HIV Risk Behavior Declining, Family Survey Shows

By Michael Smith, North American Correspondent, MedPage Today
Published: January 26, 2012
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.

Americans appear to be taking fewer chances with HIV, according to the CDC.

Slightly more than 9% of the people surveyed from June 2006 to June 2010 reported behaviors thought to increase the risk of HIV, such as male-to-male sexual contact, illicit drug injection, and higher numbers of opposite-sex partners, according to Anjani Chandra, PhD, and colleagues at the CDC.

That's down from nearly 12% when the same survey was conducted in 2002, Chandra and colleagues said in a report issued by the agency's National Center for Health Statistics.

The year 2011 marked the 30th anniversary of the first diagnosed case of HIV, they noted.

The study found that the proportion reporting at least one of a series of HIV-risky behaviors was down for both men and women, the researchers reported -- a drop that appears to be related to a decline in sexually risky practices.

The findings come from the 2006-2010 National Survey of Family Growth, involving in-person interviews with a national sample of 22,682 men and women ages 15 through 44.

Data from the survey were compared to those obtained during the 2002 family growth survey.

The 2006 to 2010 survey was conducted by trained interviewers who read most questions to participants and entered the answers in a computer.

But, because of its sensitivity, most of the data for the current analysis was obtained through what is called audio computer-assisted self-interviewing, in which a participant listens to questions through headphones or reads them on the screen, or both, and responds directly and privately into the computer.

Participants were asked about sexual risk behavior, drug use, whether they had been treated for a sexually transmitted disease within the previous year, and if a condom was used during their most recent sexual encounter.

The researchers calculated summary statistics for sexual and drug risk behaviors and found that the proportion of participants who reported risky sexual behavior fell from 8.9% on 2002 to 5.6% from 2006 to 2010.

On the other hand, there was no difference in the proportion that reported risky drug behavior -- 1.5% in both surveys.

The proportion that reported any risky behavior fell from 11.9% in 2002 to 9.2% from 2006 to 2010.

Among statistically significant changes:

• Fewer men and women reported exchanging sex for drugs or money. In 2002, 2.6% of men and 2.0% of women reported such behavior, but that fell to 1.3% and 0.7%, respectively, in the later survey.
• Fewer reported having a sex partner who injected illicit drugs. In 2002, 2.3% of men and 2.9% of women reported such behavior, but that fell to 0.7% and 0.8%, respectively, from 2006 to 2010.
• More women reported recent treatment for an STD, while the rate for men was stable at 2.6%. In 2002, the proportion of women reporting treatment was 3.4%, which rose to 4.1% from 2006 to 2010. The change was significant at P<0.05 both when comparing women in the two surveys and versus men from 2002 to 2010.
• The proportion of men reporting crack cocaine use fell from 1.8% to 0.8%. The proportion of women reporting they used the drug also fell -- from 0.8% to 0.7% -- but the change was not significant.

The researchers cautioned that the study is a "useful snapshot" of the prevalence of risky behaviors, but does not account for factors that might increase or decrease individual risk.

As well, they noted, the study only included people living in a household, so the findings might not apply, for instance, to the homeless or those in institutions.

Finally, they cautioned, the study only included people ages 15 to 44 and the results do not apply to those older or younger, who also may be at risk.

The analysis was conducted by the CDC. Authors are employees of the agency.

Primary source: National Health Statistics Reports
Source reference:
Chandra A, et al "HIV risk-related behaviors in the United States household population aged 15–44 years: data from the National Survey of Family Growth, 2002 and 2006–2010" National Health Statistics Reports 2012; 46.

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FDA Supplement Guidance Not Strict Enough, MD Says

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: January 26, 2012

An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.

More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance.

But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece.

By law, ingredients that were used and sold in supplements prior to 1994 can be marketed without any proof that they are safe or effective. But under a law called the Dietary Supplement Health and Education Act (DSHEA), manufacturers of any ingredient introduced after 1994 must provide the FDA with evidence supporting "a reasonable expectation of safety."

Cohen said that part of the law "has thus far not been enforced."

Since DSHEA became law more than 15 years ago, the number of supplements on the market has gone from 4,000 to more than 55,000. Since 1994, the FDA has received proper notification for 170 new supplement ingredients, "undoubtedly a small fraction of the ingredients for which safety data should have been submitted," Cohen said.

The FDA has mounted a new effort to discourage the sale and use of nutritional supplements that contain ingredients that are regulated as drugs. Last year, the agency issued draft guidance meant to inform supplement manufacturers about what information they must submit to the FDA, including spelling out when an ingredient is considered old and when it's considered new. (A synthetically produced replica of a botanical product, for instance, would be considered new).

In addition, the FDA is proposing that the guidance call for in vitro, animal, and long-term tolerability testing for supplements that would be marketed at higher doses than those historically ingested.

"The FDA's guidance provides a thoughtful framework for evaluating the safety of new ingredients and if implemented it would lead to substantial improvement in safety," Cohen wrote, but he said he didn't think the FDA goes far enough.

He said under the guidance, companies can use historical data (instead of clinical trials) to prove that a supplement is safe, and Cohen said that the FDA can't assess the safety of new products scientifically without experimental data.

Cohen also said that under the guidance, manufacturers would not be required to submit both favorable and unfavorable data to the FDA, so they could cherry-pick only positive data to submit.

The dietary supplement industry largely opposes the draft regulation.

One opponent is the Natural Products Association, whose 1,900 members include small health food stores and large supplement manufacturers. The group submitted its official response to the FDA's proposal in November and said the agency is "overstepping" and that the rules would have a "chilling effect" on the dietary supplement industry.

"The draft guidance as currently written sets up inappropriate barriers to market entry, imposes food additive criteria, and requires multiple ... notifications beyond those required by law," the group wrote.

Cohen said it's true that the proposed requirements would impose similar standards on supplements and food additives.

"Industry advocates are correct insofar as DSHEA does not hold established (pre-1994) supplement ingredients to the same safety standards as food additives: a chemical preservative sprayed inside a can of tomato soup or the purple dye in Jell-O requires much more evidence of safety than ingredients used in supplements," Cohen wrote.

Cohen urged the FDA to not change its proposal because of protests from industry.

"If the FDA succumbs to industry pressure, the public health consequences will be significant, as hundreds of thousands of Americans continue to turn to new supplements to sustain their health and treat their ailments," he said.

The FDA is accepting comments on the draft guidance until Feb. 1.

Cohen reported no financial conflicts of interest, other than having his travel paid for to be a guest on an episode of the Dr. Oz Show that dealt with supplements.

Source

Also See: Dietary supplements' safety regulation: too much or not enough?

Dietary supplements' safety regulation: too much or not enough?

By Melissa Healy, Los Angeles Times/For the Booster Shots blog

January 26, 2012, 5:03 p.m.

A new proposal to toughen the Food and Drug Administration's power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts up in arms. But an editorial in the New England Journal of Medicine says the drug-safety agency's proposed new powers do not go nearly far enough.

To expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use "novel" products -- minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in "mega-doses" much higher than have been customarily used in supplements. An industry that produced and marketed 4,000 distinct products in 1994, when the regulatory framework for dietary supplements was written into law, now markets about 55,000 products to Americans who believe them to be safe to take.

Since 1994, those selling "novel" products have been required to provide federal regulators with evidence supporting a product's "reasonable expectation of safety." In a New England Journal of Medicine "Perspective" article published this week, Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, suggests that even that vague standard has gone unenforced by the FDA and likely ignored by manufacturers eager to bring their supplements to market.

But in an effort to keep up, the FDA last July laid out a new raft of rules for those marketing "novel" dietary supplements in the United States. The new rules aim to spell out how a "reasonable expectation of safety" should be established. In some cases, the agency would accept documentation of a supplement's "historical use" outside the United States. For "mega-doses" that exceed commonly used levels of a given supplement, the agency wants to see evidence of safety from animal studies and from test-tube studies. (While trials using human subjects in testing a supplement's long-term use are allowed, they're not required).

These new requirements, writes Dr. Cohen, aren't enough. The "historical use" of a product where no one is looking for possible ill effects is a standard too low to assure safety, he writes. He adds that supplement manufacturers are under no obligation to share unfavorable safety data on a product with the FDA, so long as they offer studies that show the product is safe. And for products with no history of common use -- or marketed at super-high doses, "not even single-dose tolerability studies in humans would be required" by the new rules.

"If the FDA succumbs to industry pressure, the public health consequences will be significant," writes Cohen.

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Kaiser Permanente Unveils HIV Challenge to Help the U.S. Create Health Equity

PRESS RELEASE

Jan. 26, 2012, 8:00 a.m. EST

Best practices toolkit for health care organizations

WASHINGTON, Jan. 26, 2012 /PRNewswire via COMTEX/ -- Kaiser Permanente announced today the Kaiser Permanente HIV Challenge to help health care providers nationwide improve health equity for people living with HIV by increasing access to HIV care and improving health outcomes.

The HIV Challenge was announced at the Center for Medicare & Medicaid Innovation Care Innovations Summit in Washington, D.C. ( www.hcidc.org ).

Kaiser Permanente, the nation's largest nonprofit health care provider, has treated more than 60,000 people since the HIV epidemic emerged 30 years ago, and has reduced disparities among its current HIV population of more than 20,000 people by working to meet or exceed the objectives of the U.S. National HIV / AIDS Strategy.

The crux of the HIV Challenge (kp.org/hivchallenge) is to challenge other private health care providers and public and community health clinics to increase the number of HIV-positive people getting effective treatment by sharing Kaiser Permanente's toolkit of clinical best practices, provider and patient education materials, mentoring, training and health IT expertise.

http://www.youtube.com/playlist?list=PLFF12EC6E1E6A1EE7

HIV is still an epidemic in the United States, with 56,000 people becoming infected each year and more than 1.1 million Americans living with HIV, but one in five people with HIV don't know they are infected.

"The organizations presenting challenges here today are pushing the best minds in the country to create a better health care system. They represent exciting solutions to help address some of the nation's most urgent health needs," said CMS Acting Administrator Marilyn Tavenner.

Health care disparities are gaps in the quality of care associated with inequities encountered by racial, ethnic, poor and marginalized groups. The HIV Challenge is part of Kaiser Permanente's larger work to identify, measure, research and eliminate disparities in health and health care in the United States. To learn more go to kp.org/healthdisparities.

"Too many people are unaware they have HIV because access to effective prevention and care is insufficient," said Michael Horberg, MD, director of HIV/AIDS for Kaiser Permanente, executive director of research for Mid-Atlantic Permanente Medical Group, and a member of the Presidential Advisory Council on HIV/AIDS. "People with HIV need to get into treatment because quality HIV treatment prevents others from getting infected. Patients on effective therapy and better case management are living longer and more productive lives. However, quality HIV treatment requires effort."

Kaiser Permanente has demonstrated excellence in HIV clinical care outcomes with:

HIV mortality rates that are half the national average

94 percent median treatment adherence among patients regularly in care and on antiretroviral therapy

No disparities among its black and Latino HIV-positive patients for both mortality and medication rates, compared to a 15 percent higher rate in the United States for mortality and for medication

89 percent of its HIV-positive patients are in HIV-specific care within 90 days, compared to 50 percent in the U.S. within one year

69 percent of all its HIV-positive patients have maximal viral control compared to 19 percent to 35 percent nationally

As part of its HIV Challenge effort, Kaiser Permanente is sharing these best practices and tools for private health care providers and community health clinics to replicate: quality improvement programs that measure gaps in care; testing, prevention and treatment guidelines; how to set up multi-disciplinary care team models that emphasize the "medical home" so HIV specialists, care managers, clinical pharmacists and providers work together; and education for both the provider and patient.

For more details on the HIV Challenge, to download the best-practices toolkit and to watch videos of success stories in setting up HIV clinics and reducing disparities, go to: kp.org/hivchallenge

"Our success in the treatment of patients with HIV/AIDS results from the excellence of our clinicians, our advanced IT systems, our integrated delivery system and our effective coordination across specialties," said Robert Pearl, MD, chief executive officer and executive medical director of The Permanente Medical Group and Mid-Atlantic Permanente Medical Group. "In the same way that we have reduced the chances of our patients dying from cardiovascular disease and cancer significantly below the national averages, we have achieved outstanding clinical outcomes for our patients with HIV/AIDS."

The National HIV/AIDS Strategy ( http://www.aids.gov/federal-resources/policies/national-hiv-aids-strategy/ ) calls for increased testing so that all Americans can know their HIV status, increased access to culturally sensitive prevention messages, community-targeted prevention and condom and clean needle access. NHAS also calls for improving access to quality HIV care because HIV medications not only improve individuals' health and extend their life expectancy, they also reduce their risk of transmitting HIV to others. A recent scientific study found that effectively treating HIV patients with antiretroviral medications reduces HIV transmission by 96 percent. The study, known as HPTN 052, found that treating people with antiretroviral drugs before they are symptomatic can reduce the amount of virus in the blood sufficiently to reduce the risk of sexual transmission of HIV to an uninfected partner.

The Kaiser Permanente HIV Challenge is part of Kaiser Permanente's ongoing research of HIV and HIV treatment. Published Kaiser Permanente research studies include:

A study that found there are no disparities by race or ethnicity in risk of AIDS and death among HIV-infected patients in a setting of similar access to care, despite lower anti-retroviral therapy adherence among Latinos and blacks compared to whites.

A study that found HIV-infected patients are at increased risk for cancer as a result of both their impaired immune system and lifestyle factors, such as smoking.

A study that found 17 measures, such as screening and prevention for infections and monitoring of antiretroviral therapy, should be adopted uniformly to improve the quality of HIV care and treatment nationwide.

A study that found that cholesterol medications can work well among certain HIV patients who are at risk for cardiovascular disease.

About the Care Innovations Summit:

Sponsored jointly by the Department of Health and Human Services, the Centers for Medicare & Medicaid Services, Health Affairs, and the West Wireless Health Institute, the Care Innovations Summit brings together more than 1,000 health care leaders, entrepreneurs, innovators, government officials, and finance experts to stimulate investment in a high-quality, sustainable health care system. Made possible by the Affordable Care Act and the Obama Administration's commitment to open government, the Summit represents a new opportunity for industry and government to work together to help spur innovation in the public and private sectors to improve health care quality as never before and lower costs through improvement.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: www.kp.org/newscenter .

For more information Danielle Cass, danielle.x.cass@kp.org, 510-267-5354 Farra Levin, farra.r.levin@kp.org , 510-267-7364

SOURCE Kaiser Permanente

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System to deliver organ transplant drug -- without harmful side effects

This is professor Ravi Kumar of the University of Strathclyde. Credit: University of Strathclyde

Public release date: 26-Jan-2012

Contact: Paul Gallagher
corporatecomms@strath.ac.uk
44-141-548-2370
University of Strathclyde

A new system for delivering a drug to organ transplant patients, which could avoid the risk of harmful side effects, is being developed by scientists at the University of Strathclyde in Glasgow.

The drug, cyclosporine (CsA), is widely used in transplant operations and helps prevent the patient's body rejecting the organ but it can cause adverse drug reactions, of which the most serious problems are kidney and liver damage, in the doses which are currently administered in the long term.

The gap between a safe, effective dose of the treatment and a toxic dose is extremely narrow but the Strathclyde scientists have found a way of capturing CsA in very small amounts. The new system, developed in laboratory tests, enables nanoparticles of the drug to be delivered orally so that the strength of the dose can be maintained, but at a level and in a form which spares kidneys from damage.

Professor Ravi Kumar, of the Strathclyde Institute of Pharmacy and Biomedical Sciences, led the research. He said: "CsA is very useful in transplants and treating conditions such as arthritis, lupus and some forms of diabetes, but we need to address the risks it can present to the kidney and liver, apart from various other toxicities such as convulsions and high blood pressure.

"The damage it can cause can be dealt with if it's caught at an early stage but can be irreversible if it continues unchecked. Furthermore, existing formulations of cyclosporine contain castor oil-based vehicle which is used owing to the drug's poor solubility in water but which can be toxic.

"By entrapping CsA in nanoparticles, we aimed to match the maximum concentration of the most potent formulation of the drug in market. In tests, we were able to strike a balance between strength, efficacy and safety and were able to make a marked increase in the drug's bioavailability- the level of the drug which becomes active in the system.

"We were also able to reduce the toxic effects on the kidneys by slow release of the nanoparticles, which brought the drug gradually to its maximum concentration.

"As well as its use in transplants, we hope to look into the effectiveness of this system with arthritis and address what is a hugely debilitating condition for many people."

The research paper has been published in the Journal of Biomedical Nanotechnology.

Further current research is aimed at proving the therapeutic efficacy and long-term safety of cyclosporine, with a special focus on the safety of carriers- polymers used in the formulation- to fulfil regulatory requirements. The safety studies element of the research has been funded by the Cunningham Trust Scotland and will conclude early in 2013.

The research forms part of Health Technologies at Strathclyde- one of the principal themes of the University's Technology and Innovation Centre (TIC), a world-leading research and technology centre transforming the way universities, business and industry collaborate.

Through Health Technologies at Strathclyde, academics work with industry and the health sector to find technologies for earlier, more accurate disease detection and better treatments, as well as life-long disease prevention.

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Live liver donation safer than previously thought

01/26/2012

Major surgery to donate a portion of liver does not interfere with long, healthy life

People who donate a portion of their livers for transplant to a relative or friend whose liver is failing can generally expect to live long, healthy lives and recover safely from the donation surgery, Johns Hopkins researchers have found.

“The donor process is safer than some have previously thought,” says transplant surgeon Dorry L. Segev, M.D., Ph.D., an associate professor of surgery and epidemiology at the Johns Hopkins University School of Medicine and leader of the study published in the February issue of the journal Gastroenterology. “Live liver donation is a serious operation with serious risks. However, in this largest study ever conducted in the United States, we have shown that it is safer than many previously believed, with a risk of death of 1.7 per thousand donors.”

The only treatment for end stage liver disease is transplant. Without a functioning liver, patients in liver failure die. Safe live liver donation is possible because the liver is an organ that regenerates itself relatively quickly, Segev notes, allowing the harvest of a small portion of the organ which, when transplanted, grows into a liver large enough to perform its crucial roles in blood detoxification, digestion and metabolism. The regenerative ability also means donors can survive well with a smaller segment of their own livers until they, too, regrow.

A decade ago, surgeons across the United States performed an estimated 500 live liver transplants a year. In 2002, however, there was a highly publicized death of a live liver donor. Since then, live liver donation may have been perceived as more dangerous than it actually is, Segev says, and now only 200 to 300 of these surgeries are performed annually, compared to 6,000 live kidney donations in the United States each year.

More than 16,000 people are currently on the waiting list for a liver transplant in the United States, while only around 6,000 livers are available from deceased donors. “For many, the risk of dying on the waiting list is higher than the chance of getting a deceased donor transplant," Segev says. "For the right patients, with the right needs and the right donors, live donor transplantation can be the best treatment option, and this study reassures us that the risk of a catastrophic complication remains low.”

To determine the safety of live liver donation, Segev and his colleagues combed data from all 4,111 donors in the United States between April, 1994, and March, 2011, and followed patients for an average of 7.6 years. There were seven donor deaths over the period in the 90 days following surgery, but the researchers say the long-term survival rate for donors was overall equal to the long-term survival of live kidney donors and a healthy control group culled from the National Health and Nutrition Survey.

Although the rate of live liver donor death was relatively low, Segev says it is still five times that of the risk of death for live kidney donors. A study by Segev published in the Journal of the American Medical Association in March, 2010, found that the rate of death in live kidney donation in the United States is 3.1 in 10,000. However, kidney donation is a simpler process, Segev notes. The operation itself is less complicated and kidney donors are left with one completely intact healthy kidney, which is typically able to compensate for the function of the one that is removed. By contrast, if a donor does not have enough healthy liver remaining after donation, he or she may not have enough liver function to get through the regeneration process, and might actually need a transplant to survive.

Segev says he was particularly interested in studying the outcomes for donors because most of those who offer to give up part of an organ come to the process very healthy. “The ideal risk of death from donating an organ is zero and we work as hard as we can to seek that ideal,” says Segev, director of clinical research in transplant surgery at Hopkins. “But in these serious, major operations, it is unlikely the risk will ever be zero.”
Other Hopkins researchers involved in the study include Abimereki D. Muzaale, M.D., M.P.H.; Nabil N. Dagher, M.D.; and Robert A. Montgomery, M.D., D.Phil.

For more information here.

http://www.hopkinsmedicine.org/transplant/

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“B A Hero” PSA Video Contest Announced by Hep B Free Philadelphia and Hepatitis B Foundation

Help Save Lives and Stop Hepatitis B Through a PSA Video Contest

Philadelphia, PA, January 26, 2012 --(PR.com)-- Hep B Free Philadelphia, a citywide and community-owned education campaign led by the Hepatitis B Foundation to save lives and stop hepatitis B, is calling on the Greater Philadelphia community to participate in its “B A Hero” Public Service Announcement (PSA) Video Contest 2012. Interested participants are asked to create 30-second PSAs to raise awareness about hepatitis B.

There are three opportunities to submit PSAs about the subject of hepatitis B awareness in relation to the “B A Hero” theme. Deadlines are Feb. 17, 2012; Mar. 16, 2012; and Apr. 13, 2012 – no later than 11:59 p.m. EST. There will be three separate judging periods in which video submissions will be added to the Hep B Free Philadelphia Facebook page and Facebook users will have the opportunity vote on their favorite video. Three finalists will be identified and each will receive a prize of $100. The grand prize winner, selected by Hep B Free Philadelphia and Hepatitis B Foundation representatives, will receive an additional $150 and their PSA will be shown at the 2012 Philadelphia Asian American Film Festival and Hep B Free Philadelphia’s annual media event.

“Hepatitis B is a serious infection that affects at least 2 million people in the U.S. It is often known as a silent killer because its symptoms tend to be hidden until it’s simply too late,” said Chari Cohen, Hepatitis B Foundation Associate Director of Public Health. “By offering this PSA video contest, we are hoping to engage people in the Philadelphia region, create awareness about hepatitis B and help saves lives by having people get tested for this preventable and treatable disease.”

To be eligible to participate in the contest, individuals must be 18 years of age or have consent of legal guardianship and must physically live in the Greater Philadelphia region. Companies that are incorporated in the Greater Philadelphia region are also eligible. Within this contest, the Greater Philadelphia region is defined as the Pennsylvania counties of Berks, Bucks, Chester, Delaware, Lancaster, Lehigh, Montgomery and Philadelphia.

Video submissions can be in any style or genre of film or video including, but not limited to, animation, drama, still art, imagery, comedy or documentary. Videos should be formatted as MPEG-4, 320x240 files. When submitting via traditional mail or hand-delivery, the files must be saved on DVD-R discs and delivered to the Hepatitis B Foundation at 3805 Old Easton Road, Doylestown, Pa. 18902. Videos can also be submitted through the Hep B Free Philadelphia Facebook page or via large file transfer Web services to PSAContest@hepb.org. All entries must be received on or before the deadlines for contest eligibility. To learn more, go to www.hepbfreephiladelphia.org/2012/hepbpsacontest or contact Hep B Free Philadelphia Program Manager Daniel Chen at Daniel.chen@hepb.org.

About Hep B Free Philadelphia: Hep B Free Philadelphia is a public awareness and education campaign that has been launched to address the growing severity of hepatitis B and liver cancer in the U.S. The primary goals of the Philadelphia campaign include raising the public profile of hepatitis B and liver cancer as an urgent health priority; increasing hepatitis B testing and vaccination rates, particularly among at-risk populations; and involving and mobilizing stakeholders and policy decision-makers to improve access to care for both the prevention and treatment of hepatitis B and liver cancer. To learn more, go to www.hepbfreephiladelphia.org.

About the Hepatitis B Foundation: The Hepatitis B Foundation is the only national nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to www.hepb.org or call (215) 489-4900.
###

Contact Information

Hepatits B Foundation
Leah Ludwig
215-340-0480
Contact

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The answers are in your blood

Yes, you need to face the needle: Regular tests are best

By Amy Leap Pocono Record Writer

January 26, 2012

The body is an intricate machine, and normally all the organs and functions work together to keep you healthy. But doctors need to check now and then to ensure everything is working as it should — and an external exam won't suffice.

"Blood tests are one of the best ways for a physician to gain information about your health," said Anna Friemann of Hamilton Township. She is a nurse in the Level II Neuro Trauma Center at Community Medical Center, Scranton.

The Centers for Disease Control and Prevention advises having routine blood tests done somewhere around 35 and 40 years old. This gives the doctor a starting point to monitor any changes as you get older.

"At around the age of 50, there are specific blood tests the doctor should order on a yearly basis, and if you haven't had the tests, you should ask the physician about having them," she said.

When the doctor orders the lab to run a complete series of tests, you can find out about the status of the liver, the thyroid, the blood cholesterol as well as the blood sugar, Friemann said.

Women and men 50 and older

The following blood chemistry tests require a single sample of blood serum, which may require several vials of blood that can be used to run a series of tests quickly and inexpensively.

The following are the most commonly requested tests:

r Complete Blood Count is the most common test and is usually ordered as part of a complete physical examination. CBC measures the number, size and shape of the types of cells in the blood.

r Glucose test can indicate diabetes if the level is high, or hypoglycemia if it is low. A fasting glucose of less than 100 is normal, a level of 100 to 125 is abnormal and called "impaired glucose tolerance" and a level of 126 or greater means diabetes.

r Blood Urea Nitrogen and creatinine tests see if the kidneys are working normally and measures the amount of nitrogen in blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out of the body in the urine. If the kidneys are not able to remove urea from the blood normally, the BUN level rises.

The level of creatinine in the blood also tells how well the kidneys are working. A high creatinine level may mean the kidneys are not working properly. BUN and creatinine tests can be used together to find the BUN-to-creatinine ratio that tells if the kidneys are working properly.

r Sodium, potassium and chloride tests are especially important when taking diuretics, known as water pills. The tests measure the blood salts or electrolytes.

r Uric Acid test measures the level of acid, a waste product of all cells. An elevated level could mean kidney disease or gout.

r Albumin test measures the blood protein the liver produces. A low albumin count can be a sign of liver or kidney disease.

r Globulin test measures the level of blood protein produced by the immune system. A high level can point to chronic inflammation, infection or blood disorders, such as multiple myeloma.

r Calcium test has nothing to do with how much calcium is in the bones. It is a component of the blood that helps all the cells in the body function normally. A high count can point to a disorder called hyperparathyroidism, which predisposes people to kidney stones and low bone density.

r Serum Glutamine Pyruvic Transaminase test measures an enzyme normally present in liver and heart cells. SGPT is released into the blood when the liver or heart is damaged. Elevated levels of SGPT can happen as a result of a heart attack or from viral hepatitis.

r Lactate Dehydrogenase test measures an enzyme produced by many cells of the body. If LDH is extremely high, it can indicate a malignancy, and the doctor will do additional tests to rule this out.

r Bilirubin test measures a chemical in bile that gives it the yellow color. If the bile passages from the liver to the intestine are blocked, the bilirubin level will be high. Possible causes include gallstones and liver disease.

r Gamma Glutamyl Transpeptidase test measures the amount of enzyme produced by the liver. Obesity and excessive alcohol use are the most common reasons it can be mildly increased. It will also be elevated when there is blockage of bile and with liver disease.

r Blood fats or blood lipids test identifies lipids, often listed together in a separate "panel" on the blood chemistry report as Low Density Lipoprotein and High Density Lipoprotein. The total cholesterol is the sum of the LDL and HDL. High total cholesterol levels are linked to heart disease. The lower the total cholesterol the better. A total below 200 is desirable.

HDL is the good cholesterol. The more of it, the better. Ideally, the HDL cholesterol should be at least 30 percent of the total amount. In men, an HDL greater than 40 is normal; in women, an HDL greater than 50 is normal.

LDL is the bad cholesterol. A high LDL puts the patient at risk for heart disease, and the doctor will suggest diet and often medication to get the LDL cholesterol below 130. If diabetes or heart disease is present, the treatment goal for LDL cholesterol should be below 100.

Triglycerides are the other form of fat in the blood. The level will be much higher after a meal. If the level is out of range, it should be repeated after an overnight fast. Elevated levels increase the risk of heart disease and could be a sign of early diabetes. Ideally, they should be under 150.

r Thyroid function test can diagnose an underactive thyroid, a common condition in women over age 50. It also measures the level of two hormones produced by the thyroid glands: thyroxine 3 (T3) and thyroxine 4 (T4). Both regulate the metabolism.

The brain keeps levels normal by sending thyroid stimulating hormone (TSH) to the thyroid gland if the T3 and T4 are low. The TSH level is the best indicator of the condition of the thyroid and the effects of thyroid medication.

For example, if the thyroid hormone levels (T3 and T4) are low, the TSH level will be high. If the thyroid hormone levels are too high, then the TSH level will be low or immeasurable.

Just for women

r C-reactive protein test measures blood inflammation and marker of future heart disease risk. The test is recommended for women with a waist circumference over 35 inches because of increased risk for metabolic syndrome and heart disease.

Just for men

r Prostate-Specific Antigen test measures the prostate-specific protein produced by cells of the prostate gland. A high PSA can mean prostate cancer or prostate inflammation.

Source

Integrated Internist – Addiction Medicine – Hepatology Model for Hepatitis C Management for Individuals on Methadone Maintenance

From Journal of Viral Hepatitis

D. Martinez; R. Dimova; K. M. Marks; A. B. Beeder; M. Zeremski; M. J. Kreek; A. H. Talal

Posted: 01/24/2012; J Viral Hepat. 2012;19(1):47-54. © 2012 Blackwell Publishing

Abstract and Introduction

Abstract

Despite a high prevalence of hepatitis C virus (HCV) among drug users, HCV evaluation and treatment acceptance are extremely low among these patients when referred from drug treatment facilities for HCV management. We sought to increase HCV treatment effectiveness among patients from a methadone maintenance treatment program (MMTP) by maintaining continuity of care. We developed, instituted and retrospectively assessed the effectiveness of an integrated, co-localized care model in which an internist-addiction medicine specialist from MMTP was embedded in the hepatitis clinic. Methadone maintenance treatment program patients were referred, evaluated by the internist and hepatologist in hepatitis clinic and provided HCV treatment with integration between both sites. Of 401 evaluated patients, anti-HCV antibody was detected in 257, 86% of whom were older than 40 years. Hepatitis C virus RNA levels were measured in 222 patients, 65 of whom were aviremic. Of 157 patients with detectable HCV RNA, 125 were eligible for referral to the hepatitis clinic, 76 (61%) of whom accepted and adhered with the referral. Men engaged in MMTP <36 months were significantly less likely to be seen in hepatitis clinic than men in MMTP more than 36 months (odds ratio = 7.7; 95% confidence interval 2.6–22.9) or women. We evaluated liver histology in 63 patients, and 83% had moderate to advanced liver disease. Twenty-four patients initiated treatment with 19 completing and 13 (54%) achieving sustained response. In conclusion, integrated care between the MMTP and the hepatitis clinic improves adherence with HCV evaluation and treatment compared to standard referral practices.

Introduction

Five million individuals in the United States are infected with hepatitis C virus (HCV), a virus that can result in cirrhosis, end-stage liver disease and hepatocellular carcinoma. Conventional therapy, consisting of pegylated interferon (PEG-IFN) and ribavirin (RBV), results in viral eradication in roughly one-half of infected individuals.^[1,2] Currently, injection drug use is the strongest risk factor for HCV acquisition with HCV seroprevalence >70% among injection drug users (DUs) older than 40 years. However, DUs have been systematically excluded from treatment for HCV owing to stigmatization, physicians' concerns regarding adherence and patients' misinformation concerning the importance of a diagnosis of HCV.^[3,4] Between 2010 and 2030, the prevalence of cirrhosis is estimated to increase from 25% to 45% among chronic hepatitis C patients.^[5] Simultaneously, the number of treated patients is projected to decline,^[6] unless new strategies are developed to enable DUs to obtain antiviral treatment.

Despite the potential benefits of treatment, surprisingly few HCV-infected DUs are offered anti-HCV therapy, even though expert panels have endorsed HCV treatment in this population.^[7,8] Active engagement in therapy for addiction has been shown to increase treatment access for various infectious diseases, such as HIV and tuberculosis, among illicit substance users.^[9,10] It has also been demonstrated that the longer a patient is engaged in substance abuse treatment the greater the stability and retention in treatment for medical conditions.^[11]

Traditional HCV management via referral of DUs to outpatient specialty clinics has resulted in the appearance in the clinic of less than one-third of referred patients.^[12] Among DUs, therapeutic effectiveness is an issue of treatment access, acceptance and adherence rather than drug efficacy.^[13] Consequently, an approach that integrates the expertise of a variety of disciplines, including specialists in addiction medicine, hepatology, infectious diseases, primary care and psychiatry, has been advocated for the treatment of HCV among DUs.^[14] Adherence is likely to be further enhanced if a program offers familiarity, continuity among providers and ready access to health care professionals, as a strong relationship with medical personnel has been shown to be an important determinant of patients receiving preventative care as well as HCV and HIV treatment services.^[15–17]

To address these concerns, we devised the 'internist-addiction medicine-hepatology colocalization model', an integrated, co-located program in which an internist-addiction medicine specialist (ADM) evaluated methadone-maintained patients for HCV infection in the hepatology clinic under the direction of a hepatologist (AHT). We applied our model to patients from our institution's two methadone maintenance clinics located in close proximity to our viral hepatitis clinic. A primary premise of our model was that methadone-maintained patients would be more likely to accept an HCV evaluation if continuity of care was maintained between the methadone maintenance treatment program (MMTP) and the viral hepatitis clinic by the same physician caring for patients in both venues.

Methods

Treatment Setting and Patient Selection

A total of 401 patients in our institution's two MMTP clinics between July 2006 and June 2008 with available HCV serology were eligible for inclusion. Inclusion criteria were broad, and we purposefully did not exclude active drug or alcohol use except in the case of severe incapacitation as determined by either MMTP staff psychiatrists or the internist-addiction medicine specialist as we desired to pursue HCV management in as many MMTP patients as possible. Patients were excluded if HCV serostatus was unavailable or if their active enrolment in the MMTP during the period under study could not be verified. Patients who had poorly compensated psychiatric disease as determined by MMTP staff psychiatrists were also excluded. No patients were excluded for other medical co-morbidities, such as neurological, endocrine or autoimmune conditions.

The two MMTPs are located within a one-block radius of the viral hepatitis clinic and are staffed by internists, psychiatrists, nurses and social workers. The internist-addiction medicine specialist from the MMTP, who provided comprehensive medical services including chronic disease management, was the primary care physician for the majority of patients. All MMTP patients met DSM IV^[18] criteria for a diagnosis of opiate dependence and most had an additional diagnosis of dependence on alcohol, benzodiazepines or cocaine. Data were collected retrospectively through chart review. The study was conducted in accordance with a protocol approved by the Institutional Review Board and consistent with the Helsinki Declaration of 1975, as revised in 1983.

Hepatitis C virus antibody testing was performed on all individuals on admission to the MMTP and then annually in seronegative persons. Upon receipt of a positive HCV antibody test result, the patient was informed of their seropositive status, if not previously aware, provided HCV education and offered referral to the hepatitis clinic (Fig. 1). If the patient accepted referral, MMTP staff scheduled the appointment and recorded the date and time in the computerized methadone-dispensing system. During the week preceding the appointment, patients were reminded twice of their upcoming appointment. All patients who missed their initial appointments were questioned as to the reason for failure to appear. For reasons such as forgetfulness or competing priorities at the time of the initial visit, MMTP staff scheduled a second or third appointment as indicated. If a patient missed more than three appointments, they were considered noncompliant. Hepatitis C virus RNA testing was performed in the hepatitis clinic during the first 6 months of our program, and subsequently testing was performed in the MMTP to expedite the referral process. HIV antibody testing was encouraged at admission to the MMTP and repeated every six to twelve months depending upon whether or not the patient continued to engage in high-risk activities.

Figure 1. Internist-addiction medicine-hepatology colocalization model for hepatitis C evaluation and treatment among patients in the methadone maintenance treatment program. The number of patients at each step of the HCV management process is indicated. HCV, hepatitis C virus; MMTP, methadone maintenance treatment program.

In the hepatitis clinic, the patient was seen by the internist-addiction medicine specialist under the supervision of a hepatologist. All patients underwent a standard medical examination and comprehensive assessment of HCV status that included HCV RNA measurement, HCV genotyping and liver biopsy, if desired and indicated. Consistent with the 2002 NIH Consensus Conference^[19] and American Association for the Study of Liver Disease guidelines,^[20] patients were strongly encouraged to have histologic assessment of liver disease severity through biopsy as a surrogate marker of adherence. Histology was assessed by staff pathologists using the Scheuer 0–4 point scale.^[21] In five patients, we performed FibroSURE™ (LabCorp., Research Triangle Park, NC, USA), a noninvasive test of hepatic fibrosis.

After the biopsy, patients discussed potential HCV treatment in the hepatitis clinic. Besides patient's willingness, we considered fibrosis stage and potential contraindications to PEG-IFN/RBV prior to initiating therapy. All psychiatrically unstable patients underwent psychiatric assessment prior to PEG-IFN/RBV initiation and were monitored monthly while on therapy by MMTP staff psychiatrists. Staff psychiatrists were available on a daily basis in the MMTP for patient consultation. In addition, a psychosomatic medicine fellow was present in the hepatitis clinic on the designated clinic day for consultation if requested by either the hepatologist or the internist-addiction medicine specialist.

According to standard practice, daily attendance in the MMTP is required 6 days per week. Subsequently, phased reductions in attendance can be initiated if the patient maintains abstinence from the use of illicit substances, complies with the predetermined attendance schedule and actively engages in treatment including attendance at counselling sessions with their assigned social worker. Throughout the stabilization process and treatment course, the patient must comply with random urine toxicology screening at frequent intervals.

Antiviral Therapy

Pegylated interferon α-2a 180 μg/week was injected subcutaneously. Prior to initiation of treatment, all patients participated in a teaching session with nursing staff from the viral hepatitis clinic during which the patient was instructed in interferon administration. The first dose was administered during the teaching session, and all subsequent doses were self-administered. In no case did the physicians managing the patient deem it necessary that they receive directly observed therapy. Weight-adjusted RBV was taken orally twice daily at a dose of 800–1200 mg. Hematopoietic stimulating factors were utilized as indicated for anaemia and neutropenia. All patients on PEG-IFN/RBV were seen weekly in the MMTP by the internist-addiction medicine specialist and at 6-week intervals in the liver clinic by both the hepatologist and the addiction specialist on the designated clinic day. Patients were monitored for clinical evidence of opiate withdrawal on a weekly basis by the internist-addiction medicine specialist. If a patient missed the follow-up appointment in the hepatitis clinic, they were seen in the MMTP and rescheduled to be seen in the hepatitis clinic at the first availability. Haematologic parameters and aminotransferase levels were measured weekly for the first month and at 6-week intervals thereafter. Patients had the option to have their blood drawn at either the hepatitis clinic or the MMTP. The internist-addiction medicine specialist and the hepatologist maintained a list of all HCV-seropositive patients and reviewed the status of each patient on a weekly basis either by phone or in person.

Statistical Analysis

Statistical analysis was performed using SAS (SAS Institute Inc., Cary, NC, USA) and R (R Language, version 2.10.0 http://www.r-project.org) The associations between the variables of interest were determined through chi-square tests, Fisher's exact tests, logistic regression modelling and Wald tests. Model selection was based on the Akaike information criterion (AIC). Logistic regression was used to model the probability that a patient who was referred to the liver clinic was adherent and to assess the significant factors that influenced adherence with the referral. First, simple logistic regression was used to determine the factors (gender, ethnicity, age and duration in the MMTP) for inclusion in the model. Criterion for inclusion was P ≤ 0.25. Secondly, the AIC criterion was used to select the best multiple logistic model. In addition, we modelled the probability that a patient in whom treatment was indicated actually initiated PEG-IFN/RBV. The significance level for these tests was set at 0.05, two-tailed.

Results

Patient Characteristics

Of a total of 401 patients, 51% were Caucasian, 34% were Hispanic, 13% were African American and 66% were male (Table 1). HIV antibody testing results were available for 322 subjects, 48 of whom were positive. Of 48 HIV-positive patients, 2 were HCV seronegative, 13 were HCV seropositive but HCV RNA negative and 33 were co-infected with HCV (both HCV RNA and antibody positive).

HCV Disease Characteristics and Evaluation

Serology Hepatitis C virus antibody was obtained at a median age of 43 (33–50) years, on average 2 years after admission to the MMTP. Of 257 HCV-seropositive patients, 86% were older than 40 years, 48% were Caucasian, 35% Hispanic and 16% African American. We found higher HCV seroprevalence with increasing age. Subjects aged 40 years or older were more likely to be HCV antibody positive compared to younger people (odds ratio [OR] = 3.11; 95% CI: 2.00, 4.83, P < 0.0001). However, the association between anti-HCV positivity and age differs significantly among different ethnic groups (P = 0.049). While the likelihood of being anti-HCV positive was higher among Caucasians (OR = 3.5; 95% CI: 1.89, 6.39) and African Americans (OR = 20.7; 95% CI: 2.06, 206.64) older than 40 years, age was not associated with HCV serostatus among Hispanics (OR = 1.51; 95% CI: 0.72, 3.17). Seropositivity did not differ significantly by gender (P = 0.23). Our population was quite stable with a median duration in the MMTP of 65 months among seropositive individuals. We also found that patients who were in the MMTP for more than 36 months were 1.61 times more likely to be HCV seropositive compared to those enrolled in the MMTP for a shorter period (95% CI: 1.06, 2.46, P = 0.026).

HCV RNA Hepatitis C virus RNA was obtained from 222 (86%) HCV-seropositive patients. Of these, 65 (29%) patients were HCV RNA negative, indicating spontaneous viral eradication. Chronic HCV infection was detected in 157 (71%) patients as indicated by detectable HCV RNA. Of these, 33 patients were HIV/HCV co-infected. In 35 (14%) of seropositive patients, HCV viral quantitation was unattainable: 8 declined testing citing lack of interest, 8 had no insurance, 3 received HCV treatment elsewhere and 16 were inaccessible during the study owing to discharge/transfer from the MMTP (n = 9), death (n = 4) or incarceration (n = 3). Hepatitis C virus genotypes were obtained on 118 (75%) patients with chronic HCV infection. Hepatitis C virus genotype 1 was detected in 91 (77%) patients, followed by genotypes 2 and 3 (11% and 10%, respectively) (Table 2).

Liver Clinic Evaluation Of the 157 chronically HCV-infected patients, 125 were eligible to be seen in the clinic, 29 of whom were HIV co-infected. Seventy-six individuals adhered with the referral of whom 17 (25%) were HIV/HCV co-infected. The following patients were considered ineligible for referral: 13 received HCV care elsewhere; 12 were not evaluated owing to discharge (n = 5), transfer (n = 4), incarceration (n = 1) or death (n = 2) during the study period; and 7 were uninsured. Twenty-three patients refused hepatitis clinic referral citing lack of interest, and 26 initially accepted referral but failed to appear.

We found that patients who had been enrolled in the MMTP for more than 36 months were more likely to have been seen in liver clinic than those engaged in treatment for <36 months (OR = 3.32, 95% CI: 1.51, 7.28, P = 0.003). However, this relationship depended upon subject gender (P = 0.017). The odds of male patients engaged in MMTP for >36 months accepting and adhering to referral were significantly higher than for men enrolled in MMTP for <36 months (OR = 7.7; 95% CI 2.6–22.9). Among patients who were on methadone treatment for <36 months, men were significantly less likely to be seen in the liver clinic than women (OR = 0.167, 95% CI: 0.04, 0.69). No other demographic or disease-related factors predicted referral adherence. Of the 76 patients with chronic HCV infection evaluated in the viral hepatitis clinic, assessment of fibrosis was achieved in 63 (83%): 54 underwent liver biopsy to assess fibrosis, 4 were diagnosed with cirrhosis based upon laboratory data and/or imaging studies, and 5 preferred noninvasive blood testing to assess the degree of fibrosis. Among 58 patients with histologic assessment based upon biopsy or laboratory/imaging evidence of cirrhosis, 49 (84%) had moderate to advanced liver disease (stage ≥2) indicating the need for urgent treatment. Among patients with liver biopsy, advanced fibrosis (stage >2) differed significantly by ethnicity (P = 0.039); 58% of Caucasians and Hispanics combined had stage >2 vs 20% of African American subjects. Caucasian or Hispanic individuals were 5.5 times more likely to have fibrosis stage >2 when compared to African Americans (95% CI: 1.05, 33.33). Necroinflammatory activity was also significantly associated with fibrosis (P = 0.013 for lobular and P = 0.001 for portal inflammation). Age and gender were not associated with fibrosis.

HCV Treatment Characteristics

Of the 76 patients who underwent the evaluation process, 24 initiated treatment, including 9 individuals co-infected with HIV (Table 3). Thirty-five patients were ineligible for treatment including 2 (3%) with decompensated psychiatric disease, 6 (11%) with decompensated cirrhosis, 10 (13%) who refused a biopsy, 4 (5%) with no insurance and 2 (3%) who were treated elsewhere. Of these two patients, upon evaluation in the liver clinic, it was determined that one had successfully been treated at an outside institution and the other was treatment ineligible owing to severe thrombocytopenia. Eleven (14%) subjects with mild fibrosis postponed treatment based upon physician recommendation. Twenty-four of 41 treatment eligible patients began treatment. Of the remaining treatment eligible patients, 3 (4%) declined PEG-IFN/RBV citing fear of therapy-related side effects, 4 (5%) had unstable living conditions, 3 (4%) had relocated to different geographic areas complicating pursuit of anti-HCV treatment, 3 declined (4%) owing to co-occurring illnesses and 4 (5%) were lost to follow-up. Patients with stage 3–4 fibrosis were significantly more likely to be treated than those with stage 0–2 (OR = 11.2, 95% CI: 2.89, 43.35, P = 0.0005). Of 24 treatment initiators, 19 completed a full course of therapy with PEG-IFN/RBV. Three patients interrupted treatment owing to reasons unrelated to therapeutic success, including hepatic decompensation (n = 1), severe thrombocytopenia (n = 1) and nonadherence (n = 1). Thirteen patients (54%) achieved sustained virological response (SVR), eight of who were genotype 1 and four were co-infected with HIV. Two HIV/HCV co-infected patients currently remain on treatment.

Discussion

In this investigation, we demonstrate the effectiveness of an integrated, co-localized care model for HCV utilizing a multidisciplinary approach (Fig. 1). We applied our model to patients from a large MMTP in Manhattan. Overall, HCV seroprevalence was 64% and 61% of those with chronic HCV who were eligible for referral were evaluated in the hepatitis clinic. Of those who initiated treatment, 54% successfully eradicated the virus consistent with the previous studies of HCV treatment in opiate-dependent patients.^[22–26]

Despite a high prevalence of HCV infection among DUs, less than one-third of eligible individuals receive HCV therapy owing to variety of reasons at the institutional, provider and patient levels.^[3] Institutional reasons often include difficulties obtaining or navigating the complexities of the referral system. In addition, many health care providers are concerned about adherence with HCV treatment by DUs, including concerns that they may be disinterested in treatment, that interferon-based therapy may potentiate psychiatric decompensation and that they might be reinfected of continued high-risk practices. Studies of HCV reinfection among successfully treated DUs, however, have shown the converse.^[27,28] Using our model, we obtained an HCV evaluation in more than one-half of chronically infected individuals, markedly higher than previous clinic-based cohorts. In addition, we were able to stage the degree of fibrosis in 83% of those evaluated in the liver clinic. Factors that likely contributed to the high degree of acceptance of HCV management and adherence to an evaluation included evaluation by the same physician in both clinics, their geographical proximity and an institution-wide electronic medical record that fosters communication facilitating data access and continuity of care. The fact that these patients had a regular, stable source of medical care that originated in the MMTP and continued to the hepatitis clinic was likely crucial to the success of our program.^[15,17]

Substance abuse treatment can serve as an entry point into the health care system and is possibly an essential step in preparing DUs for HCV evaluation and treatment. Well-structured MMTPs, with attributes such as access to mental health professionals and general medical staff, likely have advantages for HCV evaluation and treatment over those without such services. Consistent with the findings of prior studies,^[11,29] we found that men who were engaged in the MMTP for 36 months or more were significantly more likely to appear in the hepatitis clinic than those with shorter duration of opiate substitution therapy.

Our study is limited in its retrospective, non-comparative design and its conduct at a single institution. Our goal, however, was to demonstrate the feasibility and effectiveness of an integrated, co-localized model of care. The health care services offered at our MMTP provided the requisite infrastructure to facilitate HCV evaluation and treatment among MMTP patients. Unfortunately, however, many MMTPs may not be able to offer as wide a spectrum of health care services onsite, which might impact on the ability to offer HCV management except through traditional referral based mechanisms. Our model may be utilized by community-based primary care providers or addiction medicine specialists with immediate access to experts in HCV management who can assist in navigating the complexities of treatment of the infection.

Despite our integrated, colocalized approach, a substantial number of patients did not undergo an HCV evaluation in the hepatitis clinic, with an approximate equal number refusing referral as those initially accepting referral but not appearing for their initial evaluation. Men enrolled in the MMTP for <36 months appeared to be at greatest risk for not accepting or complying with referral to the hepatitis clinic. When questioned, patients indicated that they refused HCV evaluation owing to an apparent lack of interest, reticence or a lack of education or misinformation concerning HCV. Our findings are consistent with previous data that demonstrated significant knowledge gaps among DUs.^[30] Implementation of patient-oriented interventions, such as formal, structured HCV educational programs, individual case management to address patient level barriers or staff/peer accompaniment to appointments, might improve adherence with HCV evaluation and treatment and are interventions deserving of further study.

In an effort to inform patients of the severity of their infection and consistent with standard clinical practice in 2006,^[20] we strongly encouraged patients to undergo a liver biopsy. On biopsy, we found that the vast majority of patients had at least moderate hepatic fibrosis, indicating the need for urgent treatment. In this model, 41% of patients who had accurate hepatic fibrosis assessment began PEG-IFN/RBV, 79% of whom completed a full course of therapy with an overall SVR rate of 54%. Notably, only one patient had treatment interrupted for issues relating to nonadherence and no patients discontinued treatment because of psychiatric decompensation.

In summary, we demonstrated that localization of addiction medicine specialists and hepatologists in a viral hepatitis clinic is both an effective and efficient model to deliver HCV evaluation and treatment to MMTP patients. This approach could be most appropriate in settings that offer pharmacologically based treatment of addiction which have ready access to expertise in the management of liver disease. As many DUs have advanced stages of hepatic fibrosis, HCV treatment is particularly urgent. Additionally, successful treatment combined with safe injection practices could decrease virus transmission even among individuals who continue to inject. Unless disenfranchised populations with the highest infection prevalence, such as DUs, have access to and accept treatment for HCV, the burden of disease will remain high.

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Source

France: Is more frequent monitoring for liver cancer among co-infected people needed?

9 January 2012

In high-income countries such as Canada, Australia and in Western Europe, the widespread availability of potent combination therapy for HIV (commonly called ART or HAART) has greatly reduced deaths from AIDS-related infections. Furthermore, the benefit of ART is so profound that researchers in the UK recently estimated that HIV-positive people who have minimal co-existing health conditions and who are diagnosed and receive treatment early in the course of HIV disease are very likely to have near-normal life spans.

Many possible factors can affect access to and engagement in care and treatment—and thus survival; addiction is one such factor. Some HIV-positive people may not be able to seek and receive the help and support needed to break free from addiction to substances—including alcohol, street drugs and tobacco—and their associated risks. Such risks can include serious bacterial infections, overdose, cardiovascular disease, liver and kidney damage, accidents, suicide and violence.

Even among some HIV-positive people who have been able to successfully overcome their addiction, past engagement in substance use or unprotected sex may have also exposed them to co-infections such as hepatitis B virus (HBV) and hepatitis C virus (HCV). These viruses attack the liver, injuring this vital organ. Chronic hepatitis caused by these viruses degrades the liver, causing it to lose healthy tissue and have scar tissue build up. In the absence of treatment, over time the liver becomes increasingly dysfunctional and serious complications including liver failure, liver cancer and death can occur.

Treatment

In high-income countries, treatment for HBV co-infection is usually one of the following combinations:

• 3TC (lamivudine) + tenofovir (Viread)
• tenofovir + FTC (sold as a fixed-dose combination called Truvada)

In the case of HCV mono-infection (HCV alone), a combination of the following three drugs is used:

• ribavirin
• interferon-alpha
• boceprevir (Victrelis) or telaprevir (Incivik)

Note that neither boceprevir nor telaprevir are approved in Canada for the treatment of HIV-HCV co-infection.

Viral hepatitis and liver cancer

French researchers have found that while ART can greatly reduce deaths due to AIDS-related infections, complications from liver disease are increasingly taking their toll. One complication of infection with HBV or HCV is liver cancer, and researchers in France continue to study this cancer both in people with either HBV or HCV or HIV co-infection. Their most recent study results suggest that liver cancer occurs earlier and is more extensive in some co-infected people who are at high risk for liver cancer. If the French findings are confirmed, increased medical monitoring of co-infected people at high risk for liver cancer may be necessary.

Study details

The French team reviewed data collected from 2,256 participants who were being monitored as part of research on viral hepatitis. They selected 32 people from this group for further analysis. All 32 participants had cirrhosis—extensive liver damage arising from chronic infection with HBV or HCV, whereby healthy tissue is replaced by scar tissue. Additionally, all participants had liver cancer. The diagnosis of cirrhosis was made using one or more of the following methods:

• analyzing a tiny sample of the liver
• specialized blood tests (Fibrotest)
• specialized ultrasound scans of the liver (Fibroscan)

The distribution of viral infections among the 32 participants was as follows:

• HIV-HCV co-infection – 16 participants
• HCV mono-infection – 16 participants

As people with cirrhosis are at heightened risk for the development of liver cancer, all participants underwent ultrasound scans of the liver every six months, along with medical monitoring.

On average, participants were monitored for 30 months.

All participants had tumours in their liver that arose from abnormal liver cells (primary liver cancer); none of the tumours had migrated to the liver from another part of the body.

Results

The researchers found that co-infected people were generally younger (48 years) than mono-infected people (60 years)—a statistically significant difference. Additionally, there was a trend that approached statistical significance: Co-infected people (56%) drank more alcohol than HCV mono-infected people (20%).

In reviewing the medical records, the research team found that all mono-infected participants had previously received treatment for HCV while 67% of co-infected people received this treatment. This difference was also statistically significant. The reasons for this difference were not clear to the research team.

The researchers also found that 87% of co-infected people were taking ART; of these, 69% had low levels of HIV in their blood (less than 40 copies/ml).

Cure vs. palliative therapy

Treatment for liver cancer can vary depending on several factors, including the following:

• the health of the liver
• the size and number of tumours
• whether or not the tumours have spread (metastasized) beyond the liver

In cases where doctors decide that a person does not have a good chance of recovery from cancer, palliative care—measures to minimize discomfort and complications in the short term—may be provided. In the case of the current report, when French oncologists judged that recovery was likely they choose from several options, including surgery, attacking the tumour with an electrical current (radiofrequency ablation), or surgery followed by a liver transplant.

Oncologists gave the 32 study participants either palliative or curative therapy, distributed as follows:

• HIV-HCV co-infection – 25% received therapy with the intention to cure cancer
• HCV mono-infection – 69% received therapy with the intention to cure cancer

This difference was statistically significant.

As cancer patients were assessed and treated outside of the study by oncologists, the research team is not certain why there was a difference in who received curative therapy. However, the researchers found that when liver cancer was diagnosed within the study, it was generally more severe (more and larger tumours) in co-infected people. Also, some co-infected participants had higher-than-normal levels of a protein called AFP (alpha-fetoprotein). Past studies have suggested that high levels of AFP are sometimes associated with liver cancer and that elevated AFP at liver cancer diagnosis may indicate a poor outcome. Thus it was possible that because liver cancer was more “advanced” when diagnosed in co-infected people, oncologists may have decided that the prospects of recovery in this group were poor.

Over an average of 30 months of monitoring, deaths due to complications from liver cancer were distributed as follows:

• HIV-HCV co-infection – 10 out of 16 people died
• HCV alone (mono-infection) – one out of 16 people died

Monitoring

International liver cancer management guidelines suggest that people with cirrhosis (who are at high risk for liver cancer) should undergo ultrasound scans of their liver and have AFP tests to help their doctors detect tumours. According to the researchers, these guidelines were followed in the French study. Therefore, the French team suggests that the worse pattern of liver cancer among co-infected people did not arise due to lack of monitoring.

The precise cause for the more rapid appearance of liver cancer among co-infected people in this study is not clear but it may be due to a weakened immune system caused by HIV infection. While most participants with HIV in the study were taking combination therapy, ART can only partially restore the immune system; residual immune dysfunction continues.

The French study had a major weakness: A relatively small number of participants (32). A larger study is necessary to confirm its findings.

If another team confirms the French results, more frequent monitoring of HIV-HCV co-infected people at high risk for liver cancer may be deemed necessary. For instance, the French team suggests that ultrasound scans and other tests could be done every three months. This shorter time span might allow technicians and doctors to detect liver cancer when it is at an early stage. This could make a difference to the prospects of surviving liver cancer for co-infected people.

—Sean R. Hosein

REFERENCES:

1. May M, Gompels M, Delpech V, et al. Impact of late diagnosis and treatment on life expectancy in people with HIV-1: UK Collaborative HIV Cohort (UK CHIC) Study. BMJ. 2011 Oct 11;343:d6016.
2. Larsen MV, Omland LH, Gerstoft J, et al. Impact of injecting drug use on mortality in Danish HIV-infected patients: a nation-wide population-based cohort study. Addiction. 2010 Mar;105(3):529-35.
3. Hser YI, Kagihara J, Huang D, et al. Mortality among substance-using mothers in California: a 10-year prospective study. Addiction. 2012 Jan;107(1):215-22.
4. Ferreros I, Lumbreras B, Hurtado I, et al. The shifting pattern of cause-specific mortality in a cohort of human immunodeficiency virus-infected and non-infected injecting drug users. Addiction. 2008 Apr;103(4):651-9.
5. Smit C, van den Berg C, Geskus R, et al. Risk of hepatitis-related mortality increased among hepatitis C virus/HIV-coinfected drug users compared with drug users infected only with hepatitis C virus: a 20-year prospective study. Journal of Acquired Immune Deficiency Syndromes. 2008 Feb 1;47(2):221-5.
6. Bonacini M. Alcohol use among patients with HIV infection. Annals of Hepatology. 2011 Oct-Dec;10(4):502-7.
7. Downey JS, Attaf M, Moyle G, et al. T-cell signalling in antiretroviral-treated, aviraemic HIV-1-positive individuals is present in a raised state of basal activation that contributes to T-cell hyporesponsiveness. AIDS. 2011 Oct 23;25(16):1981-6.
8. Appay V, Almeida JR, Sauce D, et al. Accelerated immune senescence and HIV-1 infection. Experimental Gerontology. 2007 May;42(5):432-7.
9. Herbeuval JP, Nilsson J, Boasso A, et al. HAART reduces death ligand but not death receptors in lymphoid tissue of HIV-infected patients and simian immunodeficiency virus-infected macaques. AIDS. 2009 Jan 2;23(1):35-40.
10. Boasso A, Royle CM, Doumazos S, et al. Overactivation of plasmacytoid dendritic cells inhibits antiviral T-cell responses: a model for HIV immunopathogenesis. Blood. 2011 Nov 10;118(19):5152-62.
11. Grebely J, Dore GJ. What is killing people with hepatitis C virus infection? Seminars in Liver Disease. 2011 Nov;31(4):331-9.
12. El-Serag HB. Hepatocellular carcinoma. New England Journal of Medicine. 2011 Sep 22;365(12):1118-27.
13. Tyson GL, Duan Z, Kramer JR, et al. Level of α-fetoprotein predicts mortality among patients with hepatitis C-related hepatocellular carcinoma. Clinical Gastroenterology and Hepatology. 2011 Nov;9(11):989-94.
14. Davila JA, Morgan RO, Richardson PA, et al. Use of surveillance for hepatocellular carcinoma among patients with cirrhosis in the United States. Hepatology. 2010 Jul;52(1):132-41.
15. Bourcier V, Winnock M, Ait Ahmed M, et al. Primary liver cancer is more aggressive in HIV-HCV coinfection than in HCV infection. A prospective study (ANRS CO13 Hepavih and CO12 Cirvir). Clinics and Research in Hepatology and Gastroenterology. 2012; in press.

Source

Effect of IL28B Genotype on Early Viral Kinetics during Interferon-Free Treatment of Patients with Chronic Hepatitis C

Gastroenterology. 2012 Jan 13. [Epub ahead of print]

Chu TW, Kulkarni R, Gane EJ, Roberts SK, Stedman C, Angus PW, Ritchie B, Lu XY, Ipe D, Lopatin U, Germer S, Iglesias VA, Elston R, Smith PF, Shulman NS.

Source

Roche, Nutley, NJ, USA.

Abstract

BACKGROUND & AIMS:

Although IL28B genotype affects the response of patients with chronic hepatitis C (CHC) to peginterferon and ribavirin, little is known its effect on response to direct-acting antivirals in interferon-free combinations. We analyzed the effects of IL28B genotype on the viral kinetic (VK) response to an interferon-free combination of the nucleoside polymerase inhibitor mericitabine (RG7128) and hepatitis C virus (HCV) protease inhibitor danoprevir.

METHODS:

We performed a double-blind, dose-escalation study of patients with chronic HCV genotype 1 infection who were interferon treatment-naive or had not responded to previous therapy with peginterferon and ribavirin. Patients were sequentially assigned to 1 of 7 cohorts, then randomly assigned to groups that received up to 13 days of treatment with mericitabine (500 or 1000 mg, twice daily) plus danoprevir (100 or 200 mg, every 8 hrs or 600 or 900 mg, twice daily) or placebo. Eighty-three of 87 patients were genotyped for the IL28B single-nucleotide polymorphism rs12979860. VKs were analyzed only in patients who received 13 days of treatment, at optimal doses, using a bi-phasic model to describe first- and second-phase slopes of viral decay during therapy.

RESULTS:

At day 14 (the end of interferon-free treatment), the mean reduction in the serum level of HCV RNA was slightly greater in patients with the CC polymorphism (5.01 log(10) IU/mL) than those without (4.59 log(10) IU/mL). Modeling revealed that patients with the CC polymorphism had slightly better early VKs, most apparent in the β-phase of viral decay. A mixed effect on the α-phase was observed, which was reduced in magnitude but prolonged in patients with CC, who also had better on-treatment response to peginterferon and ribavirin during follow up.

CONCLUSIONS:

IL28B genotype appears to affect early VKs in patients with CHC receiving interferon-free treatment.

Source

Treatment failure with new hepatitis C drugs

Expert Opin Pharmacother. 2012 Jan 14. [Epub ahead of print]

Soriano V, Vispo E, Poveda E, Labarga P, Barreiro P.

Source

Hospital Carlos III, Department of Infectious Diseases , Calle Sinesio Delgado 10, Madrid 28029 , Spain +34 91 4532500 ; +34 91 7336614 ; vsoriano@dragonet.es.

Abstract

Introduction: The combination of pegylated interferon-α plus ribavirin (pegIFNα-RBV) has been the only therapeutic option for patients with chronic hepatitis C virus (HCV) infection during the last decade. Unfortunately, it provides cure to less than a half of individuals infected with HCV genotype 1, which is by far the most prevalent worldwide. The recent introduction of new direct-acting antivirals (DAA) has revolutionized the hepatitis C field. The addition of any of the two recently approved HCV protease inhibitors, boceprevir or telaprevir, to pegIFNα-RBV results in the cure for two-thirds of HCV genotype 1, interferon-naive patients. Areas covered: This paper reviews new antivirals for hepatitis C and HCV treatment failures, along with HCV drug resistance and rescue therapies. Expert opinion: The application of early stopping rules may reduce the enrichment of drug-resistant viruses in patients failing first-generation HCV protease inhibitors, potentially allowing more chances of response to rescue interventions with other compounds within the same class in the near future. On the other hand, the advent of DAA belonging to distinct drug families may provide further opportunities for clearing definitively HCV in patients currently failing first-generation HCV protease inhibitors. Thus, hepatitis C has entered a new era that hopefully will end with its eradication. In the meantime, a wise use of DAA is warranted, including adequate selection of candidates for therapy, close monitoring of drug adherence, proper management of side effects and early application of stopping rules.

Source

Hepatitis Health Action Alert: Stop the Attacks on Prevention and Public Health Fund

Posted on January 23, 2012 on The Hepatitis B Foundation blog

Action Alert! The Hepatitis Community Responds to Health Care Reform. Tell Congress Not To Cut The Prevention and Public Health Fund

The Prevention and Public Health Fund is under attack in Congress once again. Some leaders in the House of Representatives would like to make drastic cuts to the Fund as part of negotiations on a long-term deal on the payroll tax cut and Medicare payments rates to medical providers.

The Prevention and Public Health Fund, part of the Affordable Care Act, provides money each year for vital prevention and public health services. The fund will grow each year until it eventually provides $2 billion/year.

This fund is extremely important to the nation’s fight against the viral hepatitis epidemic. Later this year, the Department of Health and Human Services is expected to allocate $10 million from the Fund for viral hepatitis screening, testing, and education programs. This initiative will greatly help efforts to identify the millions of Americans who have chronic hepatitis B or C and link them to care and treatment.

Please take a few minutes to call Congress in support of this lifesaving program!

What YOU can DO:

Please call your U.S. House Representative and two U.S. Senators immediately. We are hearing directly from Congressional staff that phone calls are the most effective form of communication.

Call the Capitol Switchboard toll-free at 1-888-876-6242 and ask to be connected to your United States Representative. When you reach your Representative’s office, tell whoever answers the phone that you are a constituent and that you would like to speak to the staff person who handles health care issues. Whether you speak to the staff person live or leave a voicemail, tell him/her:

“My name is _______________ and I live in (city/state). I am calling in strong support of the Prevention and Public Health Fund, which is an important part of the Affordable Care Act. This Fund is a great opportunity to provide badly needed funding for viral hepatitis prevention, testing, and screening programs and must be preserved. I urge Representative_____________ to oppose any efforts to cut the Fund as part of the payroll tax/Medicare physician reimbursement negotiations.”

After you speak to your Representative’s office, call the Capitol Switchboard again and deliver the same message to the health care staff person in your two U.S. Senators’ office.

Thank you for taking the time to make a difference! Please spread the word.

Get involved with Hepatitis Health Action!

• Sign up for the Hepatitis Health Action email list by visiting http://groups.google.com/group/HepHealth or, email rclary@projectinform.org and we will make sure you are added.

• Join Hepatitis Health Action’s Facebook group: http://tinyurl.com/hephealthfacebook where you can participate in discussions with other advocates and share your ideas and strategies.

Hepatitis Health Action is a campaign led by viral hepatitis advocates working to make sure that health care reform addresses hepatitis B and C.