Thursday, February 10, 2011

Hepatitis C News; FOLFOX4 Prolongs Survival in Advanced HCC

NY State Health Department, Nassau Hospital Notify Patients of Possible Hepatitis C Exposure
Four patients treated at South Nassau Communities Hospital Pain Management Center will receive letters this week advising them to be tested for hepatitis C, hepatitis B and human immunodeficiency virus (HIV) infections.
The notification is based on an investigation by the New York State Department of Health with the full cooperation of South Nassau Communities Hospital. The investigation was initiated after a patient treated at the Pain Management Center in May 2010 developed a new hepatitis C infection.
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The investigation yielded no evidence linking the patient's infection to the Pain Management Center; however, investigators found that a patient who was treated earlier on the same day had chronic hepatitis C infection. It could not be determined whether the infection was transmitted from one patient to the other or whether the finding was a coincidence. It is estimated that about 1.3 percent of the U.S. population is infected with hepatitis C.

While the chance is low that any additional patients are at risk of infection, four patients treated that same day are being notified out of an abundance of caution. It is standard procedure to recommend testing for other infections that are spread in similar ways, such as hepatitis B and HIV, when a possible transmission of hepatitis C is identified. The New York State Department of Health provides public notification when any patients are notified as a result of an investigation.

Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of persons who have this disease. Hepatitis C is usually spread by contact with the blood of an infected person, such as by sharing needles or other injection equipment.
Patients with questions can call the state Department of Health toll-free at 1-888-636-1551 during regular business hours.

MIAMI—The Veterans Administration announced this week that it discovered 12 more South Florida veterans who were not previously notified that they might have been exposed to improperly cleaned equipment during colonoscopies at the Miami VA hospital as far back as 2004. This is the third round of notices of this nature. At this point, almost 2,500 veterans have been told they may have been exposed to illness.
According a report today by the Miami Herald, the VA continues to blame the failure to notify everyone at once on the way the hospital handles medical records.
Earlier in the scandal, “Tests found three local veterans were HIV positive, seven had hepatitis C and one had hepatitis B. VA officials said there was no way to know whether the vets acquired the infections from the colonoscopies,” according to the Miami Herald. To read more of the Herald's story, click here.
Related headlines:
VA Report: VA Centers Failed to Sterilize Properly
Miami VA Hospital Faces Another Colonoscopy Scandal
Miami Endoscopy Patient to Sue VA for HIV Infection
VA Offering Infected Vets 2 Settlement Options

10. February 2011 06:26
Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

HUDDINGE, Sweden, February 10, 2011 /PRNewswire/ --
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.

TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.

The phase 1a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.

Liver Cancer

SAN FRANCISCO – The FOLFOX4 regimen improved survival of patients with advanced hepatocellular carcinoma in a phase III trial conducted among nearly 400 patients in Asia and Southeast Asia.

Updated results showed that patients treated with FOLFOX4 had a 21% reduction in the risk of death, compared with their counterparts who were treated with doxorubicin. "The FOLFOX4 regimen [has] emerged as the first chemotherapy regimen to demonstrate prolonged survival in this population," commented lead investigator Dr. Sumitra Thongprasert, who reported the findings at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

The 6.4-month median survival with FOLFOX4 was similar to the 6.5-month median survival seen with single-agent sorafenib (Nexavar) – the reference standard for HCC treatment – in a previous trial in a similar population (Lancet. Oncol. 2009;10:25-34), noted Dr. Thongprasert, an oncologist at the Chiang Mai (Thailand) University.

And the combination of sorafenib (a kinase inhibitor) with doxorubicin chemotherapy has shown greater benefit than doxorubicin alone (JAMA 2010;304:2154-60). Therefore, "our group concludes that further investigation of the combination of the FOLFOX4 regimen and sorafenib is warranted," she said.

Patients from mainland China, Taiwan, Korea, and Thailand were eligible for the trial if they had advanced and/or unresectable HCC and were cancer-treatment naive (except for surgery) or had experienced progression after previous adjuvant therapy completed at least a year earlier.
The patients were assigned in a 1:1 ratio to open-label treatment with the FOLFOX4 regimen (oxaliplatin plus 5-fluorouracil and leucovorin) given every 2 weeks, or with single-agent doxorubicin (50 mg/m2 IV) given every 3 weeks. Crossover was not permitted.
Doxorubicin was selected as the comparator agent "because this is a drug considered efficacious and [it] was a commonly used regimen in the region during the time of the study, which was 2006-2007, before the approval of sorafenib," Dr. Thongprasert explained.

The 371 patients were 49 years old on average, and 89% were men. Most (91%) had hepatitis B virus infection, and slightly more than half (54%) had cirrhosis. The majority had metastases (58%), Child-Pugh class A disease (88%), and a Barcelona Clinic Liver Cancer stage of C (80%).
The study’s prespecified final analysis, conducted after 266 deaths in the intent-to-treat population, showed a trend toward better median overall survival (the primary end point) among patients treated with FOLFOX4, compared with doxorubicin (6.40 vs. 4.97 months; hazard ratio, 0.79; P = .07). The benefit was significant in a post hoc analysis conducted after additional follow-up and 305 deaths (HR, 0.79; P = .04).

The FOLFOX4 group also fared better than the doxorubicin group in terms of median progression-free survival (2.93 vs. 1.77 months; P = .0002), response rate (8% vs. 3%; P = .02), and disease control rate (52% vs. 32%; P less than .0001).

The findings were similar in analyses that were restricted to the 279 Chinese patients, said Dr. Thongprasert. Overall and progression-free survival benefits were also seen in subgroups stratified by disease and patient characteristics as well as previous receipt of chemotherapy, except that there was little to no benefit of FOLFOX4 among patients with poorly differentiated (grade 3 or 4) tumors.

Patients in the FOLFOX4 group were more likely to experience grade 3 or higher adverse events (56% vs. 45%; P = .05). But rates of treatment discontinuation, serious adverse events, and death did not differ significantly.

Tolerability of FOLFOX4 was generally similar in patients with Child-Pugh class A and class B disease, according to Dr. Thongprasert. "However, the number of patients with Child[-Pugh class] B is quite small," she cautioned.

The trial, known as the EACH study, was supported by Sanofi-Aventis, manufacturer of oxaliplatin (Eloxatin), which is a component of the FOLFOX4 regimen. Dr. Thongprasert reported being a consultant to and receiving research funding from Sanofi-Aventis.

Two University of Louisville School of Medicine professors recently authored reference works in the field of oncology; one focusing on the use of radiation treatment for childhood cancers and the other on hepatocellular carcinoma, or liver cancer...

Healthy You

A new study from the UK suggests that women who drink coffee may perform better in stressful situations than those on decaffeinated beverages. For men, it's the opposite.

The caffeine in coffee is known to fight drowsiness and act as a stimulant, and previous research has suggested it might also protect against , , Alzheimer’s and inflammatory conditions such as gout.

Psychologist Dr Lindsay St Claire and colleagues from Bristol University decided to find out the effects of caffeinated coffee in high stress situations such as in the work place. They divided 64 coffee-drinking volunteers into pairs of the same-sex and similar ages. They then gave them a number of tasks to complete such as memory tests, puzzles, and negotiating tasks. To increase the pressure they told the pairs they would be making a public presentation on their results.

The pairs were then given decaffeinated coffee to drink, but half of them had caffeine added to their drinks. Their performance was then monitored throughout the experiments.
The aims of the experiments were to see if caffeine consumption could contribute to the experience of stress and affect performance. Since and are known to cope with stress differently, and this is thought to be because men tend toward a “fight or flight” response and women prefer a "tend or befriend" response, the experiment also aimed to explore women’s coping to see if this is a valid theory.

The results, published in the Journal of Applied Social Psychology showed that pairs of women drinking caffeinated coffee completed puzzles 100 seconds faster than those on decaffeinated coffee, while men on caffeine completed the puzzles 20 seconds slower than those on the decaffeinated. Men drinking caffeinated coffee were “greatly impaired” in the memory tasks.
The researchers pointed out that many high-level meetings are male-dominated and concluded that unlimited supplies of coffee at such meetings might not be a good idea, at least for the men attending them. They said men might even “unintentionally sabotage the partnerships forged to solve stressful issues.”

The current research on the effects of is one of several studies being carried out by Dr St Claire and her colleagues, who are looking at the effects of stress on people as individuals, in pairs and in groups. The first two studies indicated men were more vulnerable to stress than women, but men fared better in groups, even though there was a net benefit to women of working in teams. Men who consumed caffeinated tended to perform better alone than in teams.

Crucell said Oct. 28 it stopped making Quinvaxem, which protects against five childhood diseases, and the Hepavax-Gene shot for hepatitis B because of contamination caused by power failures at the Shingal plant. Crucell, based in Leiden, Netherlands, has taken steps to improve oversight and maintenance, WHO said.
“WHO is confident that Crucell is operating according to good manufacturing practices,” the agency said.

Quinvaxem protects children against diphtheria, tetanus, whooping cough, hepatitis B and the pathogen that causes meningitis and pneumonia. The shutdown of the Shingal plant contributed to a worldwide shortage of so-called pentavalent vaccines such as Quinvaxem, the WHO said last month.
A Confusing Relationship: Chronic Hep C and Cardiovascular Health
Find out why a common indicator of cardiovascular disease is inaccurate for those with chronic Hepatitis C infection. February is American Heart Month.
Pandemrix-narcolepsy link
Finland’s National Institute for Health and Welfare (THL) suggests that the link between swine flu vaccine Pandemrix and narcolepsy – a sleeping disorder that leads to extreme fatigue and can cause patients to fall asleep at unexpected times – is high.
Pandemrix was first approved for use by the European Medicines Agency (EMA) in 2009 during the H1N1 flu pandemic and was given to over 31 million people. Following concerns about the link to narcolepsy, the EMA carried out a review, but found no evidence to the fact.
Feb 09 2011
LOS ANGELES -- Drinking diet soda -- but not regular soda -- was associated with a greater risk of stroke, MI, or vascular death in an older, multiethnic cohort, researchers found.
Individuals who reported drinking diet soda every day were 48% more likely to have a vascular event through more than nine years of follow-up (RR 1.48, 95% CI 1.3 to 2.12), according to Hannah Gardener, ScD, of the University of Miami in Florida.

Vivacta Limited, the medical diagnostics company with a revolutionary system for point-of-care testing, announces it has initiated development of a new rapid diagnostic test for measuring Vitamin D...

The dietary concerns of too much fructose is well documented. High-fructose corn syrup has become the sweetener most commonly added to processed foods. Many dietary experts believe this increase directly correlates to the...


February 8, 2011 — The US Food and Drug Administration (FDA) has released its latest list of drugs to monitor based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS).The quarterly watch list consists of 13 medications that treat a wide range of conditions, including cough, angina, diabetes, cancer, and bipolar disorder.The agency is studying the 13 drugs to determine whether they are causally linked to the possible risks reported through AERS from July 1, 2010, through September 30, 2010. In the meantime, the FDA considers them pharmacologically innocent until proven guilty. Physicians should not stop prescribing these drugs, therefore, nor should patients stop taking them, according to the agency.

Off The Cuff

Doctor and Patient
When Patients Share Their Stories, Health May Improve
Published: February 10, 2011

A gifted artist in his early 60s, the patient was a liver transplant candidate who learned he had hepatitis B some 20 years earlier. Despite the worsening fatigue that accompanied his liver failure, he threw himself into preparing for his transplant. He read everything he could about the procedure and the postoperative care, drilled doctors with endless questions and continued to drag himself to the gym each day in the hopes of being better prepared to withstand the rigors of the operation.

According to legend, academic researchers are good at discovering underlying mechanisms and pathways of disease, but less so at applied research for discovering drugs that can treat disease. Now, though, a new study in the New England Journal of Medicine debunks this myth - public sector research institutions were involved in developing more than 20 percent of new, innovative drugs approved between 1990 and 2007.

A few other nuggets: Overall, the researchers identified 102 new molecular entities 36 biologic drugs and 15 vaccines for a total of 153 drugs that received 206 new-drug or biologics license applications during the past 40 years. Hematology, oncology and infectious disease accounted for 76, or roughly half of the total. As the researchers note, the disease categories are “very different from the priorities of the pharmaceutical industry.” Meanwhile, 75 PSRIs discovered or co-discovered at least one product, with the National Institutes of Health taking first place with 22 products (read the complete study here).
In Case You Missed It;


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