June 22, 2013

AIDS 10 years later: Global HIV infections decreasing

Provided by Healio

June 20, 2013

Ten years after the implementation of the US President’s Plan for Emergency AIDS Relief, or PEPFAR, 1 million babies have been born HIV-free as of June, according to a press release from the US Department of State.

“Preventing mother-to-child transmission has been a central pillar of our fight against the disease, and just this month we reached the truly landmark moment on the HIV/AIDS timeline,” US Secretary of State John Kerry said at the PEPFAR 10th Anniversary Celebration.

In the past decade, global HIV infections have decreased nearly 20%, and in sub-Saharan Africa, the number of new infections and AIDS-related deaths decreased by nearly one-third.

“Last year alone, PEPFAR supported HIV testing and counseling for nearly 50 million people, and while just 300,000 people in low and middle income countries were receiving antiretroviral treatment 10 years ago, today PEPFAR is directly supporting more than 5 million people on treatment,” Kerry said.

Today, the United States supports three times more people on ART than it did in 2008.

In July 2012, the United States announced a $20 million fund to support country-led plans to expand high-impact comprehensive package of HIV prevention, treatment and care services for key populations, including men who have sex with men, injection drugs users and sex workers.

Kerry said the funding will be awarded to Cambodia, Ghana, Nepal, Senegal, Swaziland, Zimbabwe and two regional programs.

“This has been a decade of remarkable progress,” Kerry said. “But obviously, our work is not done. Millions still become infected every year and millions are still dying. But we can now say with confidence something we could perhaps only dream of before … and that is we can achieve an AIDS-free generation, and that is within our grasp now.”

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Meds to Treat Addiction Often Hard to Get

By David Pittman, Washington Correspondent, MedPage Today

Published: June 20, 2013

WASHINGTON -- Medicaid programs and health insurance companies are hindering access to FDA-approved drugs that treat opioid addiction, according to a report released Thursday by the American Society of Addiction Medicine (ASAM).

The 216-page report -- called the "most comprehensive" on addiction medications to date -- showed wide variation in state coverage of opioid addiction medications, with many Medicaid programs requiring other treatments to fail before covering addiction drugs.

Furthermore, private insurance companies use techniques like prior authorization to restrict access to drugs like buprenorphine (Probuphine), methadone, and naltrexone (Vivitrol), the Chevy Chase, Md. group said.

The restrictions come at a time when the CDC has declared prescription opioid abuse and addiction an epidemic, with nearly 4 million Americans addicted to prescription opioids.

"We have effective ways of treating these devastating illnesses," Tom McLellan, PhD, chief executive and founder of the Treatment Research Institute -- the organization that conducted the study -- said at a press conference here. "Let's start using them."

A little more than half of state Medicaid programs (28) cover all three drugs, the report found. "However, it is important to note that the extent of coverage varies greatly among the states, and access requirements attached to any or all of these medications differ from one state to another," the authors wrote.

For example, prior authorization is required by Medicaid in 42 states for buprenorphine. Coverage limits for lifetime benefits and daily doses are also common.

The study of private insurance carriers found similar barriers in their health plans, with spotty coverage of products such as buprenorphine/naloxone (Suboxone) and injectable naltrexone.

The report shows that "we could be saving lives and effectively treating the disease of addiction if state governments and insurance companies remove roadblocks to the use of these medications," ASAM president Stuart Gitlow said at the press conference.

Removing those roadblocks, however, may be difficult for states and health plans.

Congressional limits exist on the number of patients physicians can prescribe to at once. "I have 100, and I have a waiting list of 270," Gitlow said. "I'm not coming anywhere near meeting the need, and those patients have nowhere else to go because the only other docs prescribing are full."

Also, prescribers also need a special Drug Enforcement Administration waiver created by the Drug Addiction Treatment Act of 2000 to prescribe certain opioid addiction drugs.

The FDA subjects buprenorphine-containing products to a rigorous risk evaluation and mitigation strategy (REMS) with several elements to assure safe use, including patient monitoring and prescriber certification programs. The agency has deemed the risk-benefit profile of such products unfavorable enough to try to restrict their access.

The report also examined studies that evaluated buprenorphine, methadone, injectable naltrexone, and oral naltrexone and concluded a benefit in patient outcomes as well as costs.

"I can say with no hint of opinion here, it's simple fact, they are all effective," McLellan said. "They're effective not just in reducing opioid use, they're effective in so many other ways that are important to societies and families."

He called these medications "underutilized," saying about 30% of treatment programs use such drugs and about half of the patients in those programs receive such medication.

Gitlow and McLellan called on growing a coalition of interested parties, including the various addiction medicine groups, to raise awareness on the issue and educate the public and policymakers about their needs.

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Better Testing Catches Early HIV Infection

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By Michael Smith, North American Correspondent, MedPage Today

Published: June 21, 2013

Action Points

  • New approaches to HIV testing can detect acute infections that would have gone undetected with older methods.
  • Note that new 4th-generation tests detect both immunoglobulin M-class and G-class antibodies as well as the p24 antigen whereas early immunoassays detected only immunoglobulin G-class antibodies to HIV.

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

New approaches to HIV testing can detect acute infections that would have gone undetected with older methods, according to a CDC report.

A 4th-generation immunoassay, coupled with an HIV-1/HIV-2 antibody differentiation test, picked up acute infections where traditional methods did not, according to two studies reported by CDC in the June 20 issue of Morbidity and Mortality Weekly Report.

The acute phase of infection -- which plays a "disproportionate" role in transmission -- is the period between the appearance of HIV RNA in plasma and the detection of HIV antibodies, the agency noted.

Testing for HIV has usually begun with an immunoassay, followed by a Western blot or indirect immunofluorescence assay if the initial test is positive.

Early immunoassays detected only immunoglobulin G-class antibodies to HIV. That was improved so that 4th-generation tests detect both immunoglobulin M-class and G-class antibodies as well as the p24 antigen, an important HIV protein.

Because the p24 antigen can be detected before antibodies appear, the 4th-generation tests can pick up some acute HIV infections, the agency report noted.

But a negative supplemental test with a Western blot or indirect immunofluorescence assay has often resulted in erroneously classifying people as HIV-negative, the report added.

Two evaluations of the new test algorithm suggest it is likely to do better:

  • HIV screening at a Phoenix emergency department identified 37 undiagnosed HIV infections from July 2011 through February 2013, including 12 (or 32.4%) in the acute phase that would not have been found using earlier methods.
  • A three-site screening program found 99 cases with a positive first test and a negative supplemental test; 55 (or 55.6%) were shown to be acute HIV infections but a large proportion of those would not have been found by traditional methods.

The new algorithm begins with a 4th-generation immunoassay, followed by the HIV-1/HIV-2 antibody test. If that second assay is negative or indeterminate, the definitive step is testing for the presence of HIV RNA.

In the Phoenix emergency room, the agency reported, the first test found 37 cases of infection, including 25 in which the supplemental test was positive and 12 in which it was negative or indeterminate.

RNA testing confirmed acute HIV infection in those 12, the CDC report said.

The median HIV viral load among those 12 was 3,636,176 copies of HIV RNA per milliliter, compared with 27,125 copies per milliliter among the 25 with established infection, the report said.

In the Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) study, initial testing of 37,876 patients, screened from September 2011 through September 2012, found HIV in 654, or 1.7%.

Of those, 99 had a negative or indeterminate result on the HIV-1/HIV-2 antibody differentiation test, but HIV RNA was present in 55, indicating an acute infection. The traditional supplemental tests -- Western blot or indirect immunofluorescence assay -- were negative in 37 cases and indeterminate in seven, the agency reported.

Taken together, the agency report said, the findings show that acute HIV infection detected with newer immunoassays is often misclassified as HIV-negative by traditional supplemental tests, "potentially leading to adverse clinical outcomes for patients and further HIV transmission within the community."

The researchers cautioned that the findings might not apply to all screening programs. The Phoenix program aimed to screen as many people as possible, but some tests might have been ordered because of an increased index of suspicion.

And the STOP study looked at people at high risk for HIV, so that the proportion of infections that were acute might be higher than in other populations, the agency report noted.

The analysis was supported by the CDC. Peters is an employee of the agency.

Primary source: Morbidity and Mortality Weekly Report
Source reference:
Centers for Disease Control and Prevention "Detection of acute HIV infection in two evaluations of a new HIV diagnostic testing algorithm -- United States, 2011–2013" MMWR 2013; 62: 489-494.

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Breast cancer, hep C, MS drugs may come with higher copays in California

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June 21, 2013 12:30 pm by Wolfson, Bernard J.

The Affordable Care Act might not make care much more affordable for some Californians who need expensive prescription drugs to treat chronic illnesses or just to stay alive.

The health plans to be marketed in the California insurance exchange, established under President Barack Obama's health reform law, will follow the lead of Medicare and a growing number of commercial insurers by charging co-insurance payments ranging from 10 to 30 percent on a number of high-cost "specialty" drugs. These include medications for treating rheumatoid arthritis, multiple sclerosis, hepatitis C, breast cancer, leukemia and other conditions.

Advocates for the sick are unhappy that Covered California has decided to adopt this model, which imposes much higher costs on many patients than more traditional policies that offer the drugs for a flat co-payment.

"It's disappointing that the state is in a way institutionalizing what we believe is a practice that harms those who are in the greatest medical need," says Lisa Nelson, director of state government affairs for the Leukemia and Lymphoma Society.

Whether sick patients would be financially worse off in the exchange depends on their current insurance coverage -- and on which of the four basic exchange plans they choose, since each has different premiums, co-insurance levels and annual caps on patient out-of-pocket spending.

Covered California's spokesman, Dana Howard, said the exchange officials had to balance several important factors, and in the end they believed the decisions they made were "the most feasible way to provide health plans that are affordable both in terms of premiums and cost sharing." He noted that lower-income people, who would be most affected by the high drug costs, are also the ones who will benefit the most from subsidies intended to reduce their premiums and out-of-pocket costs.

Sonja Radovic, a 45-year-old working mother of two who was diagnosed with breast cancer five years ago, would not qualify for any of those subsidies. She said her expense for Feraston, a hormonal drug, could skyrocket by as much as 10 times should she ever need to buy coverage through the exchange -- from the current $860 a year to $8,600 under the plan with the lowest premium.

She is confident that her employer, a small business with 11 employees, will keep its current coverage, though that could conceivably change should the economy sour again. "What part of 'Affordable' are they not understanding?" Radovic asks. "And that's just on one drug. What about other even more expensive specialty drugs?"

Feraston is far from the most expensive medication. The average cost of treating a variety of cancers with one of five specialty drugs is $3,682 per month, or $44,184 a year, according to Express Scripts, the giant St. Louis-based pharmacy benefit-management company. For multiple sclerosis, the average cost is $3,584 per month, and for hepatitis C the monthly price tag is $3,284.

Kalydeco, the only effective therapy for cystic fibrosis, can carry a price tag of up to $180,000 per year, says Suzanne J. Tschida, a vice president at Optum RX, a Minnesota-based pharmacy benefit-management company whose main operations are in Irvine.

In 2012, specialty drugs accounted for 24.5 percent of all U.S. prescription drug spending, even though less than 2 percent of the population is affected by the related illnesses, according to Express Scripts.

Still, if you are one of the unlucky 2 percent and you're paying 20 or 30 percent of even the somewhat-less-stratospherically-priced drugs, it could quickly overwhelm your household budget. For plans in Covered California, the amount patients must pay out of their own pockets each year before their insurers will cover 100 percent of their medical expenses is as high as $6,350 for individual plans and $12,700 for family plans.

"I think it shows that these benefits designs essentially discriminate against people who have these serious illnesses," says Dan Mendelson, CEO of Avalere Health Inc., a Washington, D.C.-based medical data company.

An Avalere study showed that when monthly out-of-pocket payments hit $100, 10 percent of patients stopped filling their prescriptions. At $500 a month, 25 percent stopped. That can lead to sicker patients and an even greater financial burden on the health care system down the line, many observers argue.

Not everybody buying coverage in the exchange will be affected equally. In Covered California's second least-expensive plan, individuals with incomes between $15,856 and $22,980 will face much lower co-insurance payments, reduced or no deductibles and an out-of-pocket maximum of just $2,250. Howard acknowledges that it might still be "a strain" for those people to cope with their medical expenses, but "we think this $2,250 annual limit on their payments will help many avoid bankruptcy."

Mendelson notes that Covered California did not invent this type of health-plan design. It is merely following a trend that started with Medicare's Part D drug benefit and has been adopted in recent years by many commercial insurers. The proportion of private commercial plans that make enrollees pay a percentage of specialty drug costs rather than a flat dollar co-payment rose from 14 percent in 2008 to 34 percent last year, according to Avalere.

"In some ways, the implementation (of such plans) by the exchange makes the affordability of specialty drugs a more visible problem, but it's not introducing a new problem for the people who need these drugs," says Ha Tu, a senior researcher at the Center for Studying Health System Change, a Washington, D.C.-based think tank.

Joan W. Clements, a 70-year-old Costa Mesa resident who was diagnosed with chronic myeloid leukemia nearly 12 years ago, knows that as well as anybody. She has been kept alive for more than a decade by Gleevec, a revolutionary drug that has turned her disease from fatal to manageable. Over the past decade, Clements has seen the total cost of her Gleevec nearly double, from $6,000 to $11,000 a month.

With a 30 percent co-insurance payment under her Medicare drug plan, and a gap in coverage known as the "donut hole," Clements' out-of-pocket payments for the drug would be unaffordable on the modest Social Security income that she and her husband, Jerry, receive each month. Luckily for her, Novartis, which manufactures Gleevec, provides a subsidy to cover the amount that Medicare doesn't. Otherwise, says Clements, "I would be dead."

Nelson, of the Leukemia and Lymphoma Society, says California could have chosen differently. She notes that the insurance exchange in New York limits patient liability on specialty drugs to a flat dollar co-payment that tops out at $70 per prescription.

Tu argues that such a generous benefit will lead to a spike in premiums that will deter the young and the healthy from buying insurance and create an ever-sicker pool of insured people whose medical needs will only reinforce the escalating cost of insurance. In California, that is unlikely to happen, she says, though the high co-insurance payments are "a horrible thing for people who are sick."

Why some drugs cost so much

By 2019 or 2020, specialty medications are expected to account for half of all drug spending. Managing their fast-rising costs is key to keeping health insurance premiums affordable for all. Here are some of the factors driving the escalation in prices and spending on specialty drugs:

Sources: Express Scripts; Ha Tu, Center for Studying Health System Change; Avalere Health Inc.

Contact the writer: 714-796-2440 or bwolfson@ocregister.com ___

(c)2013 The Orange County Register (Santa Ana, Calif.)

Visit The Orange County Register (Santa Ana, Calif.) at www.ocregister.com

Distributed by MCT Information Services

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UAB Hospital Emergency Department to screen patients for hepatitis C

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Friday, June 21, 2013

By Bob Shepard

The Emergency Department at the University of Alabama at Birmingham (UAB) Hospital will begin testing baby boomers for the hepatitis C virus (HCV) in August 2013. All patients born between 1945 and 1965 who present at the ED for any cause will be offered a blood test for HCV as part of their routine examination.

The testing is part of a Centers for Disease Control and Prevention (CDC) initiative designed to identify patients with HVC and get them into appropriate treatment. The CDC estimates that one-time testing of all Baby Boomers could detect 800,000 additional people with hepatitis C and save more than 120,000 lives because 75 percent of these infections are curable with new treatments.

“We anticipate screening between 8,000 and 12,000 Baby Boomers for HCV in 2013 and expect to identify between 260 to 400 new cases of HCV infection at UAB,” said James Galbraith, M.D., associate professor of emergency medicine and head of the UAB HIV and HCV screening programs. “The overall target is the approximate 3.2 million people in the United States who the CDC estimates have chronic hepatitis C virus infection — many of whom are unaware they are infected because they don’t look or feel sick.”

Hepatitis C is a contagious liver disease that ranges from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It is spread primarily through contact with the blood of an infected person. Today, most people become infected with the virus by sharing needles or other equipment to inject drugs. Before 1992, when widespread screening of the blood supply began in the United States, hepatitis C also was commonly spread through blood transfusions and organ transplants.

The HCV screening program mirrors a similar ED-based program at UAB Hospital to screen for HIV, the virus responsible for AIDS. That program, which began in August 2011, screens for the presence of HIV in all willing adult patients ages 18-65 seeking treatment at the UAB Emergency Department. Of the more than 30,000 screened, Galbraith says the program has identified and referred to treatment more than 150 people who were HIV positive.

The CDC estimates that one-time testing of all Baby Boomers could detect 800,000 additional people with hepatitis C and save more than 120,000 lives because 75 percent of these infections are curable with new treatments.

Patients testing positive for HCV will be linked to appropriate antiviral treatment services through the UAB Liver Center, Liver Transplant Clinic and 1917 Liver Clinic. A linkage coordinator will also help positive HCV cases establish a primary care physician to maintain consistent health care throughout the progression of their disease. UAB Charity Care services will help patients with limited resources obtain appropriate medical care.

UAB ED nurse manager India Alford, RN, says the program will not disrupt patient care in the Emergency Department.

“Patients in the Baby Boom generation will be electronically identified at registration and the patient’s nursing provider will conduct a required HCV assessment,” Alford says. “During the brief three-item assessment, nursing providers will notify the individuals about the CDC’s recommendation and the screening will be available at no cost.”

Unless they refuse, an automated HCV antibody assay will be ordered for eligible patients unaware of their HCV status. Results of the HCV assay will be available within 30 minutes and delivered to patients prior to discharge.

“These day-to-day screening operations would not be possible without the dedicated support of the ED nursing and laboratory staff,” Galbraith says.

A contract from the CDC Foundation’s Viral Hepatitis Action Coalition is providing start-up funding for the UAB project.

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June 21, 2013

Nationwide Recall of Aspirin That May Contain Acetaminophen

News Alerts > Medscape Medical News

Mark Crane

Jun 20, 2013

A single lot of Rugby-label enteric-coated aspirin tablets, 81 mg, was voluntarily recalled after the manufacturer, Advance Pharmaceutical Inc of Holtsville, New York, received a single complaint that a bottle actually contained acetaminophen 500 mg tablets, the company announced.

Lot 13A026, with an expiration date of January 2015, contained 16,440 bottles and was distributed nationwide to wholesalers and retailers by Rugby Laboratories of Livonia, Michigan, Abu Z. Amanatullah, quality assurance and regulatory affairs manager for Advance Pharmaceutical Inc, told Medscape Medical News.

The over-the-counter product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablets with NDC 0536-3086-41 and UPC 3 0536-3086-41 9.

The recall was ordered June 17 to prevent consumers from inadvertently taking acetaminophen 500 mg, which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day, or those who have liver disease, the company said in a statement.

The label directions instruct patients to take 4 to 8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of acetaminophen, which is about 6 times the maximum recommended daily dose, the company said.

Consumers who have the affected lot should immediately discontinue its use and return it to the pharmacy or store where it was purchased. Consumers with questions about the recall may contact Advance Pharmaceutical Inc, Monday through Friday, 9 am to 5 pm EST, at 631-981-4600, or by email at mail@advancepharmaceutical.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product, the company said.

This recall is being conducted with the knowledge of the FDA.

Any adverse reactions experienced with the use of this product should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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June 20, 2013

FDA Requests Additional Safety Data for Idenix Hepatitis C Drug

By Nathalie Tadena

June 20, 2013, 5 p.m. ET

Idenix Pharmaceuticals Inc. (IDIX) said the U.S. Food and Drug Administration has requested additional preclinical safety data for one of the biopharmaceutical company's hepatitis C treatments, which will delay the start of clinical trials.

Shares, which had been halted ahead of the news, slumped 25% to $3.87 after hours when trading resumed. The stock has fallen 52% over the past 12 months, through the close.

The company said it must provide a satisfactory response to the FDA before clinical trials can begin in the U.S. for its IDX20963 lead uridine nucleotide prodrug candidate. Idenix said it recently submitted an investigational new drug application for IDX20963 to the FDA that included preclinical data demonstrating potent, pan-genotypic activity.

Hepatitis C is a blood-borne virus that afflicts an estimated four million Americans and 170 million people world-wide. The disease often is contracted during sex or by sharing needles. Current treatment of the drug requires long courses of painful injections and often doesn't work. Drug makers have been racing to find pills that are both more potent and easier to take.

In February, the company said it would discontinue its clinical development program for two of its investigational treatments for hepatitis C, after the FDA said the treatments would remain on clinical hold.

Write to Nathalie Tadena at nathalie.tadena@dowjones.com

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State Legislature passes bill requiring doctors to offer hepatitis C tests to baby boomers

By James T. Mulder | jmulder@syracuse.com The Post-Standard
on June 20, 2013 at 4:21 PM, updated June 20, 2013 at 4:29 PM

Syracuse, N.Y. -- Baby boomers in New York will be offered screening tests for hepatitis C when they visit a doctor or hospital under a bill passed by the state Legislature today.

The bill requires screening tests to be offered to people born between 1945 and 1965.

Many baby boomers may have hepatitis C and not know it. An estimated 3.2 million Americans -- including about 20,000 New Yorkers -- are infected with hepatitis C, most of them baby boomers.

Hepatitis C is a serious virus infection that over time can cause liver damage and even liver cancer. Early treatment can prevent this damage. Many people with hepatitis C do not get the care they need because they don't know they are infected. It can take many years before someone who is infected exhibits symptoms.

Hepatitis C is mostly spread through contact with an infected person's blood. Some people could have gotten infected before widespread screening of blood began in 1992. People who have injected drugs, even if only once in the past, could have been infected by sharing a needle or drug equipment with someone who had hepatitis C.

The bill passed the Senate today 63-0. It passed the Assembly by a vote of 138-1 June 10. AARP, which backed the bill, is calling on Gov. Andrew Cuomo to sign the measure into law.

The Medical Society of the State of New York, which represents doctors, opposed the bill because the U.S Preventive Services Task Force has recommended against routine screening of adults who do not have symptoms and are not considered to be at high risk of having hepatitis C.

The influential task force is at odds with the federal Centers for Disease Control and Prevention which has called for hepatitis C screening of baby boomers.

The bill was sponsored by Sen. Kemp Hannon, R-Long Island, and Assemblyman Kenneth Zebrowski, D-New York City.

Zebrowski's father died in 2006 at age 61 of liver failure and cirrhosis caused by hepatitis C. He contracted the disease from a 1973 blood transfusion, according to his son.

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NY Baby Boomers Could Avoid Serious Disease With New Hep C Test Requirement

June 20, 2013

Bill Passed by Legislature Requires Offer of Screening Test for Boomers Visiting Doctor or Hospital; Follows Recommendation by Centers for Disease Control

(ALBANY, N. Y.)Baby boomers across New York, many of whom may have hepatitis C without knowing it, will be offered a screening test when visiting health care providers under an AARP-backed bill passed by the state Legislature today.

The bill (S2750A/A1286), sponsored by Senate Health Committee Chairman Kemp Hannon (R-Nassau) and Assemblyman Kenneth Zebrowski (D-New City), requires people born between 1945 and 1965 to be offered a screening test for hepatitis C – a potentially fatal illness - when seeing their primary care doctor and receiving hospital inpatient and outpatient care.

The federal Centers for Disease Control and Prevention (CDC) called for such testing last August after finding people born between 1945 and 1965 are at risk for Hepatitis C infection. Those baby boomers accounted for 75 percent of the estimated 3.2 million Americans infected with hepatitis C, the CDC found.

An estimated 200,000 New Yorkers are living with Hepatitis C, and it’s an increasing cause of illness and death. But 45 percent to 85 percent of people living with the disease are unaware they have it, since it often shows no symptoms, according to a CDC report.

Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver and can lead to cirrhosis (scarring of the liver) or fatal liver cancer.

“This is truly a life and death matter, and AARP is so pleased that Senator Hannon and Assemblyman Zebrowski won such an important victory for baby boomers,” said Beth Finkel, AARP New York State Director. “Offering a screening test to the thousands of New Yorkers whose lives could be saved or improved is just plain common sense.”

The bill passed the Senate today 63-0. It passed the Assembly 138-1 on June 10.

There have been great advances over the past few years in treatments for hepatitis C and many carrying the disease can be cured.

By increasing testing opportunities, the bill will make more people living with hepatitis C aware of their infection status, get available treatment, and take steps to prevent transmission.

Empowering individuals to know their hepatitis C infection status is an important step toward meeting the public health challenges presented by a disease which is contagious and communicable. Given that many people infected with this disease show no symptoms, testing is a crucial factor in disease prevention.

New York City Mayor Michael Bloomberg’s health commissioner, Dr. Thomas Farley, urged colleagues this spring to test all baby boomers for hepatitis C.

AARP New York, which advocates on behalf of New Yorkers 50 and older, is calling on Governor Andrew Cuomo to sign the bill into law.

Follow us on Twitter: @AARPNY and Facebook: AARP New York

AARP is a nonprofit, nonpartisan organization, with a membership of more than 37 million, that helps people turn their goals and dreams into real possibilities, strengthens communities and fights for the issues that matter most to families such as healthcare, employment and income security, retirement planning, affordable utilities and protection from financial abuse. We advocate for individuals in the marketplace by selecting products and services of high quality and value to carry the AARP name as well as help our members obtain discounts on a wide range of products, travel, and services. A trusted source for lifestyle tips, news and educational information, AARP produces AARP The Magazine, the world’s largest circulation magazine; AARP Bulletin; www.aarp.org; AARP TV & Radio; AARP Books; and AARP en Español, a Spanish-language website addressing the interests and needs of Hispanics. AARP does not endorse candidates for public office or make contributions to political campaigns or candidates. AARP Foundation is an affiliated charity of AARP that is working to win back opportunity for struggling Americans 50+ by being a force for change on the most serious issues they face today: housing, hunger, income and isolation. AARP has staffed offices in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Learn more at www.aarp.org.

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          The State Of The Hepatitis C Pill Race: Gilead Vs. AbbVie

          Jun 20 2013, 15:59

          Peter Geschek

          Gilead Sciencies (GILD) is believed to be leading the hepatitis C pill race, but AbbVie (ABBV) is not far behind. According to Scott Brun, AbbVie's head of pharmaceutical development, AbbVie may even win the race.

          In June, at the Goldman Sachs Annual Global Healthcare Conference, he said:

          "I'll say that it is a very tight race and like I said we're executing extremely well and I think we've got a very good shot at being first, but it's close."

          Gilead

          In a Phase II trial, Gilead's all-oral hepatitis C treatments sofosbuvir and ledipasvir, an NS5A inhibitor, cured 95 percent of patients after eight weeks of the therapy.

          Sofosbuvir, which Gilead acquired in 2012 in the famous $11 billion acquisition of Pharmasset, has proved itself in four completed Phase III studies.

          In May, following the encouraging interim results from a Phase II trial of sofosbuvir and ledipasvir, Gilead Sciences announced plans for a Phase III trial of a fixed dose of the two drugs. Called ION-3, the study will test a once-daily fixed-dose combination therapy of the two drugs both with and without ribavirin for eight weeks, as well as without ribavirin for 12 weeks. Six hundred non-cirrhotic, new-to-treatment patients with genotype 1 of the virus will participate in the trial.

          In June, Gilead received a priority review designation from the FDA, a step that can save about four months in the approval process.

          Confident in approval, Gilead is getting ready for the launch of sofosbuvir in the first quarter of 2014 in the U.S. and the second quarter in Europe by preparing sales teams and arranging training opportunities for physicians.

          AbbVie

          According to Brun, Gilead's advantage is overstated.

          AbbVie is running 6 Phase III trials in 30 countries around the world with over 2200 patients.

          It is running a dedicated study in cirrhotic patients, who are the hardest to treat of all. Cirrhosis means the liver is scarred, and it functions poorly. Cirrhosis is considered the final stage of chronic liver disease. AbbVie's treatment represents a possible cure, even for these hard-to-treat patients.

          AbbVie's HCV portfolio includes experimental medicines with three different mechanisms of action. The compounds in the studies are ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor).

          AbbVie's treatment will require three pills in the morning and one at night, according to Brun. In a Phase II trial with the drugs, 90 percent of patients who completed the eight-week regimen had the virus cleared from their body.

          Some analysts consider AbbVie's treatment cumbersome compared to Gilead's because it requires four pills a day. But according to Brun, this is a very manageable regimen when you consider the situation of the HIV infected patients who receive Ritonavir (AbbVie's drug for HIV) boosted regimens for a lifetime on a much more complicated schedule. It is a matter of patient education.

          AbbVie also is working on next generation programs already: ABT-493 is a protease inhibitor and ABT-530 is an NS5A inhibitor, both with very favorable pharmacologic characteristics, and neither will need Ritonavir boosting.

          AbbVie also testing a regimen in Japan for genotype 1b patients requiring two pills once a day for 12 weeks with no Ribavirin. It is using the co-formulation of the ABT-450 and ABT-267 with Ritonavir. This combination is also being prepared for western markets.

          Continue reading full article ….

          Older Liver Cancer Patients Respond to Radioembolisation Using Sir-Spheres Equally as Well as Younger Patients, New Study in Journal of Hepatology Says

          Provided by Canada Newswire

          June 20, 2013 11:37 AM

          Based on New Data from Multi-Centre ENRY Evaluation of 325 Patients, Authors Suggest that Radioembolisation May Be a Well-Tolerated and Effective Option for an Increasing Population of Older Patients

          BOLOGNA, Italy, June 20, 2013 /CNW/ - Results of a new analysis by members of the multi-centre European Network on Radioembolisation with Yttrium-90 Resin Microspheres (ENRY), published on-line in the Journal of Hepatology, the peer-reviewed official journal of the European Association for the Study of the Liver[1], may have important implications for older patients with inoperable primary liver cancer (hepatocellular carcinoma, or HCC).

          (Logo: http://photos.prnewswire.com/prnh/20130620/622581 )

          The analysis found essentially identical long-term treatment outcomes following radioembolisation using SIR-Spheres in 128 elderly (age 70 years or older) compared to 197 younger (less than 70 years of age) patients with otherwise similar demographics.  "Our findings suggest that age alone should not be a discriminating factor for the management of HCC patients.  This is important because there is a trend towards increased age in patients diagnosed with HCC, particularly in developed countries," said the article's lead author, Rita Golfieri, MD, Professor of Radiology in the Department of Digestive Diseases and Internal Medicine of The University of Bologna.

          Prof. Golfieri also stated that "While age should not be a barrier to the management of older patients with HCC, physicians should definitely take age and frailty into account when deciding which treatments to use.

          "For example, the relative mildness of procedure-related events after radioembolisation with SIR-Spheres compared with transarterial chemoembolisation, or TACE, suggests that an effective single radioembolisation procedure may be more acceptable to elderly patients than the multiple courses of treatment required with TACE.

          "In addition, while the tyrosine kinase inhibitor, sorafenib, represents a good treatment option for many elderly patients with HCC, the increased frequency of adverse events associated with its use in patients over 75 years old may require dose-modification," Prof. Golfieri said.

          The new study is the most recent report based on an extensive evaluation of 325 HCC patients treated by teams of liver specialists, oncologists, interventional radiologists and nuclear medicine physicians at eight centres in Germany, Italy and Spain, and coordinated by Bruno Sangro, MD, PhD, Director of the Liver Unit at Clinica Universidad de Navarra, Pamplona, Spain, and chair of the ENRY group.

          About Hepatocellular Carcinoma

          Hepatocellular carcinoma (HCC) occurs in people whose livers have become severely damaged or cirrhotic, due to conditions such as hepatitis and alcoholism.  It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and the third-leading cause of cancer deaths.[2]  It occurs with greatest frequency in regions where hepatitis is most often diagnosed, such as in Asia Pacific and Southern Europe.

          Hepatocellular cancer can be cured only by surgery, either by resecting the diseased parts of the liver, or by transplantation with a liver from a healthy donor.  These interventions, however, are inappropriate for the great majority of patients, whose survival may range from a few months to two or more years depending largely on the state of their liver at the time of their diagnosis and the extent of tumour invasion.

          Key Findings of the Age-based ENRY Evaluation

          The new analysis compared HCC treatment outcomes among 128 patients age 70 or older (mean age 74) with those for 197 younger patients (median age 58).  The authors also performed an additional sub-analysis of 49 very elderly patients ranging from 75-87 years (median age 78).

          The elderly and younger age groups had similar baseline characteristics, with many having multi-nodular, advanced-stage HCC which was present in both lobes of the liver and had reasonably-well compensated (Child-Pugh class A) underlying cirrhosis.  Elderly patients had a significantly lower tumour burden, smaller liver volume - both overall and the amount targeted by radioembolisation - and were less likely to have had hepatitis B viral infection.

          Overall survival of patients in the study was not statistically significant between elderly (median 14.5 months) and younger (12.8 months) patients.  There was also no significant difference in survival between very elderly patients (75 years or older) and those under that age (median 14.9 vs. 12.8 months).

          Radioembolisation with SIR-Spheres was equally well-tolerated in both age groups.  Common procedure-related events, such as fatigue, nausea and/or vomiting, abdominal pain, fever and raised bilirubin, were predominantly mild-to-moderate in severity and short in duration.  Almost none of these events were rated at grade 3 or above, the exceptions being one reported case of grade 3 fatigue and two grade 4 elevations in bilirubin.  Gastrointestinal (GI) ulceration (caused by the inadvertent deposition of microspheres in the GI tract) was similarly infrequent and of mild-to-moderate intensity in the two age groups.  Severe GI ulcers (grade 3 and above) were actually almost three times less common among older patients (0.8% vs. 2.7%).

          When the consolidated ENRY data were first published in 2011,[3] Professor Sangro noted that: "As ENRY was not a prospective study, our findings must be interpreted conservatively.  What we can say, based on our evaluation of a broad range of patients with HCC treated in routine clinical practice, is that radioembolisation using SIR-Spheres directly targets tumours and spares viable liver tissue, which enables us to reduce the burden of disease and potentially increase both the patient's survival and quality of life.  The greatest survival benefit can be expected in those patients with better performance status, fewer tumour nodules and no occlusion of the portal vein.

          "What we can now also say based on Prof. Golfieri's analyses, is that the benefits we observed apply as much to older patients as to younger ones, with some potential added value for radioembolisation based on its relatively mild side-effect profile compared to other treatments for this very serious disease.  These patients have few other treatment options," Prof. Sangro explained.

          Other treatment options that have been demonstrated to extend survival for patients with inoperable HCC include TACE, which requires repeated interventional procedures and hospitalisation due to the resulting post-embolisation syndrome; and sorafenib, an oral medication taken twice daily which can give side effects leading to discontinuation of the drug in more than a third of patients (38%).[4]

          "Radioembolisation may also be a synergistic option when combined with newer pharmaceutical treatments, such as sorafenib," Prof. Sangro said.

          Physicians and patients interested in participating in one of three on-going randomised controlled trials of radioembolisation using SIR-Spheres may learn more at:

          References:

          1. Golfieri R, Bilbao JI, Carpanese L, et al on behalf of European Network on Radioembolization with Yttrium-90 resin microspheres (ENRY).  Comparison of the survival and tolerability of radioembolization in elderly versus younger patients with unresectable hepatocellular carcinoma.  Journal of Hepatology 2013; ePub doi: http//dx.doi.org/10.1016/j.jhep.2013.05.025.
          2. GLOBOCAN.  Liver Cancer Incidence and Mortality Worldwide in 2008.  http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.
          3. Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90 resin microspheres (ENRY).  Survival after 90Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation.  Hepatology 2011;54:868-878.
          4. Llovet J, Ricci S, Mazzaferro V et al for the SHARP Investigators Study Group.  Sorafenib in advanced hepatocellular carcinoma.  New England Journal of Medicine 2008;359:378-390.

          708-EUA-0613

          Photo: http://photos.prnewswire.com/prnh/20130620/622581

          SOURCE: ENRY Trialists

          For further information:

          Contact: Gill Dunn, email: gill@auroracomms.com, office: +44-207-148-4175, mobile: +44-7713-112600 
          Further materials can be found at http://www.sirtpressroom.com

          Source

          Hepatitis C Virus Survival: Syringe Specifics

          Syringes

          June 20, 2013

          Proving the virus can survive in a syringe for up to 63 days, research demonstrates three different characteristics that make Hepatitis C transmission viable from a needle.

          By Nicole Cutler L.Ac.

          Hepatitis C is known to be transmitted via blood to blood contact; however, there is still some grey area regarding how long the virus can persist out of the body. Putting a time limit on Hepatitis C’s viability on inanimate surfaces helps quantify how long a contaminated object can transmit this infection. In an attempt to gain clarity on the survivability of Hepatitis C long after the contaminated blood is no longer fresh, a study delves into the virus’s longevity in its most likely vehicle.

          Before 1992, when widespread screening of the blood supply began in the United States, Hepatitis C was commonly spread through blood transfusions and organ transplants. Today, most new Hepatitis C infections are a result of the sharing of needles or other drug-injecting equipment. To learn more about Hepatitis C’s ability to survive in the environment most implicated in its spread, Yale researchers investigated whether or not the virus remains viable for long periods in contaminated syringes. What they found cements our regard for Hepatitis C as being a hardy virus – and it provides an explanation for a good percentage of Hepatitis C transmissions.

          Continue reading this entire article:

          Liver biopsy, mental health did not affect HCV treatment

          Provided by Healio

          Kluck J. Hepat Res Treat. 2013;doi:10.1155/2013/653976.

          June 20, 2013

          Having a pretreatment liver biopsy did not predict whether patients completed a full treatment course for hepatitis C, researchers reported. In subsequent analyses, the presence of a psychiatric disorder also did not affect treatment completion.

          Using a computerized patient record system, researchers examined the effect of having liver biopsy and the presence of psychiatric disorders on the the treatment response and completion rates among 375 HCV-infected veterans who were being treated at the VA Philadelphia Medical Center. Treatment, which began within 1 year of the biopsy, included combination pegylated interferon plus ribavirin for 24 weeks for HCV genotypes 2 and 3, or 48 weeks for HCV genotypes 1 and 4.

          Sustained virological response was achieved in 31% of patients, and 45% completed the full treatment course.

          The researchers hypothesized that having an invasive procedure such as a liver biopsy would make patients more aware of their disease and “psychologically” motivate them to complete the extensive HCV treatment. Additionally, HCV treatment has been associated with psychiatric adverse effects — including anxiety, depression and posttraumatic stress disorder — which also may lead to treatment discontinuation.

          However, of the patients who received a liver biopsy, 44% completed treatment vs. 46% of those with no biopsy.

          Although biopsy status had no effect on treatment completion, the researchers said having a biopsy may be associated with treatment uptake. For example, the biopsy rate among the cohort was 23% vs. the biopsy rate among those at the VA center who were untreated (3.8%).

          Psychiatric disorders, which were based on ICD-9 codes, progress notes and prescription records, were common in the cohort (59.7% having at least one disorder), but did not significantly alter the treatment course.

          The most common reasons for discontinuation among those with psychiatric disorders were medication-related adverse effects, virological failure and loss to follow-up.

          “Interestingly, our study showed that the rates of HCV therapy discontinuation due to psychiatric-related adverse drug effects were similar between patients with a mental health disorder at baseline and with no mental health disorder at baseline,” the researchers wrote.

          Disclosure: The researchers report no relevant financial disclosures.

          Source

          FDA Approves First Genotyping Test for Patients with Hepatitis C Virus

          FDA NEWS RELEASE

          For Immediate Release: June 20, 2013
          Media Inquiries: Susan Laine 301-796-5349, susan.laine@fda.hhs.gov
          Consumer Inquiries: 888-INFO-FDA

          FDA approves first genotyping test for patients with hepatitis C virus

          The U.S. Food and Drug Administration today approved a test that identifies the genotypeof hepatitis C virus (HCV) that apatientis carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment.   Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.

          “Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.”

          According to the Centers for Disease Control and Prevention, HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants. About 3.2 million people in the United States have a chronic HCV infection and approximately 15,000 people die from the effects of the virus each year. Seventy-five to 85 percent of people infected with HCV are not able to fight off the virus on their own and develop a chronic HCV infection that requires treatment. Untreated chronic HCV infections may lead to liver cancer, severe liver damage and liver failure.

          HCV is transmitted through blood and other bodily fluids. Injection drug users who share needles are at the highest risk for HCV infection. Health care workers stuck by needles that have been used on HCV-infected patients and children born to HCV-infected mothers are also at risk.

          The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS.

          The FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test's accuracy in differentiating specific HCV viral genotypes compared to a validated genesequencing method.  The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.

          The Abbott RealTime HCV Genotype II test is manufactured by Abbott Molecular Inc.,
          in Des Plaines, Ill.

          For more information:

          The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring 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 the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

          # # #

          Page Last Updated: 06/20/2013
          Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

          Source

          SVR after triple therapy maintained long-term durability in HCV patients

          Provided by Healio

          Rutter K. Aliment Pharmacol Ther. 2013;38:118-123.

          June 20, 2013

          Nearly all patients with chronic hepatitis C who achieved sustained virologic response to therapy with pegylated interferon, ribavirin and direct-acting antivirals continued to have undetectable HCV RNA over long-term follow-up in a recent study.

          Researchers followed 103 white patients with chronic HCV who had participated in randomized, controlled trials or an extended access program in which they achieved sustained virologic response (SVR) at 24 weeks after completing combination therapy with peginterferon alfa-2a and ribavirin and a direct-acting antiviral (DAA). Evaluated DAAs included protease inhibitors (90.3% of cases), NS5B polymerase inhibitors (6.8%) and both in combination (2.9%). Patients were followed for a median of 21 months after achieving SVR (range 7 to 64 months).

          The cohort included 80 treatment-naive patients, 17 who had been nonresponsive and six who had relapsed during prior therapy. Nearly all patients were infected with HCV genotype 1, including 34 with genotype 1a and 67 with 1b, while two patients had genotype 4.

          Relapse occurred in two patients who had genotype 1b and had been treated with faldaprevir. Both patients achieved undetectable HCV RNA levels at 4 weeks, and cloning sequencing after relapse indicated identical sequences to those observed at baseline. Viral resistance was unseen in either case.

          One treatment-naive, noncirrhotic woman who relapsed had detectable HCV RNA 8 months after therapy cessation, which increased to pretreatment levels in subsequent months. Retreatment with 24 weeks of peginterferon, ribavirin and telaprevir resulted in undetectable RNA levels. The second relapser, a treatment-naive cirrhotic man, had detectable HCV RNA 12 months after therapy ended that returned to pretreatment levels shortly after detection.

          “To the best of our knowledge, this is the first study reporting long-term virological outcomes in patients with hepatitis C after successful antiviral triple therapy,” the researchers wrote. “Our study shows that HCV eradication by triple therapy remains durable and confirms an excellent long-term prognosis of HCV patients with SVR. To assess the long-term clinical benefit of triple therapy, studies with a longer follow-up and larger patient numbers are needed.”

          Disclosure: See the study for a full list of relevant disclosures.


          Perspective

          WilliamCareyMD

          William Carey

          Sustained virological response, historically, has been tantamount to a cure in patients who are treated for hepatitis C. The problem, of course, is that with every change in therapy, it's necessary to validate that the concept of SVR - no virus detectable in the blood 6 months after stopping treatment - actually applies. It applies for pegylated interferon and ribavirin, and now we're seeing evidence that it also applies when we're using direct-acting antiviral agents in addition.

          [This is] an important study to do. I think the strength of it is that it has at least a moderate number of patients, over 100, and they found, not surprisingly, that SVR 24 weeks after stopping treatment seems to be associated with permanent eradication of detectable virus. Again, this is not surprising, but still an important detail that needs to be hammered out, and the study goes a long way toward doing that.

          The limitations of the study are that they looked at many different direct-acting agents, and so the number of patients treated with any particular direct-acting agent is somewhat limited. This really comes into focus when we look at the two breakthrough patients: They were both treated with the same drug. So [the study] raises, but doesn't answer the question: "Is faldaprevir different than the other agents that were tested?" It's really impossible to say, because the numbers are too small, but it raises the question of whether this agent is going to be associated with a higher rate of breakthrough than the other agents tested here.

          Instead of 100 patients, I'd like to see 1,000, and certainly there are many many hundreds of patients who have been in randomized trials, and this data is or will soon become available. So I think that this is a good beginning, but we just need to see larger numbers, and we need to see numbers that are specific to each and every direct-acting antiviral drug.

          William Carey, MD

          Professor of medicine, Cleveland Clinic Liver College of Medicine
          Founding member, Cleveland Clinic Hepatology section

          Disclosures: Dr. Carey reported no relevant financial disclosures.

          Source

          Perceptions of drug users regarding Hepatitis C screening and care: a qualitative study

          Published on: 2013-06-20

          Illicit drug users have a high prevalence of HCV and represent the majority of newly infected persons in the U.S. Despite the availability of effective HCV treatment, few drug users have been evaluated or treated for HCV.

          Racial and ethnic minorities have a higher incidence and prevalence of HCV and higher HCV-related mortality. Factors contributing to poor engagement in care are incompletely understood.

          Methods: Fourteen mixed-gender focus groups of either African American or Latino/a drug users (N = 95) discussed barriers to HCV testing and treatment.

          Themes were identified through content analysis of focus group discussions.

          Results: Many drug users were tested for HCV in settings where they were receiving care. Outside of these settings, most were unaware of voluntary test sites.

          After testing HCV positive, drug users reported not receiving clear messages regarding the meaning of a positive HCV test, the impact of HCV infection, or appropriate next steps including HCV clinical evaluations. Many drug users perceived treatment as unimportant because they lacked symptoms, healthcare providers minimized the severity of the diagnosis, or providers did not recommend treatment.

          Mistrust of the motivations of healthcare providers was cited as a barrier to pursuing treatment. Social networks or social interactions were a source of HCV-related information and were influential in shaping drug users perceptions of treatment and its utility.

          Conclusion: Drug users perceived a paucity of settings for self-initiated HCV testing and poor provider-patient communication at test sites and during medical encounters.

          Notably, drug users reported having an unclear understanding about the meaning of a positive HCV test, the health implications of HCV infection, the importance of clinical evaluations and monitoring, and of treatment options for HCV. Efforts to improve the delivery of clinical messages about HCV infection for drug users at test settings and clinical encounters are needed.

          Author: Ashly E JordanCarmen L MassonPedro Mateu-GelabertCourtney McKnightNicole PepperKatie BoucheLaura GuzmanEvan KletterRandy M SeewaldDon C Des-JarlaisJames L SorensenDavid C Perlman

          Credits/Source: Harm Reduction Journal 2013, 10:10

          Source

          June 19, 2013

          Federal Agencies Address Hepatitis B Discrimination

          Provided by Infection Control Today

          11 hours ago

          Posted in News, Hepatitis, Centers For Disease Control And Prevention (CDC), Department Of Health And Human Services (HHS)

          The Department of Justice, the Department of Education, and the Department of Health and Human Services have sent a joint letter to the nation’s medical schools, dental schools, nursing schools, and other health-related schools regarding hepatitis B discrimination.

          In the letter, the departments express concern that some health-related schools may be making enrollment decisions based on an incorrect understanding of the hepatitis B virus, resulting in discrimination.

          The letter updates schools on the latest recommendations from the Centers for Disease Control and Prevention (CDC) regarding the participation of students with hepatitis B in health-related schools. The letter also emphasizes the importance of CDC’s recommendations, especially as they relate to the schools’ obligation to comply with federal laws prohibiting discrimination on the basis of disability, race, color, and national origin.

          Approximately 800,000 to 1.4 million people in the United States have hepatitis B.  Asians, Native Hawaiians, and Pacific Islanders make up roughly 4.5 percent of the U.S. population, but represent 50 percent of the persons with hepatitis B in the United States.

          The letter cites to a March 2013 settlement agreement that the Justice Department reached with a medical school and a school of osteopathic medicine resolving allegations that the schools violated the Americans with Disabilities Act by excluding previously-accepted applicants with hepatitis B from their programs.

          The updated CDC recommendations, based on the most current scientific information, dispel many myths associated with hepatitis B and provide guidance to health-related schools on managing students with the virus. The CDC also notes that since the last update of the recommendations in 1991, there have been no reports of hepatitis B transmission in the United States or other developed countries from medical or dental students to patients. Among other recommendations, the CDC recommends that chronic hepatitis B virus infection, in itself, should not preclude the study or practice of medicine, surgery, dentistry, or allied health professions.

          “The Justice Department strongly urges health-related schools to review the CDC’s recommendations and to ensure that their policies and practices comply with federal nondiscrimination laws,” says Jocelyn Samuels, principal deputy assistant attorney general for the Civil Rights Division of the Justice Department.  “Applicants and students with hepatitis B should not have to face exclusion on the basis of unfounded fears and stereotypes, and the Justice Department will not tolerate it.”

          “Both public health and civil rights will be promoted when medical schools rely on the most recent scientific information, not overbroad generalizations, in dealing with medical students with hepatitis B,” says Seth Galanter, acting assistant secretary for civil rights in the Department of Education.

          Leon Rodriguez, director of the Office for Civil Rights in the Department of Health and Human Services, agrees that health-related schools must ensure that they do not deny equal access to individuals based on discrimination, adding, “The CDC recommendations promote public health and safety while also offering guidance on the management of students with hepatitis B.  Our agencies place considerable weight on this guidance in our enforcement of Federal civil rights laws.”

          The Departments of Justice, Education, and Health and Human Services share responsibility for protecting the rights of students and applicants with disabilities, including those with hepatitis B, in schools of higher education by enforcing titles II and III of the Americans with Disabilities Act and Section 504 of the Rehabilitation Act.  These laws prohibit covered postsecondary institutions from discriminating on the basis of disability and from refusing to make reasonable modifications to their policies, practices, or procedures when necessary to avoid discrimination on the basis of disability, unless such modifications would fundamentally alter the nature of the program or the services provided. The Departments of Justice, Education, and Health and Human Services also enforce Title VI of the Civil Rights Act, which prohibits discrimination on the basis of race, color, or national origin in programs and activities receiving federal financial assistance, including those of health-related schools.

          The joint letter can be found on OCR’s website at: http://www.hhs.gov/ocr/office/hep-b-letter.pdf

          Source

          Dietary fructose causes liver damage in animal model, study finds

          Provided by Science Codex

          Posted By News On June 19, 2013 - 7:01pm

          WINSTON-SALEM, N.C. – June 19, 2013 – The role of dietary fructose in the development of obesity and fatty liver diseases remains controversial, with previous studies indicating that the problems resulted from fructose and a diet too high in calories.

          However, a new study conducted in an animal model at Wake Forest Baptist Medical Center showed that fructose rapidly caused liver damage even without weight gain. The researchers found that over the six-week study period liver damage more than doubled in the animals fed a high-fructose diet as compared to those in the control group.

          The study is published in the June 19 online edition of the American Journal of Clinical Nutrition.

          "Is a calorie a calorie? Are they all created equal? Based on this study, we would say not," said Kylie Kavanagh, D.V.M., assistant professor of pathology-comparative medicine at Wake Forest Baptist and lead author of the study.

          In a previous trial which is referenced in the current journal article, Kavanagh's team studied monkeys who were allowed to eat as much as they wanted of low-fat food with added fructose for seven years, as compared to a control group fed a low-fructose, low-fat diet for the same time period. Not surprisingly, the animals allowed to eat as much as they wanted of the high-fructose diet gained 50 percent more weight than the control group. They developed diabetes at three times the rate of the control group and also developed hepatic steatosis, or non-alcoholic fatty liver disease.

          The big question for the researchers was what caused the liver damage. Was it because the animals got fat from eating too much, or was it something else?

          To answer that question, this study was designed to prevent weight gain. Ten middle-aged, normal weight monkeys who had never eaten fructose were divided into two groups based on comparable body shapes and waist circumference. Over six weeks, one group was fed a calorie-controlled diet consisting of 24 percent fructose, while the control group was fed a calorie-controlled diet with only a negligible amount of fructose, approximately 0.5 percent.

          Both diets had the same amount of fat, carbohydrate and protein, but the sources were different, Kavanagh said. The high-fructose group's diet was made from flour, butter, pork fat, eggs and fructose (the main ingredient in corn syrup), similar to what many people eat, while the control group's diet was made from healthy complex carbohydrates and soy protein.

          Every week the research team weighed both groups and measured their waist circumference, then adjusted the amount of food provided to prevent weight gain. At the end of the study, the researchers measured biomarkers of liver damage through blood samples and examined what type of bacteria was in the intestine through fecal samples and intestinal biopsies.

          "What surprised us the most was how quickly the liver was affected and how extensive the damage was, especially without weight gain as a factor," Kavanagh said. "Six weeks in monkeys is roughly equivalent to three months in humans."

          In the high-fructose group, the researchers found that the type of intestinal bacteria hadn't changed, but that they were migrating to the liver more rapidly and causing damage there. It appears that something about the high fructose levels was causing the intestines to be less protective than normal, and consequently allowing the bacteria to leak out at a 30 percent higher rate, Kavanagh said.

          One of the limitations of the study was that it only tested for fructose and not dextrose. Fructose and dextrose are simple sugars found naturally in plants.

          "We studied fructose because it is the most commonly added sugar in the American diet, but based on our study findings, we can't say conclusively that fructose caused the liver damage," Kavanagh said. "What we can say is that high added sugars caused bacteria to exit the intestines, go into the blood stream and damage the liver.

          "The liver damage began even in the absence of weight gain. This could have clinical implications because most doctors and scientists have thought that it was the fat in and around tissues in the body that caused the health problems."

          The Wake Forest Baptist team plans to begin a new study using the same controls but testing for both fructose and dextrose over a longer time frame.

          Source: Wake Forest Baptist Medical Center

          Source

          Organ Donors Will Sign Up on Facebook

          39946

          By Kathleen Struck, Senior Editor, MedPage Today

          Published: June 18, 2013

          Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

          Action Points

          • Online registration rates in the U.S. increased dramatically after the Facebook organ donor initiative.
          • Note that the study raises the possibility that social media might be effectively utilized in other refractory public health problems in which communication and education are essential.

          Despite years of media and public service campaigns appealing for organ donations, donor rates remained static while demand increased -- until Facebook, researchers reported.

          On May 1, 2012, the social media website launched its organ donor initiative that allowed users to change their status to indicate "organ donor," triggering a link to their official state donor registry. On that day, there were 13,054 new online registrations, representing a 21.1-fold increase over the baseline average of 616 registrations daily, according to Andrew Cameron, MD, PhD, of the Johns Hopkins University School of Medicine, and colleagues.

          The first-day effect ranged from 6.9-fold in Michigan to 108.9-fold in Georgia, with registration rates remaining elevated over the subsequent 12 days, they wrote online in the American Journal of Transplantation.

          During the same time period, organ donor registrations through motor vehicle divisions (DMV) saw no increases, Cameron and colleagues noted.

          However, Cameron cautioned in a statement that "the bump we saw did diminish over weeks, implying that more work is needed to assure sustainability or 'virality' in this case."

          Nonetheless, "novel applications of social media may prove effective in increasing organ donation rates and likewise might be utilized in other refractory public health problems in which communication and education are essential," they wrote.

          Registrations totaled 39,818 over the 13-day study period, 32,958 more than would have been expected from the baseline registration rate, researchers stated.

          Before the advent of social media, organ donation awareness and registration was done through school-based campaigns, work site events, and at the DMV, the authors pointed out, leading to about 100 million people in the U.S. signing up as donors.

          "While this number represents a significant accomplishment, it still amounts to only around one-third of the country's population and has proved inadequate to meet the need of the growing number added to transplant waitlists," they explained.

          Facebook collaborated with members of the transplant team at Johns Hopkins, the Living Legacy Foundation of Baltimore, and Donate Life America, to allow specification of organ donor designation on their "Timeline" platform.

          Cameron and colleagues then studied the number of Facebook organ donor profile updates for the month of May 2012. Data were available for online registration for 43 of 50 states and the District of Columbia. Alaska, Delaware, North Dakota, New Jersey, Pennsylvania, South Dakota, and West Virginia were excluded.

          DMV data were available for Michigan, Montana, Texas and Washington for three days in early May 2012.

          States with higher online registration rates before the Facebook organ donor initiative had higher rates of online registration after the initiative was introduced, the researchers stated. However, they had a lower proportional increase (a lower Facebook effect) than states with lower rates of online registration before the Facebook organ donor initiative was begun, they wrote.

          The association between baseline registration and registration after the initiative was suggestive, but not statistically significant, with one additional registration per day per million people during baseline period associated with four additional registrations per million people on May 1 (95% CI minus 0.3-8.3, P=0.10).

          Conversely, one additional registration per day per million people during baseline period was associated with a decrease in Facebook effect of 5.8 (95% CI, minus 8.7 -minus 3.0, P<0.001).

          Study limitations included unknown durability of the Facebook effect, the authors wrote, and years will be required to register an increase in deceased organ donations from the social media effort. Also, the observational approach does not specify the extent donor registration was increased because of social versus conventional media.

          "The next challenge for efforts like the organ donor initiative will be utilization of social media applications like Facebook, Twitter, YouTube, or Instagram more effectively and more durably," they concluded.

          The authors had no conflicts to report.

          Primary source: American Journal of Transplantation
          Source reference:
          Cameron A, et al "Social media and organ donor registration: The Facebook effect" Am Journal Transplantation 2013; DOI: 10.1111/ajt.12312.

          Source

          HHS Releases New Guideline to Reduce Disease Transmission Through Organ Transplantation

          Provided by Infection Control Today

          4 hours ago

          Posted in News, Transplantation, Guidelines, Hepatitis, Human Immunodeficiency Virus (HIV)

          The U.S. Department of Health and Human Services (HHS) has released a new guideline to improve patient safety by reducing unexpected disease transmission through organ transplantation. This guideline updates the 1994 U.S. Public Health Service (PHS) guideline for preventing transmission of human immunodeficiency virus (HIV) through organ transplantation and adds guidance for reducing unexpected transmission of hepatitis B virus (HBV) and hepatitis C virus (HCV) through organ transplants.

          The 2013 PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus and Hepatitis C Virus Transmission through Organ Transplantation, published in Public Health Reports, recommends the use of more sensitive tests so that patients can be informed of risks to the greatest extent possible and protected from unintentional infections caused by transplanted organs.

          The major changes from the previous PHS guideline are:

          • Recommendation that donors be screened for both HBV and HCV, in addition to HIV. Although organ donors are routinely screened for HBV and HCV, there were no specific PHS recommendations for this screening included in the 1994 guideline.

          • Recommendation for new, more sensitive laboratory testing. Since the 1994 PHS guideline was published, more sensitive tests for HIV, HBV and HCV have become available. The 2013 guideline recommends the use of more sensitive tests for living and deceased organ donors.

          • Inclusion of a revised set of risk factors for HIV, HBV or HCV infection. Updated information about risk factors for these diseases can give clinicians a clearer picture about possible risks associated with donated organs to improve recipient informed consent, and in certain circumstances, to trigger more sensitive laboratory testing of the donor and recipients.

          • Focus on organs and vessel conduits recovered for transplantation, and not on tissues, eyes or cellular products. The Food and Drug Administration (FDA) has implemented more comprehensive regulations for tissue and semen donors since the 1994 PHS guideline was published.

          • Recommendation for a robust informed consent discussion between the transplant candidate (or medical decision maker) and the clinician. With the availability of more sensitive tests, doctors and patients can have a more thorough discussion about potential risks and benefits associated with accepting and rejecting individual organs.

          For more information about transplant safety, CLICK HERE. 

          Source

          SVR more dependent on adherence to treatment duration than dosing interval

          Provided by Healio

          Gordon SC. Aliment Pharmacol Ther. 2013;38:16-27.

          June 19, 2013

          Patients with chronic hepatitis C genotype 1 had higher sustained virologic response rates with better treatment duration adherence, while adherence to the assigned dosing interval had less impact in a recent study.

          Researchers evaluated treatment adherence among 1,500 adult patients with chronic HCV genotype 1 treated with pegylated interferon-alfa and ribavirin. Adherence to the assigned duration of therapy and the thrice-daily dosing interval for boceprevir (BOC) were determined via patients’ dosing diaries and the amount of study drug dispensed to and returned from participants. The data was collected from the SPRINT-2 (n=1,097, treatment-naive participants) and RESPOND-2 (n=403, participants who failed prior peginterferon/ribavirin therapy) trials.

          Sixty-three percent to 71% of patients were 80% adherent or better to treatment duration, and displayed sustained virologic response (SVR) rates between 86% and 90%. Among patients who were less than 80% adherent to duration, SVR rates were lower (8% to 32%; P<.0001). This difference was pronounced among those who had failed previous therapy (8% to 15%).

          Between 42% to 52% of patients were 80% adherent or better to the thrice-daily BOC treatment interval. No significant difference in SVR rates was seen among treatment-naive patients (P=.195) according to interval adherence, but SVR rates were lower among nonadherent patients who had failed prior therapy (48% to 50% among those less than 60% adherent vs. 60% to 77%; P=.005).

          Investigators said patients with 80% or better duration adherence had similar SVR rates to patients with high adherence to duration and interval (78% to 100% vs. 89% to 91%). Patients who were less adherent to duration had low SVR rates regardless of dosage adherence (0% to 50%).

          “The present study shows that the ability to respond successfully to treatment was more dependent on adherence to the actual assigned duration of therapy,” researcher S.C. Gordon, MD, Henry Ford Hospital in Detroit, Mich., told Healio.com. “This ‘duration of viral negativity’ while on therapy translates to higher SVR rates. The study validates previous research, both in HIV therapy and in previous pegylated interferon and ribavirin therapies for hepatitis C, showing that patient adherence is key to a successful treatment course.”

          Source