Terrence Higgins Trust unveils It Starts With Me HIV campaign video

Provided by PinkNews

by Staff Writer, Outside News Agency for PinkNews.co.uk
15 May 2013, 11:05am

Terrence Higgins Trust (THT) has released a short video clip outlining the science behind It It Starts With Me, HIV Prevention England’s new campaign for gay and bisexual men. The clip shows how a combination of testing, treatment and condoms would lead to a significant reduction in HIV transmissions within the gay community.

There is still no cure, but treatment is now better than ever. It can reduce the amount of virus in the body to an undetectable level, so it’s very unlikely to be passed on. The problem is that one in four gay and bisexual men with HIV don’t know they have it yet, so are not on treatment. If everyone gets tested regularly and everyone who needs treatment gets it, we can stop HIV.

Most people get HIV from someone who doesn’t know they have it. That’s why we need to protect ourselves and others. Condoms are the best barrier against HIV And other sexually transmitted infections. Together, testing, treatment and condoms can stop the spread of HIV.

Share this video with everyone you know and spread the word. Visit It Starts With Me for lots more information on how you can join the fight to stop HIV.

Disclosure: THT is promoting the It Starts With Me campaign with PinkNews.co.uk over the spring and summer.

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The ABCs of Hepatitis: Mayo Clinic Expert Explains Types, Prevention

Provided by Infection Control Today

Posted May 14, 2013

It’s Hepatitis Awareness Month. Understanding the different forms of hepatitis, who is at risk and how it can be prevented and treated can be confusing. Mayo Clinic infectious diseases expert Stacey Rizza, MD, offers the following primer:

Hepatitis A: A highly contagious viral condition that causes inflammation affecting the liver’s ability to function, hepatitis A is most likely contracted from contaminated food, water or someone already infected. Mild cases don’t require treatment, and most who have the infection recover completely with no permanent liver damage. Effective vaccines are available and recommended for children at age 1; for older children who didn’t get the vaccine at age 1; and for people traveling to areas with high rates of the illness, among others. Practicing good hand hygiene is one of the best ways to protect against hepatitis A.

Hepatitis B: For some people, hepatitis B infection becomes chronic, leading to liver failure, liver cancer or cirrhosis -- a condition that causes permanent scarring of the liver. It is spread through bodily fluids. Most people infected as adults recover fully, even if their signs and symptoms are severe. Infants and children are much more likely to develop a chronic hepatitis B infection.

Although no cure exists for hepatitis B, treatment options are available and a vaccine can prevent the disease. Vaccination is recommended for infants; children who weren’t vaccinated in infancy; people being treated for a sexually transmitted infection; health care workers and others who come in contact with blood on the job; people with end-stage kidney disease; and people traveling to areas with high rates of hepatitis B, among others. If a person is already infected, taking certain precautions can help prevent the spread of hepatitis B to others.

Hepatitis C: Most people infected with the hepatitis C virus have no symptoms. And most don’t know they have the hepatitis C infection until liver damage shows up decades later during routine medical tests. Generally considered to be among the most serious of the three viruses, hepatitis C is passed through contact with contaminated blood -- most commonly through needles shared during illegal drug use. Hepatitis C infection is treated with antiviral medications intended to clear the virus from the body.

“Hepatitis C infection can be asymptomatic for decades but typically appears as liver problems over time,” Rizza says. “This can happen faster if people’s immune systems decline due to other conditions as they age. It’s a good idea to ask your physician about testing for it during your regular checkup. All forms of hepatitis should be taken seriously as the risks for them have increased in recent years.”

The Centers for Disease Control and Prevention (CDC) recommends hepatitis C screening for all baby boomers.

Source: Mayo Clinic

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Psychiatric treatment considerations with direct acting antivirals in hepatitis C

Published on: 2013-05-14

Despite recent advances in hepatitis C (HCV) treatment, specifically the addition of direct acting antivirals (DAAs), pegylated interferon-alpha remains the backbone of HCV therapy.Therefore, the impact of DAAs on the management of co-morbid psychiatric illness and neuropsychiatric sequalae remains an ongoing concern during HCV therapy. This paper provides a review of the neuropsychiatric adverse effects of DAAs and drug-drug interactions (DDIs) between DAAs and psychiatric medications.

Methods: We conducted a Pubmed search using relevant search terms and hand searched reference lists of related review articles.

In addition, we searched abstracts for major hepatology conferences and contacted respective pharmaceutical companies for additional studies.

Results: Limited data is available on the neuropsychiatric adverse effectsof DAAs; however, data from major clinical trials suggest that DAAs have minimal neuropsychiatric risk. DAAs can potentially interact with a variety of psychotropic agents via cytochrome P450 and p-glycoprotein interactions.

Triazolam, oral midazolam, St. John's Wort, carbamazepine and pimozide, are contraindicated with DAAs.

DDIs between DAAs and antidepressants, anxiolytics, hypnotics, mood stabilizers, antipsychotics and treatments for opioid dependence are summarized.

Conclusions: Although DAAs do not add significant neuropsychiatric risk, the potentialfor DDIs is high. Consideration of DDIs is paramount to improving medication adherence and mitigating adverse effects during HCV therapy.

Author: Sanjeev SockalingamAlice TsengPierre GiguereDavid Wong
Credits/Source: BMC Gastroenterology 2013, 13:86

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Central team discuses Hepatitis-C endemic with Director SKIMS

Last Update: May 14th, 2013 - IST

SRINAGAR, Kashmir -- A special team of doctors deputed by government of India to assess Hepatitis-C endemic in Kokernag area of South Kashmir held a meeting at Sher-e-Kashmir Institute of Medical Sciences Soura on Tuesday.

The team which has been deputed to Kashmir on the instructions of Union Health Minister Ghulam Nabi Azad held the meeting with director SKIMS Dr. Showkat A. Zargar. In the meeting there was exhaustive

In a statement to KNS Public Relations Officer (PRO) SKIMS Kulsoom Bhat said during the meeting discussion to devise a methodology to administer the treatment for endemic was done.

“The meeting was preceded by an exhaustive exchange of views with SKIMS experts from department of gastroenterology, microbiology, immunology and community medicine. Besides financial support Director SKIMS stressed for strengthening of lab at SKIMS and provide required infrastructure both in center and peripheries to ensure better treatment to the patients,” she said.

Associate Professor, Department of Gastroenterology Dr Mushtaq Ahmad Khan gave a comprehensive presentation about the disease prevalent in the areas including Takiya Magam Sonbrari and Zalangam in Kokenag block.

He informed preliminary analysis shows Takiya magma constitutes 62.5% HCV positive, Sonabrari 27.4 percent and 5.26 percent from Zalangam. “The overview and analysis suggests there is immediate need to arrest the spread of infection and treatment of the infected individuals. Experts pressed for treatment of 776 infected patients who suffer chronic hepatitis C which will help to reduce the viral load and spread of infection. The team was informed the treatment is costly and the people being poor can’t afford the treatment ranging from 1.5-3 lakhs/individual depending on the genotype of the virus and weight of the patient,” the PRO said.

Experts from SKIMS while expressing their concern said there should be extensive surveillance and screening for HCV to know the quantum of infection, source of infection and mode of spread and manifestation of the infection and vigorous awareness and health education programs.

The team comprising Dr. S.K Sarin, Director Institute of Liver and Biliary Sciences, Dr. L S Chauhan Director NCDC, New Delhi, Dr. S.K Acharya HOD Gastroenterology AIIMS, New Delhi, Dr. B.D Athani, MS Safdarjang Hospital, Dr Sandeep Tyagi, Army R&R Hospital, New Delhi earlier visited the affected district to assess the situation on ground.

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Antiretrovirals Linked to Liver Fibrosis

Daniel M. Keller, PhD

May 14, 2013

AMSTERDAM, the Netherlands — Despite hepatitis B virus suppression provided by current drugs, many patients coinfected with hepatitis B and HIV have advanced liver fibrosis, according to new research.

"Of the patients we had liver biopsies on, 31 of 53 — more than half — had advanced fibrosis, bridging fibrosis, or cirrhosis. That was despite their hepatitis B being reasonably controlled," said Richard Sterling, MD, chief of hepatology at Virginia Commonwealth University in Richmond. "Liver enzymes were not that high, and most patients had low or undetectable hepatitis B DNA."

Dr. Sterling cited 2 possible reasons for this. "Many of these patients could have been on older antiretroviral therapy that included lamivudine, which we know is not a good long-term drug for hepatitis B. As a result, over time their liver disease progressed sort of under the radar of their HIV provider," he explained.

"We also know that hepatitis B liver disease is immune mediated," he added. "Perhaps immune reconstitution, when their HIV therapy was just starting, actually caused more liver disease, unbeknownst to the HIV provider."

Hepatitis B is prevalent in about 8% to 10% of patients infected with HIV and is controlled with some of the same drugs. However, few patients are biopsied, so little is known about liver disease in this population.

To learn more, Dr. Sterling and colleagues conducted a retrospective analysis of coinfected patients who had undergone liver biopsy. He presented the results here at the International Liver Congress 2013.

The researchers compared demographic and clinical characteristics of patients with and without advanced fibrosis. In 95% of patients, the level of HIV RNA was undetectable. In 30%, the level of hepatitis B DNA was undetectable; in 35%, it was below 1000 IU/mL. In 62%, the test for hepatitis B e antigen was positive.

Patients with advanced fibrosis had lower levels of hepatitis B DNA (P = .03) than those without advanced fibrosis, and more were on antiretroviral therapy (P = .02). For those with advanced fibrosis, there was a trend toward higher levels of aspartate transaminase (P = .08) and lower CD4 counts (P = .08).

There were no differences between patients with and without advanced fibrosis in terms of HIV RNA level, hepatitis B antigen status, the specific drugs used to treat hepatitis B, or the proportion with low or undetectable levels of hepatitis B DNA.

"The important thing is that the hepatitis B DNA was undetectable in the same proportion of patients who had mild disease and who had advanced disease," Dr. Sterling said. However, median levels were lower in the group with advanced fibrosis. "It's not clear whether they were lower because those patients were being treated and their hepatitis B was suppressed, or whether the virus count was lower because their disease was worse. We don't know which came first," he noted.

A high proportion of coinfected patients had advanced fibrosis despite hepatitis B suppression. Dr. Sterling explained that liver histology needs to be studied in a larger group of patients to define the spectrum of liver disease and to find biomarkers that predict advanced disease.

Limitations of this study were its retrospective nature and the selection bias of patients undergoing biopsy.

"I think the bottom line with hepatitis B is that it's forgotten but not gone," he said. Up to half of patients can have advanced fibrosis, despite having well-controlled HIV and, "on paper, not looking too bad as far as their hepatitis B, alanine transaminase, and DNA," he explained, "which certainly puts them at higher risk for developing hepatic decompensation and hepatocellular carcinoma."

Fabien Zoulim, MD, PhD, who was asked by Medscape Medical News to comment on the findings, said he agrees that coinfected patients can have advanced fibrosis even when hepatitis B has been suppressed. He is medical director of the Department of Hepatology at the Hospices Civils de Lyon, and scientific director of the Department of Immunology and Virology of an INSERM unit in Lyon, France, and was not involved with this study.

"The problem is that we don't know how long these patients have been treated, how many lines of antiviral therapy they've gone through. Have they failed an antihepatitis B regimen in the past?... I think it's difficult to make a good interpretation of their results" in light of these uncertainties, Dr. Zoulim explained.

Besides the question of whether hepatitis B was well controlled in the past, there is an issue of liver toxicity from previous antiretroviral treatments. "Some of these regimens in the past may have been toxic for the liver, and this may have induced liver fibrosis," Dr. Zoulim said. "This type of information is really important to know."

Dr. Zoulim advises that treating physicians get a very good assessment of the severity of liver disease in coinfected patients. That can involve noninvasive tests such as FibroScan or blood markers if the patients appear well. For abnormal liver function tests, he would do a biopsy because of the variety of conditions associated with older antiretroviral therapies and the hepatitis B itself, he explained.

With newer treatment regimens, the situation is "getting much better than it was 5 years ago," he said. For coinfected patients who start first-line treatment today, "I wouldn't predict major problems."

Dr. Sterling has disclosed no relevant financial relationships. Dr. Zoulim reports being is a consultant to Gilead, BMS, and Roche.

International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL). Abstract 429. Presented April 25, 2013.

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Liver transplantation reduced fatigue among patients with primary biliary cirrhosis

Provided by Healio.com

Carbone M. J Hepatol. 2013;doi:10.1016/j.jhep.2013.04.017.

May 14, 2013

Patients with primary biliary cirrhosis who underwent liver transplantation experienced a significant and persistent reduction in fatigue symptoms, although almost half continued to experience fatigue in a recent study.

Researchers administered a 40-item quality of life questionnaire to 49 adult liver transplant (LT) recipients with primary biliary cirrhosis (PBC), along with 31 matched controls without PBC and 124 patients with PBC who did not undergo LT (n=124). Questionnaires were completed at baseline and at 6, 12 and 24 months after LT. Fatigue responses were evaluated, with scores of 11 or lower indicating no fatigue, 12-28 mild, 29-39 moderate and 40 or greater severe fatigue.

Among 31 evaluable patients who underwent LT, lower fatigue scores were observed post-transplant during follow-up (40.7 ± 11.4 vs. 27.7 ± 9.5 at 6 months, 28.7 ± 10.1 at 12 months and 26.2 ± 10.1 at 24 months post-transplant; P<.0001). This improvement occurred regardless of MELD score, and fatigue scores also were better among transplant recipients compared with nonrecipients with PBC (31.1 ± 11.6; P=.03). Scores at 24 months, however, were higher among transplant recipients than controls without PBC (17.8 ± 5.9; P<.0001).

Moderate to severe fatigue (scores of 29 or greater) was observed in 44% of the cohort, including 47% of patients with low MELD scores, at 24 months. Severe fatigue was observed in 12% of LT recipients at 12 months and 6% at 24 months post-transplant.

“We have shown that fatigue improves after LT,” the researchers concluded. “However, almost half of the patients fatigued before transplant remained significantly fatigued at 2 years after transplant. … These findings raise concerns regarding the appropriateness of transplantation as a treatment modality for fatigue alone in PBC, balanced against the real risk of mortality and morbidity from the transplant procedure itself. With improving long-term transplantation outcomes, we should focus more on the long-term improvement of the quality of life after LT. Further studies on fatigue in transplant recipients … are clearly warranted in order to confirm these findings.

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Obesity Trumps Alcohol in Liver Damage

Daniel M. Keller, PhD

May 13, 2013

AMSTERDAM, the Netherlands — In terms of liver-related morbidity and mortality, obesity is even more dangerous than alcohol consumption, a study of more than 100,000 women has shown.

"For both overweight and obese women in this study, heavy drinking increased the absolute risk of liver events." The effect was additive if the women were overweight and super additive if they were obese, said lead author Paul Trembling, BM, MRCP, clinical research fellow at the Institute for Liver and Digestive Health, University College London, the United Kingdom.

Dr. Trembling presented the results here at the International Liver Congress 2013.

Dr. Trembling and his team examined the effect of the interaction between body mass index and alcohol consumption on liver-related events in the general population of women middle-aged and older.

The researchers obtained data on 107,742 women who participated in the UK Collaborative Trial of Ovarian Cancer Screening. They obtained follow-up data from routine healthcare databases and death certificates.

BMIs were calculated from self-reported height and weight at recruitment, and subjects reported their alcohol consumption 3.5 years after recruitment.

Median age at baseline was 61 years, 35% of the participants were smokers, 32% had hypertension, 24% had hypercholesterolemia, 6% had heart disease, and 5% had diabetes.

For alcohol intake, 62% of participants consumed 0 to 3 units per week (23% drank 0), 3% drank 16 to 20 units per week, and 2% drank more than 20 units per week.

For BMI, 44% of participants were in the normal range (18.50 - 24.99 kg/m²), 37% were overweight (25.00 - 29.99 kg/m²), and 19% were obese (≥30.00 kg/m²).

Investigators used hospital inpatient data and death certificates with any mention of alcoholic liver disease or fatty liver to determine the outcome measure of the incidence of a first event related to chronic liver disease, cirrhosis, or decompensation of cirrhosis.

During follow-up, there were 616 first events, including 110 deaths, 74 of which were from a liver-related cause. The standardized event rate was 0.06 per 100 participant-years.

For women who drank 20 units per week or less, being overweight was a risk-factor equivalent to drinking more than 21 units of alcohol per week, Dr. Trembling reported (adjusted hazard ratio, 1.7 vs 1.8). "For those who drink heavily, the risk of an event increases whether or not you are overweight and whether or not you are obese."

Table. Influence of Weight and Alcohol on Risk for Liver Outcomes

BMI (kg/m²)	Alcohol (Units/Week)	Adjusted Hazard Ratio (95% Confidence Interval)*
<30	<21	1.0
≥30	<21	1.7 (1.4–2.0)
<30	≥21	1.8 (1.0–3.4)
≥30	≥21	2.4 (0.8–7.6)

*After adjustment for metabolic factors.

Dr. Trembling reported that the event rate was higher in heavy drinkers who are overweight than in heavy drinkers who are not. It was also higher in people who are overweight but do not drink heavily. "The combined risk here is additive," he pointed out.

The risk is even higher in those who drink heavily and are obese. "The combined risk here is super additive," he said. The risk for an event is higher in those who are overweight than in those who drink heavily, and higher in those who are obese than those who drink heavily, he noted.

After adjustment for factors other than metabolic risk, the hazard ratios increase, indicating that features of metabolic syndrome contribute to the risk associated with weight.

Dr. Trembling concluded that the absolute risk for liver events increases with increasing alcohol consumption and weight gain, but BMI appears to be the greater risk. The absolute risk for events attributable to high alcohol intake is similar to that attributable to being overweight, and obesity results in a higher risk than heavy alcohol consumption.

"If you're obese, the damage that you do to yourself by drinking is much greater than if you're just overweight, explained senior researcher William Rosenberg, MBBS, DPhil, professor of hepatology at University College London.

"This is the first study really to demonstrate this in a large population of women," he said. "People are not aware that they are putting themselves at this risk."

During a news conference, moderator Daniele Prati, MD, from the Ospedale Alessandro Manzoni in Lecco, Italy, pointed out that Europe has the heaviest alcohol consumption in the world, and that alcohol consumption is the third leading cause of early death and illness, after tobacco and hypertension.

"From the early 1970s to 2000 in England, there was a 10-fold increase in women aged 35 to 44 dying from liver cirrhosis," he said.

He praised the study for its large size and for its assessment of the influence of alcohol and weight on liver-related morbidity and mortality. "There is a need to better set the proper thresholds, alone and in combination, to be able to prevent liver disease," Dr. Prati explained.

Solutions do not lie with hepatologists, he told Medscape Medical News. "Most of the work should be done with education and by the government in terms of...sensitizing the population to the risk. That's probably the only way, because both obesity and alcohol, despite the relevance for public health (not only in terms of liver disease), are conditions for which we have no really effective treatments," he concluded.

Dr. Trembling and Dr. Rosenberg have disclosed no relevant financial relationships. Dr. Prati reports consulting for Roche, Bristol-Myers Squibb, Novartis, and AbbVie.

International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL). Abstract 115. Presented April 27, 2013.

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OraSure Technologies, Walgreens and Chronic Liver Disease Foundation to Launch Rapid Hepatitis C Testing Initiative in Support of National Hepatitis Testing Day

Select Walgreens Locations to Offer Rapid HCV Testing With OraQuick(R) HCV Rapid Test

WAG | 5/13/2013 10:00:30 AM

BETHLEHEM, Pa., May 13, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR), Walgreens (NYSE:WAG), and the Chronic Liver Disease Foundation announced today that they have joined with local health organizations to offer hepatitis C (HCV) testing with the OraQuick® HCV Rapid Test to individuals who may be at risk for HCV infection. The testing will be available in select Walgreens locations across 11 states in observance of National Hepatitis Testing Day, May 19. The on-site testing, patient education and linkage to care will be conducted by local health organizations. National Hepatitis Testing Day was established by the Centers for Disease Control and Prevention (CDC) as an opportunity to remind healthcare providers and those individuals at risk that they should be tested for viral hepatitis.

"Today, approximately 4 million Americans are infected with hepatitis C and the vast majority does not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "However, new therapies are now available that can effectively treat and in some cases eliminate the virus from the body, making testing for HCV – particularly among baby boomers – a critical step in fighting this epidemic."

"Hepatitis C is a silent epidemic and these testing events can help make a meaningful impact on prevention, treatment and awareness," said Glen Pietrandoni, Walgreens senior manager of virology. "By working collaboratively, we can help educate communities on the risk factors and link people to appropriate care."

OraQuick® HCV is the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using venipuncture or fingerstick blood.

"Using traditional laboratory testing, individuals typically wait days or weeks before receiving their hepatitis C test results," said Douglas A. Michels, President and CEO of OraSure Technologies. "The OraQuick® HCV Rapid Test is ideal for use at the point of care – it's easy, accessible and provides lab-accurate results in 20 minutes – enabling individuals presumed to be infected to be referred immediately for follow-up care."

In addition to this initiative with Walgreens and CLDF, OraSure's OraQuick HCV Rapid Test is being deployed at public testing events in Washington, D.C., Los Angeles, New York City, Chicago, Pittsburgh, and other cities across the U.S. in recognition of National Hepatitis Testing Day.

For more information, including Walgreens testing locations and hours, please visit: http://www.TestHepC.com/Walgreens.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration for the Company's OraQuick® In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market - making it the first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

For more information on OraSure Technologies, please visit www.orasure.com.

About Walgreens

As the nation's largest drugstore chain with fiscal 2012 sales of $72 billion, Walgreens (www.walgreens.com) vision is to become America's first choice for health and daily living. Each day, Walgreens provides more than 6 million customers the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice in communities across America. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with respiratory services. These services help improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. The company operates 8,086 drugstores in all 50 states, the District of Columbia and Puerto Rico. Take Care Health Systems is a Walgreens subsidiary that is the largest and most comprehensive manager of worksite health and wellness centers and in-store convenient care clinics, with more than 700 locations throughout the country.

About the Chronic Liver Disease Foundation

Established in 2001, the Chronic Liver Disease Foundation is a nonprofit 501(c)(3) educational organization dedicated to providing hepatology related continuing medical education, news and information to healthcare professionals across the US. The CLDF is led by a Board of Trustees comprised of nationally renowned liver disease specialists. Furthermore, the CLDF believes that educational programs should be developed by the specialists who are actively involved in the research, treatment and management of a disease. As such the CLDF has developed a network of 75 Centers of Educational Expertise and multiple Advisory Boards who are actively involved in program creation related to specific disease topics which include; hemochromatosis, hepatic encephalopathy, hepatitis B, hepatitis C, hepatocellular carcinoma, HIV co-infection, liver transplantation and NASH/NAFLD. The CLDF's educational opportunities are offered in a variety of formats including an interactive web site, live meetings, teleconferences, print pieces, webcasts and other electronic mediums. For more information, please visit www.chronicliverdisease.org.

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Toward Improved Outcomes in HCV Mono- and Coinfection

Valerie Martel-Laferriere, MD, Douglas Dieterich, MD

May 13, 2013

The International Conference on Viral Hepatitis (ICVH), organized in collaboration with the International Association of Providers of AIDS Care and the Icahn School of Medicine at Mount Sinai in New York and held March 25-26, 2013, focused on the use of new agents in the treatment of hepatitis C (HCV), and particularly on the rapid progress made in the treatment of HIV/HCV-coinfected patients.

Management of HCV Monoinfection: The Promise of Novel Agents

New data on 2 novel agents in development were presented during ICVH. SOUND-C2 is a phase 2b open-label randomized trial in treatment-naive patients with HCV genotype 1; it is evaluating the combination of faldaprevir, a NS3/4A protease inhibitor, and BI 207127, a nonnucleoside NS5B inhibitor.^[1] This was a 5-arm study: faldaprevir 120 mg daily, BI 207127 600 mg 3 times daily, and ribavirin for 16 weeks, 28 weeks, or 40 weeks; faldaprevir 120 mg daily, BI 207127 600 mg twice daily, and ribavirin for 28 weeks; or faldaprevir 120 mg daily and BI 207127 600 mg 3 times daily, without ribavirin, for 28 weeks. A total of 362 patients were enrolled, approximately two thirds of whom were HCV genotype 1b. Around 25% were IL28B CC, and 10% were cirrhotic. The primary endpoint was achievement of sustained virologic response 12 weeks after treatment (SVR12).

The arm in which BI 207127 was administered twice daily had the best response, with an SVR12 of 69%. The arm without ribavirin did the worst, with an SVR12 of only 39%. Subgroup analysis showed that genotype had a very important effect on results: SVR12 ranged from 11% to 47% for patients with genotype 1a to 56% to 85% for patients with genotype 1b. IL28B had less of an effect, with a difference of 10%-25% between IL28B non-CC vs CC. In multivariate analysis, sex, HCV subtype, IL28B genotype, and baseline gamma-glutamyltransferase level significantly affectedSVR12.

No patients had relapse between week 12 and 24 post-treatment, but not all patients reached this time point. There was 1 late relapse that occurred between 24 and 48 weeks post-treatment.

Side effects were tolerable: Grade 3 hemoglobin levels were reported in 8 patients, 1 patient had a grade 4 anemia, and 7 patients developed severe rashes. As expected, depending on study arm, 13%-46% of patients developed grade 3/4 elevated total bilirubin levels. Phase 3 studies combining faldaprevir 120 mg daily, BI 207127 600 mg twice daily, and ribavirin are under way.

Finally, 2 presentations discussed the resistance profile of the novel protease inhibitor MK-5172.^[2,3] In vitro studies identified mutations associated with resistance in genotype 1a (Q41R, D168A/E/G/V), genotype 1b (F43S, A156S/T, D168A/G/V), genotype 2a (Y56H, V71A, A156T, D168E), and genotype 3a (Q168R).^[2] After treatment with MK-5172 monotherapy for 14 days, D168A/E/V was found in genotype 1a, A156S/T and D168A/V were found in genotype 1b, and Q168R was found in genotype 3a.

Of note, MK-5172 maintained good antiviral activity when tested against virus with mutations associated with failure of first-generation protease inhibitor treatment.^[3] MK-8742, an NS5A inhibitor, demonstrated fewer resistant replicons than did daclatasvir or ledipasvir (GS-5885) when tested alone or in combination with MK-5172.^[3] The barrier to resistance of the combination of MK-5172 and MK-8742 is thought to be high because combined mutations conferring resistance to NS3 and NS5A were rare in the replicons.

HIV/HCV Coinfected Patients: Focus on Acute Infections and Reinfections

HCV is now recognized as a sexually transmitted disease in HIV-infected men who have sex with men (MSM). Over the 5-year period from 2008 to 2012, Sanchez and colleagues^[4] recorded an increase in the rate of syphilis in Madrid, Spain, from 3.1% to 10.4%, whereas the rate of HCV increased from 0.05% to 0.3%. These results are concordant with those seen in the CASCADE Collaboration study,^[5] which showed a slowly but steadily increase of HCV in HIV-infected MSM between 1990 and 2007, increasing from 0.09-0.22 per 100 person-years in 1990 to 2.34-5.11 per 100 person-years in 2007.

The close relationship with viruses seen in intravenous drug users in Spain and the concomitant diagnosis of syphilis and HCV seen in 7 patients underscores the importance of preventive measures and periodic HCV screening among MSM to maximize treatment benefit during the acute phase of HCV infection.

Treatment of acute HCV infection in HIV infected patients is associated with significantly better outcomes than is treatment of chronic infection: SVR rates range from 53% to 82% for acute HCV infection vs 14% to 38% for chronic HCV genotype 1 and 44% to 72% for HCV genotype 2 or 3.^[6-17] Dr. Daniel Fierer of Mount Sinai Hospital^[18] presented results of a study of 20 consecutive HIV-infected MSM with newly diagnosed HCV treated with 12 weeks of telaprevir, pegylated interferon, and ribavirin. The study is still ongoing, but preliminary data show SVR at 4 weeks of 85% (17 of 20 patients). A limitation of the study is that the favorable IL28B polymorphism CC was overrepresented (65%) compared with what is usually seen in the US population, and this may partially account for the high response rate.

Despite the effectiveness of treatment for acute HCV infection, reinfection remains a concern. In 2011, Lambers and colleagues^[19] showed that among 51 HIV-infected MSM treated successfully for an acute HCV infection at 2 clinics in Amsterdam, The Netherlands, 11 became reinfected shortly after, resulting in a reinfection rate of 15.2 over 100 person-years. At ICVH, Dr. Emma Page of the Chelsea and Westminster Hospital in the United Kingdom^[20] reported data from a similar evaluation conducted at her hospital, where the incidence rate of reinfection was 8.1 per 100 person-years among a cohort of 145 MSM followed from January 2004 to April 2012. Of note, reinfection occurred within 4 years of documented negative HCV antibody testing.

Treating Chronic HCV Infection: Real-Life Experiences

The addition of telaprevir and boceprevir to treatment regimens for HCV genotype 1 has greatly changed the outcome of chronic HCV treatment. However, these drugs have significant side effects and drug interactions, little is known so far about their effectiveness in real life, and their use in HCV/HIV-coinfected patients is off-label.

Ahmed and colleagues^[21] presented the experience at Chelsea and Westminster Hospital with using boceprevir and telaprevir in 5 coinfected patients with previous treatment failure and who had bridging fibrosis or cirrhosis on liver biopsy. All patients achieved early virologic response, and 4 patients achieved SVR at 24 weeks. The remaining patient had an undetectable viral load at the end of treatment but died during follow-up.

Adverse events, including anemia, were common, and 80% of patients received erythropoietin. No patient had a detectable HIV load during treatment. Evaluation of 7 coinfected patients who started a telaprevir-based regimen is ongoing.

The use of telaprevir at the Icahn School of Medicine at Mount Sinai and John Hopkins University^[22] in 33 coinfected and 117 monoinfected patients also showed good results and no statistically significant difference between groups in the SVR12 rate (61% vs 43%; P = .07), even though the coinfected group consisted of a more difficult-to-treat population (more African Americans and more prior nonresponders or patients who were intolerant of therapy). Discontinuation because of adverse events and severe anemia was common, but the proportions did not differ between the groups.

Drug/Drug Interactions

A recurrent theme during ICVH was the issue of drug/drug interactions with the use of the new direct-acting antivirals, especially in coinfected patients.^[23] Boceprevir and telaprevir are both CYP3A inhibitors, although telaprevir is a little more permissive than boceprevir when it comes to drug/drug interactions. For example, efavirenz can be used at an increased dose (1125 mg 3 times daily) with telaprevir, but cannot be used with boceprevir.^[24,25] Atazanavir boosted with ritonavir is also an acceptable option in patients taking telaprevir, but the US Food and Drug Administration does not recommend its use with boceprevir because of the potential for HIV escape.^[25,26] Because data on drug/drug interactions in clinical settings are not always available, clinicians should be cautious when they select a treatment regimen for coinfected patients.

Liver Transplantation in Coinfected Patients: Facing the Challenges

For many years, HIV-infected patients were not considered potential liver transplant candidates. Now, well-selected HIV-positive patients can benefit from liver transplant, but the outcomes vary widely. Thus, given the shortage of available donor livers, the debate is still open about whether HIV-positive patients should undergo transplant.

In a series of 22 patients with hepatitis B coinfection, the difference in the 5-year survival rate did not statistically differ between coinfected and monoinfected patients (86% vs 100%; P = .09).^[27] No patients died of HIV or hepatitis B virus infection during follow-up. Of note, around one half of the patients had low viremia, which may support the long-term use of hepatitis B immunoglobulins plus antivirals.

The benefits of transplantation in HIV/HCV coinfection are more difficult to assess: Studies have shown higher rates of wait-list mortality, higher rates of post-transplant mortality, and more severe recurrent HCV disease.^[28] Indeed, data from a prospective multicenter trial showed significantly higher 3-year survival and graft survival in HCV-monoinfected transplant recipients vs coinfected transplant recipients (overall survival, 60% vs 79% [P < .001]; graft survival, 53% vs 74% [P < .001]).^[29] However, contrary to what was expected, acute rejection was more common in coinfected patients than it was in monoinfected patients (35% vs 18%). The challenges of managing immunosuppressive drugs in already immunosuppressed patients, as well as a potential drug/drug interactions, may explain this phenomenon. As a precaution, some have advised that HIV protease inhibitors be avoided in this population to reduce the risk for interactions.^[28]

Conclusions

Hepatitis C research is a rapidly moving field. Over the past year, the epidemiology of the disease has started to change with the appearance of more sexually transmitted cases among HIV-infected patients. Understanding of the timing of treatment in acute infection has been refined, and new treatments are available and in development for chronic infection. Although HIV is still a barrier to liver transplantation in coinfected patients, it is no longer an absolute contraindication.

Source

Addressing Psychosocial Issues in Patients With Hepatitis C

Jeffrey Weiss, PhD, MS

May 13, 2013

Editor's Note: The International Conference on Viral Hepatitis (ICVH) 2013 -- held in New York on March 25-26, 2013, and jointly sponsored by the International Association of Providers of AIDS Care and the Icahn School of Medicine at Mount Sinai -- was designed to update practitioners and scientists on the most recent advances in the management of hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV/hepatitis coinfection.

Jeffrey Weiss, PhD, MS, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, moderated a panel at ICVH 2013 featuring patients discussing barriers to care in hepatitis^[1] and comoderated another panel on optimizing outcomes in patients with liver disease.^[2] Here, he shares his thoughts on some of the key issues raised during these panel discussions regarding psychosocial issues in patients with HCV.

Two issues raised during ICVH 2013 highlight some of the challenges facing clinicians in managing patients with hepatitis. The Institute of Medicine recommendations for the prevention and control of HBV and HCV noted the need for improved knowledge and awareness about hepatitis among healthcare and social-service providers and the public, especially in at-risk people, as well as the need for improved access to available services.^[3] One method raised by the panelists to improve engagement in care was to increase deployment of the peer influence model, which has been used as part of HCV and HIV prevention strategies.^[4] Adapting this model to focus on access to and engagement in hepatitis care, peers would go into targeted, hard-to-reach communities to provide education and to connect individuals with testing and treatment opportunities.

Creating tools for primary care physicians to readily educate patients about the importance of effective treatment for hepatitis was also discussed as a potential method for increasing education about and engagement in care. This type of coordinated care has been identified as critical to increasing screening and prevention strategies and may play a key role in improving outcomes in patients with chronic disease.^[5]

Yet, engaging patients in care is only a first step toward maximizing treatment benefit in patients with HCV infection. A wide variety of psychosocial factors can influence adherence and treatment effectiveness, particularly among injection drug users, which is a key at-risk population.^[6] A structured, integrated approach to ensuring medication adherence in patients with HCV infection is currently lacking at most sites of care,^[7] but patients who are given the necessary pretreatment preparation and on-treatment support are more likely to be retained in care and adhere to medication regimens, thus increasing the likelihood for improved outcomes.

References

Source

Facing the Challenges in Managing HCV/HIV Coinfection

Mark R. Nelson, MD

DisclosuresMay 13, 2013

Editor's Note: The International Conference on Viral Hepatitis (ICVH) 2013 -- held in New York on March 25-26, 2013, and jointly sponsored by the International Association of Providers of AIDS Care and the Icahn School of Medicine at Mount Sinai -- was designed to update practitioners and scientists on the most recent advances in the management of hepatitis B virus, hepatitis C virus (HCV), and HIV/hepatitis coinfection.

Mark R. Nelson, MD, Physician and Clinical Lead for In-Patient Services at the Chelsea and Westminster Hospital in London, United Kingdom, and Co-chair of ICVH 2013, shared his thoughts on some of the key issues discussed at the conference.

We are continually learning about the management of patients with HCV infection and are exploring new ways to improve treatment outcomes in both monoinfected and HCV/HIV-coinfected patients.

With the wide array of new drugs and new treatment approaches on the horizon,^[1] we need to take a step back and consider the personal and public health implications of immediate treatment, given the unknown drug/drug interactions and toxicities -- especially in coinfected patients.^[2-4]

But we know that we cannot hold off on treatment for too long. Among coinfected patients in particular, survival in those with end-stage liver disease is poor, and the value of transplantation in this population is still being debated.^[5]

Another critical issue that needs to be addressed is the growing epidemic of acute hepatitis C among patients with HIV -- first described at our hospital -- that is rapidly replacing those with chronic HCV infection who were successfully treated.^[6] The reinfection rate in these patients can be high, and treatment can be costly. How will that affect patients who need repeated treatments over the long term?

This is a very exciting time for clinicians and researchers involved in the management of patients with HCV infection. But it is also a time in which we need to consider how to obtain the data we need to develop strategies that can offer the best opportunity for improved outcomes.

References

Source

FDA is announcing a Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research

Date:
June 14, 2013
Time:
9:30 a.m. to 5:30 p.m
Location:
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993

On June 14, 2013, as part of the Patient-Focused Drug Development initiative intended to enhance patient input, FDA will be hosting a public meeting on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. FDA is interested in obtaining patient input on the impact of HIV on daily life and currently available therapies to treat the condition (topic 1), and patients’ views on issues related to HIV cure research (topic 2).

Topic 1 is expected to be discussed from approximately 9:30 AM to noon, and Topic 2 approximately 1:30 - 5:30 PM.

Questions intended to frame discussion on these topics are provided below.

For each topic, a panel of patients and patient representatives/advocates will present comments to begin the dialogue which will be followed by a facilitated discussion inviting comments from other patients and patient representatives in the White Oak audience.

If you are interested in providing comments as part of one of the initial panel discussions, please indicate so during the registration process. Participants selected for the panel discussions will be confirmed prior to the meeting.

There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting. For more information, refer to the FDA Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research website (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm348598.htm).

There is no cost for registration, but please register (below) by June 5, 2013.

The meeting will be webcast, however, remote viewers will not be able to directly participate in the discussions.
Questions for Discussion

Topic 1: Patients’ perspective on current approaches to managing HIV and on symptoms experienced because of HIV or its treatment

1) What are you currently doing to help manage your HIV and any symptoms you experience because of your condition or other therapies? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies such as diet modification.)

a) What specific symptoms do your therapies or treatments address?

b) How long have you been on treatment and how has your treatment regimen changed over time?

2) How well does your current treatment regimen treat any significant symptoms of your condition?

a) How well have these treatments worked for you as your condition has changed over time?

b) Are there symptoms that your current regimen does not address at all, or does not treat as well as you would like?

3) What are the most significant downsides to your current therapies or treatments, and how do they affect your daily life? (Examples of downsides could include bothersome side effects, physical change to your body because of treatment, going to the hospital for treatment, etc.)

4) Of all the symptoms that you experience because of your condition, or because of your therapy or treatment, which 1-3 symptoms have the most significant impact on your life? (Examples could include diarrhea, insomnia, difficulty concentrating, etc.)

a) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, etc.)

5) Assuming there is currently no complete cure for your condition, what specific things would you look for in an ideal therapy or treatment to manage your condition?

Topic 2: Patients’ perspectives on HIV Cure Research

1) What do you believe are the benefits of participating in an HIV cure research study?

2) What would motivate you to participate or to not participate in an HIV cure research study?

3) What risks would you find unacceptable for participating in an HIV cure research study, and why? (Examples of risks that may be associated with participation in an HIV cure research study include common side effects such as nausea and fatigue, and less common but serious adverse events such as blood clots, infection, seizures and cancer.)

4) In certain HIV cure research studies, you would be asked to stop any other HIV medications that you are currently taking. How would this affect your decision whether to participate in an HIV cure research study?

5) The process of informed consent is an important way for the researchers to communicate the purpose of an HIV research study, as well as its expected benefits and potential risks, so that people can make an informed decision whether to participate in the study.

a) How should the informed consent clearly communicate to you the purpose of an HIV cure research study, particularly when a study is designed only to provide scientific information that could guide future research and development of treatments?

b) How should the informed consent clearly communicate to you the potential benefits of an HIV cure research study? In particular, how should the informed consent describe benefit when we do not think that participants in the study may gain any direct health benefits?

c) How should informed consent communicate clearly to you the potential risks of participating in an HIV cure research study? In particular, how should the informed consent describe a study if there is very limited understanding about how the medications or interventions may affect participants or what are the potential risks of those interventions or medications?

d) Is there any other information that you would find helpful when deciding whether to enter an HIV cure research study?

6) What else do you want FDA to know about HIV Cure Research from your perspective?
Registration:

To register for this meeting, visit http://patientfocusedhiv.eventbrite.com.
→ Registration will close on June 5, 2013.

The registration website contains links to background materials, and will be updated as additional meeting materials are developed, including a background document intended to help, along with the questions above, to frame discussion on the day of the meeting. That backgrounder will also be provided via this list serve prior to the meeting.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

Received as Email Alert from FDA May 13, 2013

U.S. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C

13-May-13 Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.

“This is a very important step bringing simeprevir closer to the market, making this therapy available to hepatitis C patients” comments Charlotte Edenius, EVP Development of Medivir.

The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.

The regulatory submission by Janssen for simeprevir is supported in part by data from three pivotal phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. Janssen also recently submitted simeprevir for marketing authorization to regulatory authorities in Japan and Europe.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292

About Simeprevir
Simeprevir is a new generation NS3/4A protease inhibitor jointly developed by Medivir and Janssen for the treatment of chronic hepatitis C in adult patients with compensated liver disease.

For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 150 million people are infected with hepatitis C worldwide, and about 350,000 people per year die from the disease.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.

Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s lives.

Source

Top 6 natural remedies to keep your liver healthy

Provided by health.india.com

Anusuya Suresh, Last Updated: May 13, 2013 at 12:49 PM

The liver is one of our body’s busiest organs, with a role to play in most of the biochemical processes that sustain life. It produces bile that is vital to digestion, produces plasma proteins, stores iron, regulates the clotting of blood, synthesizes cholesterol, stores glucose as glycogen, regulates the levels of amino acids in blood, is involved with clotting of blood, removes toxins from the body and produces immune factors that help prevent infections. With our modern-day food and lifestyles (think greater junk food, alcohol, smoking, stress and medication) we put a greater pressure on our liver and this can cause several health problems right from allergies and migraines to obesity and indigestion. Here are a few herbal remedies that can help your liver stay healthy.

Amla or Gooseberry

The Indian gooseberry or amla is known as one of the richest sources of vitamin C. What is less well-known is its ability to keep the liver functioning at optimal levels. This herb has been used extensively in Ayurveda for treatment of a sluggish liver; now researchers are finding in laboratory studies that extracts from amla have liver-protective function. However, there is no clear indication of whether it is useful to treat hepatitis B infection. Amla is one of the important components in Chyawanpraash that has immunity boosting, digestive and liver-protective action. The best way to consume it is raw as small pieces in your salad or by making a raitha with grated amla and curd.

Jethimad or Licorice

People with non- alcoholic fatty liver disease show increased levels of the transaminase enzymes called ALT and AST. Studies have found that the use of licorice (Jethimad or Mulhati in Hindi) extracts led to reduced concentrations of these enzymes indicating that licorice has beneficial effects on the liver. Although licorice is more well-known for its sweet taste and anti-ulcer action, it has been used in Ayurvedic remedies to cure liver ailments. Licorice is available at stores selling Indian medicinal herbs; get the root, powder it at home and make a tea by pouring boiling water into the powder, steeping for a few minutes and then straining the liquid.

Amrith or Guduchi

Yet another herb that Ayurveda considers to have rejuvenating properties, Amrith is commonly grown in many kitchen gardens. It is said to have the ability to clear toxins from the liver as well as strengthen its functioning; more importantly, it does not cause any significant complications even on using long-term. However, Ayurvedic physicians warn that using this herb can precipitate a liver crisis if the patient has a large amount of toxins in the liver; therefore, it is best to use this only under an Ayurvedic practitioner’s guidance.

Haldi or Turmeric

Full of valuable antioxidants, turmeric is an important herb that improves liver health. No wonder then that people in Asian countries use it so extensively in their cooking. Now, it is being recognized even in western countries for its liver-protective value. Some studies have also found that the antiviral action of turmeric is effective in preventing the multiplication of the viruses causing hepatitis B and C. The easiest way to take turmeric is to include it in your cooking; you can also make it a practice to drink a little turmeric-flavoured milk on a regular basis to get its benefits.

Flaxseeds

Certain receptor sites normally bind hormones and keep them circulating in the blood. This puts a strain on the liver which has to filter out these excess hormones. Studies have found that the phytoconstituents in flaxseeds have the capacity to bind with such receptor sites and this prevents hormonal binding, and this means less work for the liver. Just sprinkling a few crushed or whole flaxseeds on your toast, salad or cereals can help you make use of their liver-protective effect.

Vegetables

Certain vegetables contain ingredients that help the liver secrete greater concentrations of important enzymes; in turn, these enzymes help to excrete potential carcinogens (cancer-causing substances) from the body. Beet, cabbage, carrot, broccoli, onion and garlic are important vegetables with such an action. Broccoli, onion and garlic are believed to provide sulfur to the body; this helps in the detoxification reactions the liver carries out and prevents damage to the liver.

Along with the use of these natural remedies, it is also important to avoid foods that cause damage to the liver. If you eat foods that are highly processed with a large number of additives, or if you take too many medications, your liver has to work overtime to tackle this greater chemical load and this can cause damage. Food that is rich in hydrogenated oil, high fructose corn syrup, artificial sweetening agents and alcohol are some of the other substances that can put a greater load on your liver. Along with consuming of liver-protective herbs, it is also important to make sure you avoid the foods that cause it harm.

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First Published: May 13, 2013 at 12:29 PM

Source

Hepatitis C education important

Provided by Cape Breton Post

Published on May 13, 2013

By Judy Kelley (Your Health, Your Community)

One of the most challenging yet exciting aspects of my job as a public health nurse is having the opportunity to educate the community about hepatitis C.

I have come to learn that there are some common misconceptions about hepatitis C.

An estimated 250,000 Canadians have hepatitis C, but many don't know it. Hepatitis C can be silent in your body and you can have it for decades without having any symptoms. Approximately one in five people who are infected with hepatitis C is not aware they are infected and may unknowingly spread the disease to others.

The hepatitis C virus lives in the blood and can survive on surfaces for three days or longer. The majority of people contract the virus through injection drug use by sharing needles, spoons/cookers, rinse water and other gear that has been contaminated with hepatitis C infected blood. People will usually become infected within the first three years of drug use.

It can also be spread from sharing other items that may have microscopic amounts of blood on them, such as straws for snorting drugs, crack pipes, toothbrushes, razors, needles, nail clippers, tattoo guns and ink.

Prior to 1990, the Canadian blood system did not test blood for hepatitis C and some people were infected through blood transfusion. Blood transfusions are now screened and considered safe from hepatitis C.

It should be stressed that hepatitis C is spread through blood-to-blood contact and it cannot be spread through casual contact like handshakes, hugs and sharing eating utensils (used for eating, not injection drug use).

Many people get mixed up about the three most common types of viral hepatitis (hepatitis A, B and C). They may think they are protected from all hepatitis viruses by getting a Twinrix vaccine (hepatitis A and B vaccine). While the Twinrix vaccine is safe and effective in preventing hepatitis A and B, it does not offer any protection against hepatitis C.

The hepatitis C virus is like the common cold in that it replicates and changes so much that the body can never be immune to it. That being said, there is hope that a hepatitis C vaccine will someday be available.

Tattoos and multiple piercings are risk factors for hepatitis C. As a result, public health has partnered with HepNS to deliver safer tattooing and piercing messages (Hip not Hep) to the Grade 9 students within the Cape Breton-Victoria Regional School Board. Students are given information of the associated risks of tattoos and piercings and are encouraged to make informed decisions about their health.

Getting tested is the only way to find out if you have hepatitis C or not. It is a leading cause of cirrhosis, liver cancer and can lead to liver transplant. New treatments are available that can cure hepatitis C, prevent further liver damage and improve health outcomes for people infected.

Cape Breton has higher rates of hepatitis C than other parts of the province. This is due to many variables which are compounded by poverty, food and housing issues.

The most important thing to remember is if you have ever engaged in a high risk activity, even if it was only once and a longtime ago, consider getting tested for hepatitis C.

Judy Kelley is a public health nurse with the Cape Breton District Health Authority. This column is part of a locally written series on population health, which looks at factors like income, education, social support, housing etc., that influence the health of a community.

Source

In Brazil, Mexico and Argentina, Dual Combination Therapy With Peg-IFN-alpha and Ribavirin Remains the Most Commonly Prescribed Treatment for all Hepatitis C Virus-Infected Patients

PRESS RELEASE

May 13, 2013, 9:00 a.m. EDT

However, Recent Changes in Brazil and Argentina are Expected to Drive a Shift in Treatment of HCV Genotype 1 Infections, According to a New Report From Decision Resources

BURLINGTON, Mass., May 13, 2013 /PRNewswire via COMTEX/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of hepatitis C virus (HCV) patients in Brazil, Mexico and Argentina rely entirely on government-sponsored medical programs to cover their treatment costs. However, in Mexico, approximately half of the population remains uncovered for HCV therapies, while the remaining population has access to only dual therapy through Social Security (SS). Surveyed clinicians in this country point to out-of-pocket costs and government/hospital-imposed budget restrictions as barriers to prescription drug treatment. Moreover, although Brazilian clinicians report higher rates of prescription drug treatment in all segments of diagnosed, viremic HCV public patients compared with physicians in Mexico and Argentina, treatment rates of nonresponders among surveyed clinicians are usually less than 40 percent in all countries.

The Emerging Markets Physician & Payer Forum report entitled Positioning of Current and Emerging Agents for Hepatitis C Virus: Physician and Payer Perspectives on the Prescribing and Patient Access Landscape in Brazil, Mexico, and Argentina also finds that peg-IFN-alpha (Roche's Pegasys and Merck's PegIntron) enjoys full government sponsorship in all three countries, but current access to protease inhibitors (Johnson & Johnson's Incivo and Merck's Victrelis) is still very limited in some of the markets; therefore, peg-IFN/ribavirin is the treatment that surveyed clinicians most frequently prescribe to treatment-naive and nonresponder public patients. In Brazil, for example, triplet regimens are used in the treatment of only 20 percent of nonresponder HCV1 public patients and in only 5 percent of those who are treatment-naive.

The report also finds that in a scenario where all treatments for HCV are reimbursed by the government, surveyed clinicians clearly indicate their willingness to prescribe triple therapy to their HCV patients, including those with HCV genotype 2/3, despite the lack of evidence for clinical benefit in this subpopulation.

"Initiatives to include protease inhibitors in public programs in all three countries are currently gaining momentum," said Decision Resources Analyst Andreia Ribeiro, Ph.D. "In Brazil, Incivo and Victrelis are now being incorporated in public reference hospitals and state HCV programs, after a positive recommendation by CONITEC (the national HTA body) for the inclusion of protease inhibitors in the National Health System in July, 2012. In Argentina, the Superintendencia de Servicios de Salud recently included protease inhibitors in the coverage of the Single Refund System. Therefore, the different SS funds (Obras Sociales) can now be reimbursed for the provision of triple therapy treatment to HCV1 patients. Additionally, in Mexico, the fact that Victrelis was recently included in the national formularies may lead to the incorporation of this drug in the SS sector soon."

About Decision ResourcesDecision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources GroupDecision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

SOURCE Decision Resources

Source

May is Hepatitis Awareness Month

May is Hepatitis Awareness Month

National Hepatitis Testing Day on May 19th

May is dedicated to highlighting the silent epidemic of chronic hepatitis B and hepatitis C infections that affects more than 5 million Americans. Most, however, are unaware of their infection. To boost screening rates, the Centers for Disease Control and Prevention (CDC) has designated May 19 as National Hepatitis Testing Day. Find an event near you to support during May at Hep B United, a national hepatitis B campaign spearheaded by the HBF and AAPCHO, and the Centers for Disease Control. Read more.

May is National Hepatitis Awareness Month and the goal is to highlight the silent epidemic of more than 5 million Americans suffering from chronic hepatitis B and hepatitis C infections. With most Americans unaware that they are infected with these serious liver infections, it is essential to improve screening and testing rates to reduce the burden of illness and death from these diseases.

May 19 is National Hepatitis Testing Day, an educational initiative of the Center for Disease Control (CDC) Division of Viral Hepatitis and the U.S. Department of Health & Human Services, to boost screening rates in the U.S.

For more information about May Hepatitis Awareness Month and to find an event near you for May 19 Hepatitis Testing Day, visit the following websites:

Hep B United – A national hepatitis B campaign to support and leverage local coalitions around the country addressing hepatitis B and liver cancer. Includes links to Hepatitis B Testing events in different states.

CDC Hepatitis Awareness Month - Check back over the course of the month as exciting new resources and tools are added to this page maintained by the CDC.

CDC NPIN – Find events across the country on this CDC webpage that includes an interactive map of the U.S.

Source

Radioactive Microspheres Match Embolization for Liver Cancer

Daniel M. Keller, PhD

May 10, 2013

AMSTERDAM, the Netherlands — For patients with unresectable intermediate-stage hepatocellular carcinoma, selective internal radioembolization and standard transarterial chemoembolization provide equivalent outcomes, new research shows. The advantage of radioembolization is that it can be administered in a single treatment.

"Our small pilot study suggests that a single session of radioembolization is as safe and effective as multiple sessions of chemoembolization. There are no differences between radioembolization and chemoembolization in terms of health-related quality of life, progression-free survival, or severity of adverse events," said Frank Kolligs, MD, from the University of Munich in Germany.

Dr. Kolligs presented the study results here at the International Liver Congress 2013.

Although both approaches can result in downstaging of the disease, possibly allowing for curative surgery or transplantation, chemoembolization is considered the treatment of choice for inoperable intermediate-stage hepatocellular carcinoma in guidelines from the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases. However, chemoembolization is often associated with postembolization syndrome.

Dr. Kolligs and his team conducted an open-label, randomized, prospective study of 28 evaluable patients from 2 university centers. This sample size allowed them to compare the different approaches for health-related quality of life.

They screened patients with liver angiography and then randomized them to radioembolization or chemoembolization. Study participants were 18 years or older, had a performance status of 0 or 1, Child–Pugh class B-7 cirrhosis or lower, and a bilirubin level of 2 mg/dL or less. Exclusion criteria were previous chemoembolization treatment, extrahepatic disease or portal vein occlusion, more than 5 lesions, any lesion 10 cm or larger, a cumulative lesion diameter of 20 cm or larger, and anticipated liver resection or transplantation.

At baseline, 85% of participants were men, mean age was 65.6 years, and time since diagnosis ranged from 0.8 to 1.1 months. Most had a Child–Pugh score of 5; the rest (31% in the radioembolization group and 40% in the chemoembolization group) had a score of 6 or 7. Six of 13 patients in the radioembolization group and 4 of 15 in the chemoembolization group had Barcelona Clinic Liver Cancer stage A disease; the rest of the patients had stage B disease.

Patients in the radioembolization group received a single brachytherapy treatment as a whole-liver, lobar, or segmental procedure (n = 13) using yttrium-90 radionuclide microspheres (32 µm; median, 1.6 Gbq). Patients in the chemoembolization group (n = 15) were treated with epirubicin 50 mg in Lipiodol 5 mL (iodized oil) and Embosphere microspheres (150 to 300 µm or 300 to 500 µm) every 6 weeks. Chemoembolization patients were assessed before each procedure, and underwent a mean of 3.5 sessions.

Treatment response was assessed by local and independent central examiners using RECIST (Response Evaluation Criteria in Solid Tumors). Patients were followed for a minimum of 12 months or until death.

Quality of Life Maintained With Either Therapy

We found "no detectable difference in health-related quality of life" between the 2 treatments over the first 12 weeks, Dr. Kolligs reported. Quality-of-life measures included dimensions of physical, social, emotional, and functional well being, as well as health concerns assessed on a hepatobiliary scale.

There was no difference between radioembolization and chemoembolization in progression-free survival, determined by intention-to treat-analysis (3.6 vs 3.7 months; log-rank P = .374).

There was also no difference in objective response rates between radioembolization and chemoembolization (23.1% vs 33.3%), and no difference in disease control rates (69.2% vs 67.7%).

At follow-up, 1 radioembolization patient and 2 chemoembolization patients were downstaged for liver transplantation. In addition, 1 radioembolization patient was downstaged for radiofrequency ablation, and that patient "has had no evidence of disease for the past 3 years," Dr. Kolligs reported.

Kaplan–Meier analysis showed no difference in survival between the radioembolization and chemoembolization groups at 6-month follow-up (69.2% vs 86.7%) or at 12-month follow-up (46.2% vs 66.7%; P = .244).

After progression, 4 patients in the chemoembolization group underwent additional treatment and 2 underwent radioembolization. One patient in the radioembolization group had additional treatment and 1 underwent additional chemoembolization.

There were 4 serious adverse events (grade 3 or 4) in each group. The most common adverse events were ascites, fatigue, and infection in the radioembolization group, and infection in the chemoembolization group.

There were only minor changes in liver function tests from baseline, and only in the radioembolization group, where total bilirubin elevations of grade 3 or higher were seen in 2 patients at 3 months and in 1 patient at 6 months.

For radioembolization, patient selection is important. "If you don't pay attention to liver function, and I guess the best parameter is bilirubin, then the patient has a risk of developing radiation-induced liver disease, which is a further impairment of liver function, ascites, and other symptoms," Dr. Kolligs told Medscape Medical News. A bilirubin level of 2 mg/dL should be the cutoff, he said.

Treatment decisions are made by an interdisciplinary tumor board. "We usually perform chemoembolization in patients with a limited number of tumor nodules that are usually not larger than 6 to 8 cm. If patients have very many nodules or very large nodules, if patients have a portal vein thrombosis, then we discuss performing radioembolization," he explained.

In response to an audience question about whether the 32 µm radioactive microspheres could end up in the systemic circulation, he said that all patients are screened with magnetic resonance angiography before initiating therapy to rule out significant shunting. In fact, 2 patients were excluded from the study for this reason.

In my opinion, these findings "show that it would be very reasonable and timely to have a large phase 3 study conducted to compare these 2 treatments in patients with intermediate [hepatocellular carcinoma] to really show where the place of this treatment could be," said Markus Peck-Radosavljevic, MD, from the Medical University of Vienna in Austria, and the new EASL secretary general.

Dr. Kolligs added a caveat: "There is definitely a place for radioembolization in the treatment algorithm. However, because of the lack of randomized clinical studies, we can't tell exactly where this place is." Unfortunately, a noninferiority trial would require 1500 patients, and a trial with adequate power to show the superiority of one treatment over the other would require 60,000 patients, Dr. Kolligs explained.

"This underscores the problem of designing a randomized controlled study for intermediate-stage hepatocellular carcinoma," he noted, but added that there are 3 trials in progress for more advanced disease.

In general, some intermediate-stage patients do quite well with chemoembolization, but others do not, Dr. Peck-Radosavljevic pointed out. "The problem is that when you do a transarterial treatment, you block the arterial blood supply to the liver. That kills the tumor but is not always good for the liver," he explained. "What you see when you're treating those patients is that some have very, very, very long survival, whereas others, who you think are in quite good condition, deteriorate very fast after this kind of treatment."

Dr. Kolligs reports being a speaker for Sirtex Medical, Bayer, and Pfizer, and a member of the advisory board for Bayer. Dr. Peck-Radosavljevic reports being a consultant to AbbVie, Roche, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead Sciences, Janssen, Eli Lilly, Jennerex, Merz, MSD, and Novartis.

International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL). Abstract 114. Presented April 27, 2013.

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Coumarin in Cinnamon and Cinnamon-Based Products and Risk of Liver Damage

"True," or Ceylon, cinnamon is expensive, so most breads, sticky buns and other products in the United States use dried cassia bark, or cassia cinnamon. (Credit: © Jacek Chabraszewski / Fotolia)

May 8, 2013 — Many kinds of cinnamon, cinnamon-flavored foods, beverages and food supplements in the United States use a form of the spice that contains high levels of a natural substance that may cause liver damage in some sensitive people, scientists are reporting. Their study, published in ACS' Journal of Agricultural and Food Chemistry, found similar results as those published in the European Union.

Ikhlas Khan and colleagues explain that cinnamon, which comes from the bark of certain trees, is one of the most important flavoring agents used in foods and beverages. "True," or Ceylon, cinnamon is expensive, so most breads, sticky buns and other products in the United States use dried cassia bark, or cassia cinnamon.

Ceylon cinnamon contains very little coumarin, a naturally occurring substance that has been linked to liver damage in people sensitive to the substance. However, cassia cinnamon can contain larger amounts. Khan's team decided to check on the coumarin content of a wide variety of food products.

"As found in this study, coumarin was present, sometimes in substantial amounts, in cinnamon-based food supplements and cinnamon-flavored foods," they say.

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The above story is reprinted from materials provided by American Chemical Society.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

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Journal Reference:

1. Yan-Hong Wang, Bharathi Avula, N. P. Dhammika Nanayakkara, Jianping Zhao, Ikhlas A. Khan. Cassia Cinnamon as a Source of Coumarin in Cinnamon-Flavored Food and Food Supplements in the United States. Journal of Agricultural and Food Chemistry, 2013; 61 (18): 4470 DOI: 10.1021/jf4005862

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Reducing Risk for Mother-to-Infant Transmission of Hepatitis C Virus: A Systematic Review for the U.S. Preventive Services Task Force

Annals of Internal Medicine

15 January 2013, Vol 158, No. 2>

Erika Barth Cottrell, PhD, MPP; Roger Chou, MD; Ngoc Wasson, MPH; Basmah Rahman, MPH; and Jeanne-Marie Guise, MD, MPH

[+-] Article and Author Information

Abstract

Background: Mother-to-infant transmission is the leading cause of childhood hepatitis C virus (HCV) infection, with up to 4000 new cases each year in the United States.

Purpose: To evaluate effects of mode of delivery, labor management strategies, and breastfeeding practices on risk for mother-to-infant transmission of HCV.

Data Sources: MEDLINE (1947 to May 2012), the Cochrane Library Database, clinical trial registries, and reference lists.

Study Selection: Randomized trials and observational studies on mode of delivery, labor management strategies, and breastfeeding practices and risk for mother-to-infant transmission of HCV.

Data Extraction: Investigators abstracted and reviewed study details and quality using predefined criteria.

Data Synthesis: Eighteen observational studies evaluated the association between mode of delivery, labor management strategies, or breastfeeding practices and risk for mother-to-infant HCV transmission. Fourteen studies (2 good-quality, 4 fair-quality, and 8 poor-quality studies) found no clear association between mode of delivery (vaginal versus cesarean delivery) and risk for transmission. Two studies (1 good-quality and 1 poor-quality study) reported an association between prolonged duration of ruptured membranes and increased risk for transmission. Fourteen studies (2 good-quality, 2 fair-quality, and 10 poor-quality studies) found no association between breastfeeding and risk for transmission.

Limitations: Only English-language articles were included. Studies were observational, and most had important methodological shortcomings, including failure to adjust for potential confounders and small sample sizes.

Conclusion: No intervention has been clearly demonstrated to reduce the risk for mother-to-infant HCV transmission. Avoidance of breastfeeding does not seem to be indicated for reducing transmission risk.

Primary Funding Source: Agency for Healthcare Research and Quality.

An estimated 40 000 children are born to hepatitis C virus (HCV)–positive women each year (1). Mother-to-infant (vertical) transmission is the main route of childhood HCV infection (2). Estimates for the rate of vertical transmission range from 3% to 10% (2 - 5). Risk for transmission is highest among women with a high viral load at delivery (2 - 6) and those co-infected with HIV (5,7). Although antiviral therapies are contraindicated in pregnancy because of teratogenic risks, prenatal HCV screening to identify HCV-infected women unaware of their status might lead to other interventions during labor and delivery or in the perinatal period that reduce risk for mother-to-infant transmission (8).

The purpose of this review was to synthesize the evidence on the effects of mode of delivery, labor management strategies, and breastfeeding practices on risk for mother-to-infant transmission. This review was performed as part of a larger report on HCV screening (9) and will be used by the U.S. Preventive Services Task Force (USPSTF) to inform its prenatal HCV screening recommendations.

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