Liver fibrosis staging with a new 2D-shear wave elastography using comb-push technique: Applicability, reproducibility, and diagnostic performance
Sang Min Lee,
Jeong Min Lee ,
Hyo-Jin Kang,
Hyung Kung Yang,
Jeong Hee Yoon,
Won Chang,
Su Joa An,
Kyoung Bun Lee,
Seung Yon Baek
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Published: May 16, 2017
https://doi.org/10.1371/journal.pone.0177264
Abstract
Objective
To evaluate the applicability, reproducibility, and diagnostic performance of a new 2D-shear wave elastography (SWE) using the comb-push technique (2D CP-SWE) for detection of hepatic fibrosis, using histopathology as the reference standard.
Materials and methods
This prospective study was approved by the institutional review board, and informed consent was obtained from all patients. The liver stiffness (LS) measurements were obtained from 140 patients, using the new 2D-SWE, which uses comb-push excitation to produce shear waves and a time-aligned sequential tracking method to detect shear wave signals. The applicability rate of 2D CP-SWE was estimated, and factors associated with its applicability were identified. Intraobserver reproducibility was evaluated in the 105 patients with histopathologic diagnosis, and interobserver reproducibility was assessed in 20 patients. Diagnostic performance of the 2D CP-SWE for hepatic fibrosis was evaluated by receiver operating characteristic (ROC) curve analysis.
Results
The applicability rate of 2D CP-SWE was 90.8% (109 of 120). There was a significant difference in age, presence or absence of ascites, and the distance from the transducer to the Glisson capsule between the patients with applicable LS measurements and patients with unreliable measurement or technical failure. The intraclass correlation of interobserver agreement was 0.87, and the value for the intraobserver agreement was 0.95. The area under the ROC curve of LS values for stage F2 fibrosis or greater, stage F3 or greater, and stage F4 fibrosis was 0.874 (95% confidence interval [CI]: 0.794–0.930), 0.905 (95% CI: 0.832–0.954), and 0.894 (95% CI: 0.819–0.946), respectively.
Conclusion
2D CP-SWE can be employed as a reliable method for assessing hepatic fibrosis with a reasonably good diagnostic performance, and its applicability might be influenced by age, ascites, and the distance between the transducer and Glisson capsule.
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0177264
Wednesday, May 17, 2017
Examined - Coverage of all HCV treatment regimens in state Medicaid fee-for-service programs and managed care organizations
"HCV Next" offers information on a range of liver topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, practice management issues, to name a few.
The following articles appeared in the May/June print edition of HCV NEXT, provided online at Healio.
Table of Contents
The following articles appeared in the May/June print edition of HCV NEXT, provided online at Healio.
Table of Contents
Call to Action: Physicians Needed to Alleviate HCV Treatment Restrictions
Robert Greenwald, JD
Robert Greenwald, JD
In our report, Hepatitis C: The State of Medicaid Access, co-written and produced by the Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable, we examined coverage of all HCV treatment regimens in state Medicaid fee-for-service programs and managed care organizations. What we found is some improvement in treatment access since 2014, but that many Medicaid programs continue to restrict access to HCV treatments using medically unjustifiable requirements....
Sitting among the sessions at the International Liver Congress in Amsterdam, I had the distinct feeling that we are reaching an end to the era of revolutionary change in hepatitis C, but there remained impressive data, engaging debates and ongoing research given to us to better serve our patients. For those of us long involved in this field, we rejoice with our patients, often on a daily basis, and we intend to remain heavily engaged in addressing the remaining issues even as we heed the clarion call to immerse ourselves ever more deeply in the attempts to conquer other prevalent liver diseases...
AMSTERDAM — Achieving global elimination of hepatitis C requires actionable plans and changes on many levels of society from allowance of non-specialist prescribing to universal access, a group of experts explained at the International Liver Congress.
AMSTERDAM — Adherence to treatment and subsequent sustained virologic response were unaffected by drug use in a study of patients enrolled in an opioid agonist treatment program, according to a presenter at the International Liver Congress...
When we started using interferon-free regimens for the first time — for us, it was off-label with simeprevir/sofosbuvir (Olysio, Janssen/Sovaldi, Gilead Sciences) — to treat our many patients with HIV coinfection, we found ourselves restricted by insurance companies...
Tuesday, May 16, 2017
In major shift, Pa. to expand hepatitis C treatment for Medicaid patients
In major shift, Pa. to expand hepatitis C treatment for Medicaid patients
by Don Sapatkin
The Wolf administration said Tuesday that it would expand Medicaid coverage for treatment of hepatitis C, a major shift that has long been supported by medical organizations but delayed because of potentially high costs to the state.
“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” Department of Human Services Secretary Ted Dallas said in a statement. “Moving forward, the severity of this disease can no longer prevent all [Medicaid] beneficiaries from getting access to treatment if they need it.”
Continue reading....
Wolf Administration Announces Medicaid Policy Change for Individuals Suffering from Hepatitis C Virus Department of Human Services continues to expand access to high-quality services Harrisburg, PA – Today, the Department of Human Services (DHS) is announcing changes to the state’s Medicaid (MA) policy to expand coverage of life-saving drugs to treat Hepatitis C (HCV) virus. Beginning on July 1, the Department will begin phasing in coverage for individuals who have liver function test scores of “F1” or “F0”.
HCV test scores are categorized by the severity of the disease from F0 through F4, with F0 being the least severe form of the disease and F4 being the most severe. Prior to this announcement, the department provided health care coverage through Medicaid for individuals whose scores ranged from F2 through F4 unless they also had other clinical complications.
“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” said DHS Secretary Ted Dallas. “Moving forward, the severity of this disease can no longer prevent all MA beneficiaries from getting access to treatment if they need it.”
The policy change follows the clinical recommendations presented by the department’s Pharmacy & Therapeutics Committee.
Under the new policy, the department will authorize the drugs for beneficiaries with test scores of F1 starting on July 1, 2017 and will authorize treatment for beneficiaries with scores of F0 starting on January 1, 2018. Adding F0 and F1 will ensure that all qualified individuals with HCV will have access to pharmaceuticals that can now cure this disease.
HCV is a communicable disease that causes chronic inflammation throughout the body and can lead to serious liver damage, cancer, and death. At least 20,000 people in the United States die each year due to liver disease caused by HCV, making it the deadliest communicable disease in the country. Individuals with HCV can suffer from diabetes, lymphoma, fatigue, joint pain, depression, and other diseases even before reaching the advanced state of the disease.
“Pennsylvania’s new approach will directly improve the lives of many of our clients – some of Pennsylvania’s most vulnerable citizens,” said Laval Miller Wilson, Executive Director of the Pennsylvania Health Law Project (PHLP).
“I would like to thank Laval, Amy Hirsch, Kevin Costello and everyone at PHLP, Community Legal Services, Kairys Rudovsky, Messing & Feinberg, and Center for Health Law & Policy Innovation of Harvard Law School who worked with the department on finding a path forward,” said Secretary Dallas. “Their help has been invaluable throughout the process and been a critical component of being able to make today’s announcement.”
Media Contact: Rachel Kostelac, DHS, 717-425-7606
http://www.chlpi.org/wp-content/uploads/2017/05/PA_HCV_press-release_05_16_17.pdf
by Don Sapatkin
The Wolf administration said Tuesday that it would expand Medicaid coverage for treatment of hepatitis C, a major shift that has long been supported by medical organizations but delayed because of potentially high costs to the state.
“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” Department of Human Services Secretary Ted Dallas said in a statement. “Moving forward, the severity of this disease can no longer prevent all [Medicaid] beneficiaries from getting access to treatment if they need it.”
Continue reading....
Wolf Administration Announces Medicaid Policy Change for Individuals Suffering from Hepatitis C Virus Department of Human Services continues to expand access to high-quality services Harrisburg, PA – Today, the Department of Human Services (DHS) is announcing changes to the state’s Medicaid (MA) policy to expand coverage of life-saving drugs to treat Hepatitis C (HCV) virus. Beginning on July 1, the Department will begin phasing in coverage for individuals who have liver function test scores of “F1” or “F0”.
HCV test scores are categorized by the severity of the disease from F0 through F4, with F0 being the least severe form of the disease and F4 being the most severe. Prior to this announcement, the department provided health care coverage through Medicaid for individuals whose scores ranged from F2 through F4 unless they also had other clinical complications.
“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” said DHS Secretary Ted Dallas. “Moving forward, the severity of this disease can no longer prevent all MA beneficiaries from getting access to treatment if they need it.”
The policy change follows the clinical recommendations presented by the department’s Pharmacy & Therapeutics Committee.
Under the new policy, the department will authorize the drugs for beneficiaries with test scores of F1 starting on July 1, 2017 and will authorize treatment for beneficiaries with scores of F0 starting on January 1, 2018. Adding F0 and F1 will ensure that all qualified individuals with HCV will have access to pharmaceuticals that can now cure this disease.
HCV is a communicable disease that causes chronic inflammation throughout the body and can lead to serious liver damage, cancer, and death. At least 20,000 people in the United States die each year due to liver disease caused by HCV, making it the deadliest communicable disease in the country. Individuals with HCV can suffer from diabetes, lymphoma, fatigue, joint pain, depression, and other diseases even before reaching the advanced state of the disease.
“Pennsylvania’s new approach will directly improve the lives of many of our clients – some of Pennsylvania’s most vulnerable citizens,” said Laval Miller Wilson, Executive Director of the Pennsylvania Health Law Project (PHLP).
“I would like to thank Laval, Amy Hirsch, Kevin Costello and everyone at PHLP, Community Legal Services, Kairys Rudovsky, Messing & Feinberg, and Center for Health Law & Policy Innovation of Harvard Law School who worked with the department on finding a path forward,” said Secretary Dallas. “Their help has been invaluable throughout the process and been a critical component of being able to make today’s announcement.”
Media Contact: Rachel Kostelac, DHS, 717-425-7606
http://www.chlpi.org/wp-content/uploads/2017/05/PA_HCV_press-release_05_16_17.pdf
Monday, May 15, 2017
Limited Impact of Awareness-Raising Campaigns on Hepatitis C Testing Practices among General Practitioners
Limited Impact of Awareness-Raising Campaigns on Hepatitis C Testing Practices among General Practitioners
Authors A McLeod, B L Cullen, S J Hutchinson, K M Roy, J F Dillon, E A Stewart, D J Goldberg Accepted manuscript online: 14 May 2017
Full publication history DOI: 10.1111/jvh.12724
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This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/jvh.12724
Abstract
Authors A McLeod, B L Cullen, S J Hutchinson, K M Roy, J F Dillon, E A Stewart, D J Goldberg Accepted manuscript online: 14 May 2017
Full publication history DOI: 10.1111/jvh.12724
View Article
Full Text PDF
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/jvh.12724
Abstract
The global hepatitis strategy calls for increased effort to diagnose those infected, with a target of 90% diagnosed by 2030. Scotland's Action Plan on Hepatitis C included awareness-raising campaigns, undertaken during 2008-2011, to promote testing by General Practitioners. We examined HCV testing practice among general practitioners before and following these campaigns. Scottish general practitioners were surveyed, using Dillman's method, in 2007 and 2013; response rates were 69% and 60%, respectively. Most respondents offer testing when presented with a risk history (86% in 2007, 88% in 2013) but only one fifth actively sought out risk factors (19 in 2007, 21% in 2013). Testing was reportedly always/almost always/usually offered to people who inject drugs (84% in 2007, 87% in 2013). Significant improvements in the offer of testing were reported in patients with abnormal LFTs (41% in 2007, 65% in 2013, p<0.001) and who had received medical/dental treatment in high prevalence countries (14% in 2007, 24% in 2013, p=0.001). In 2013, 25% of respondents had undertaken HCV-related Continued Professional Development. This group were significantly more likely to actively seek out risk factors (p=0.009) but only significantly more likely to offer a test to patients who had received medical/dental treatment in high prevalence countries (p=0.001). Our findings suggest that government-led awareness-raising campaigns have limited impact on general practitioners’ testing practices. If the majority of the HCV infected population are to be diagnosed, practitioner-based or physician-centred interventions should be considered alongside educational initiatives targeted at professional.
Continue to article
Continue to article
Listen - Testing, Care, and Cure of Hepatitis C Can Be Done in Primary Care
Testing, Care, and Cure of Hepatitis C Can Be Done in Primary Care
Medscape
News & Perspective > CDC Expert Commentary
Despite many challenges, an increasing number of HCV-infected patients are being treated and cured, and many can be managed in primary care.
As we consider opportunities for improving testing, care, and cure of HCV in the United States, it can be useful to visualize a person progressing along a care cascade from HCV diagnosis to cure. In essence, it starts with a person being tested for HCV with an HCV antibody test. If the test is positive, then the diagnosis must be confirmed with an HCV RNA test.
Persons who test positive for HCV RNA should have their genotype checked and an assessment of the severity of liver disease. Their healthcare provider can then implement an HCV treatment plan appropriate to the person's specific needs. Sustained virologic response or cure is determined by testing for the presence of HCV RNA 12 weeks after the completion of treatment.
Listen here.....
Or watch here...
Medscape
News & Perspective > CDC Expert Commentary
COMMENTARY
Alexander Millman, MD
As we consider opportunities for improving testing, care, and cure of HCV in the United States, it can be useful to visualize a person progressing along a care cascade from HCV diagnosis to cure. In essence, it starts with a person being tested for HCV with an HCV antibody test. If the test is positive, then the diagnosis must be confirmed with an HCV RNA test.
Persons who test positive for HCV RNA should have their genotype checked and an assessment of the severity of liver disease. Their healthcare provider can then implement an HCV treatment plan appropriate to the person's specific needs. Sustained virologic response or cure is determined by testing for the presence of HCV RNA 12 weeks after the completion of treatment.
Listen here.....
Or watch here...
Which Patients Are at Greatest Risk From Mushroom Poisoning?
Which Patients Are at Greatest Risk From Mushroom Poisoning?
Kristine Novak
Almost 20% of patients with liver damage from mushroom (Amanita) poisoning and peak levels of total bilirubin greater than 2 mg/dL require liver transplantation or die, researchers report in the May issue of Clinical Gastroenterology and Hepatology.
The authors show that peak level of aspartate aminotransferase (AST) below 4000 IU/L identifies patients who can be safely monitored in a local hospital, whereas patients with levels of bilirubin >2 mg/dL or AST >4000 IU/L should be transferred to a liver transplant center. Women and older patients were more likely to have a poor outcome than men and younger patients.
Acute liver failure after toxic mushroom ingestion is a significant problem worldwide and in the United States. The genus Amanita accounts for more than 90% of fatal mushroom poisonings. Although exposures to toxic mushrooms often cause no or only mild symptoms, some patients develop severe hepatic necrosis and fulminant hepatic failure.
There has been no reliable system to differentiate between patients who can be safely treated at a local hospital vs those that require transfer to a transplant center.
Almost 20% of patients with liver damage from mushroom (Amanita) poisoning and peak levels of total bilirubin greater than 2 mg/dL require liver transplantation or die, researchers report in the May issue of Clinical Gastroenterology and Hepatology.
The authors show that peak level of aspartate aminotransferase (AST) below 4000 IU/L identifies patients who can be safely monitored in a local hospital, whereas patients with levels of bilirubin >2 mg/dL or AST >4000 IU/L should be transferred to a liver transplant center. Women and older patients were more likely to have a poor outcome than men and younger patients.
Acute liver failure after toxic mushroom ingestion is a significant problem worldwide and in the United States. The genus Amanita accounts for more than 90% of fatal mushroom poisonings. Although exposures to toxic mushrooms often cause no or only mild symptoms, some patients develop severe hepatic necrosis and fulminant hepatic failure.
There has been no reliable system to differentiate between patients who can be safely treated at a local hospital vs those that require transfer to a transplant center.
Emerging Therapies for Genotype 3 HCV
EASL 2017: Emerging Therapies for Genotype 3 HCV
| Nancy Reau MD, FAASLD, AGAF - 5/12/2017 |
Genotype 3 HCV infection is concerning, not just because of its natural history but also because of its potential role in reinfection. New data from EASL offer promise for the treatment of this challenging patient population.
Experimental Pangenotypic Therapies
When we consider the data presented for the next wave of HCV therapy, I believe we are approaching this objective. The currently approved pangenotypic fixed-dose combination of sofosbuvir (SOF)/velpatasvir (VEL) for 12 weeks offers high cure rates (95%) for genotype 3 HCV infection regardless of cirrhosis status. The 3 pangenotypic therapies in development promise even more options..
When we consider the data presented for the next wave of HCV therapy, I believe we are approaching this objective. The currently approved pangenotypic fixed-dose combination of sofosbuvir (SOF)/velpatasvir (VEL) for 12 weeks offers high cure rates (95%) for genotype 3 HCV infection regardless of cirrhosis status. The 3 pangenotypic therapies in development promise even more options..
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New Hepatitis C Infections Hit 15-Year High: CDC
Heroin Epidemic Is Driving A Spike In Hepatitis C Cases, CDC Says
From 2010 to 2015, the number of new infections leaped nearly 300 percent, according to the Centers for Disease Control and Prevention. And researchers appear confident of the cause.(Image credit: Spencer Platt/Getty Images) (Source: NPR Health and Science)
Continue Reading...
New Hepatitis C Infections Hit 15-Year High: CDC
FRIDAY, May 12, 2017 -- Reports of new hepatitis C infections in the United States nearly tripled over five years, reaching a 15-year high, federal government data show.
The highest number of new infections were reported among 20- to 29-year-olds. Many stemmed from the growing use of injected drugs linked to the current opioid epidemic, officials said.
The number of reported cases rose from 850 in 2010 to 2,436 in 2015, according to the U.S. Centers for Disease Control and Prevention.
But nearly half of people who have the liver infection don't know it, so most new cases are never reported. The CDC estimated there were actually about 34,000 new hepatitis C infections nationwide in 2015.
"We must reach the hardest-hit communities with a range of prevention and treatment services that can diagnose people with hepatitis C and link them to treatment. This wide range of services can also prevent the misuse of prescription drugs and ultimately stop drug use -- which can also prevent others from getting hepatitis C in the first place," said Dr. Jonathan Mermin in a CDC news release.
He is director of the agency's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
The virus can be spread by sharing drugs and needles, the stick of a contaminated needle, and through sex. A child can also catch it if born to an infected mother.
More Americans die from hepatitis C than any other infectious disease reported to the CDC. Nearly 20,000 Americans died from hepatitis C-related causes in 2015, and most were age 55 and older, according to the new report.
Three-quarters of the 3.5 million Americans infected with hepatitis C are baby boomers, born between 1945 and 1965. They are six times more likely to be infected than people in other age groups and have a much higher risk of death from the virus, the CDC said.
Recent CDC studies also show that hepatitis C infections are rising among women of childbearing age, putting a new generation at risk.
New medicines can cure hepatitis C in as little as two to three months, but many people who need treatment can't get it, according to the CDC.
"Stopping hepatitis C will eliminate an enormous disease and economic burden for all Americans," said Dr. John Ward, director of CDC's Division of Viral Hepatitis.
"We have a cure for this disease and the tools to prevent new infections. Now we need a substantial, focused and concerted national effort to implement the National Viral Hepatitis Action Plan and make effective prevention tools and curative treatment available to Americans in need," Ward said.
The federal action plan sets goals for improving prevention, care and treatment of viral hepatitis and eliminating new infections.
More information
The U.S. Centers for Disease Control and Prevention has more on hepatitis C.
From 2010 to 2015, the number of new infections leaped nearly 300 percent, according to the Centers for Disease Control and Prevention. And researchers appear confident of the cause.(Image credit: Spencer Platt/Getty Images) (Source: NPR Health and Science)
Continue Reading...
New Hepatitis C Infections Hit 15-Year High: CDC
FRIDAY, May 12, 2017 -- Reports of new hepatitis C infections in the United States nearly tripled over five years, reaching a 15-year high, federal government data show.
The highest number of new infections were reported among 20- to 29-year-olds. Many stemmed from the growing use of injected drugs linked to the current opioid epidemic, officials said.
The number of reported cases rose from 850 in 2010 to 2,436 in 2015, according to the U.S. Centers for Disease Control and Prevention.
But nearly half of people who have the liver infection don't know it, so most new cases are never reported. The CDC estimated there were actually about 34,000 new hepatitis C infections nationwide in 2015.
"We must reach the hardest-hit communities with a range of prevention and treatment services that can diagnose people with hepatitis C and link them to treatment. This wide range of services can also prevent the misuse of prescription drugs and ultimately stop drug use -- which can also prevent others from getting hepatitis C in the first place," said Dr. Jonathan Mermin in a CDC news release.
He is director of the agency's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
The virus can be spread by sharing drugs and needles, the stick of a contaminated needle, and through sex. A child can also catch it if born to an infected mother.
More Americans die from hepatitis C than any other infectious disease reported to the CDC. Nearly 20,000 Americans died from hepatitis C-related causes in 2015, and most were age 55 and older, according to the new report.
Three-quarters of the 3.5 million Americans infected with hepatitis C are baby boomers, born between 1945 and 1965. They are six times more likely to be infected than people in other age groups and have a much higher risk of death from the virus, the CDC said.
Recent CDC studies also show that hepatitis C infections are rising among women of childbearing age, putting a new generation at risk.
New medicines can cure hepatitis C in as little as two to three months, but many people who need treatment can't get it, according to the CDC.
"Stopping hepatitis C will eliminate an enormous disease and economic burden for all Americans," said Dr. John Ward, director of CDC's Division of Viral Hepatitis.
"We have a cure for this disease and the tools to prevent new infections. Now we need a substantial, focused and concerted national effort to implement the National Viral Hepatitis Action Plan and make effective prevention tools and curative treatment available to Americans in need," Ward said.
The federal action plan sets goals for improving prevention, care and treatment of viral hepatitis and eliminating new infections.
More information
The U.S. Centers for Disease Control and Prevention has more on hepatitis C.
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