June 22, 2013

Which Drugs Are Safe in Patients with Cirrhosis?

Published in Journal Watch Gastroenterology June 21, 2013

A new review contains practical guidance to answer this oft-asked, important question.

Prescribing providers routinely raise the concern of medication safety for their patients with cirrhosis because of fear of precipitating hepatic decompensation from acute, drug-induced liver injury. To synthesize current information on this topic, investigators systematically reviewed relevant articles indexed in MEDLINE and unpublished information from the U.S. Food and Drug Administration.

Highlights include the following:

  • Because of pharmacokinetic changes that occur in patients with cirrhosis and may necessitate dose adjustments, lower doses are generally recommended, especially in patients with significant liver dysfunction.
  • Opioid analgesics, anxiolytics, and sedatives should be used with caution because they can precipitate hepatic encephalopathy.
  • Nonsteroidal anti-inflammatory drugs should be avoided, as they are a common cause of adverse drug reactions (renal failure and gastrointestinal bleeding) in this population.
  • Paracetamol (acetaminophen) can be used safely at low doses (2–3 g daily) for short durations and should be considered first-line treatment for pain.
  • Statins can be used safely; they are considered by the FDA to carry a very low risk for serious liver injury, and recent studies support their safety in liver disease and suggest a possible beneficial effect in fatty liver disease.
  • Proton-pump inhibitors and, to a lesser degree, histamine-2 blockers have recently been associated with serious infections in patients with cirrhosis, so clinicians should limit their use to valid indications.

Comment: Although most medications have not been sufficiently studied in patients with cirrhosis, most can be safely prescribed in this setting. Even certain potentially hepatotoxic drugs can be used safely if given at a lower dose and monitored carefully. Importantly, clinicians need to be more concerned about drugs that precipitate or worsen renal failure or provoke either gastrointestinal bleeding or encephalopathy, all of which are more common in this patient population.

Atif Zaman, MD, MPH

Citation(s):

Lewis JH and Stine JG. Review article: Prescribing medications in patients with cirrhosis — a practical guide. Aliment Pharmacol Ther 2013 Jun; 37:1132. (http://dx.doi.org/10.1111/apt.12324)

Medline abstract (Free)

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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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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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118297969

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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