December 17, 2013

Magnetic resonance elastography for the detection and staging of liver fibrosis in chronic hepatitis B

Eur Radiol. 2014 Jan;24(1):70-8. doi: 10.1007/s00330-013-2978-8. Epub 2013 Aug 9.

Venkatesh SK, Wang G, Lim SG, Wee A.


OBJECTIVES: We measured the accuracy of magnetic resonance elastography (MRE) for the detection and staging of liver fibrosis in chronic hepatitis B (CHB) and compared it with serum fibrosis markers.

METHODS: Prospective comparison of MRE and routine serum fibrosis markers, namely serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), ALT/AST ratio (AAR), AST to platelet ratio index (APRI) and prothrombin index (PI), was performed in 63 consecutive CHB patients who underwent MRE and histological confirmation of liver fibrosis within a 6-month interval. Diagnostic performance of MRE and serum markers for staging fibrosis (≥F1), significant fibrosis (≥F2), advanced fibrosis (≥F3) and cirrhosis (F4) was compared.

RESULTS: The study group comprised 63 patients (19 female; mean age ± SD, 50 ± 11.9 years). MRE (ρ = 0.94, P < 0.0001), APRI (ρ = 0.42, P = 0.0006), PI (ρ = 0.42, P = 0.0006) and AST (ρ = 0.28, P = 0.028) results correlated significantly with fibrosis stage. MRE was significantly more accurate than serum fibrosis markers for the detection of significant fibrosis (0.99 vs. 0.55-0.73) and cirrhosis (0.98 vs. 0.53-0.77). Sensitivity, specificity, positive predictive and negative predictive values for MRE for significant fibrosis and cirrhosis were 97.4 %, 100 %, 100 % and 96 %, and 100 %, 95.2 %, 91.3 % and 100 %, respectively.

CONCLUSION: MRE is an accurate non-invasive technique for the detection and staging of liver fibrosis in CHB.

KEY POINTS: • Magnetic resonance elastography is accurate for liver fibrosis detection and staging. • MR elastography is more accurate than serum tests for staging liver fibrosis. • MR elastography can potentially replace liver biopsy in chronic hepatitis B.

PMID: 23928932 [PubMed - in process]


Can antiviral treatment for hepatitis C be safely and effectively delivered in primary care?

Authors: Brew, Iain F1; Butt, Christine2; Wright, Nat3

Source: British Journal of General Practice, Volume 63, Number 617, December 2013 , pp. e842-e851(10)

Publisher: Royal College of General Practitioners



The burden of hepatitis C (HCV) treatment is growing, as is the political resolve to tackle the epidemic. Primary care will need to work more closely with secondary care to succeed in reducing the prevalence of chronic HCV.


To identify research relating to the provision of antiviral treatment for HCV in primary care.

Design and setting

A narrative systematic review of six databases.


Medline, Embase, Cinahl, PsycINFO, Web of Science, and Cochrane were searched. Relevant journals were searched by hand for articles to be included in the review. Reference lists of relevant papers were reviewed and full-text papers were retrieved for those deemed to potentially fulfil the inclusion criteria of the review.


A total of 683 abstracts led to 77 full-text articles being retrieved, of which 16 were finally included in the review. An evidence base emerged, highlighting that community-based antiviral treatment provision is feasible and can result in clinical outcomes comparable to those achieved in hospital outpatient settings. Such provision can be in mainstream general practice, at community addiction centres, or in prisons. GPs must be trained before offering such a service and there is also a need for ongoing specialist supervision of primary care practice. Such training and supervision can be delivered by teleconference, although, even with such ready availability of training and supervision, only a minority of GPs are likely to want to provide antiviral treatment.


There is emerging evidence supporting the effectiveness of antiviral treatment provision for patients with chronic hepatitis C in a wide variety of primary care and wider community settings. Training and ongoing supervision of primary care practitioners by specialists is a prerequisite. There is an opportunity through future research activity to evaluate typologies of patients who would be best served by primary care-based treatment and those for whom hospital-based outpatient treatment would be most appropriate.

Keywords: general practice; hepatitis C; pegylated interferon; primary care; ribavirin

Document Type: Research Article


Affiliations: 1: In hepatitis C; Clinical director of Leeds Prison Healthcare Department, HMP Leeds, Leeds. 2: Clinical research fellow, Clinical director of Leeds Prison Healthcare Department, HMP Leeds, Leeds. 3: Clinical director of Leeds Prison Healthcare Department, HMP Leeds, Leeds.

Publication date: December 2013


Raising Hope for Those Living With Hepatitis C

Provided by The Huffington Post

Rebecca Haag
CEO, AIDS Action Committee of Massachusetts

Posted: 12/17/2013 4:45 pm


Science Photo Library - MEHAU KULYK via Getty Images

Viral hepatitis has been called a "silent epidemic" by Dr. Howard Koh, the U.S. Health and Human Services Assistant Secretary for Health. People can live for decades with the disease without knowing they have it. When they are finally diagnosed, it often comes after they have developed severe complications, such as liver cancer. The end result is much more costly -- and ineffective -- care.

But new treatment options, including two drugs (sofosbuvir and simeprevir) recently approved by the Federal Drug Administration, offer hope to those living with hepatitis C, a serious disease that causes inflammation of the liver, which can lead to cirrhosis, liver failure, and liver cancer, and is the most common form of viral hepatitis. As of this writing, standard treatment for hepatitis C includes the drug interferon. Interferon does not come in pill form. It must be injected, and it often has acute side effects, including debilitating fatigue. The drug is so unpleasant that it isn't uncommon for some people who've been prescribed it to stop taking it before they've completed a full course of treatment.

The new drugs (sofosbuvir, approved earlier this month, and simeprevir, which was approved in November) could be game changers in the treatment of hepatitis C because they open up the possibility of combatting the disease without the use of interferon. And they can supplement other new drugs already in use -- the direct-acting antiviral medications telaprevir and boceprevir -- that have already been shown to dramatically improve hepatitis C cure rates, and shorten the length of hepatitis C treatment.

But none of this will matter if those living with hepatitis C remain unaware of their infection. Currently, there are an estimated 2.7-3.9 million people infected with heptatis C in the U.S., according to the CDC. (Though some say the number could be as high as 5.2 million people as the CDC may not be adequately counting those who are incarcerated, homeless, live in nursing homes, are hospitalized, or serve in the military.) Either way, researchers agree that the vast majority of those infected (approximately 75 percent) have no idea that they have hepatitis C.

To help get those infected with hepatitis C into care earlier, the U.S. Centers for Disease Control (CDC) in 2012 issued recommendations that Baby Boomers, those born between 1945 and 1965, get tested for hepatitis C. For reasons that aren't fully understood, rates of hepatitis C infection are five times higher among Baby Boomers than the general population.

In 2012, the CDC also launched the annual Hepatitis Testing Day on May 19 as a way to remind the general public and health care providers -- many of whom remain unaware of the CDC's testing recommendations -- of the need for everyone who is at high risk for hepatitis infection to get tested. Other high risk groups include injection drug users, people living with HIV, and men who have sex with men.

Getting those with hepatitis C into treatment before they develop serious complications such as liver cancer or cirrhosis could potentially save $8.6 billion in national health care costs related to advanced liver disease, according to a 2012 report published in Hepatology.

Early diagnosis and treatment of hepatitis C is critical to ending the epidemic. The addition of sofosbuvir and simeprevir to the treatment arsenal, combined with evidenced-based behavioral health interventions such as needle exchange and peer support, can -- and will -- save lives.


Naturally occurring resistance mutations to inhibitors of HCV NS5A region and NS5B polymerase in DAA treatment-naive patients

Virology Journal 2013, 10:355 doi:10.1186/1743-422X-10-355

Stefania Paolucci (
Loretta Fiorina (
Bianca Mariani (
Roberto Gulminetti (
Stefano Novati (
Giorgio Barbarini (
Raffaele Bruno (
Fausto Baldanti (

ISSN 1743-422X

Article type Research
Submission date 23 September 2013
Acceptance date 3 December 2013
Publication date 17 December 2013

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Direct-acting antiviral (DAA) agents target HCV proteins; some of these have already been approved for the treatment of HCV infection, while others are in development. However, selection of DAA-resistant viral variants may hamper treatment. The aim of this study was to illustrate potential natural DAA-resistance mutations in the HCV NS5A and NS5B regions of HCV genotypes 1a and 1b from DAA-naïve patients.


Direct sequencing of HCV NS5A and NS5B regions was performed in 32 patients infected with HCV genotype 1a and 30 patients infected with HCV genotype 1b; all subjects were naïve to DAAs.


In genotype 1a strains, resistance mutations in NS5A (M28V, L31M and H58P) were observed in 4/32 (12.5%) patients, and resistance mutations in NS5B (V321I, M426L, Y448H, Y452H) were observed in 4/32 (12.5%) patients. In genotype 1b, resistance mutations in NS5A (L28V, L31M, Q54H, Y93H and I280V) were observed in 16/30 (53.3%) patients, while resistance mutations in NS5B (L159F, V321I, C316N, M426L, Y452H, R465G and V499A) were observed in 27/30 (90%) patients.


Mutations conferring DAA resistance were detected in NS5A and NS5B of HCV genotypes 1a and 1b from DAA-naïve patients. Although some mutations confer only a low level of resistance, the presence at baseline of mutated HCV variants should be taken into consideration in the context of DAA therapy.

Keywords Hepatitis C virus, HCV baseline resistance, NS5A and NS5B genes, DAA inhibitors


Hepatitis C virus (HCV) is classified into six genotypes (1–6) and more than 100 subtypes. The most common genotypes in Western countries are 1a and 1b [1]. Peginterferon/ribavirin (PegIFN/RBV) for the treatment of HCV infection is burdened by adverse reactions in at least 10% of patients [2]. Moreover, a sustained virological response is achieved in only 50% of patients infected with HCV genotype 1 [3]. PegIFN/RBV treatment failure is mainly attributed to its low efficacy against genotypes 1 and 4, but also, to some extent to its side effects [3,4]. Recently developed direct-acting antiviral agents (DAAs) are predicted to have a major impact both in combination with PegIFN/RBV, as well as in IFN-free regimens and telaprevir and boceprevir have now been approved as standard of care treatment [5]. Targets for DAA include HCV NS3 protease, NS5B polymerase and NS5A protein which are essential for virus replication. [6-12].

Nevertheless, the combination of a high HCV replication rate, the low fidelity of HCV polymerase and selective pressures by the immune system and drug treatment lead to the in vivo development of viral quasispecies with high sequence diversity among various genotypes and subtypes [13,14] with the potential accumulation of virus variants showing mutations with varying degrees of resistance to DAAs [11-13,15-22], even in the absence of pre-existing drug-exposure [17,23-26]. In particular, natural changes in HCV NS5A and NS5B amino acids (aa) associated with reduced drug susceptibility have been observed in treatment naïve patients [17,27,28].

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Donor characteristics that are associated with survival in liver transplant recipients older than 70 years with grafts

Transplant Proc. 2013 Dec;45(10):3633-6. doi: 10.1016/j.transproceed.2013.10.031.

Alamo JM, Olivares C, Jiménez G, Bernal C, Marín LM, Tinoco J, Suárez G, Serrano J, Padillo J, Gómez MÁ.


INTRODUCTION: The use of grafts from donors older than 70 years of age is increasing due to the decrease in the number of donors and the increase in waiting list patients.

MATERIAL AND METHODS: We undertook a univariate and multivariate analysis of 980 adult recipients of whole liver grafts, 129 of them from donors aged 70 years or older.

RESULTS: No differences were found in patient survival compared with recipients of younger grafts. There were no higher rates of rejection, vascular or biliary complications, postoperative bleeding, or infections, but older grafts were associated with graft dysfunction (P = .01) and a higher frequency of postoperative refractory ascites (P = .007), but without a greater need for retransplantation. As graft-associated factors, the joint presence in the donor of diabetes (P = .00; confidence interval [CI] = 0.04-0.117), hypertension (P = .00; CI = 0.22-0.39), and weight of more than 90 kg (P = .031; CI = 0.05-0.104) were suggestive of poor prognostic factors in recipient survival. Survival in hepatitis C virus (HCV) recipients or recipients aged older than 60 years was worse with donors aged older than 70 years, although not significantly so. With grafts from donors aged older than 80 years (n = 15), although patient survival rate was good (70% at 10 years), there was a higher rate of retransplantation (20%) and the early mortality rate was 13.3%.

CONCLUSIONS: Use of grafts from donors aged older than 70 years is safe, with similar survival to patients with younger grafts. The appearance of initial dysfunction with prolonged ascites may be due to a delay in reaching a correct functionality, but was not associated with increased mortality, complications, or need for retransplantation. It should also be avoided in recipients older than 60 years or with HCV. Grafts older than 80 years were associated with a good long-term patient survival but at the expense of a higher rate of retransplantation. However, it helps to reduce the time on the waiting list and, thus, mortality. We noted decreased survival associated with donor hypertension, diabetes, and obesity, so these donors should be selected more rigorously.

Copyright © 2013 Elsevier Inc. All rights reserved.

PMID: 24314980 [PubMed - in process]


Two More Studies Slam Multivitamins

Published: Dec 16, 2013

By Todd Neale, Senior Staff Writer, MedPage Today

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco


Action Points

  • A daily multivitamin failed to improve cognitive function in older men and did not reduce cardiovascular events in patients after a recent MI.
  • Note that previously reported guidance from the U.S. Preventive Services Task Force found insufficient evidence to recommend for or against vitamin and mineral supplementation for the primary prevention of cardiovascular disease or cancer in healthy adults.

A daily multivitamin failed to improve cognitive function in older men and did not reduce cardiovascular events in patients after a recent myocardial infarction (MI), two randomized trials showed.

In the first, there was no difference in the change in global cognitive function or in verbal memory between the multivitamin and placebo groups over an average follow-up of 8.5 years, reported Francine Grodstein, ScD, of Brigham and Women's Hospital in Boston, and colleagues.

And in the second, the rate of a composite endpoint that included total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina was 27% with a high-dose multivitamin and multimineral mixture and 30% with placebo (hazard ratio 0.89, 95% CI 0.75-1.07), reported Gervasio Lamas, MD, of Mount Sinai Medical Center in Miami Beach, Fla., and colleagues.

Both studies, as well as previously reported guidance from the U.S. Preventive Services Task Force that found insufficient evidence to recommend for or against vitamin and mineral supplementation for the primary prevention of cardiovascular disease or cancer in healthy adults, were published in the Annals of Internal Medicine.

"Other reviews and guidelines that have appraised the role of vitamin and mineral supplements in primary or secondary prevention of chronic disease have consistently found null results or possible harms," noted Eliseo Guallar, MD, DrPH, of the Johns Hopkins Bloomberg School of Public Health, and colleagues in an accompanying editorial.

Despite that, the percentage of Americans using multivitamin supplements and other dietary supplements has been growing, with a previous study showing an increase from 42% from 1988 to 1994 to 53% from 2003 to 2006.

"Evidence is sufficient to advise against routine supplementation, and we should translate null and negative findings into action," Guallar and colleagues wrote. "The message is simple: Most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided."

"This message is especially true for the general population with no clear evidence of micronutrient deficiencies, who represent most supplement users in the U.S. and in other countries," they added.

Effects on Cognition

To address inconclusive evidence about the effects of multivitamin supplements on cognitive health, Grodstein and colleagues examined the cognitive function substudy of the Physicians Health Study II (PHS II). Previous results from the trial showed that multivitamins modestly reduced the risk for cancer but did not cut cardiovascular events.

The substudy included 5,947 male physicians who were 65 or older (mean age 71.6). They were randomized to a daily multivitamin (Centrum Silver) or placebo and had their cognitive function assessed up to four times during follow-up.

The primary measure of cognitive function was a global composite score that included five tests of global cognition, verbal memory, and category fluency. Verbal memory was also examined separately as a secondary outcome.

Cognitive function was similar in the intervention and placebo groups at each assessment during the study, and there were no between-group differences in the changes in cognitive health over time.

For the global composite score, the difference in the change during follow-up with the multivitamin versus placebo was -0.01 standardized units (95% CI minus 0.04-0.02). Similarly, the difference in the change in verbal memory was not significant (-0.005 SU, 95% CI minus 0.04-0.03).

The lack of benefit was consistent across various subgroups.

"These data do not provide support for use of multivitamin supplements in the prevention of cognitive decline," Grodstein and colleagues wrote. "However, it is important to consider other health effects of multivitamin supplementation, including modest protection against overall cancer risk in the PHS II with long-term use and any potential effects on other important health outcomes yet to be evaluated."

They added that the effects of multivitamin supplementation in a less well-nourished population still need to be evaluated.

"This is of particular interest in an aging population because older persons are often at risk for nutritional deficiencies due to reduced micronutrient intake, altered absorption, and the metabolic requirements of vitamins," they wrote.

Effects of Cardiovascular Events

Lamas and colleagues reported the results of the multivitamin intervention included in the TACT trial. Prior results released from the trial demonstrated a slight, but significant benefit from chelation therapy for patients after an MI.

The trial, which was conducted at 134 centers in the U.S. and Canada, included 1,708 patients 50 or older (median age 65; 18% female) who had an MI at least 6 weeks before the study started (median interval 4.6 years) and who had serum creatinine levels of 2.0 mg/dL or lower. The patients were randomized to a 28-component high-dose multivitamin and multimineral mixture or placebo.

Median follow-up in the trial was 4.6 years and patients took their assigned treatments for a median of 31 months in the multivitamin group and 35 months in the placebo group.

A composite of cardiovascular events occurred at similar rates in the two groups, with no difference for the individual components or for cardiovascular death (5% versus 7%, HR 0.80, 95% CI 0.54-1.18).

A subgroup analysis suggested that the multivitamin intervention might have been beneficial for patients who were not taking a statin at baseline, although the patient numbers were small.

There was no evidence of harm from the intervention, with serious adverse events occurring in 15% of the multivitamin group and 12% of the placebo group.

Interpretation of the results is complicated, however, by the high rates of nonadherence (46% of patients in each group discontinued their treatment) and study withdrawal (17%), according to the researchers.

But for the editorialists, the message from accumulated evidence regarding dietary supplementation is clear.

"Although available evidence does not rule out small benefits or harms or large benefits or harms in a small subgroup of the population, we believe that the case is closed -- supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful," Guallar and colleagues wrote. "These vitamins should not be used for chronic disease prevention. Enough is enough."

The study by Grodstein and colleagues was supported by grants from the NIH and an investigator-initiated grant from BASF. Study agents and packaging were provided by BASF and Pfizer, and study packaging was provided by DSM Nutritional Products.

Grodstein reported receiving grants from the NIH. Her co-authors reported relationships with the NIH, BASF, Pfizer, DSM Nutritional Products, and Novartis.

The study by Lamas and colleagues was supported by grants from the National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine.

Lamas reported relationships with the National Heart, Lung and Blood Institute, the National Center for Complementary and Alternative Medicine, the Patient Centered Outcomes Research Institute, the American Chiropractic Association, Healthwise, the University of Missouri-Kansas City, Kansas City University of Medicine and Bioscience, Quality Insights of Pennsylvania, Palmer College of Chiropractic, the U.S. Army, the U.S. Health Resources & Services Administration, Michigan State University, Prezacor, Boston University, the University of Ottawa, the NIH, Linkoping University, the University of Calgary, Eli Lilly, Medtronic, the Seattle Institute for Cardiac Research, and AstraZeneca.

Guallar reported that he had no conflicts of interest. One of his co-authors reported a relationship with Rubin/Anders Scientific. Another author reported working for Annals of Internal Medicine, a journal that has published systematic reviews and trials related to vitamins and mineral supplements.

Primary source: Annals of Internal Medicine
Source reference: Grodstein F, et al "Long-term multivitamin supplementation and cognitive function in men: the Physicians Health Study II" Ann Intern Med 2013; 159; DOI: 10.7326/0003-4819-159-12-201312170-00006.

Additional source: Annals of Internal Medicine
Source reference:Lamas G, et al "Oral high-dose vitamins and minerals after myocardial infarction: a randomized, controlled trial" Ann Intern Med 2013; 159; DOI: 10.7326/0003-4819-159-12-201312170-00004.

Additional source: Annals of Internal Medicine
Source reference:Guallar E, et al "Enough is enough: stop wasting money on vitamin and mineral supplements" Ann Intern Med 2013; 159: 850-851.


FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps


For Immediate Release: Dec. 16, 2013
Media Inquiries: Andrea Fischer, 301-796-0393,
Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.

Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE.  Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”

Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used.  More information on appropriate hand washing from the CDC may be found here.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.

The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by helping to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for helping to ensure the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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