NIH launches HerbList, app with information about safety and effectiveness of herbal products

NIH launches HerbList, a mobile app on herbal products

To help consumers navigate information about popular herbs and herbal supplements, the National Institutes of Health’s National Center for Complementary and Integrative Health has launched HerbList™ – an app for research-based information about the safety and effectiveness of herbal products. Developed by NCCIH and launched through the National Library of Medicine’s app pages, HerbList is available on the Apple App Store (link is external) and Google Play Store (link is external).

HerbList helps consumers, patients, healthcare providers, and other users to quickly access information about the science of popular herbs and herbal supplements including kava, acai, ginkgo, turmeric, and more than 50 others marketed for health purposes.

Users can access information on potential safety problems, side effects, and herb-drug interactions with additional links to resources for more information. They can also mark favorite herbs for quick recall and offline accessibility.

HerbList provides only scientific, research-driven information to provide consumers and health care practitioners with unbiased information to make informed decisions about supplement use.

"Providing an app for users is part of NCCIH's effort to inform consumers and health care providers within the complementary and integrative health space," said David Shurtleff, Ph.D., acting director of NCCIH. "People are considering herbs and herbal supplements for various reasons, and it is important that they are aware of what the research says about safety and effectiveness."

The app was built using NCCIH's Herbs at a Glance webpage; a series of brief fact sheets that provide basic information about specific herbs or botanicals—common names, what the science says, potential side effects and cautions, and resources for more information.

HerbList is available to download for your iPhone or iPad from the Apple App Store (link is external) or to your Android device via Google Play (link is external).

About the National Center for Complementary and Integrative Health (NCCIH): NCCIH’s mission is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health approaches and their roles in improving health and health care. For additional information, call NCCIH’s Clearinghouse toll free at 1-888-644-6226. Follow us on Twitter (link is external), Facebook (link is external), and YouTube.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Hepatitis C and Dietary Supplements

NASH - Israeli company Galmed gets positive trial results for liver drug

Israeli company Galmed gets positive trial results for liver drug
Last Updated: 2018-06-12
By Reuters Staff

TEL AVIV (Reuters) - Galmed Pharmaceuticals said on Tuesday patients in a mid-stage trial for its treatment for non-alcoholic steatohepatitis (NASH), a fatty liver disease linked to obesity, showed a statistically significant reduction in liver fat. The results will allow Galmed to meet with regulators as soon as possible and discuss a pivotal Phase 3 study design, Galmed CEO Allen Baharaff said.

Read it here: http://www.chronicliverdisease.org/reuters/article.cfm?article=20180612Other2021305796

Press Release

Galmed's 600 mg Aramchol™ Achieved a Regulatory Approvable Endpoint Showing NASH Resolution Without Worsening of Fibrosis, in NASH Patients, in the Global Phase 2b ARREST 52-Week Study

Data Strongly Support Advancement of Aramchol™ 600mg to Phase 3

TEL AVIV, Israel, June 12, 2018 /PRNewswire/ --
Statistically significant reduction in liver fat was demonstrated by Magnetic Resonance Spectroscopy (MRS) in patients completing 52 weeks of treatment with Aramchol 400mg vs. placebo. Post hoc analysis of MRS responders, defined by a reduction of =5% absolute change from baseline, demonstrated a clinically and statistically significant effect of Aramchol 600mg vs. placebo.

Significantly more patients treated with Aramchol 600mg vs. placebo showed NASH resolution without worsening of fibrosis in the 52-week biopsy, a regulatory approvable endpoint.

A higher proportion of patients with at least one-point improvement in fibrosis score without worsening of NASH was demonstrated in Aramchol 600mg vs. placebo, in the 52-week biopsy, a regulatory approvable endpoint.

Statistically significant reductions in ALT and AST were demonstrated in Aramchol 400mg and 600mg vs. placebo.

Aramchol continues to show favorable safety and tolerability profile.

Continue reading: https://www.prnewswire.com/news-releases/galmeds-600-mg-aramchol-achieved-a-regulatory-approvable-endpoint-showing-nash-resolution-without-worsening-of-fibrosis-in-nash-patients-in-the-global-phase-2b-arrest-52-week-study-300664733.html

USA HCV Dataset - Patients’ age, location, disease severity, treatment and cure status 2013-2016

Advances in Therapy

Development of a Comprehensive Dataset of Hepatitis C Patients and Examination of Disease Epidemiology in the United States, 2013–2016

Viktor V. Chirikov Steven E. Marx Shivaji R. Manthena John P. Strezewski Sammy Saab

First Online: 09 June 2018
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Hepatitis C virus (HCV) infection may cause serious health problems and death. Unfortunately, the health care community does not have complete identification of patients with HCV. This study describes the creation of a dataset that combines information for HCV patients and shows relevant information about HCV patients’ age, geographic location, disease severity, and treatment and cure status from 2013 through 2016. This dataset helps the health care community understand the HCV patient landscape and make informed decisions about how to best treat this population.

Abstract
Introduction
Chronic infection with hepatitis C virus (HCV) is a leading cause of liver disease and infectious disease deaths. While recent and emerging treatment options for HCV patients have enabled higher rates of sustained virologic response (SVR), the demographic, clinical, geographic, and payer characteristics of the estimated 3.4 million chronic HCV patients in the USA are poorly understood. The goal of this study was to create a dataset describing the current HCV patient landscape in the USA.

Methods
Data from two large national laboratory companies representing the majority of US patients screened for HCV antibody and/or tested for HCV RNA from 2013 through 2016 were organized into the present study dataset. Age, gender, payer channel, 3-digit ZIP code and ordering physician specialty, and 3-digit ZIP code information were available for all patients. Among RNA-positive patients, additional clinical characteristics included HCV genotype, fibrosis stage, renal function, and HIV status. Initiating treatment and attaining cure were imputed using data-driven algorithms based on successive RNA viral load measurements.

Results
The number of RNA-positive HCV patients increased from 200,066 patients in 2013 to 469,550 in 2016. The availability of clinical data measurements and rates of treatment initiation increased over the study period, indicating improved care engagement for HCV patients. Treatment and cure rates varied by age, disease severity, geographic location, and payer channel. Sensitivity and specificity of the cure prediction algorithms were consistently above 0.90, validating the robustness of the data imputation approach.

Conclusion
This is the largest, most comprehensive dataset available to describe the current US HCV patient landscape. Our results highlight that the epidemiology of HCV is evolving with an increasing number of patients who are younger and have milder disease than described in previous years. Results of this study should help guide efforts toward the elimination of HCV in this country. Future work will focus on factors associated with varying treatment and cure patterns and describing recent changes in the HCV patient landscape.

Analysis of Treated Patients by State

To investigate treatment trends further, the prevalence of nearly 90,000 treated HCV patients in 2016 was determined on a state-by-state basis. States with the highest prevalence of treated HCV patients were mainly found on the West Coast, Appalachia, the Northeast, and the Southeast, while much of the Upper Midwest and Great Plains had the lowest prevalence of treated patients 

Continue reading: https://link.springer.com/article/10.1007/s12325-018-0721-1

HCV/HIV-coinfection - Successful direct acting antiviral (DAA) treatment before and after liver transplantation

PLOS ONESuccessful direct acting antiviral (DAA) treatment of HCV/HIV-coinfected patients before and after liver transplantation

Julia M. Grottenthaler, Christoph R. Werner, Martina Steurer, Ulrich Spengler, Thomas Berg, Cornelius Engelmann, Heiner Wedemeyer, Thomas von Hahn, Wolfgang Stremmel, Anita Pathil, Ulrich Seybold, Eckart Schott, Usha Blessin, Christoph P. Berg

Published: June 6, 2018 https://doi.org/10.1371/journal.pone.0197544 

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Abstract
Objectives
The aim of this multicenter retrospective study was to investigate safety and efficacy of direct acting antiviral (DAA) treatment in the rare subgroup of patients with HCV/HIV-coinfection and advanced liver cirrhosis on the liver transplant waiting list or after liver transplantation, respectively.

Methods
When contacting 54 German liver centers (including all 23 German liver transplant centers), 12 HCV/HIV-coinfected patients on antiretroviral combination therapy were reported having received additional DAA therapy while being on the waiting list for liver transplantation (patient characteristics: Child-Pugh A (n = 6), B (n = 5), C (n = 1); MELD range 7–21; HCC (n = 2); HCV genotype 1a (n = 8), 1b (n = 2), 4 (n = 2)). Furthermore, 2 HCV/HIV-coinfected patients were denoted having received DAA therapy after liver transplantation (characteristics: HCV genotype 1a (n = 1), 4 (n = 1)).

Results
Applied DAA regimens were SOF/DAC (n = 7), SOF/LDV/RBV (n = 3), SOF/RBV (n = 3), PTV/r/OBV/DSV (n = 1), or PTV/r/OBV/DSV/RBV (n = 1), respectively. All patients achieved SVR 12, in the end. In one patient, HCV relapse occurred after 24 weeks of SOF/DAC therapy; subsequent treatment with 12 weeks PTV/r/OBV/DSV achieved SVR 12. One patient underwent liver transplantation while on DAA treatment. Analysis of liver function revealed either stable parameters or even significant improvement during DAA therapy and in follow-up. MELD scores were found to improve in 9/13 therapies in patients on the waiting list for liver transplantation; in only 2 patients a moderate increase of MELD scores persisted at the end of follow-up.

Conclusion
DAA treatment was safe and highly effective in this nation-wide cohort of patients with HCV/HIV-coinfection awaiting liver transplantation or being transplanted.

Full article: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0197544

Half of hepatitis C patients with private insurance denied life-saving drugs

Open Forum Infectious Diseases
Infectious Diseases Society of America

Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study
Charitha Gowda Stephen Lott Matthew Grigorian Dena M Carbonari M Elle Saine Stacey Trooskin Jason A Roy Jay R Kostman Paul Urick Vincent Lo Re, III
Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy076, https://doi.org/10.1093/ofid/ofy076
Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.
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Half of hepatitis C patients with private insurance denied life-saving drugs

University of Pennsylvania School of Medicine
PHILADELPHIA - The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) - once-a-day pills that first became available in the United States in 2014 - are highly effective, with a 95 percent cure rate and few side effects for patients with chronic hepatitis C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

"Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector," said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. "It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states."

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It's likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study's 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

"From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer," Lo Re said. "In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the liver, such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others."

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and private insurers remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all chronic hepatitis C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

"Eliminating hepatitis C in the U.S. is a feasible goal," Lo Re said, "but that's going to be hard to achieve if payers are not reimbursing for the treatment."

Today's News
There's a Cure for Hepatitis C, but Insurance Companies Don't Want to Pay for It
Insurance companies have argued that the restrictions ensure treatments aren’t wasted on people who won’t benefit from it.

Judge gives early OK to deal to expand Medicaid hep C relief
DETROIT (AP) - A judge has given preliminary approval to a deal that would expand access to hepatitis C treatments for Michigan residents on Medicaid.

On This Blog

The controversy over expensive new drugs for hepatitis C

Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Treatment of HCV‐Associated Extrahepatic Manifestations in 2018

Clinical Liver Disease
© The American Association for the Study of Liver Diseases
Clinical Liver Disease (CLD) is an online learning resource of AASLD offering research articles with audio, video, webinars, and other interactive content designed for any physician or healthcare provider caring for a patient with liver disease.

Here is the latest June content: 

Reviews

Guest Edited by Elizabeth May, MD

Treatment of the extrahepatic manifestations of chronic hepatitis C infection

Karn Wijarnpreecha M.D.
Wisit Cheungpasitporn M.D.
Surakit Pungpapong M.D.
Kiran R. Nakkala M.D., M.P.H. 

When we look at the landscape in 2018, we find that the guidelines of the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA) and European Association for the Study of the Liver (EASL) are in agreement that all patients with HCV infection should be treated with effective antiviral therapy.3, 4 Table 2 categorizes HCV‐associated EHMs according to severity.5 Treatment of patients with mild‐to‐moderate HCV‐associated EHMs is important because the first‐line treatment of HCV‐associated EHMs of mild‐to‐moderate severity is always initiation of DAA therapy. Patients with severe or life‐threatening EHMs of HCV should also receive the most appropriate DAAs.... 
Pages: 115-118
First Published:05 June 2018
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Risk factors, scoring systems, and interventions for alcohol relapse after liver transplantation for alcoholic liver disease

Jane Lim M.D. 

Vinay Sundaram M.D., M.Sc.

Pages: 105-110
First Published:05 June 2018
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Hepatic fibrosis: Avenues of investigation and clinical implications
Jessica E.S. Shay M.D.
James P. Hamilton M.D., Ph.D.
Pages: 111-114
First Published:05 June 2018
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ALF Debate 2017

Guest Edited by Lisa B. VanWagner, MD
Free Access
PRO (“The Window Is Open”): In patients with cirrhosis with prior variceal hemorrhage and ascites, the clinical benefits of nonselective beta‐blockers outweigh the risks and should be prescribed
Danielle Tholey M.D.
Nitzan Roth M.D., Ph.D.
Thomas Schiano M.D.
Pages: 119-122
First Published:05 June 2018
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CON (“The window is closed”): In patients with cirrhosis with ascites, the clinical risks of nonselective beta‐blocker outweigh the benefits and should NOT be prescribed
Ariel W. Aday M.D.
Nicole E. Rich M.D.
Arjmand R. Mufti M.D.
Shannan R. Tujios M.D.
Pages: 123-127
First Published:05 June 2018
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Radiology in Liver Disease
Megan G. Lubner, MD
Free Access
Imaging of abnormal liver function tests
Saivenkat H. Vagvala D.O.
Stacy D. O'Connor M.D., M.P.H.
Pages: 128-134
First Published:05 June 2018
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Mayo Clinic researchers take a step closer to developing a DNA test for liver cancer

WASHINGTON, D.C. - A group of researchers from Mayo Clinic and Exact Sciences Corporation have completed a phase II study comparing a set of DNA markers to alpha fetoprotein as a method to test for liver cancer. The researchers presented their findings today at the 2018 Digestive Disease Week conference in Washington, D.C.

"We currently test for liver cancer using ultrasound and a blood protein marker called alpha fetoprotein," says John Kisiel, M.D., a gastroenterologist at Mayo Clinic. "Unfortunately, these tests are not very sensitive for curable stage liver cancers, and most patients who need this testing do not have it easily available or [are] not able to receive it often enough to be effective."

Dr. Kisiel and his colleagues developed a simple blood test using abnormal DNA markers that are known to exist in liver cancer tissues. They were able to confirm that the abnormal DNA markers were present in the overwhelming majority of blood samples that came from people with primary liver cancers. Simultaneously, these markers were absent in healthy individuals and individuals with cirrhosis of the liver but no evidence of tumors on their clinical follow-up.

"We were most excited that our DNA markers were able to detect more than 90 percent of patients with curable stage tumors," says Dr. Kisiel. "This is the main reason why we think a DNA test will make difference, compared to currently available tests." Dr. Kisiel says the next step will be to validate these markers in blood testing on much larger patient cohorts.

According to the National Cancer Institute, the number of new cases of liver and bile duct cancer in the U.S. was 8.8 per 100,000 men and women per year. Dr. Kisiel says primary liver cancer is a major cause of suffering and death for patients who have cirrhosis of the liver or patients with hepatitis B infections. Worldwide, liver cancer is the second most common cause of cancer death.

https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-researchers-take-a-step-closer-to-developing-a-dna-test-for-liver-cancer/

DDW 2018: PPIs Are Taken Inappropriately by Patients With GERD

June 5, 2018—Washington, DC—In patients with gastroesophageal reflux disease, proton pump inhibitors are initiated at the appropriate dose as per American College of Gastroenterology guidelines.

Lifestyle modifications are seldom discussed by primary care providers, and the majority of patients continue to take proton pump inhibitors after 8 weeks.

This conclusion, based on results of a retrospective chart review, was presented at Digestive Disease Week (DDW) 2018, from June 2 – 5.

Proton pump inhibitors have been reported recently to be associated with multiple serious side effects including chronic kidney disease, dementia, infection, osteoporotic fracture, cardiovascular events, and increased mortality.

Continue reading...…..

Recommended Reading
Proton pump inhibitors (PPIs) are medicines that work by reducing the amount of stomach acid made by glands in the lining of your stomach.