Showing posts with label svr. Show all posts
Showing posts with label svr. Show all posts

Thursday, February 14, 2019

Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C

Page updated with additional links on Feb 14, 2019

The Lancet
Published: February 11, 2019
DOI: https://doi.org/10.1016/S0140-6736(18)32111-1
Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study
Although direct-acting antivirals have been used extensively to treat patients with chronic hepatitis C virus (HCV) infection, their clinical effectiveness has not been well reported. We compared the incidence of death, hepatocellular carcinoma, and decompensated cirrhosis between patients treated with direct-acting antivirals and those untreated, in the French ANRS CO22 Hepather cohort.
Continue to "full-text article"
PDF shared on twitter by @HenryEChang

Direct-acting antiviral treatment for hepatitis C - Linked Comment
Writing in a linked Comment, Dr Raymond T Chung, Director of the Liver Center at Massachusetts General Hospital, USA, says: 
"The study by Carrat and colleagues offers substantive evidence that cure of HCV delivered by all-oral direct-acting antiviral regimens is associated with clinical benefits. These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection. Finally, they provide credence to the achievability of the goals set out by WHO, not only to eliminate HCV but also to substantially reduce its complications." 
Read full comment here....

Media Coverage
Patient-friendly article
Feb 14, 2019
Scientists have firmly established an association between direct-acting antiviral treatment and a lower risk of liver cancer and death.

Feb 11, 2019
Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C 
Professor Fabrice Carrat of the Sorbonne Université, France, said: "Taking a large cohort like this provides the opportunity to evaluate the effect of direct-acting antiviral therapy on the long-term outcomes of patients with hepatitis C. We saw a reduction of risk for complications related to the disease, and to mortality, and believe this treatment should be considered for all patients with chronic hepatitis C infection."

The first prospective, longitudinal study investigating treatment of chronic hepatitis C with direct-acting antivirals finds that the treatment is associated with reduced risk of mortality and liver cancer, according to a study published in The Lancet.

The research is the first to demonstrate the clinical effectiveness of direct-acting antivirals on the disease and suggests that they should be considered for all patients with chronic hepatitis C infection.

For ethical reasons a trial with a control arm is not possible and researchers approached this by setting up an observational study of around 10,000 patients. At follow up, about three-quarters had been treated with direct-action antivirals and a quarter were untreated. The incidence of death and hepatocellular carcinoma - the most common form of liver cancer - were significantly decreased in patients who were treated. Their risk of decompensated cirrhosis was not reduced by the treatment.

Around the world, an estimated 71 million people are chronically infected with the hepatitis C virus (HCV). The infection causes complications such as cirrhosis, liver disease, hepatocellular carcinoma, and many people die as a result. Over the last 15 years, these complications have tripled and models predict they will peak between 2030 and 2035. The World Health Organization (WHO) has set targets for the elimination of hepatitis C, and a reduction of related complications. Recently, a modelling study published in The Lancet found that major progress towards these targets by 2030 is possible, but will require vast improvements in screening, prevention, and treatment [1].

Previous work has shown there is a reduction of risk for complications and mortality in patients who are treated with interferon or direct-acting antivirals, but few studies have compared treated and untreated patients. The aim of direct-acting antiviral drugs is to achieve a sustained virological response, meaning that the virus is undetectable in the blood of the patients. A recent Cochrane Review [2] found no evidence for or against the treatment having a long-term effect on death and disease, so this large study is timely, and may help doctors and patients with treatment plans.

In this study, 10,166 patients were recruited from 32 centres in France. At a median of 33 months, 9,895 patients had available follow up information and were included in the analysis, with 7,344 treated with direct-acting antivirals and 2,551 untreated. During follow-up, 218 patients died (129 treated, 89 untreated), 258 reported hepatocellular carcinoma (187 treated, 71 untreated), and 106 had decompensated cirrhosis (74 treated, 32 untreated).

Overall, the study finds that direct-acting antiviral treatment is associated with reduced risk for global mortality and hepatocellular cancer, but not decompensation of cirrhosis. The researchers initially found an increase in risk associated with treatment with direct-acting antiviral treatment, but once they had adjusted for variables such as age, sex, body-mass index, severity of liver disease, geographical origin, infection route and other factors, they found a reduced risk.

Patients who were treated were 52% less likely to die prematurely than people who were not treated (the estimated adjusted risk of death at one year in untreated patients in the cohort is 84 deaths per 10,000 patients, and in those who were treated was 40 per 10,000), and 33% less likely to present with hepatocellular carcinoma (the estimated adjusted risk of developing hepatocellular carcinoma within a year in untreated patients in the cohort was 129 cases per 10,000 patients, and 86 per 10,000 in people who were treated). [3]

In a subgroup of 3,045 patients with cirrhosis at baseline, the same association was found for mortality and hepatocellular cancer, provided the patients achieved an undetectable level of HCV in their blood. The researchers believe this is because the treatment induces a sustained virological response, allowing the liver to regenerate which decreases risk.

Professor Fabrice Carrat of the Sorbonne Université, France, said: "Taking a large cohort like this provides the opportunity to evaluate the effect of direct-acting antiviral therapy on the long-term outcomes of patients with hepatitis C. We saw a reduction of risk for complications related to the disease, and to mortality, and believe this treatment should be considered for all patients with chronic hepatitis C infection." [4]

In the study, only a few patients underwent liver biopsy to confirm cirrhosis, with platelet levels or prothrombin time - a blood test - used to classify whether a patient had cirrhosis or not. A validation study using other non-invasive markers of fibrosis suggested that their methods correctly classified cirrhosis in the patients.

Patients who received more than one course of direct-acting antivirals were considered to have had continuous exposure, even where there may have been a lag time or if the first course may not have been associated with sustained virological response. This should have underestimated the response to the drugs rather than overestimated them so does not affect the result.

The study excluded patients with a history of decompensated cirrhosis and liver transplantation and these are the patients who would be at highest risk for complications. The potential benefits of treatment in this group could be underestimated because of their exclusion, as trial data shows improvements in liver function in patients with decompensated cirrhosis who achieved a sustained virological response.
https://www.eurekalert.org/pub_releases/2019-02/tl-pss020819.php

Recommended Reading
lastair Heffernan, MResProf Graham S Cooke, DPhilShevanthi Nayagam, PhDProf Mark Thursz, MDProf Timothy B Hallett, PhD
Jan 28, 2019
The revolution in hepatitis C virus (HCV) treatment through the development of direct-acting antivirals (DAAs) has generated international interest in the global elimination of the disease as a public health threat. In 2017, this led WHO to establish elimination targets for 2030. We evaluated the impact of public health interventions on the global HCV epidemic and investigated whether WHO's elimination targets could be met.

Monday, February 11, 2019

Insights From Antiviral Therapy Into Immune Responses to Hepatitis B and C Virus Infection

Gastroenterology
January 2019 Volume 156, Issue 2, Pages 369–383 

Insights From Antiviral Therapy Into Immune Responses to Hepatitis B and C Virus Infection Barbara Rehermann, Robert Thimme 

Abstract
There are 257 million persons worldwide with chronic hepatitis B virus (HBV) infection, a leading causes of liver cancer. Almost all adults with acute HBV infection have a rapid immune response to the virus, resulting in life-long immunity, but there is no cure for individuals with chronic HBV infection, which they acquire during early life. The mechanisms that drive the progression of HBV through distinct clinical phases to end-stage liver disease are poorly understood. Likewise, it is not clear whether and how immune responses can be modulated to allow control and/or clearance of intrahepatic HBV DNA. We review the innate and adaptive immune responses to acute and chronic HBV infections and responses to antiviral therapy. Comparisons with hepatitis C virus infection provide insights into the reversibility of innate inflammatory responses and the potential for successful therapy to recover virus-specific memory immune responses.

Shared On Twitter: Henry E. Chang

Testosterone in Men With Chronic Hepatitis C Infection and After Hepatitis C Viral Clearance

Corrected Proof
Clinical Infectious Diseases, ciy965, https://doi.org/10.1093/cid/ciy965
Published: 02 February 2019
Testosterone in Men With Chronic Hepatitis C Infection and After Hepatitis C Viral Clearance
We evaluated testosterone levels and the prevalence of low testosterone in a cohort of 327 men with chronic HCV infection (human immunodeficiency virus [HIV] coinfection = 150) and in a subset of 85 men with testosterone levels obtained pre-HCV treatment and after sustained virologic response (SVR). Median follow-up was 36 months.
Full text available online:

Commentary: Healio
Low testosterone persists after HCV clearance
February 11, 2019 
Low levels of free testosterone are common among men with chronic hepatitis C infection following SVR and persist after HCV clearance, according to findings from a prospective, longitudinal cohort study.

“Previous research has shown that low total testosterone (TT), low free testosterone (FT), and elevated sex hormone-binding globulin (SHBG) are extrahepatic manifestations of chronic HCV when compared with healthy controls,” Chloe S. Chaudhury, MD, post-baccalaureate research fellow at the National Institute of Allergy and Infectious Diseases, and colleagues wrote. “There is now a need for studies to examine the effect of HCV and HCV viral clearance on long-term testosterone levels and hypogonadal status.” 

Read more:

Saturday, February 9, 2019

Mavyret - Safety and efficacy in patients receiving opioid substitution therapy/HCV genotypes 1-6

Int J Drug Policy. 2019 Feb 5;66:73-79. doi: 10.1016/j.drugpo.2019.01.011. [Epub ahead of print]

Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1-6 receiving opioid substitution therapy.
Grebely J1, Dore GJ2, Alami NN3, Conway B4, Dillon JF5, Gschwantler M6, Felizarta F7, Hézode C8, Tomasiewicz K9, Fredrick LM3, Dumas EO3, Mensa FJ3.

Open Access

Abstract
BACKGROUND:
International guidelines recommend treatment of hepatitis C virus (HCV) infection in people who inject drugs (PWID), including those on opioid substitution therapy (OST). The pangenotypic combination of glecaprevir and pibrentasvir has shown high sustained virologic response at post-treatment Week 12 (SVR12) in clinical trials. Herein, we evaluate the safety and efficacy of glecaprevir/pibrentasvir in patients receiving OST.

METHODS:
Pooled data from patients with HCV genotypes 1-6 who were treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks in eight Phase 2 and 3 trials were categorized by use of OST. Treatment completion, treatment adherence, SVR12, adverse events (AEs), and laboratory abnormalities were evaluated for patients receiving and not receiving OST.

RESULTS:
Among 2256 patients, 157 (7%) were receiving OST. Compared with patients not receiving OST, OST patients were younger (mean age, 46.8 vs 52.8 years), male (69% vs 54%), white (93% vs 80%), HCV treatment-naïve (86% vs 72%), had HCV genotype 3 (60% vs 26%), and had a history of depression or bipolar disorder (43% vs 19%). Most patients completed (OST: 98% [n/N = 154/157]; non-OST: 99% [n/N = 2070/2099]) and were adherent (received ≥90% of study drug doses) to glecaprevir/pibrentasvir treatment (OST: 98% [n/N = 121/123]; non-OST: 99% [n/N = 1884/1905] among patients with available data). In the intention-to-treat population, SVR12 rates in OST and non-OST patients were 96.2% (n/N = 151/157; 95% CI 93.2-99.2) and 97.9% (n/N = 2055/2099; 95% CI 97.3-98.5), respectively. For OST patients, reasons for nonresponse included virologic relapse (<1%; n = 1), premature study drug discontinuation (<1%; n = 1), and loss to follow-up (3%; n = 4). AEs occurring in ≥10% of OST patients were headache, fatigue, and nausea. Drug-related serious AEs, AEs leading to study drug discontinuation, and Grade 3 or higher laboratory abnormalities were infrequent in both groups (<1%). No HCV reinfections occurred through post-treatment Week 12.

CONCLUSION:
Glecaprevir/pibrentasvir is highly efficacious and well tolerated in HCV-infected patients receiving OST.


Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.
KEYWORDS: Glecaprevir/pibrentasvir; Hepatitis C virus; Opioid substitution therapy; People who inject drugs

Thursday, February 7, 2019

Hepatitis C cure does not improve glucose control in type 2 diabetes

Article Source: infohep
The aim of infohep.org is to develop a high-quality online resource to increase awareness of viral hepatitis, its treatment, and the needs of people living with viral hepatitis in Europe. NAM (aidsmap.com) is working with the World Hepatitis Alliance and the European Liver Patients Association (ELPA) on infohep.org.

Hepatitis C cure does not improve glucose control in type 2 diabetes
Michael Carter
Published: 07 February 2019
A successful response to HCV therapy does not result in long-term improvements in glucose metabolism for patients with type-2 diabetes, according to US research published in Liver International. 
A sustained virological response (SVR) was associated with a short-term improvement in a key marker of glucose control, but these improvements were not sustained in the longer-term and within three years glucose control was comparable between SVR patients and individuals who did not receive any HCV therapy or who had an unsuccessful treatment response. 
The investigators found the same results when they restricted their analysis to patients who had a SVR after receiving treatment with direct-acting agents (DAAs). “A number of studies have reported significant decreases in HbA1c [glycosolated haemoglobin] immediately after SVR. In contrast, a recent report found that reductions in HbA1c immediately following successful treatment were not sustained after a mean duration of 2.5 years,” write the authors. “A strength of our longitudinal analysis is that our results allow us to reconcile these apparently conflicting reports.”
Read more: http://www.infohep.org/page/3426435/
Abstract: Sustained virological response does not improve long‐term glycaemic control in patients with type 2 diabetes and chronic hepatitis C

Wednesday, February 6, 2019

2019 Hepatitis C - Testing, Treatment Options, Stages of fibrosis and Care

Caring for patients with chronic hepatitis C infection
Basic information about hepatitis C, published Jan 31, 2019 in: Nursing2019 - Ahead of Print, available in PDF format only.

Highlights
Who is at risk?
How HCV infection progresses
Extrahepatic complications of HCV infection
Testing for HCV
Stages of fibrosis
Treatment options
Removing treatment barriers
Promising future

Nursing. 2019 Jan 31. doi: 10.1097/01.NURSE.0000553271.39804.a4. [Epub ahead of print]
Caring for patients with chronic hepatitis C infection
Chaney, Amanda, DNP, APRN, FNP-BC, FAANP
Abstract:
Hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the US. This article discusses the pathophysiology of HCV infection, new treatment options, and nursing care and patient teaching for patients with chronic HCV infection.
Begin, here..….

For Patients On This Site
2019 February Hepatitis Newsletters: Finding Support 

Sunday, February 3, 2019

Interferon-free hepatitis C therapies: barriers to adherence and optimizing treatment outcomes

Research Article
Experiences with interferon-free hepatitis C therapies: addressing barriers to adherence and optimizing treatment outcomes 
Avy A. Skolnik, Amanda Noska, Vera Yakovchenko, Jack Tsai, Natalie Jones, Allen L. Gifford and D. Keith McInnes

https://doi.org/10.1186/s12913-019-3904-9
Received: 24 August 2018
Accepted: 14 January 2019
Published: 1 February 2019


Despite medications with increased efficacy and effectiveness, and few onerous side-effects, there is much to be learned about achieving high rates of SVR while delivering positive patient treatment experiences. Newer HCV medications carry considerable financial costs, and are not without context-related adherence barriers, side effects, and potential for complex dosing. This suggest that even amidst optimism about dramatically reducing rates of HCV, patient access to medications, treatment adherence and treatment completion remain critical issues in combatting HCV.

Abstract
Background
Millions of Americans are living with hepatitis C, the leading cause of liver disease in the United States. Medication treatment can cure hepatitis C. We sought to understand factors that contribute to hepatitis C treatment completion from the perspectives of patients and providers.

Methods
We conducted semi-structured interviews at three Veterans Affairs Medical Centers. Patients were asked about their experiences with hepatitis C treatments and perspectives on care. Providers were asked about observations regarding patient responses to medications and perspectives about factors resulting in treatment completion. Transcripts were analyzed using a grounded thematic approach—an inductive analysis that lets themes emerge from the data.

Results
Contributors to treatment completion included Experience with Older Treatments, Hope for Improvement, Symptom Relief, Tailored Organized Routines, and Positive Patient-Provider Relationship. Corresponding barriers also emerged, including pill burden and skepticism about treatment effectiveness and safety.

Conclusion
Despite the improved side-effect profile of newer HCV medications, multiple barriers to treatment completion remain. However, providers and patients were able to identify avenues for addressing such barriers.

Continue to full-text article available online:

Wednesday, January 30, 2019

Listen: Liver Cancer After Treatment For Hepatitis C

HCC After DAA Treatment
Listen to Dr. Behnam Saberi of the Icahn School of Medicine at Mount Sinai discuss; “HCC After DAA Treatment” using case based scenarios in this easy to access webinar series provided by HepCure.

Links

View All Presentations

Navigate This Website
Liver Cancer After Treatment For Hepatitis C
Index of articles with current data investigating the possible risk of developing liver cancer (hepatocellular carcinoma HCC) during and after direct-acting antiviral therapy in patients with hepatitis C.

Friday, January 25, 2019

Discussion on critical points for a tailored therapy to cure hepatitis C virus infection

Clin Mol Hepatol. 2019 Jan 23. doi: 10.3350/cmh.2018.0061. [Epub ahead of print]

Discussion on critical points for a tailored therapy to cure hepatitis C virus infection.
Marascio N1, Quirino A1, Barreca GS1, Galati L1, Costa C2, Pisani V2, Mazzitelli M2, Matera G1, Liberto MC1, Focà A1, Torti C2.

Full Review

Abstract
Hepatitis C virus (HCV) infects around 71 million people worldwide and in 2018 it is still a major health problem. Since 2011, anti-HCV therapy with availability of direct-acting antiviral drugs has revolutionized the clinical response and paved the way to eradication strategies. However, despite the high rate of sustained virological response, treatment failure may occur in a limited percentage of patients, possibly due to resistance-associated substitutions (RASs), either emergent or pre-existent even in minority viral populations. Clearly this problem may impair success of eradication strategies. With this background, several questions marks still exist around HCV treatment, including whether pan-genotypic treatments with complete effectiveness in any clinical conditions really exist outside clinical trials, the actual cost-effectiveness of genotyping testing, and utility of RAS detection in viral quasispecies by next generation sequencing approach. In this review, we describe these critical points by discussing recent literature data and our research experience.

PMID: 30669818 DOI: 10.3350/cmh.2018.0061
Source https://www.e-cmh.org/upload/pdf/cmh-2018-0061.pdf

Monday, January 21, 2019

Opioid and HCV Epidemics - Spreading rapidly in new generations, but boomers bear biggest burden

For Patients: Basic HCV Information
In this program launched by PeerView, Dr. Mark Sulkowski heads an expert panel addressing the evolving opioid and Hepatitis C epidemics. The good doctor will discuss basic HCV information for both the baby boomer generation (born between 1945 and 1965) and a younger at risk population, people less than 40 years old. 

Here are a few highlights to get you started, followed by tips for navigating the presentation.

Did you know?
Hepatitis C is spreading rapidly in new generations, but boomers bear the biggest burden.
Dr. Sulkowski: This group is critically important, because they’ve lived so long with the infection. They’re now presenting with liver disease, such as cirrhosis, decompensation—and they’re what’s behind the rise in liver cancer.. We’ll talk a bit more about that in a minute. And these individuals are dying about 15,000 deaths per year.


Dr. Sulkowski: So, let’s move into the first lecture portion of this, where we’re going to try to cover some of the basics about the burden of hepatitis C, where we stand with treatment and cure, and then we’re going to focus more on the local picture. Hep C is a major cause of mortality in America, more than any other infectious disease, even when you combine them. And I’ll come back to that with some actual data from the CDC. So, [HCV is] a major problem in the United States.

Opiate epidemic in the United States 
18-to 29-year-olds and 30- to 39-year-olds.
Dr. Sulkowski: In parallel with that is hepatitis C. One thing that characterizes this virus is it is very transmissible by blood contamination. But it’s not just reuse of needles; it’s reuse of any of the works, including water, that have been used to prepare drugs.

And it’s so contagious that people acquire it unknowingly. So, you can see that staggering increase in hepatitis C among this population, and that’s what’s driving that second hump on our epidemiology graphics in California but also here in Maryland.


Topics
A Closer Look at the Burden of HCV Infection in a New Era of Treatment and Cure
Hepatitis C and Injection Drug Use in the Urban Setting: Perspectives From the Front Lines 
Hepatitis C and Injection Drug Use in the Rural Setting: Perspectives From the Front Lines 
Practice Aids, Slides, Monograph and Live Roundtable Discussion Summary 
Experts discuss working with patients with substance use disorder 

For Patients: How To Navigate The Program 
Begin: Click here
-Select any specialty or profession
-The program will begin
-Interactive questions will appear; respond by clicking "N/A" or click "Next Button" on the top of your screen.
-Pause program click on the video presentation. 
-No registration is required

Recommended Reading
Screening For HCV Is Lacking - Baby Boomers
Screening strategies have been in place for baby boomers since 2012, but according to research, and the American Liver Foundation, "Few boomers are getting screened for hep C'

Screening For HCV Is Lacking - Young People At Risk
Screening young people most at risk for HCV is lacking as well, last month an article written by Michelle Andrews, published by Kaiser Health News (KHN) found facilities ready to serve people who use drugs are not always screening patients, read the article here.

The opioid epidemic is a major contributor to the current rise in HCV infections. Recently, HepVu launched a map on the impact of hepatitis C across the U.S. In some states the map shows a concentration of infections most impacted by the opioid epidemic.

Taking Down the Opioid Crisis 
Andrew Reynolds writes about the opioid crisis online at POSITIVELY AWARE (PA)
This article will provide you with a broad overview of the scope of the problem, basic information to understand what opioids are and how they lead to overdoses, and some harm reduction tips and resources so that you, or someone you know who uses drugs, can be safe. 
Read it here, follow Andrew on twitter. Visit Project Inform to read additional articles about the opioid crisis. 

Andrew Reynolds
Andrew Reynolds is the Hepatitis C Education Manager at Project Inform, and facilitates several HCV support groups in the San Francisco Bay Area. He's also a counselor on the HELP-4-HEP HCV phoneline (877-435-7443). Call him if you have any questions about HCV care and treatment.

Healio’s Opioid Resource Center
Healio’s Opioid Resource Center compiles the latest stories across a range of specialties, covering the latest research into the epidemic, FDA decisions on treatments and other related announcements.

Thanks for stopping by
Tina 

Thursday, January 17, 2019

After The Cure: What’s Next? Hepatitis C Post-Treatment Management

Listen to experts discuss important HCV related topics in the following easy to access webinar series provided by HepCure.

Achieved SVR, What’s Next? HCV Post-Treatment Management
This month Dr. Anthony Martinez of University at Buffalo presented; Achieved SVR, What’s Next? HCV Post-Treatment Management. 

Topics Discussed
1. Define sustained virologic response (SVR).
2. Describe how to manage cirrhotic patients post-SVR
3. Discuss at-risk populations for HCV reinfection

Begin here.....

View All Presentations

Recommended Reading 
AASLD-IDSA Hepatitis C Guidance:
Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy
Post-Treatment Follow-Up for Patients Who Achieved a Sustained Virologic Response
Patients who have undetectable HCV RNA in the serum, as assessed by a sensitive polymerase chain reaction (PCR) assay, ≥12 weeks after treatment completion are deemed to have achieved SVR. In these patients, HCV-related liver injury stops, although they remain at risk for non-HCV–related liver disease, such as fatty liver disease or alcoholic liver disease. Patients with cirrhosis or advanced fibrosis remain at risk for developing hepatocellular carcinoma (HCC).
Continue reading...….

May 2017 Gastroenterology
American Gastroenterological Association Institute Clinical Practice Update—Expert Review: Care of Patients Who Have Achieved a Sustained Virologic Response After Antiviral Therapy for Chronic Hepatitis C Infection
Ira M. Jacobson, Joseph K. Lim, Michael W. Fried

Full-text - Download PDF

Background and Objective
With the advent of safe and highly effective DAAs, cure of HCV infection has become more frequent. On the basis of randomized and observational studies, systematic reviews, and expert opinion, the authors of this clinical practice update present key recommendations about whether, when, and how long HCV patients who have achieved SVR should receive ongoing liver care.

Key Points
Confirm long-term virologic response at 48 weeks posttreatment. This recommendation is based on clinical trial results that have identified a late-relapse rate of ±0.5%. However, further confirmation of virologic response beyond 48 weeks posttreatment is not supported by the available evidence.

For patients with stage 3 fibrosis or liver cirrhosis, continue post-SVR surveillance for hepatocellular carcinoma (HCC) for an indefinite period of time, since research has identified no point beyond which the risk for HCC is reduced to that of patients without liver disease. For patients with earlier stages of fibrosis, no surveillance is recommended.

Continue endoscopic screening for varices in all patients with cirrhosis (whether or not they have SVR). However, in patients with SVR who are not at risk for progressive liver disease, if no varices are identified within 2 to 3 years, cessation of further surveillance may be considered.

Noninvasive methods can be used to assess progression and regression of fibrosis after SVR. However, do not alter HCC surveillance protocols in patients with baseline cirrhosis, even when regression of fibrosis is noted, since fibrosis regression assessed by noninvasive testing has not been shown to accurately indicate a reduction in HCC risk.


Thursday, January 10, 2019

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up Amber Litzroth Email author View ORCID ID profile , Vanessa Suin, Chloé Wyndham-Thomas, Sophie Quoilin, Gaëtan Muyldermans, Thomas Vanwolleghem, Benoît Kabamba-Mukadi, Vera Verburgh, Marjorie Jacques, Steven Van Gucht and Veronik Hutse

BMC Public Health 201919:39
https://doi.org/10.1186/s12889-018-6347-z
© The Author(s). 2019
Received: 21 September 2018
Accepted: 19 December 2018
Published: 8 January 2019

Abstract
Background
Prevalence data of chronic hepatitis C virus (HCV) infection are needed to estimate the budgetary impact of reimbursement of direct-acting antivirals (DAAs). In Belgium, the restricted reimbursement criteria are mainly guided by regional seroprevalence estimates of 0.87% from 1993 to 1994. In this first Belgian nationwide HCV prevalence study, we set out to update the seroprevalence and prevalence of chronic HCV infection estimates in the Belgian general population in order to guide decisions on DAA reimbursement.

Methods
Residual sera were collected through clinical laboratories. We collected data on age, sex and district. HCV antibody status was determined with ELISA and confirmed with a line-immunoassay (LIA). In specimens with undetermined or positive LIA result, HCV viral load was measured. Specimens were classified seronegative, seropositive with resolved infection, indicative of chronic infection and with undetermined HCV status according to the test outcomes. Results were standardized for age, sex and population per district, and adjusted for clustered sampling.

Results
In total 3209 specimens, collected by 28 laboratories, were tested. HCV seropositivity in the Belgian general population was estimated to be 0.22% (95% CI: 0.09–0.54%), and prevalence of chronic HCV infection 0.12% (95% CI: 0.03–0.41). In individuals of 20 years and older, these estimates were 0.26% (95% CI: 0.10–0.64%) and 0.13% (95% CI: 0.04–0.43), respectively. Of the total estimated number of HCV seropositive individuals in Belgium, 66% were between 50 and 69 years old.

Conclusions
Prevalence of HCV seropositivity and chronic infection in the Belgian general population were low and comparable to many surrounding countries. These adjusted prevalences can help estimate the cost of reimbursement of DAAs and invite Belgian policy makers to accelerate the scaling up of reimbursement, giving all chronically infected HCV patients a more timely access to treatment.

Full-text available online:

Wednesday, January 2, 2019

Ombitasvir/Paritaprevir/Ritonavir in HCV Genotype 1 Elderly Japanese Patients

Annals Of Hepatology

Efficacy and Tolerability of Ombitasvir/Paritaprevir/Ritonavir in HCV Genotype 1-infected Elderly Japanese Patients 
Haruki Uojima,*,† Shuzo Kobayashi,‡ Hisashi Hidaka,† Takeshi Kinbara,* Tomoaki Fujikawa,§ Tsuyoshi Nakayama,|| Hiroki Yamanoue,¶ * Takayuki Kanemaru,** Tohru Hashimoto,†† Ji Hyun Sung,* Makoto Kako,* Wasaburo Koizumi†

Download Full-text article

ABSTRACT 
Introduction and aim
We assessed the characteristics of virological response to a combination treatment of ombitasvir, paritaprevir, and ritonavir in hepatitis C virus genotype 1-infected elderly Japanese patients. 

Material and Methods. 
This multicenter prospective study was conducted at six locations in Japan. Seventy patients with chronic hepatitis C virus genotype 1b infection were orally administered ombitasvir/paritaprevir/ritonavir once daily for 12 weeks. The primary endpoint was the proportion of elderly patients with sustained virological response (SVR) 12 weeks after the completion of treatment. Adverse events were also recorded to evaluate drug safety and tolerability during the trial period. SVR in elderly patients (age > 65; 94% [47 / 50]) was lower than that in younger patients (100% [20 / 20]). 

Results. 
No significant differences in SVR 12 weeks after the completion of treatment were observed between the age groups (P = 0.153). Adverse events were observed in 16 patients (23.3%). Multivariate analysis confirmed that the change or discontinuation of concomitant drugs owing to drug interactions was independent of risk factors for adverse events associated with this drug combination (P = 0.015; odds ratio, 15.9; 95% confidence interval, 1.79 - 148). Ombitasvir/paritaprevir/ritonavir combination treatment was highly effective in elderly patients. 

Conclusion. 
Tolerability should be monitored in older patients for whom concomitant medications are discontinued or changed because of drug interactions.

Hepatitis C: Mavyret (glecaprevir/pibrentasvir) in patients aged 65 years or older

Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in patients aged 65 years or older
Graham R. Foster , Tarik Asselah, Sarah Kopecky-Bromberg, Yang Lei, Armen Asatryan, Roger Trinh, Neddie Zadeikis, Federico J. Mensa

Full-text article

Abstract
Finding safe and effective treatments for chronic hepatitis C virus (HCV) infection in the elderly is of clinical interest given the comorbidities and associated polypharmacy in this population. However, the number of patients older than age 65 years enrolled into clinical trials of anti-HCV medications generally have been limited and thus reaching meaningful conclusions for this demographic has been difficult. Glecaprevir/pibrentasvir is a once-daily, all-oral, ribavirin-free, pangenotypic direct-acting antiviral (DAA) combination therapy that has demonstrated high sustained virologic response rates at post-treatment week 12 (SVR12) and a favorable safety profile in patients with chronic HCV infection. This analysis evaluated the safety and efficacy of glecaprevir/pibrentasvir in patients aged ≥65 years. Data were pooled for treatment-naïve and -experienced patients with chronic HCV genotype (GT) 1–6 infections who received glecaprevir/pibrentasvir for 8, 12, or 16 weeks in 9 Phase 2 and 3 trials. SVR12 and adverse events (AEs) were evaluated for patients aged ≥65 versus <65 years. Of the 2369 patients enrolled, 328 (14%) were aged ≥65 years. Among patients aged ≥65 years, 42% and 34% had GT1 and GT2, respectively; 40% were treatment-experienced and 20% had compensated cirrhosis. Glecaprevir/pibrentasvir treatment resulted in SVR12 rates of 97.9% (95% CI, 96.3–99.4; n/N = 321/328) for patients aged ≥65 years and 97.3% (95% CI, 96.6–98.0; n/N = 1986/2041) for patients aged <65 years. The rates were not significantly different between the two age groups (P = 0.555). DAA-related AEs leading to treatment discontinuation, or serious AEs were similarly rare (<0.5%) for patients ≥65 and <65 years old. Glecaprevir/pibrentasvir is an efficacious and well-tolerated treatment option for patients aged ≥65 years with chronic HCV infection.
Full article: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0208506 

Tuesday, January 1, 2019

Hep C Review: 2019 Newsletters & Updates


Hep C Review: 2019 January Newsletters 
Happy New Year! Check out the best of the best viral hepatitis publications, news and research articles of 2018.

Across The Globe 
As always, brought to you by a handful of devoted people across the globe who continue to share information about viral hepatitis, its cure, and in many cases individual support. An online support community can have a profound effect on curing the whole person, not only their illness.

Thank You
Thank you to every website, publication, monthly newsletter, blogger, patient blogger, and hepatitis advocate who worked so hard in 2018 to promote access to safe, effective and affordable treatment. 

Shout-out
A special thank you to Don Crocock for caring so much, for so long, about the HCV community. Don is a sassy, kind, and determined retired addiction/EAP counsellor who tweets about HCV in Canada.
Follow Don on twitter: @dcrocock or find him on Facebook: HCV Dragon Slayer.

Elsewhere On This Site 
HCV Newsletters & Blog Updates
Read easy to understand articles covering HCV-related topics that matter most to patients.

On Twitter: Top Hepatitis Articles Of 2018 Henry E. Chang is counting down his top 10 most engaging viral hepatitis tweets of 2018. Follow the links provided to review full-text journal articles.

1 - Chronic hepatitis B virus infection
Seminar — a clinically-focused cutting-edge review of chronic hepatitis B virus infection

2 - Marked reduction in prevalence of hepatitis C viremia among people who inject drugs(PWID)during 2nd year of the Treatment as Prevention(TraPHepC) program in Iceland
Treatment: for who–when–where-which ?

3 - Hepatitis C management simplification from test to cure: a framework for primary care physicians
This article proposes a strategy for primary care providers to begin treating patients with hepatitis C virus (HCV).

4 -Is there sufficient evidence to repeal three decades of clinical research on chronic hepatitis C?
Another brilliant rebuttal to the flawed & misleading Cochrane review on DAAs for HCV

5 - Hepatocellular Carcinoma
Summary of scientific evidence that supports current recommendations for clinical practice & areas in which more research is needed.

6 - Protocol for surveillance of the fraction of cirrhosis and hepatocellular carcinoma attributable to viral hepatitis in clinical centres of excellence
WHO launches new surveillance protocol & calls for better monitoring of viral hepatitis & liver cancer by documenting mortality causes more accurately on scope of problem at regional & global levels.


8 - Who is wrong?
Authors of Cochrane HCV DAA review respond to AmJGastro Red Section commentary with their uncompromising worship for "well-designed & executed RCTs to assess the utility of DAA treatment"

Study suggests that these patients should be identified and receive a triple DAA combination regimen as first-line treatment.

Absolute denials of DAA regimens by insurers in the have remained high & increased over time, regardless of type of insurance.

Follow Henry E. Chang on twitter: 

Henry Chang is Twitter Ambassador for @EASLNews, The European Association for the Study of the Liver, Board Member @HepFreeNYC, The New York City Hepatitis C Task Force, @WIHA_NG @sylifuganda, was involved with @_MdMUSA, Doctors Of The World, @GBCHealth and @AIDSHealthcare. In 2018 his twitter feed was a must follow for patients interested in reading articles about the treatment and management of hepatitis C.

CDC 2018 In Review
CDC Looks Back at the Year’s Most Pressing Health Threats
From the opioid overdose epidemic to foodborne disease outbreaks and antimicrobial resistance to the Ebola virus outbreak in the Democratic Republic of Congo (DRC), CDC worked around the clock – and around the globe – to protect Americans from health threats in 2018.

Publications
National Viral Hepatitis Action Plan 2017-2020
Simply stated: 
With more than 4 million Americans from every state and all walks of life infected with hepatitis B (HBV) or hepatitis C (HCV), and the number of new infections growing, we are losing ground in the battle against viral hepatitis. 
The National Viral Hepatitis Action Plan 2017-2020 (Action Plan), is a new phase in the fight against viral hepatitis in the United States. The updated plan outlines four major goals, strategies to achieve those goals, and indicators to help track progress between now and 2020. The plan was developed collaboratively by more than 20 federal partners from the U.S. Departments of Health and Human Services, Housing and Urban Development, Justice, and Veterans Affairs with input from nonfederal stakeholders. Also read; Viral Hepatitis in the U.S.: What Is the Problem and Why are We Losing Ground?

On This Blog - Quick Links
Collection of 2018 articles;
Research Articles
Fibrosis
Cirrhosis
Liver Cancer
Liver Transplants
Fatty Liver Disease
HCV-elderly
Possible Side Effects Of HCV Therapy
Other Conditions Related To HCV

Most Read 2018 Article On This Blog
November 24, 2018
NEW YORK (Reuters Health) - In about half of patients with hepatitis C virus (HCV) infection, response-guided therapy with oral direct-acting antiviral agents (DAAs) can be reduced from the standard 12 weeks to as little as six weeks and still be effective, according to a new pilot study.

News & Review 
Check out a collection of noteworthy hepatitis C news articles in the latest issue of the Weekly Bull, published by the Canadian non-profit organization HepCBC.

Of Interest
8 gastrointestinal, liver cancer stories you may have missed
 January 24, 2019
 Recently published studies have demonstrated new developments in the testing, diagnosis and treatment of gastrointestinal and liver cancers. In case you missed it, the…

Hepatitis A Outbreak Reaches 10,582 Cases During 2018
International travelers, food staff and those living in Heartland states were at risk for hepatitis A virus HAV during 2018

January Newsletters
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
JANURARY NEWSLETTER 
Topics
Top News Stories of 2018, by Alan Franciscus. It was an interesting year in HCV that was full of ups and downs but progress is being made in the fight against HCV.
Everyone Needs to Know About Liver Cancer by Lucinda Porter, RN writes about the causes, prevention, screening, treatment and cure of this life-threatening disease.
Hepatitis Headlines provides snapshots of trending news about hepatitis.
What’s Up! Features an updated Guide and four of our updated fact sheets as well as our Patient Video and Resource for patients:
HCV: A Guide to Healthy Living with HCV
One of the best strategies to prevent illness is Hand Washing: A Primer
Learn about the many different types of and benefits of Meditation
The new year is time to start eating thinking about Nutrition and HCV
One of the most important components of health is Sleep
Watch our patient video about treating and curing HCV.
Do you have hepatitis C? Get support. Get answers. A free program for patients – PackHealth.
Begin here...….

CATIE strengthens Canada’s response to HIV and hepatitis C by bridging research and practice. We connect healthcare and community-based service providers with the latest science, and promote good practices for prevention and treatment programs. As Canada’s official knowledge broker for HIV and hepatitis C, you can count on us for up-to-date, accurate and unbiased information.
2018 has been a pivotal year for HIV and hepatitis C prevention, testing and treatment. Researchers and clinicians have pioneered game-changing HIV treatment regimens, Canadian liver experts have expanded recommendations for hepatitis C testing, and the overdose crisis has triggered an unprecedented response from harm reduction workers, coast to coast. From the good news to the bad, below are the top 10 stories that made headlines in 2018, as determined by our readers.

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 HepMag.com are the go-to source for educational and social support for people living with hepatitis.
News
High-Fat, High-Cholesterol Diet Can Lead to NASH
Non-alcoholic steatohepatitis, or NASH, is a form of non-alcoholic fatty liver disease.
Features 
2018 Top Hep Treatment Stories
Most read treatment stories on Hep this year.
Read more here...……

HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
Read the latest: HCV Action e-update
In early December The London Joint Working Group on Substance Use and Hepatitis C held its annual conference, focusing on the prospect of achieving hepatitis C elimination in London by 2025.
Review the highlights:
A news story providing a round-up of the event can be accessed here. All of the presentation and workshop slides from the event, along with a summary report, featuring key themes of the conference and main points from the workshop, are available on the London Joint Working Group website here. Videos of the presentations and three short awareness films about the impact of hepatitis C can also be viewed here.

The World Hepatitis Alliance goal is to achieve a world free from viral hepatitis, World Hepatitis Alliance provides global leadership in awareness-raising, advocacy and in efforts to find the missing millions.
News & Headlines
Newsletter
The latest issue of hepVoice:
Making the Financial Case for Hepatitis C Elimination in Nigeria
WHA Board Elections
Find The Missing Millions in India
Highlights from AASLD and WISH
and much more. Download a pdf of this edition here.

The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to
work on projects in order to meet needs identified by the community.
NYC Hep C Task Force
All - Hep Free NYC Newsletters

Hepatitis NSW provides information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.
My Health Record: Information about your options
All News - Updates

GI & Hepatology News covers the world of liver disease with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online.
Biomarker algorithm may offer noninvasive look at liver fibrosis 
HCC screening linked with improved tumor detection 
View all updates here....

Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
View the Latest Newsletter, or relax and listen to a short podcast interviewing health experts and practioners on topics related to viral hepatitis.

Latest Podcast - View all, here.....



The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services. 
Posted on 11th December 2018
In November, as part of our Love Your Liver roadshow in Wales, our mobile unit stopped in Cardiff town centre. Here, we screened hundreds of attendees and caught the attention of ITV Wales. ITV Wales reporter Richard Morgan not only visited the unit to find out more about the campaign but also undertook a liver scan to check his liver health.
View Recent Newsletters, here.

Love Your Liver



The Hepatitis C Trust is run by patients with the goal of eliminating HCV in the United Kingdom. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no-one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.

The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
NVHR 2018 Year in Review
View all NVHR newsletters

Check out the latest National Institutes of Health Newsletter.
January Newsletter

Blog Updates
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
Latest blog entry: Heal Your Liver with Bone Broth
Find Karen on Facebook
YouTube Page

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C. 
Latest blog entry: Wishing All a Wabi-sabi New Year
View all new blog updates, here....

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog updates:
The Best Hepatitis C Treatment
By Greg Jefferys
A Hepatitis Story
By Lucinda K. Porter, RN
By Connie M. Welch
View all blog updates, here...

AGA Blog
Gastroenterology and Clinical Gastroenterology and Hepatology
View all blog updates, here...

Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Tests for Hepatitis C
View all updates, here...

Canadian Liver Foundation
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
View all blog updates, here...

The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: New Year’s Resolutions: Taking Control of Your Hepatitis B Infection
View all updates, here....

ADRLF (Al D. Rodriguez Liver Foundation)
Al D. Rodriguez Liver Foundation is a non-profit organization that provides resources, education and information related to screening, the prevention of and treatment for the Hepatitis Virus and Liver Cancer. 
Energizing Ayurvedic Cleanse Tips This Winter Season
View all updates, here....

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.
Holiday Happiness with Hepatitis C  By Karen Hoyt
View all updates, here....

Kevin Pho is a practicing physician and most known for his blog KevinMD. Thousands of authors contribute to his blog: primary care doctors, surgeons, specialist physicians, nurses, medical students, policy experts. And of course, patients, who need the medical profession to hear their voices. 
Seasoned medical professionals prescribe new medicines sparingly
View latest blog entry, here... 

Harvard Health Blog
The goal of our publications is to bring people around the world the most current health information that is authoritative, trustworthy, and accessible, drawing on the expertise of the 10,000+ faculty physicians at Harvard Medical School.
Latest blog entry: 6 steps toward a successful exercise resolution
All articles, here....

Providing physicians with virtual access to specialists can be lifesaving to liver disease patients.
A look back on the year’s most popular Michigan Medicine stories and the groundbreaking studies that made global headlines.

In Case You Missed It
Swiss Hepatitis Strategy: Is HCV elimination possible by 2030?

Wishing you all a healthy year ahead, stay informed.
Tina

Check back for updates...