Saturday, February 19, 2011

Hepatitis C News; Children Respond Well To Peginterferon/Ribavirin

Local hospitals are seeing success in their efforts to reduce a dangerous hospital-acquired infection.
Those efforts range from tweaking basic sanitation practices to using special lighting systems in hospital rooms that have housed patients infected with C. difficile, or c. diff.
C. diff, a bacterial infection, affects about 700,000 people in the United States a year. Many are hospitalized when they develop it.
"It's a big problem in health-care," said Bruce Yacyshyn, a digestive diseases expert and C. diff researcher at University Hospital and the University of Cincinnati. "It kills more people than HIV."
Children With Chronic Hepatitis C Respond Well to Peginterferon Plus Ribavirin
Reuters Health Information, February 17, 2011

By Bob Saunders
NEW YORK (Reuters Health) Feb 16 - Ribavirin added to pegylated interferon more than doubles the sustained viral response rate in children with chronic hepatitis C, a multicenter team reports in the February issue of Gastroenterology.
"Children with hepatitis C require the combination of pegylated interferon and ribavirin for optimum viral clearance," Dr. Kathleen Schwarz advised in an email to Reuters Health.
There may be 132,000 HCV antibody-positive children in the United States, with 7200 new cases annually, observe Dr. Schwarz, with The Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues at 11 university medical centers, in the introduction to their paper.

"Recommendations for treatment of HCV infection in children have been derived from trials in adults, although the efficacy and safety of these therapies may be different in children," the researchers write. They therefore conducted a randomized controlled trial of peginterferon and ribavirin, compared with peginterferon monotherapy, in children 5 to 17 years old with chronic hepatitis C.

By random assignment, 55 children received pegylated interferon alfa-2a (180 mcg/1.73 m� body surface area, subcutaneously weekly) and ribavirin (15 mg/kg orally in two doses daily), while 59 children were given peginterferon and placebo, for 48 weeks.

A sustained virologic response, defined as undetectable plasma levels of HCV RNA at least 24 weeks after stopping treatment, was documented in 29 children in the peginterferon-ribavirin group (53%) compared with 12 in the peginterferon-placebo group (20.3%), according to the report.

"In our study viral eradication was maintained for the two years we followed the children," Dr. Schwarz commented. "Children receiving this therapy should be monitored carefully for side effects, particularly neutropenia, which may require dose reduction," she added.
Almost all the children experienced headache, influenza-like symptoms and adverse GI effects, the researchers found. WBC and neutrophil counts dropped, along with hemoglobin levels, but returned to baseline when therapy ended. Dose reductions of peginterferon or ribavirin were common but didn't affect sustained responses in either group.
As in other studies, subjects with HCV genotype 1 had lower sustained response rates than those with the other genotypes, the investigators found.

"These results indicate that children with chronic hepatitis C should not receive peginterferon monotherapy," Dr. Schwarz and colleagues conclude. "The response rates in this trial were comparable to those in uncontrolled clinical trials of peginterferon and ribavirin in children and were similar to rates reported in adults."

So, are children the same as adults? asks an editorialist. "'Yes,' in that they benefit from combined therapy for HCV," writes Dr. Aymin Delgado-Borrego at the University of Miami Miller School of Medicine, Florida. "'No,' in some ways, including altered viral kinetics. 'We don't know' in most ways. Efforts to accelerate trials in children will be essential to understand the key host differences between children and adults."
Gastroenterology. 2011;140:450-458.

From Natap

APASL: 12-Week Effiacy and Safety of ABT-072 or ABT-333 with Pegylated Interferon + Ribavirin, Following 3-Day Monotherapy in Genotype 1 HCV-Infected Treatment-Naïve Subjects -


APASL: Telaprevir-based Therapy in Genotype 1 Hepatitis C Virus-infected Patients with Prior Null Response, Partial Response or Relapse to Peginterferon/Ribavirin: REALIZE Trial Final Results -


New hope for hepatitis C, an often hidden disease

1/18/2011 12:23 PM

WASHINGTON (AP) — There's new hope for an overlooked epidemic: Two powerful drugs are nearing the market that promise to help cure many more people of liver-attacking hepatitis C — even though most who have the simmering infection don't know it yet.
Surprisingly, two-thirds of hepatitis C sufferers are thought to be baby boomers who've harbored since their younger, perhaps wilder, years a virus that can take two or three decades to do its damage.

What could be a treatment revolution is spurring the government to consider if it's time to start screening aging baby boomers for hepatitis C, just like they get various cancer checks.
"We're entering a whole new era of therapy," says Dr. John Ward, hepatitis chief at the Centers for Disease Control and Prevention. "We really want to begin that clarion call for action for this population who's at risk."

Today's two-drug treatment for hepatitis C cures only about 40% of people with the most common variety of the virus, and causes some grueling side effects. Now major studies show that adding a new drug —either Vertex Pharmaceuticals' telaprevir or Merck & Co.'s boceprevir — can boost those cure rates as high as 75%. And they allow some people to cut treatment time in half, to six months, thus lessening how long they must deal with those side effects.
If the Food and Drug Administration approves the drugs — a decision widely expected this summer — they would be the first that work by directly targeting the hepatitis C virus. Specialists draw comparisons to the early 1990s when potent combination therapies emerged to treat AIDS. Many recently diagnosed patients are postponing therapy to await these new drug cocktails in hopes of a better chance at a faster cure, says Dr. Paul Pockros, hepatology chief at the Scripps Clinic in La Jolla, Calif., who helped test telaprevir.

However, the bigger impact could come if more people get tested for hepatitis C, a blood-borne virus. It's often stigmatized as a risk only to people who inject illegal drugs. But the virus could have begun festering from a blood transfusion before 1992, when testing of the blood supply began.

Lapses in infection control in health facilities still occasionally expose people today. So could even a one-time experiment with drugs way back in college, something doctors are reluctant to ask a now middle-aged, button-downed patient to reveal, says Ward.
"It cuts across every segment of society," adds Dr. Arun Sanyal of Virginia Commonwealth University, past president of the American Association for the Study of Liver Diseases. "I can tell you our hepatitis C treatment clinic is a great social equalizer."

About 3.2 million Americans, and 170 million people worldwide, have chronic hepatitis C. In the U.S., new infections have dropped dramatically — although the disease's toll is rising as people infected decades earlier reach ages where their livers start showing damage. Hepatitis C already is a leading cause of liver transplants, and it kills about 12,000 U.S. patients a year, a number expected to triple within 20 years.

Most people find out they're infected like Brian Graham of Briarcliff Manor, N.Y., during a routine check-up that spotted elevated liver enzymes. He'd never heard of hepatitis C and had no obvious risk factors. But tests showed the virus had begun to scar his liver. So over the last decade he tried three rounds of traditional treatments, with increasingly tough side effects, to no avail.

"I didn't want to die of liver disease or cancer or suffer the prospect of having to tee up for a liver transplant. Scary stuff," says Graham, now 56.
Enter the new drugs. They work by blocking an enzyme named protease that's key for the virus to reproduce. But they must be taken together with standard medications — ribavirin pills plus injections of interferon-alpha — that are thought to boost the immune system.
According to studies presented at a recent medical meeting, 67% to 75% of patients given treatment including either boceprevir or telaprevir, respectively, had what doctors call a cure. That's defined as no sign of the hepatitis C virus six months after their last dose. Importantly, only about a quarter of black patients are helped by standard therapy but adding one of the new drugs more than doubled their cure rates.

People getting their first-ever treatment did best, but the studies also found improvements in hard-to-treat patients like Graham.

"The fourth time did the trick," says Graham, who volunteered for an early telaprevir study and says he's been hepatitis-free for three years.

The new drugs do add side effects to the flulike symptoms and other complaints of existing treatment. Telaprevir's main risk is a rash that is sometimes severe, and boceprevir's is anemia.
"The future looks very bright beyond telaprevir and boceprevir," notes Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles, who has studied both drugs and consults for several companies. He points to additional drugs in earlier-stage testing that promise to target more types of hepatitis C and perhaps eventually allow for pill-only, interferon-free treatment.
Manufacturers haven't said how much the new drugs will add to the price of treatment that already can cost $30,000, albeit far cheaper than a liver transplant.
A stickier issue: Not everyone suffers serious liver damage and it's hard to predict who will, raising questions about exactly who needs treatment even as drug companies help push for more screening."

That's a concern, acknowledges Jeff Levi of the nonprofit Trust for America's Health, also a screening proponent. But when to treat is a doctor-patient decision, and "anyone with chronic infection you do want to be monitoring so you can intervene at the right moment," he adds.
Plus, people with hepatitis C should avoid alcohol and consider other liver-protection steps — and know how to avoid infecting others, he stresses.
Stay tuned: The CDC has begun a study at four hospitals — in New York, Detroit, Houston and Birmingham, Ala. — to see if a one-time hepatitis C test for baby boomers makes sense. Among the boomers, black men in their 50s are at particular risk. CDC plans new guidelines next year.
Meanwhile, "start that conversation" at a routine doctor's visit by asking about hepatitis C risks and testing, Ward advises boomers.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Prevention of hepatitis infections in patients with inflammatory bowel disease
The latest issue of Alimentary Pharmacology & Therapeutics investigates the prevention and management of hepatitis B and C infections in patients with inflammatory bowel disease.

Viral hepatitis is a very common infection.
The prevalence of both hepatitis B virus and hepatitis C virus infection in IBD patients is now similar to that of the general population.
All IBD patients should be screened for HBV markers at diagnosis.

Dr Gisbert and colleagues from Spain reviewed the prevention and management of hepatitis B virus and hepatitis C virus infection in inflammatory bowel disease (IBD).
The team performed bibliographical searches in MEDLINE up to 2010.

The research team found that liver dysfunction in IBD patients treated with immunosuppressants is more frequent and severe in hepatitis B than in hepatitis C carriers, and is associated with combined immunosuppression.

In patients receiving anti-TNF drugs, hepatitis B virus reactivation is common unless anti-viral prophylaxis is administered.

Hepatitis B surface antigen-positive patients should receive anti-viral prophylaxis before starting immunosuppressants.

The research team found that, as interferon might worsen underlying IBD, nucleoside/nucleotide analogues are preferred for anti-viral prophylaxis in patients with hepatitis B.

IBD patients should be vaccinated against hepatitis B virus at diagnosis.
The researchers noted that the response rate to hepatitis B virus vaccination is low, mainly in those receiving anti-tumor necrosis factor therapy.

The serological response to hepatitis B virus vaccine should be confirmed, and patients with an inadequate response should receive a second full series of vaccine.

Peginterferon for hepatitis C virus infection is as effective and safe as in non-IBD patients.
Dr Gisbert's team concudes, "The present manuscript poses a series of questions on the prevention and management of HBV/HCV infection in IBD, and attempts to answer them using scientific evidence in order to provide practical conclusions for the clinician."
Aliment Pharmacol Ther 2011; 33: 619–63318 February 2011

Boosting Immune System Could Help Fight HIV
by Gopalan T on February 20, 2011 at 7:58 AM

Australian scientists have successfully cleared a HIV-like infection in mice by boosting the function of cells vital to the immune response. A team led by Dr Marc Pellegrini from the Walter and Eliza Hall Institute showed that a cell signaling hormone called interleukin-7 (IL-7) reinvigorates the immune response to chronic viral infection, allowing the host to completely clear virus. Their findings have been released the journal Cell.

Dr Pellegrini, from the institute’s Infection and Immunity division, said the finding could lead to a cure for chronic viral infections such as HIV, hepatitis B and C, and bacterial infections such as tuberculosis, which are significant economic and global health burdens. Current approaches to curing chronic infections tend to focus on generating a long-lived immune response to a specific disease.

Dr Pellegrini, working with colleagues Mr Simon Preston and Mr Jesse Toe, and collaborators Professors Pamela Ohashi and Tak Mak from the Ontario Cancer Institute, argues that long-lived immune responses to chronic diseases are not always effective, and has instead concentrated on how the immune response can be manipulated to better fight infection.

“Viruses such as HIV and hepatitis B and C overwhelm the immune system, leading to establishment of chronic infections that are lifelong and incurable,” Dr Pellegrini said. “Despite tremendous efforts, long-lived immune responses for some of these viruses are ineffective, because the body is so overrun by virus that the immune system, in particular T cells, just give up trying to battle the infection. Some people have coined the phrase ‘immune exhaustion’ to explain the phenomenon. Our approach is to discover some of the mechanisms that cause this immune exhaustion, and manipulate host genes to see if we can boost the natural immune response in order to beat infection.”

Healthy You
André Picard(The Globe and Mail, Toronto, February 16, 2011)"
Much is said and written about the global trade in illegal drugs such as cocaine and heroin…But rarely do we hear about an equally shady activity that almost rivals 'recreational' drugs in size, scope and impact -- the counterfeiting of medicines. ..It’s a deadly business, one that kills an estimated 700,000 people a year. That’s because a lot of medicines…are fakes."Free registration required.
Study: Doctors Order Tests Out of Fear of Lawsuits
February 17, 2011
SAN DIEGO (AP) -- CT scans, MRIs and other pricey imaging tests are often more for the doctor's benefit than the patient's, new research confirms.

Roughly one-fifth of tests that bone and joint specialists order are because a doctor fears being sued, not because the patient needs them, a first-of-its-kind study in Pennsylvania suggests.

The study comes a day after President Barack Obama began a push to overhaul state medical malpractice laws as a way to reduce unnecessary tests that drive up health care costs.

"This study is a glimpse behind the curtain of what's happening in a doctor's mind," said its leader, Dr. John Flynn of Children's Hospital of Philadelphia. If doctors sense you might second-guess them or cause trouble, "you could potentially be risking more tests being done."

Results were reported Wednesday at an American Academy of Orthopedic Surgeons conference in California.

Patients expect the highest level of care and think this means the most advanced technology, Flynn said. Many patients feel better when a doctor orders lots of tests -- until they get the bill.

Besides hurting your wallet and adding to health care costs, unnecessary tests can expose people to radiation that accumulates over a lifetime and can raise the risk of cancer. Ordinary X-rays are rarely a concern, but an MRI, or magnetic resonance imaging scan, can cost $1,000 or more. And super-sharp X-rays called CT scans involve relatively large radiation doses.

Yet doctors often order tests they don't really think a patient needs because they fear being sued if the diagnosis was wrong or they miss detecting a problem.

Previous studies of how often this happens have relied on doctor surveys. This is the first one to enlist doctors in advance to track their decisions over time.

It involved 72 orthopedic surgeons throughout Pennsylvania who tracked tests they ordered on 2,068 patients, mostly adults, in ordinary office visits, emergency rooms and other settings. Doctors checked a box saying a test was either required for clinical care or done "for defensive reasons."

Defensive imaging accounted for 20 percent of total tests -- 11 percent of X-rays, 38 percent of MRIs, 33 percent of CT scans, 57 percent of bone scans and 53 percent of ultrasounds.

Defensive medicine also accounted for 35 percent of costs, nearly all of it from MRIs.

One example: a torn meniscus, a knee cartilage injury that is a leading reason for knee surgery. Studies have shown that a doctor's judgment based on symptoms and an exam is even better than an MRI to diagnose the condition. Yet patients hardly ever go to surgery without having the imaging test, Flynn said.

Surprisingly, the study found that newer doctors were less likely to be defensive.

"That's counterintuitive," Flynn said. "You would expect when you're new in practice, not as trustful of your clinical judgment, you'd order more."

Doctors who have been sued in the last five years were more likely to order tests defensively, said Robert Miller, a Temple University medical student who helped lead the study and presented the results at the conference. The authors said similar studies are needed on defensive imaging in other specialties.

Dr. Lawrence Wells, a Philadelphia surgeon who participated in the study, said doctors learn to develop "a radar" for problem patients.

"It's disheartening" to be sued, he said. "Someone's accusing you of a bad outcome or a wrong," and that can affect how a doctor behaves the next time he sees a similar case.

Patients need to trust their doctor's judgment on what is needed, Wells said.

On Tuesday, Obama made a budget proposal that includes money to help states rewrite malpractice laws. Possible measures include caps on awards. The administration also has proposed health courts where specially trained judges rather than juries would decide such cases.

Questions to ask about a medical test:

-Is it truly needed? How will it change my care?

-Have you or another doctor done this test on me before?

-Does the test involve much radiation and is there an alternative that does not?

-How many images are needed?

-Do you have a financial stake in the machines that will be used?

by Michele R. Berman, MD

Earlier this month, the legendary Playboy mansion was the site of a fundraiser as part of a yearly event called the DOMAINfest Global Conference.A few days later, dozens of guests from the party had become ill, and the Los Angeles Times reports that L.A. County health officials have been called in to investigate.......

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