Line HCV Treatment

Alert 2: Treating DAA-Experienced Pts With HCV
Alert 3: HCV Elimination

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Key changes highlighted in adult, pediatric immunizations

Key changes highlighted in adult, pediatric immunizations
Last Updated: 2018-02-06
By Marilynn Larkin

NEW YORK (Reuters Health) - Newly released immunization guidelines from the Advisory Committee on Immunization Practices for adults, and from the American Academy of Pediatrics for children and adolescents, feature important changes that physicians should be aware of, experts say.

"The big change to this year's adult immunization schedule is the addition of the new recombinant zoster vaccine (RZV; Shingrix, GSK)," Dr. David Kim of the Centers for Disease Control and Prevention in Atlanta told Reuters Health by email.

"Adults ages 50 and older are recommended to receive two doses, two to six months apart, regardless of past episodes of shingles or receipt of the zoster vaccine live (ZVL; Zostovax, Merck)."

"Physicians should wait at least two months before administering RZV to adults who have received ZVL," he added. "RZV is preferred over ZVL but, for adults 60 or older, ZVL - which is a one-dose regimen - remains an option."

RZV can be given to adults with chronic health conditions; however, currently there are no recommendations for people with immunocompromising conditions, including HIV infection. Those recommendations, he said, "are under discussion."

Another change highlighted in the latest recommendations, published online February 5 in the Annals of Internal Medicine, is that an additional dose of measles-mumps-rubella (MMR) vaccine should be given to people who had previously received up to two doses and are identified by a public health authority to be at increased risk during a mumps outbreak.

"The new zoster vaccination recommendations are a reminder for healthcare providers, including pharmacists, to routinely discuss vaccinations with their adult patients and educate them that there are vaccines specifically recommended for adults," Dr. Kim said.

"The strongest predictor for adults getting vaccinated," he stressed, "is a recommendation from their health care provider."

The full ACIP recommendations for each vaccine are available on the CDC's website (https://www.cdc.gov/vaccines/hcp/acip-recs/index.html).

The latest pediatric immunization guidelines, published online February 6 in Pediatrics, also emphasize a third dose of a mumps-containing vaccine as an option for children during a mumps outbreak.

Dr. Adam Ratner, director of the Division of Pediatric Infectious Diseases at Hassenfeld Children's Hospital at NYU Langone Health in New York City, told Reuters Health by email that another key recommendation is "the re-emphasis on the importance of influenza vaccine in all children age six months or older."

"This is an especially important recommendation given the severity of this year's epidemic," said Dr. Ratner, who was not involved in developing the guidelines. "It also provides guidance for the use of existing vaccines in outbreak settings, such as clusters of mumps or meningococcal disease, both of which have recently occurred on college campuses."

Among the other items in the 2018 pediatric schedule are:

- A recommendation that 11- or 12-year-olds receive two doses of the human papillomavirus vaccine, and three doses after age 15.

- Information on the timing of the birth dose of a hepatitis B vaccine for infants whose birth weights are greater than 2,000 grams (4.4 pounds).

- A catch-up schedule for children and adolescents who start late or are more than a month behind in vaccines.

"Because immunization is among the safest and most cost-effective methods for protecting children from disease, it is particularly important that pediatricians have access to the most up-to-date information regarding vaccines," Dr. Ratner concluded.

SOURCES: http://annals.org/aim/fullarticle/2671913/recommended-immunization-schedule-adults-aged-19-years-older-united-states and http://pediatrics.aappublications.org/content/early/2018/02/02/peds.2018-0083
Ann Intern Med 2018 and Pediatrics 2018.

Source: http://www.chronicliverdisease.org/reuters/article.cfm?article=20180206Other1212356543

Hepatitis C: daclatasvir/asunaprevir may improve HRQOL and hepatic functional reserve, particularly in elderly patients

Exp Ther Med. 2018 Jan;15(1):970-976. doi: 10.3892/etm.2017.5488. Epub 2017 Nov 10.

Health-related quality of life on the clinical course of patients with chronic hepatitis C receiving daclatasvir/asunaprevir therapy: A prospective observational study comparing younger (<70) and elderly (≥70) patients.

Ohashi K1,2, Ishikawa T2,3, Suzuki M2,4, Abe H1,2, Koyama F1,2, Nakano T1,2, Ueki A1,2, Noguchi H1,2, Hasegawa E1,2, Hirosawa S1,2, Kobayashi M1,2, Hirosawa H2,5, Sato K2,6, Fukazawa T2,6, Maruyama Y2,7, Yoshida T3.

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Abstract
Interferon-free direct acting antiviral agent regimens for chronic hepatitis C (CHC) have been developed. These regimens have shown a high rate of sustained virologic response (SVR), and a reduction in side effects during treatment is also anticipated. However, the impact of the regimens on health-related quality of life (HRQOL) and side effects during treatment is not fully understood. The purpose of the present study was to evaluate HRQOL in the clinical course of patients with CHC receiving daclatasvir/asunaprevir (DCV/ASV) therapy using the Short Form-36 (SF-36) method. Twenty-eight patients with CHC receiving DCV/ASV therapy were analyzed in the present study, and HRQOL was measured by SF-36. Patients were asked to fill out the SF-36 prior to therapy (baseline), following 12 weeks of therapy, at the end of treatment and at SVR week 24 (SVR24) to evaluate HRQOL. Laboratory data were also investigated during the same period, and associations between these results and SF-36 were investigated. Aspartate aminotransferase, alanine aminotransferase, serum albumin, α-fetoprotein, platelet counts and Fibrosis (Fib)-4 index were all significantly improved at each time point when compared with baseline. With regard to alterations in HRQOL during therapy, the ≥70-year-old group displayed a significantly greater improvement in physical functioning during the period between baseline and 12 weeks when compared with the <70-year-old group. In the analysis of the SF-36 differences within each group, general health improved significantly in the ≥70-year-old group, as well as albumin levels. In addition, Fib-4-index significantly improved at all time points (12 and 24 weeks, and SVR24) when compared with baseline in the ≥70-year-old group. Therefore, DCV/ASV therapy may improve HRQOL and hepatic functional reserve, particularly in elderly patients.

Continue to article: https://www.spandidos-publications.com/10.3892/etm.2017.5488

The Canadian Treatment Action Council Launches Campaign to End Hepatitis C in Canada

CTAC Launches Campaign to End Hepatitis C in Canada

TORONTO, Feb. 6, 2018 /CNW/ - The Canadian Treatment Action Council (CTAC) has published a white paper entitled, "The time has come to eliminate hepatitis C in Canada," which summarizes the increasing gaps in Canada's response to the hepatitis C epidemic and identifies seven calls-to-action. CTAC is once again demonstrating its commitment to securing and ensuring access to testing, treatment, care and support for Canadians living with HIV and hepatitis C virus (HCV).

Along with like-minded allies, CTAC is calling upon policymakers and community leaders to respect their engagement to eliminate hepatitis C infection in Canada by adopting a public health strategy and making a clear commitment toward the elimination of viral hepatitis. Commenting on the campaign, CTAC Executive Director Shelina Karmali said, "We're hoping our white paper stimulates a response at all levels of government so that every Canadian managing HCV will have access to equitable and timely testing and treatment." Ms. Karmali added, "HCV is 100 per cent curable."

The Issues
An estimated 220,000 - 245,000 Canadians are infected with HCV. Unfortunately, around 44% of those individuals are unaware of their status, and are often only diagnosed incidentally to something else. There is a large population of individuals currently aging with HCV, whether diagnosed or not, who are now experiencing complications of HCV, some of which are quite severe, such as cirrhosis, liver failure and death. The cost to the healthcare system is greater than treating HCV. Indigenous communities, people who inject drugs, ethno-cultural communities and baby boomers are at an increased risk of being affected by HCV.

In 2016, Canada committed at the WHO to work to eliminate HCV as a public health threat by 2030. Canada's WHO commitment is to have treated 80% of people with the disease. In 2018, hepatitis C prevention and care strategies remain fragmented across the country.

A Unique Opportunity
The goal to cure hepatitis C is achievable, and Canada has had access to these curative medications (highly effective, highly tolerable direct-acting antivirals) since 2015. The pan-Canadian Pharmaceutical Alliance (pCPA) announced in early 2017 a new framework that has brought down the price of treatment. Despite significant treatment cost reductions; too few people are being treated, and in Canada, as elsewhere, hepatitis C rates are on the rise because we have not implemented comprehensive public health strategies to stem the tide.

The 7-Point Solution
There is a role for coordinated national response, including collaboration between federal, provincial and territorial governments, around ending hepatitis C in the next 10 years. CTAC is calling for policymakers and community leaders to adopt a more comprehensive action plan of how hepatitis C elimination will be achieved in Canada by adopting the following:
Increased access to testing, including point-of-care testing, rapid testing, and one-time cohort screening for all baby boomers
Removal of restrictive eligibility requirements to access treatment
Access to all hepatitis C medications approved by Health Canada on public drug programs
Creation of a framework by the pan-Canadian Pharmaceutical Alliance (pCPA) to standardize processes and timelines and add transparency
Removal of the time delay between the close of pCPA negotiations and the signing of Product Listing Agreements with individual provincial and territorial formularies
Lower drug costs
A standalone viral hepatitis plan

Get Involved
CTAC is asking individual and organizational influencers to endorse the calls to action. This can be done electronically by going to www.ctac.ca/EliminateHepC. In addition, for those wishing to take further action, a letter-generated electronic form will be available for submission to individual provincial and territorial health ministers so that a unified voice can be heard and action taken to get Canada back on track toward its stated commitment to eliminate HCV as a public health threat by 2030.

About CTAC
CTAC is Canada's non-governmental organization led by and for people living with HIV and HIV/HCV co-infection, focusing on access to treatment. Since 1996, we have been working to secure and ensure equitable, affordable and timely access to testing, treatment, care and support for people in Canada living with HIV and HIV/HCV co-infection and other co-morbidities. We work with community, public, private and not-for-profit leaders to inform research and public policy, and promote public awareness and discussion.

SOURCE Canadian Treatment Action Council

https://www.newswire.ca/news-releases/ctac-launches-campaign-to-end-hepatitis-c-in-canada-672915243.html
Canadian Treatment Action Council

AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™

AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™ - an oral therapy for the treatment of patients with hepatitis C

MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1
MAVIRET previously received a Notice of Compliance from Health Canada on August 16, 2017
MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, Feb. 6, 2018 /CNW/ - AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that the CADTH Canadian Drug Expert Committee (CDEC) issued a positive recommendation for MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6)2. MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who make up a large portion of HCV patients in Canada. 

The recommendation states that glecaprevir/pibrentasvir be reimbursed for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis, including patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors, if specific conditions are met.3

"Continued efforts are fundamental to the ultimate goal of eliminating hepatitis C, which is a serious and complex disease in Canada. It is vital that as many patients as possible are able to achieve a virologic cure, as quickly as possible, and we hope that patients throughout Canada will be able to benefit from this latest treatment, which has the potential to cure most HCV patients in eight weeks," states Dr. Samuel Lee, Hepatologist and Professor, Cumming School of Medicine, University of Calgary.

Approximately 300,000 Canadians are infected with hepatitis C.4 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.5 GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.4,6 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years7 of infection. Additionally, HCV is common among people with severe chronic kidney disease (CKD), and some of these patients previously did not have a direct-acting antiviral (DAA)-based treatment option.8

"Our goal is to see Canada meet its commitment to the World Health Organization's Global Strategy on Viral Hepatitis by eliminating hepatitis C by 2030. This is within our reach, but we need a coordinated national response with a comprehensive action plan to prevent, screen, diagnose and treat Canadians living with hepatitis C," says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation and Toronto-based hepatologist. "The Canadian Liver Foundation recommends screening for hepatitis C based on risk factors, plus a one-time test for all Canadians born 1945 – 19759. Furthermore, treatment eligibility restrictions that currently exist need to be removed, so that physicians and their patients have affordable and equitable access to all available treatment options, regardless of background, disease severity or the province in which they live."

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).

"AbbVie is deeply committed to curing Canadians of hepatitis C. We strongly believe in providing patient and doctor choice when selecting the appropriate medication," explains Stéphane Lassignardie, General Manager, AbbVie Canada. "The CADTH positive recommendation reinforces our belief that there is a need for innovative therapies like MAVIRET in order to reach the goal set out by the World Health Organization to eliminate HCV by 2030 in Canada and across the world."

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,*1 such patients comprising the majority of people living with HCV. 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 and development-based 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 CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed February 2018.
4Messina, JP et al. "Global distribution and prevalence of hepatitis C virus genotypes." Hepatology, 2015; 61: 77–87. Supporting information http://onlinelibrary.wiley.com/wol1/doi/10.1002/hep.27259/full. Accessed January 2018.
5 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 February 2018.
6 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.
7 Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 2018.
8 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
9 The Canadian Liver Foundation, press release: https://www.newswire.ca/news-releases/not-getting-the-message-too-many-canadians-born-between-1945-1975-unaware-of-their-increased-risk-of-undiagnosed-hepatitis-c-587783871.html. Accessed February 2018.

SOURCE AbbVie Canada

Podcast - Referring, and Managing Patients with HCV

Consultant360.com

Published - January 26, 2018

Dr. Jorge Herrera, director of the Section of Hepatology and professor of Internal Medicine at the University of South Alabama, discusses screening, referring, and managing patients with hepatitis C virus.

Overview
Hepatitis C Risk Factors
Testing
Primary Care Physicians Treating HCV
Referral Process
Drug interactions
Define Cure
Treat Early
Quality of life after SVR
Treat All

Find more hepatitis-related content at our specialty site here.

Hep C in the Prison Population

Hep C in the Prison Population

by William Rankin, MD February 05, 2018

Prison medical director discusses diagnosis and treatment for inmates

MedPage Today is pleased to introduce a blog that focuses on providing medical care in jails and prisons, written by a physician with intimate knowledge of the topic. The purpose is to enlighten those not involved in such care as well as to invite those who are so involved to lend their perspective.

Continue reading: https://www.medpagetoday.com/blogs/doing-time/70960

NAFLD: The evolving landscape

The Journal of Hepatology
February 2018
Volume 68, Issue 2, Pages 227–229

DOI: https://doi.org/10.1016/j.jhep.2017.11.016

NAFLD: The evolving landscape
Jacob George, Quentin Anstee, Vlad Ratziu, Arun Sanyal

Non-alcoholic fatty liver disease (NAFLD) comprising non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH), together with their complications of cirrhosis, liver failure and liver cancer will be the predominant liver disease for the conceivable future. Traditionally, viral hepatitis has been the focus of basic and clinical research, and the bread and butter for clinicians in the field. However, with the advent of therapies that suppress hepatitis B virus replication and the shift in standard of care for the treatment of hepatitis C to highly effective direct acting antivirals, the focus of clinical practice and research has altered. For hepatitis C, the goal has moved to elimination strategies and the massive treatment scale up required to achieve this outcome. For hepatitis B, lifelong antiviral therapy for those that require it, as well as cancer surveillance for at-risk groups, has established a relatively easy to follow management algorithm, as we transition to global hepatitis B eradication through immunisation and development of strategies to achieve a functional cure.

While these achievements are a highlight for the speciality, NAFLD has now replaced viral hepatitis as the mainstay of clinical hepatology. Not only does NAFLD and its many variations comprise an ever-increasing number and proportion of referrals to specialists, but it also represents a challenge for primary care physicians managing the early and intermediate stages of the disease. In this respect, disease due to fatty liver is a relative late comer to the limelight in Hepatology, compared to the consequences of the same systemic metabolic derangements to other organ systems including type 2 diabetes, cardiovascular and cerebrovascular disease, and chronic kidney disease.

As we move towards a world where the glimmer of viral hepatitis elimination is becoming a possibility and NAFLD related disease increases, it is appropriate that the Journal commissioned this supplement.

Continue reading: http://www.journal-of-hepatology.eu/article/S0168-8278(17)32439-X/fulltext